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BigScience Biomedical Datasets 111

[ { "id": "NCT00730301_exc_text", "type": "exclusion", "text": [ "Prior endobronchial treatment for emphysema \nPleural or interstitial disease that precludes surgery. \nPrior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy. \nClinically significant bronchiectasis \nPulmonary nodule requiring surgery \nHistory of recurrent respiratory infections (> 3 hospitalization in the last year) \nClinically significant (> 4 Tablespoons per day) sputum production \nFever, elevated white cell count, or other evidence of active infection \nDysrhythmia that might pose a risk during exercise or training \nCongestive heart failure within 6 mo and LVEF < 45% \nEvidence or history of Cor Pulmonale \nResting bradycardia (< 50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT \nHistory of exercise-related syncope \nMI within 6 mo and LVEF < 45% \nEvidence of systemic disease or neoplasia expected to compromise survival during 5-yr period \nAny disease or condition that interferes with completion of initial or follow-up assessments \nPatient is currently enrolled in another clinical trial \nPatient is unable to complete 3 minutes of unloaded peddling on cycle ergometer \nAlpha-1-Antitrypsin Deficiency \n \n" ], "offsets": [ [ 0, 1179 ] ] } ]

[ { "id": "NCT00730301_exc_T1", "type": "Procedure", "text": [ "endobronchial treatment" ], "offsets": [ [ 6, 29 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T2", "type": "Condition", "text": [ "emphysema" ], "offsets": [ [ 34, 43 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T3", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T4", "type": "Condition", "text": [ "Pleural", "disease" ], "offsets": [ [ 45, 52 ], [ 69, 76 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T5", "type": "Condition", "text": [ "interstitial disease" ], "offsets": [ [ 56, 76 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T6", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 92, 99 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T7", "type": "Scope", "text": [ "Pleural or interstitial disease" ], "offsets": [ [ 45, 76 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T8", "type": "Negation", "text": [ "precludes" ], "offsets": [ [ 82, 91 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T9", "type": "Qualifier", "text": [ "precludes surgery" ], "offsets": [ [ 82, 99 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T10", "type": "Procedure", "text": [ "lung transplant" ], "offsets": [ [ 108, 123 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T11", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 102, 107 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T12", "type": "Procedure", "text": [ "LVRS" ], "offsets": [ [ 125, 129 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T13", "type": "Procedure", "text": [ "median sternotomy" ], "offsets": [ [ 131, 148 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T14", "type": "Procedure", "text": [ "bullectomy" ], "offsets": [ [ 150, 160 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T15", "type": "Procedure", "text": [ "lobectomy" ], "offsets": [ [ 164, 173 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T16", "type": "Scope", "text": [ "lung transplant, LVRS, median sternotomy, bullectomy or lobectomy." ], "offsets": [ [ 108, 174 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T17", "type": "Condition", "text": [ "bronchiectasis" ], "offsets": [ [ 199, 213 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T18", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 176, 198 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T19", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 242, 249 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T20", "type": "Condition", "text": [ "Pulmonary nodule" ], "offsets": [ [ 215, 231 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T21", "type": "Condition", "text": [ "respiratory infections" ], "offsets": [ [ 272, 294 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T22", "type": "Multiplier", "text": [ "recurrent" ], "offsets": [ [ 262, 271 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T23", "type": "Observation", "text": [ "History" ], "offsets": [ [ 251, 258 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T24", "type": "Multiplier", "text": [ "> 3", "in the last year" ], "offsets": [ [ 296, 299 ], [ 316, 332 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T25", "type": "Procedure", "text": [ "hospitalization" ], "offsets": [ [ 300, 315 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T26", "type": "Scope", "text": [ "> 3 hospitalization in the last year" ], "offsets": [ [ 296, 332 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T27", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 335, 357 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T28", "type": "Multiplier", "text": [ "> 4 Tablespoons per day" ], "offsets": [ [ 359, 382 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T29", "type": "Observation", "text": [ "sputum production" ], "offsets": [ [ 384, 401 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T30", "type": "Condition", "text": [ "Fever" ], "offsets": [ [ 403, 408 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T31", "type": "Measurement", "text": [ "white cell count" ], "offsets": [ [ 419, 435 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T32", "type": "Value", "text": [ "elevated" ], "offsets": [ [ 410, 418 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T33", "type": "Condition", "text": [ "active infection" ], "offsets": [ [ 458, 474 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T34", "type": "Mood", "text": [ "evidence" ], "offsets": [ [ 446, 454 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T35", "type": "Condition", "text": [ "Dysrhythmia" ], "offsets": [ [ 476, 487 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T36", "type": "Condition", "text": [ "pose a risk" ], "offsets": [ [ 499, 510 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T37", "type": "Temporal", "text": [ "during exercise" ], "offsets": [ [ 511, 526 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T38", "type": "Reference_point", "text": [ "exercise" ], "offsets": [ [ 518, 526 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T39", "type": "Temporal", "text": [ "during", "training" ], "offsets": [ [ 511, 517 ], [ 530, 538 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T40", "type": "Reference_point", "text": [ "training" ], "offsets": [ [ 530, 538 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T41", "type": "Scope", "text": [ "during exercise or training" ], "offsets": [ [ 511, 538 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T42", "type": "Condition", "text": [ "Congestive heart failure" ], "offsets": [ [ 540, 564 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T43", "type": "Temporal", "text": [ "within 6 mo" ], "offsets": [ [ 565, 576 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T44", "type": "Measurement", "text": [ "LVEF" ], "offsets": [ [ 581, 585 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T45", "type": "Value", "text": [ "< 45%" ], "offsets": [ [ 586, 591 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T46", "type": "Condition", "text": [ "Cor Pulmonale" ], "offsets": [ [ 616, 629 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T47", "type": "Mood", "text": [ "Evidence" ], "offsets": [ [ 593, 601 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T48", "type": "Observation", "text": [ "history" ], "offsets": [ [ 605, 612 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T49", "type": "Scope", "text": [ "Evidence or history" ], "offsets": [ [ 593, 612 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T50", "type": "Condition", "text": [ "Resting bradycardia" ], "offsets": [ [ 631, 650 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T51", "type": "Value", "text": [ "< 50 beats/min" ], "offsets": [ [ 652, 666 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T52", "type": "Condition", "text": [ "multifocal PVCs" ], "offsets": [ [ 678, 693 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T53", "type": "Multiplier", "text": [ "frequent" ], "offsets": [ [ 669, 677 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T54", "type": "Condition", "text": [ "complex ventricular arrhythmia" ], "offsets": [ [ 695, 725 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T55", "type": "Condition", "text": [ "sustained SVT" ], "offsets": [ [ 727, 740 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T56", "type": "Condition", "text": [ "syncope" ], "offsets": [ [ 770, 777 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T57", "type": "Qualifier", "text": [ "exercise-related" ], "offsets": [ [ 753, 769 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T58", "type": "Observation", "text": [ "History" ], "offsets": [ [ 742, 749 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T59", "type": "Condition", "text": [ "MI" ], "offsets": [ [ 779, 781 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T60", "type": "Temporal", "text": [ "within 6 mo" ], "offsets": [ [ 782, 793 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T61", "type": "Measurement", "text": [ "LVEF" ], "offsets": [ [ 798, 802 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T62", "type": "Value", "text": [ "< 45%" ], "offsets": [ [ 803, 808 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T67", "type": "Condition", "text": [ "Alpha-1-Antitrypsin Deficiency" ], "offsets": [ [ 1136, 1166 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T63", "type": "Condition", "text": [ "systemic disease" ], "offsets": [ [ 822, 838 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T68", "type": "Condition", "text": [ "neoplasia" ], "offsets": [ [ 842, 851 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T69", "type": "Qualifier", "text": [ "expected to compromise survival" ], "offsets": [ [ 852, 883 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T70", "type": "Scope", "text": [ "systemic disease or neoplasia" ], "offsets": [ [ 822, 851 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T71", "type": "Temporal", "text": [ "during 5-yr period" ], "offsets": [ [ 884, 902 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T65", "type": "Observation", "text": [ "enrolled in another clinical trial" ], "offsets": [ [ 1019, 1053 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T66", "type": "Observation", "text": [ "unable to complete" ], "offsets": [ [ 1066, 1084 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T72", "type": "Qualifier", "text": [ "3 minutes of unloaded peddling on cycle ergometer" ], "offsets": [ [ 1085, 1134 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T64", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 908, 915 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T73", "type": "Condition", "text": [ "condition" ], "offsets": [ [ 919, 928 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T74", "type": "Qualifier", "text": [ "interferes with completion of initial or follow-up assessments" ], "offsets": [ [ 934, 996 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T75", "type": "Scope", "text": [ "disease or condition" ], "offsets": [ [ 908, 928 ] ], "normalized": [] }, { "id": "NCT00730301_exc_T76", "type": "Temporal", "text": [ "currently" ], "offsets": [ [ 1009, 1018 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00730301_exc_R2", "type": "Has_temporal", "arg1_id": "NCT00730301_exc_T1", "arg2_id": "NCT00730301_exc_T3", "normalized": [] }, { "id": "NCT00730301_exc_R3", "type": "Has_negation", "arg1_id": "NCT00730301_exc_T6", "arg2_id": "NCT00730301_exc_T8", "normalized": [] }, { "id": "NCT00730301_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT00730301_exc_T7", "arg2_id": "NCT00730301_exc_T9", "normalized": [] }, { "id": "NCT00730301_exc_R5", "type": "Has_temporal", "arg1_id": "NCT00730301_exc_T16", "arg2_id": "NCT00730301_exc_T11", "normalized": [] }, { "id": "NCT00730301_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT00730301_exc_T17", "arg2_id": "NCT00730301_exc_T18", "normalized": [] }, { "id": "NCT00730301_exc_R8", "type": "Has_multiplier", "arg1_id": "NCT00730301_exc_T21", "arg2_id": "NCT00730301_exc_T22", "normalized": [] }, { "id": "NCT00730301_exc_R9", "type": "Has_multiplier", "arg1_id": "NCT00730301_exc_T25", "arg2_id": "NCT00730301_exc_T24", "normalized": [] }, { "id": "NCT00730301_exc_R10", "type": "Has_temporal", "arg1_id": "NCT00730301_exc_T21", "arg2_id": "NCT00730301_exc_T23", "normalized": [] }, { "id": "NCT00730301_exc_R11", "type": "Subsumes", "arg1_id": "NCT00730301_exc_T21", "arg2_id": "NCT00730301_exc_T26", "normalized": [] }, { "id": "NCT00730301_exc_R13", "type": "Subsumes", "arg1_id": "NCT00730301_exc_T27", "arg2_id": "NCT00730301_exc_T28", "normalized": [] }, { "id": "NCT00730301_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT00730301_exc_T29", "arg2_id": "NCT00730301_exc_T27", "normalized": [] }, { "id": "NCT00730301_exc_R14", "type": "Has_value", "arg1_id": "NCT00730301_exc_T31", "arg2_id": "NCT00730301_exc_T32", "normalized": [] }, { "id": "NCT00730301_exc_R15", "type": "Has_mood", "arg1_id": "NCT00730301_exc_T33", "arg2_id": "NCT00730301_exc_T34", "normalized": [] }, { "id": "NCT00730301_exc_R18", "type": "Has_scope", "arg1_id": "NCT00730301_exc_T36", "arg2_id": "NCT00730301_exc_T41", "normalized": [] }, { "id": "NCT00730301_exc_R19", "type": "AND", "arg1_id": "NCT00730301_exc_T35", "arg2_id": "NCT00730301_exc_T36", "normalized": [] }, { "id": "NCT00730301_exc_R20", "type": "Has_value", "arg1_id": "NCT00730301_exc_T44", "arg2_id": "NCT00730301_exc_T45", "normalized": [] }, { "id": "NCT00730301_exc_R21", "type": "Has_temporal", "arg1_id": "NCT00730301_exc_T42", "arg2_id": "NCT00730301_exc_T43", "normalized": [] }, { "id": "NCT00730301_exc_R22", "type": "Has_scope", "arg1_id": "NCT00730301_exc_T46", "arg2_id": "NCT00730301_exc_T49", "normalized": [] }, { "id": "NCT00730301_exc_R23", "type": "Has_value", "arg1_id": "NCT00730301_exc_T50", "arg2_id": "NCT00730301_exc_T51", "normalized": [] }, { "id": "NCT00730301_exc_R24", "type": "Has_multiplier", "arg1_id": "NCT00730301_exc_T52", "arg2_id": "NCT00730301_exc_T53", "normalized": [] }, { "id": "NCT00730301_exc_R25", "type": "Has_qualifier", "arg1_id": "NCT00730301_exc_T56", "arg2_id": "NCT00730301_exc_T57", "normalized": [] }, { "id": "NCT00730301_exc_R26", "type": "Has_temporal", "arg1_id": "NCT00730301_exc_T56", "arg2_id": "NCT00730301_exc_T58", "normalized": [] }, { "id": "NCT00730301_exc_R27", "type": "Has_temporal", "arg1_id": "NCT00730301_exc_T59", "arg2_id": "NCT00730301_exc_T60", "normalized": [] }, { "id": "NCT00730301_exc_R28", "type": "Has_value", "arg1_id": "NCT00730301_exc_T61", "arg2_id": "NCT00730301_exc_T62", "normalized": [] }, { "id": "NCT00730301_exc_R29", "type": "Has_qualifier", "arg1_id": "NCT00730301_exc_T70", "arg2_id": "NCT00730301_exc_T69", "normalized": [] }, { "id": "NCT00730301_exc_R30", "type": "Has_temporal", "arg1_id": "NCT00730301_exc_T69", "arg2_id": "NCT00730301_exc_T71", "normalized": [] }, { "id": "NCT00730301_exc_R31", "type": "Has_qualifier", "arg1_id": "NCT00730301_exc_T66", "arg2_id": "NCT00730301_exc_T72", "normalized": [] }, { "id": "NCT00730301_exc_R32", "type": "Has_qualifier", "arg1_id": "NCT00730301_exc_T75", "arg2_id": "NCT00730301_exc_T74", "normalized": [] }, { "id": "NCT00730301_exc_R33", "type": "Has_temporal", "arg1_id": "NCT00730301_exc_T65", "arg2_id": "NCT00730301_exc_T76", "normalized": [] } ]

[ { "id": "NCT00730301_inc_text", "type": "inclusion", "text": [ "Patient diagnosed by HRCT Core Lab with eligible heterogeneous disease distribution and at least one complete oblique fissure. \nAge from 40 to 75 years \nBMI < 32 kg/m2 \nFEV1 < 40% of predicted value, FEV1/FVC < 70% \nTLC > 120% predicted, RV > 150% predicted. \nStable with < 20 mg prednisone (or equivalent) qd \nPaCO2 < 50mm Hg \nPaO2 > 45 mm Hg on room air \n6-min walk of > 50m (without rehabilitation) or > 100m (with rehabilitation) \nNonsmoking for 4 months prior to initial interview and throughout screening \nThe patient agrees to all protocol required follow-up intervals. \nThe patient has no child bearing potential \nThe patient is willing and able to complete protocol required baseline assessments and procedures \n" ], "offsets": [ [ 0, 721 ] ] } ]

[ { "id": "NCT00730301_inc_T1", "type": "Procedure", "text": [ "HRCT Core Lab" ], "offsets": [ [ 21, 34 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T2", "type": "Condition", "text": [ "heterogeneous disease distribution" ], "offsets": [ [ 49, 83 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T3", "type": "Multiplier", "text": [ "at least one" ], "offsets": [ [ 88, 100 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T4", "type": "Condition", "text": [ "complete oblique fissure" ], "offsets": [ [ 101, 125 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T5", "type": "Person", "text": [ "Age" ], "offsets": [ [ 128, 131 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T6", "type": "Value", "text": [ "from 40 to 75 years" ], "offsets": [ [ 132, 151 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T7", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 153, 156 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T8", "type": "Value", "text": [ "< 32 kg/m2" ], "offsets": [ [ 157, 167 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T9", "type": "Measurement", "text": [ "FEV1" ], "offsets": [ [ 169, 173 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T10", "type": "Value", "text": [ "< 40% of predicted value" ], "offsets": [ [ 174, 198 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T11", "type": "Measurement", "text": [ "FEV1/FVC" ], "offsets": [ [ 200, 208 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T12", "type": "Value", "text": [ "< 70%" ], "offsets": [ [ 209, 214 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T13", "type": "Measurement", "text": [ "TLC" ], "offsets": [ [ 216, 219 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T14", "type": "Value", "text": [ "> 120% predicted" ], "offsets": [ [ 220, 236 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T15", "type": "Measurement", "text": [ "RV" ], "offsets": [ [ 238, 240 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T16", "type": "Value", "text": [ "> 150% predicted" ], "offsets": [ [ 241, 257 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T17", "type": "Multiplier", "text": [ "< 20 mg", "qd" ], "offsets": [ [ 272, 279 ], [ 307, 309 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T18", "type": "Drug", "text": [ "prednisone" ], "offsets": [ [ 280, 290 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T19", "type": "Measurement", "text": [ "PaCO2" ], "offsets": [ [ 311, 316 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T20", "type": "Value", "text": [ "< 50mm Hg" ], "offsets": [ [ 317, 326 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T21", "type": "Measurement", "text": [ "PaO2" ], "offsets": [ [ 328, 332 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T22", "type": "Value", "text": [ "> 45 mm Hg" ], "offsets": [ [ 333, 343 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T23", "type": "Qualifier", "text": [ "on room air" ], "offsets": [ [ 344, 355 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T24", "type": "Measurement", "text": [ "6-min walk" ], "offsets": [ [ 357, 367 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T25", "type": "Value", "text": [ "> 50m" ], "offsets": [ [ 371, 376 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T26", "type": "Value", "text": [ "> 100m" ], "offsets": [ [ 405, 411 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T27", "type": "Negation", "text": [ "without" ], "offsets": [ [ 378, 385 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T28", "type": "Qualifier", "text": [ "rehabilitation" ], "offsets": [ [ 386, 400 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T29", "type": "Qualifier", "text": [ "rehabilitation" ], "offsets": [ [ 418, 432 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T30", "type": "Scope", "text": [ "> 50m (without rehabilitation) or > 100m (with rehabilitation)" ], "offsets": [ [ 371, 433 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T31", "type": "Condition", "text": [ "Nonsmoking" ], "offsets": [ [ 435, 445 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T32", "type": "Temporal", "text": [ "for 4 months prior to initial interview" ], "offsets": [ [ 446, 485 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T33", "type": "Reference_point", "text": [ "initial interview" ], "offsets": [ [ 468, 485 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T34", "type": "Temporal", "text": [ "throughout screening" ], "offsets": [ [ 490, 510 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T35", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 501, 510 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T37", "type": "Condition", "text": [ "child bearing potential" ], "offsets": [ [ 597, 620 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T38", "type": "Negation", "text": [ "no" ], "offsets": [ [ 594, 596 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T39", "type": "Observation", "text": [ "willing and able to complete protocol" ], "offsets": [ [ 637, 674 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T36", "type": "Observation", "text": [ "agrees to all protocol required follow-up intervals" ], "offsets": [ [ 524, 575 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T40", "type": "Visit", "text": [ "follow-up intervals" ], "offsets": [ [ 556, 575 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T41", "type": "Procedure", "text": [ "baseline assessments" ], "offsets": [ [ 684, 704 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T42", "type": "Procedure", "text": [ "baseline", "procedures" ], "offsets": [ [ 684, 692 ], [ 709, 719 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T43", "type": "Scope", "text": [ "baseline assessments and procedures" ], "offsets": [ [ 684, 719 ] ], "normalized": [] }, { "id": "NCT00730301_inc_T44", "type": "Condition", "text": [ "Stable" ], "offsets": [ [ 260, 266 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00730301_inc_R1", "type": "Has_multiplier", "arg1_id": "NCT00730301_inc_T4", "arg2_id": "NCT00730301_inc_T3", "normalized": [] }, { "id": "NCT00730301_inc_R2", "type": "Has_value", "arg1_id": "NCT00730301_inc_T5", "arg2_id": "NCT00730301_inc_T6", "normalized": [] }, { "id": "NCT00730301_inc_R3", "type": "Has_value", "arg1_id": "NCT00730301_inc_T7", "arg2_id": "NCT00730301_inc_T8", "normalized": [] }, { "id": "NCT00730301_inc_R4", "type": "Has_value", "arg1_id": "NCT00730301_inc_T9", "arg2_id": "NCT00730301_inc_T10", "normalized": [] }, { "id": "NCT00730301_inc_R5", "type": "Has_value", "arg1_id": "NCT00730301_inc_T11", "arg2_id": "NCT00730301_inc_T12", "normalized": [] }, { "id": "NCT00730301_inc_R6", "type": "Has_value", "arg1_id": "NCT00730301_inc_T15", "arg2_id": "NCT00730301_inc_T16", "normalized": [] }, { "id": "NCT00730301_inc_R7", "type": "Has_value", "arg1_id": "NCT00730301_inc_T13", "arg2_id": "NCT00730301_inc_T14", "normalized": [] }, { "id": "NCT00730301_inc_R8", "type": "Has_multiplier", "arg1_id": "NCT00730301_inc_T18", "arg2_id": "NCT00730301_inc_T17", "normalized": [] }, { "id": "NCT00730301_inc_R9", "type": "Has_value", "arg1_id": "NCT00730301_inc_T19", "arg2_id": "NCT00730301_inc_T20", "normalized": [] }, { "id": "NCT00730301_inc_R10", "type": "Has_qualifier", "arg1_id": "NCT00730301_inc_T22", "arg2_id": "NCT00730301_inc_T23", "normalized": [] }, { "id": "NCT00730301_inc_R11", "type": "Has_value", "arg1_id": "NCT00730301_inc_T21", "arg2_id": "NCT00730301_inc_T22", "normalized": [] }, { "id": "NCT00730301_inc_R12", "type": "Has_qualifier", "arg1_id": "NCT00730301_inc_T26", "arg2_id": "NCT00730301_inc_T29", "normalized": [] }, { "id": "NCT00730301_inc_R13", "type": "Has_negation", "arg1_id": "NCT00730301_inc_T28", "arg2_id": "NCT00730301_inc_T27", "normalized": [] }, { "id": "NCT00730301_inc_R14", "type": "Has_qualifier", "arg1_id": "NCT00730301_inc_T25", "arg2_id": "NCT00730301_inc_T28", "normalized": [] }, { "id": "NCT00730301_inc_R15", "type": "Has_scope", "arg1_id": "NCT00730301_inc_T24", "arg2_id": "NCT00730301_inc_T30", "normalized": [] }, { "id": "NCT00730301_inc_R16", "type": "Has_index", "arg1_id": "NCT00730301_inc_T34", "arg2_id": "NCT00730301_inc_T35", "normalized": [] }, { "id": "NCT00730301_inc_R17", "type": "Has_temporal", "arg1_id": "NCT00730301_inc_T31", "arg2_id": "NCT00730301_inc_T32", "normalized": [] }, { "id": "NCT00730301_inc_R18", "type": "Has_temporal", "arg1_id": "NCT00730301_inc_T31", "arg2_id": "NCT00730301_inc_T34", "normalized": [] }, { "id": "NCT00730301_inc_R19", "type": "Has_negation", "arg1_id": "NCT00730301_inc_T37", "arg2_id": "NCT00730301_inc_T38", "normalized": [] }, { "id": "NCT00730301_inc_R21", "type": "Has_scope", "arg1_id": "NCT00730301_inc_T39", "arg2_id": "NCT00730301_inc_T43", "normalized": [] }, { "id": "NCT00730301_inc_R22", "type": "AND", "arg1_id": "NCT00730301_inc_T1", "arg2_id": "NCT00730301_inc_T2", "normalized": [] }, { "id": "NCT00730301_inc_R23", "type": "AND", "arg1_id": "NCT00730301_inc_T1", "arg2_id": "NCT00730301_inc_T4", "normalized": [] } ]

[ { "id": "NCT00749112_exc_text", "type": "exclusion", "text": [ "Current viral or bacterial infection. \nPositive serology for HIV, HCV, HBV. \n \n" ], "offsets": [ [ 0, 88 ] ] } ]

[ { "id": "NCT00749112_exc_T1", "type": "Condition", "text": [ "bacterial infection" ], "offsets": [ [ 17, 36 ] ], "normalized": [] }, { "id": "NCT00749112_exc_T2", "type": "Condition", "text": [ "infection", "viral" ], "offsets": [ [ 27, 36 ], [ 8, 13 ] ], "normalized": [] }, { "id": "NCT00749112_exc_T3", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT00749112_exc_T4", "type": "Scope", "text": [ "viral or bacterial infection" ], "offsets": [ [ 8, 36 ] ], "normalized": [] }, { "id": "NCT00749112_exc_T5", "type": "Measurement", "text": [ "serology for HIV" ], "offsets": [ [ 48, 64 ] ], "normalized": [] }, { "id": "NCT00749112_exc_T6", "type": "Measurement", "text": [ "serology for", "HCV" ], "offsets": [ [ 48, 60 ], [ 66, 69 ] ], "normalized": [] }, { "id": "NCT00749112_exc_T7", "type": "Measurement", "text": [ "serology for", "HBV" ], "offsets": [ [ 48, 60 ], [ 71, 74 ] ], "normalized": [] }, { "id": "NCT00749112_exc_T8", "type": "Value", "text": [ "Positive" ], "offsets": [ [ 39, 47 ] ], "normalized": [] }, { "id": "NCT00749112_exc_T9", "type": "Scope", "text": [ "serology for HIV, HCV, HBV" ], "offsets": [ [ 48, 74 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00749112_exc_R1", "type": "Has_temporal", "arg1_id": "NCT00749112_exc_T4", "arg2_id": "NCT00749112_exc_T3", "normalized": [] }, { "id": "NCT00749112_exc_R2", "type": "Has_value", "arg1_id": "NCT00749112_exc_T9", "arg2_id": "NCT00749112_exc_T8", "normalized": [] } ]

[ { "id": "NCT00749112_inc_text", "type": "inclusion", "text": [ "Age: > or = 16 years \nWeight: more than 40 Kg \nAutoimmune Hemolytic anemia with clinical and biochemical evidence of hemolysis refractory to treatment, in relapse or steroids dependant \nIdiopathic thrombocytopenic purpura with platelet counts < 50,000, refractory to treatment, in relapse or steroids dependant \n" ], "offsets": [ [ 0, 312 ] ] } ]

[ { "id": "NCT00749112_inc_T1", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T2", "type": "Value", "text": [ "> or = 16 years" ], "offsets": [ [ 5, 20 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T3", "type": "Measurement", "text": [ "Weight" ], "offsets": [ [ 22, 28 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T4", "type": "Value", "text": [ "more than 40 Kg" ], "offsets": [ [ 30, 45 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T5", "type": "Condition", "text": [ "Autoimmune Hemolytic anemia" ], "offsets": [ [ 47, 74 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T6", "type": "Mood", "text": [ "biochemical evidence" ], "offsets": [ [ 93, 113 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T7", "type": "Mood", "text": [ "evidence", "clinical" ], "offsets": [ [ 105, 113 ], [ 80, 88 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T8", "type": "Condition", "text": [ "hemolysis" ], "offsets": [ [ 117, 126 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T9", "type": "Qualifier", "text": [ "refractory to treatment" ], "offsets": [ [ 127, 150 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T10", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 141, 150 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T11", "type": "Qualifier", "text": [ "steroids dependant" ], "offsets": [ [ 166, 184 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T12", "type": "Qualifier", "text": [ "in relapse" ], "offsets": [ [ 152, 162 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T13", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 166, 174 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T14", "type": "Scope", "text": [ "in relapse or steroids dependant" ], "offsets": [ [ 152, 184 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T15", "type": "Condition", "text": [ "Idiopathic thrombocytopenic purpura" ], "offsets": [ [ 186, 221 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T16", "type": "Measurement", "text": [ "platelet counts" ], "offsets": [ [ 227, 242 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T17", "type": "Value", "text": [ "< 50,000" ], "offsets": [ [ 243, 251 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T18", "type": "Qualifier", "text": [ "refractory to treatment" ], "offsets": [ [ 253, 276 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T19", "type": "Drug", "text": [ "treatment" ], "offsets": [ [ 267, 276 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T20", "type": "Qualifier", "text": [ "in relapse" ], "offsets": [ [ 278, 288 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T21", "type": "Qualifier", "text": [ "steroids dependant" ], "offsets": [ [ 292, 310 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T22", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 292, 300 ] ], "normalized": [] }, { "id": "NCT00749112_inc_T23", "type": "Scope", "text": [ "refractory to treatment, in relapse or steroids dependant" ], "offsets": [ [ 253, 310 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00749112_inc_R1", "type": "Has_value", "arg1_id": "NCT00749112_inc_T1", "arg2_id": "NCT00749112_inc_T2", "normalized": [] }, { "id": "NCT00749112_inc_R2", "type": "Has_value", "arg1_id": "NCT00749112_inc_T3", "arg2_id": "NCT00749112_inc_T4", "normalized": [] }, { "id": "NCT00749112_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT00749112_inc_T8", "arg2_id": "NCT00749112_inc_T9", "normalized": [] }, { "id": "NCT00749112_inc_R6", "type": "Has_scope", "arg1_id": "NCT00749112_inc_T8", "arg2_id": "NCT00749112_inc_T14", "normalized": [] }, { "id": "NCT00749112_inc_R7", "type": "Has_mood", "arg1_id": "NCT00749112_inc_T8", "arg2_id": "NCT00749112_inc_T7", "normalized": [] }, { "id": "NCT00749112_inc_R8", "type": "Has_mood", "arg1_id": "NCT00749112_inc_T8", "arg2_id": "NCT00749112_inc_T6", "normalized": [] }, { "id": "NCT00749112_inc_R9", "type": "Has_value", "arg1_id": "NCT00749112_inc_T16", "arg2_id": "NCT00749112_inc_T17", "normalized": [] }, { "id": "NCT00749112_inc_R12", "type": "Has_scope", "arg1_id": "NCT00749112_inc_T15", "arg2_id": "NCT00749112_inc_T23", "normalized": [] } ]

[ { "id": "NCT00752310_exc_text", "type": "exclusion", "text": [ "No positive HIV 1 or HIV 2 test at screening \nno history of significant skin disease such as, but not limited to rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis, or urticaria \nno history of allergy to drugs such as, but not limited to, sulphonamides and penicillins \nno previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication administered in this trial \nno female subject of childbearing potential without use of effective nonhormonal birth control methods, or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period \nno positive pregnancy test or breast feeding at screening \n \n" ], "offsets": [ [ 0, 763 ] ] } ]

[ { "id": "NCT00752310_exc_T1", "type": "Value", "text": [ "positive" ], "offsets": [ [ 3, 11 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T2", "type": "Measurement", "text": [ "HIV 1", "test" ], "offsets": [ [ 12, 17 ], [ 27, 31 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T3", "type": "Measurement", "text": [ "HIV 2 test" ], "offsets": [ [ 21, 31 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T4", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 32, 44 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T5", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 35, 44 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T6", "type": "Scope", "text": [ "HIV 1 or HIV 2 test" ], "offsets": [ [ 12, 31 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T8", "type": "Condition", "text": [ "skin disease" ], "offsets": [ [ 72, 84 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T10", "type": "Observation", "text": [ "history" ], "offsets": [ [ 49, 56 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T11", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 60, 71 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T13", "type": "Condition", "text": [ "rash" ], "offsets": [ [ 113, 117 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T14", "type": "Condition", "text": [ "eruptions" ], "offsets": [ [ 121, 130 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T15", "type": "Condition", "text": [ "drug allergies" ], "offsets": [ [ 132, 146 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T16", "type": "Condition", "text": [ "food allergy" ], "offsets": [ [ 148, 160 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T17", "type": "Condition", "text": [ "dermatitis" ], "offsets": [ [ 162, 172 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T18", "type": "Condition", "text": [ "eczema" ], "offsets": [ [ 174, 180 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T19", "type": "Condition", "text": [ "psoriasis" ], "offsets": [ [ 182, 191 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T20", "type": "Condition", "text": [ "urticaria" ], "offsets": [ [ 196, 205 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T21", "type": "Scope", "text": [ "rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis, or urticaria" ], "offsets": [ [ 113, 205 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T22", "type": "Observation", "text": [ "history" ], "offsets": [ [ 210, 217 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T24", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 221, 228 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T25", "type": "Drug", "text": [ "sulphonamides" ], "offsets": [ [ 267, 280 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T26", "type": "Drug", "text": [ "penicillins" ], "offsets": [ [ 285, 296 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T27", "type": "Scope", "text": [ "sulphonamides and penicillins" ], "offsets": [ [ 267, 296 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T30", "type": "Procedure", "text": [ "pregnancy test" ], "offsets": [ [ 705, 719 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T31", "type": "Value", "text": [ "positive" ], "offsets": [ [ 696, 704 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T33", "type": "Observation", "text": [ "breast feeding" ], "offsets": [ [ 723, 737 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T34", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 738, 750 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T35", "type": "Scope", "text": [ "positive pregnancy test or breast feeding" ], "offsets": [ [ 696, 737 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T29", "type": "Temporal", "text": [ "previously" ], "offsets": [ [ 301, 311 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T36", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 325, 347 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T37", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 348, 355 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T38", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 359, 375 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T39", "type": "Drug", "text": [ "excipients of the investigational medication" ], "offsets": [ [ 390, 434 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T40", "type": "Scope", "text": [ "allergy or hypersensitivity" ], "offsets": [ [ 348, 375 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T7", "type": "Person", "text": [ "female" ], "offsets": [ [ 466, 472 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T9", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 484, 506 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T23", "type": "Negation", "text": [ "without" ], "offsets": [ [ 507, 514 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T28", "type": "Qualifier", "text": [ "effective" ], "offsets": [ [ 522, 531 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T32", "type": "Procedure", "text": [ "nonhormonal birth control" ], "offsets": [ [ 532, 557 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T41", "type": "Negation", "text": [ "not" ], "offsets": [ [ 570, 573 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T42", "type": "Mood", "text": [ "willing to continue practicing" ], "offsets": [ [ 574, 604 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T43", "type": "Procedure", "text": [ "birth control methods" ], "offsets": [ [ 611, 632 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T44", "type": "Temporal", "text": [ "for at least 30 days after the end of the treatment period" ], "offsets": [ [ 633, 691 ] ], "normalized": [] }, { "id": "NCT00752310_exc_T45", "type": "Reference_point", "text": [ "the end of the treatment period" ], "offsets": [ [ 660, 691 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00752310_exc_R2", "type": "Has_value", "arg1_id": "NCT00752310_exc_T6", "arg2_id": "NCT00752310_exc_T1", "normalized": [] }, { "id": "NCT00752310_exc_R3", "type": "Has_temporal", "arg1_id": "NCT00752310_exc_T6", "arg2_id": "NCT00752310_exc_T4", "normalized": [] }, { "id": "NCT00752310_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT00752310_exc_T8", "arg2_id": "NCT00752310_exc_T11", "normalized": [] }, { "id": "NCT00752310_exc_R6", "type": "Has_temporal", "arg1_id": "NCT00752310_exc_T8", "arg2_id": "NCT00752310_exc_T10", "normalized": [] }, { "id": "NCT00752310_exc_R8", "type": "Subsumes", "arg1_id": "NCT00752310_exc_T8", "arg2_id": "NCT00752310_exc_T21", "normalized": [] }, { "id": "NCT00752310_exc_R9", "type": "Has_scope", "arg1_id": "NCT00752310_exc_T24", "arg2_id": "NCT00752310_exc_T27", "normalized": [] }, { "id": "NCT00752310_exc_R10", "type": "Has_temporal", "arg1_id": "NCT00752310_exc_T24", "arg2_id": "NCT00752310_exc_T22", "normalized": [] }, { "id": "NCT00752310_exc_R12", "type": "Has_value", "arg1_id": "NCT00752310_exc_T30", "arg2_id": "NCT00752310_exc_T31", "normalized": [] }, { "id": "NCT00752310_exc_R14", "type": "Has_temporal", "arg1_id": "NCT00752310_exc_T35", "arg2_id": "NCT00752310_exc_T34", "normalized": [] }, { "id": "NCT00752310_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT00752310_exc_T40", "arg2_id": "NCT00752310_exc_T36", "normalized": [] }, { "id": "NCT00752310_exc_R16", "type": "AND", "arg1_id": "NCT00752310_exc_T40", "arg2_id": "NCT00752310_exc_T39", "normalized": [] }, { "id": "NCT00752310_exc_R18", "type": "Has_temporal", "arg1_id": "NCT00752310_exc_T40", "arg2_id": "NCT00752310_exc_T29", "normalized": [] }, { "id": "NCT00752310_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT00752310_exc_T32", "arg2_id": "NCT00752310_exc_T28", "normalized": [] }, { "id": "NCT00752310_exc_R7", "type": "Has_index", "arg1_id": "NCT00752310_exc_T44", "arg2_id": "NCT00752310_exc_T45", "normalized": [] }, { "id": "NCT00752310_exc_R11", "type": "Has_temporal", "arg1_id": "NCT00752310_exc_T43", "arg2_id": "NCT00752310_exc_T44", "normalized": [] }, { "id": "NCT00752310_exc_R13", "type": "Has_mood", "arg1_id": "NCT00752310_exc_T43", "arg2_id": "NCT00752310_exc_T42", "normalized": [] }, { "id": "NCT00752310_exc_R17", "type": "Has_negation", "arg1_id": "NCT00752310_exc_T42", "arg2_id": "NCT00752310_exc_T41", "normalized": [] }, { "id": "NCT00752310_exc_R19", "type": "Has_negation", "arg1_id": "NCT00752310_exc_T32", "arg2_id": "NCT00752310_exc_T23", "normalized": [] } ]

[ { "id": "NCT00752310_inc_text", "type": "inclusion", "text": [ "Non-smoking, or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection \nNormal weight as defined by a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included \nAble to comply with protocol requirements. Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram (ECG), vital signs, and the results of blood biochemistry, blood coagulation, and hematology tests and a urinalysis carried out at screening. \n" ], "offsets": [ [ 0, 643 ] ] } ]

[ { "id": "NCT00752310_inc_T1", "type": "Condition", "text": [ "smoking" ], "offsets": [ [ 4, 11 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T2", "type": "Negation", "text": [ "Non" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T3", "type": "Condition", "text": [ "smoking" ], "offsets": [ [ 16, 23 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T4", "type": "Multiplier", "text": [ "no more than 10", "per day" ], "offsets": [ [ 24, 39 ], [ 76, 83 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T5", "type": "Observation", "text": [ "cigarettes" ], "offsets": [ [ 40, 50 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T6", "type": "Observation", "text": [ "cigars" ], "offsets": [ [ 57, 63 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T7", "type": "Multiplier", "text": [ "no more than", "2", "per day" ], "offsets": [ [ 24, 36 ], [ 55, 56 ], [ 76, 83 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T8", "type": "Multiplier", "text": [ "no more than", "2", "per day" ], "offsets": [ [ 24, 36 ], [ 68, 69 ], [ 76, 83 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T9", "type": "Observation", "text": [ "pipes" ], "offsets": [ [ 70, 75 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T10", "type": "Scope", "text": [ "no more than 10 cigarettes, or 2 cigars, or 2 pipes per day" ], "offsets": [ [ 24, 83 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T11", "type": "Temporal", "text": [ "for at least 3 months prior to selection" ], "offsets": [ [ 84, 124 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T12", "type": "Reference_point", "text": [ "selection" ], "offsets": [ [ 115, 124 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T13", "type": "Measurement", "text": [ "Body Mass Index" ], "offsets": [ [ 156, 171 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T14", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 173, 176 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T15", "type": "Measurement", "text": [ "weight in kg divided by the square of height in meters" ], "offsets": [ [ 178, 232 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T16", "type": "Scope", "text": [ "BMI, weight in kg divided by the square of height in meters" ], "offsets": [ [ 173, 232 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T17", "type": "Value", "text": [ "18.0 to 30.0 kg/m2, extremes included" ], "offsets": [ [ 237, 274 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T18", "type": "Condition", "text": [ "Normal weight" ], "offsets": [ [ 126, 139 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T19", "type": "Observation", "text": [ "Able to comply with protocol requirements" ], "offsets": [ [ 276, 317 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T20", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 319, 326 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T21", "type": "Procedure", "text": [ "medical evaluation" ], "offsets": [ [ 345, 363 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T22", "type": "Negation", "text": [ "absence" ], "offsets": [ [ 381, 388 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T23", "type": "Qualifier", "text": [ "clinically relevant" ], "offsets": [ [ 396, 415 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T24", "type": "Condition", "text": [ "abnormality" ], "offsets": [ [ 416, 427 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T25", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 443, 463 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T26", "type": "Procedure", "text": [ "medical history" ], "offsets": [ [ 465, 480 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T27", "type": "Procedure", "text": [ "electrocardiogram" ], "offsets": [ [ 482, 499 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T28", "type": "Procedure", "text": [ "vital signs" ], "offsets": [ [ 507, 518 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T29", "type": "Procedure", "text": [ "ECG" ], "offsets": [ [ 501, 504 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T30", "type": "Procedure", "text": [ "blood biochemistry", "tests" ], "offsets": [ [ 539, 557 ], [ 593, 598 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T31", "type": "Procedure", "text": [ "blood coagulation", "tests" ], "offsets": [ [ 559, 576 ], [ 593, 598 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T32", "type": "Procedure", "text": [ "hematology tests" ], "offsets": [ [ 582, 598 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T33", "type": "Procedure", "text": [ "urinalysis" ], "offsets": [ [ 605, 615 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T34", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 628, 640 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T35", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 631, 640 ] ], "normalized": [] }, { "id": "NCT00752310_inc_T36", "type": "Scope", "text": [ "physical examination, medical history, electrocardiogram (ECG), vital signs, and the results of blood biochemistry, blood coagulation, and hematology tests and a urinalysis" ], "offsets": [ [ 443, 615 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00752310_inc_R1", "type": "Has_negation", "arg1_id": "NCT00752310_inc_T1", "arg2_id": "NCT00752310_inc_T2", "normalized": [] }, { "id": "NCT00752310_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT00752310_inc_T5", "arg2_id": "NCT00752310_inc_T4", "normalized": [] }, { "id": "NCT00752310_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT00752310_inc_T6", "arg2_id": "NCT00752310_inc_T7", "normalized": [] }, { "id": "NCT00752310_inc_R4", "type": "Has_multiplier", "arg1_id": "NCT00752310_inc_T9", "arg2_id": "NCT00752310_inc_T8", "normalized": [] }, { "id": "NCT00752310_inc_R5", "type": "Has_scope", "arg1_id": "NCT00752310_inc_T3", "arg2_id": "NCT00752310_inc_T10", "normalized": [] }, { "id": "NCT00752310_inc_R7", "type": "Has_temporal", "arg1_id": "NCT00752310_inc_T3", "arg2_id": "NCT00752310_inc_T11", "normalized": [] }, { "id": "NCT00752310_inc_R8", "type": "Subsumes", "arg1_id": "NCT00752310_inc_T13", "arg2_id": "NCT00752310_inc_T16", "normalized": [] }, { "id": "NCT00752310_inc_R9", "type": "Has_value", "arg1_id": "NCT00752310_inc_T13", "arg2_id": "NCT00752310_inc_T17", "normalized": [] }, { "id": "NCT00752310_inc_R10", "type": "AND", "arg1_id": "NCT00752310_inc_T18", "arg2_id": "NCT00752310_inc_T13", "normalized": [] }, { "id": "NCT00752310_inc_R11", "type": "Subsumes", "arg1_id": "NCT00752310_inc_T27", "arg2_id": "NCT00752310_inc_T29", "normalized": [] }, { "id": "NCT00752310_inc_R12", "type": "Has_index", "arg1_id": "NCT00752310_inc_T34", "arg2_id": "NCT00752310_inc_T35", "normalized": [] }, { "id": "NCT00752310_inc_R13", "type": "Has_qualifier", "arg1_id": "NCT00752310_inc_T24", "arg2_id": "NCT00752310_inc_T23", "normalized": [] }, { "id": "NCT00752310_inc_R14", "type": "Has_negation", "arg1_id": "NCT00752310_inc_T24", "arg2_id": "NCT00752310_inc_T22", "normalized": [] }, { "id": "NCT00752310_inc_R15", "type": "Has_scope", "arg1_id": "NCT00752310_inc_T21", "arg2_id": "NCT00752310_inc_T36", "normalized": [] }, { "id": "NCT00752310_inc_R16", "type": "AND", "arg1_id": "NCT00752310_inc_T21", "arg2_id": "NCT00752310_inc_T24", "normalized": [] }, { "id": "NCT00752310_inc_R17", "type": "Has_temporal", "arg1_id": "NCT00752310_inc_T21", "arg2_id": "NCT00752310_inc_T34", "normalized": [] }, { "id": "NCT00752310_inc_R18", "type": "AND", "arg1_id": "NCT00752310_inc_T21", "arg2_id": "NCT00752310_inc_T20", "normalized": [] } ]

[ { "id": "NCT00785213_exc_text", "type": "exclusion", "text": [ "Recent participation (within 28 days) in other research studies \nRecent significant blood donation or plasma donation \nPregnant or lactating \nTest positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) \nRecent (2-year) history or evidence of alcoholism or drug abuse \nHistory or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease \nSubjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study \nDrug allergies to quinine sulfate or rosiglitazone \n \n" ], "offsets": [ [ 0, 813 ] ] } ]

[ { "id": "NCT00785213_exc_T1", "type": "Temporal", "text": [ "within 28 days" ], "offsets": [ [ 22, 36 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T4", "type": "Procedure", "text": [ "blood donation" ], "offsets": [ [ 84, 98 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T5", "type": "Procedure", "text": [ "plasma donation" ], "offsets": [ [ 102, 117 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T6", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 72, 83 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T8", "type": "Temporal", "text": [ "Recent" ], "offsets": [ [ 65, 71 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T9", "type": "Scope", "text": [ "blood donation or plasma donation" ], "offsets": [ [ 84, 117 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T7", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 119, 127 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T11", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 131, 140 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T13", "type": "Value", "text": [ "positive" ], "offsets": [ [ 147, 155 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T14", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 156, 168 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T15", "type": "Measurement", "text": [ "human immunodeficiency virus (HIV)" ], "offsets": [ [ 173, 207 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T16", "type": "Measurement", "text": [ "hepatitis C virus (HCV)" ], "offsets": [ [ 249, 272 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T17", "type": "Measurement", "text": [ "hepatitis B surface antigen (HbsAg)" ], "offsets": [ [ 209, 244 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T12", "type": "Scope", "text": [ "human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)" ], "offsets": [ [ 173, 272 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T18", "type": "Condition", "text": [ "alcoholism" ], "offsets": [ [ 313, 323 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T19", "type": "Condition", "text": [ "drug abuse" ], "offsets": [ [ 327, 337 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T20", "type": "Observation", "text": [ "history" ], "offsets": [ [ 290, 297 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T21", "type": "Mood", "text": [ "evidence" ], "offsets": [ [ 301, 309 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T22", "type": "Temporal", "text": [ "Recent" ], "offsets": [ [ 274, 280 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T23", "type": "Temporal", "text": [ "2-year" ], "offsets": [ [ 282, 288 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T24", "type": "Scope", "text": [ "alcoholism or drug abuse" ], "offsets": [ [ 313, 337 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T25", "type": "Scope", "text": [ "history or evidence" ], "offsets": [ [ 290, 309 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T27", "type": "Drug", "text": [ "drugs", "known to inhibit", "cytochrome (CYP) P450 enzymes" ], "offsets": [ [ 579, 584 ], [ 599, 615 ], [ 626, 655 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T28", "type": "Drug", "text": [ "drugs", "known to", "induce cytochrome (CYP) P450 enzymes" ], "offsets": [ [ 579, 584 ], [ 599, 607 ], [ 619, 655 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T29", "type": "Drug", "text": [ "drugs", "known to inhibit", "P-glycoprotein (P-gp)" ], "offsets": [ [ 579, 584 ], [ 599, 615 ], [ 663, 684 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T30", "type": "Drug", "text": [ "drugs", "known to", "induce", "P-glycoprotein (P-gp)" ], "offsets": [ [ 579, 584 ], [ 599, 607 ], [ 619, 625 ], [ 663, 684 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T31", "type": "Temporal", "text": [ "within 28 days prior to the first dose" ], "offsets": [ [ 685, 723 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T32", "type": "Temporal", "text": [ "throughout the study" ], "offsets": [ [ 728, 748 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T33", "type": "Scope", "text": [ "drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp)" ], "offsets": [ [ 579, 684 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T34", "type": "Condition", "text": [ "allergies" ], "offsets": [ [ 755, 764 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T36", "type": "Drug", "text": [ "quinine sulfate" ], "offsets": [ [ 768, 783 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T37", "type": "Drug", "text": [ "rosiglitazone" ], "offsets": [ [ 787, 800 ] ], "normalized": [] }, { "id": "NCT00785213_exc_T35", "type": "Scope", "text": [ "quinine sulfate or rosiglitazone" ], "offsets": [ [ 768, 800 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00785213_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT00785213_exc_T9", "arg2_id": "NCT00785213_exc_T6", "normalized": [] }, { "id": "NCT00785213_exc_R2", "type": "Has_temporal", "arg1_id": "NCT00785213_exc_T9", "arg2_id": "NCT00785213_exc_T8", "normalized": [] }, { "id": "NCT00785213_exc_R3", "type": "Has_value", "arg1_id": "NCT00785213_exc_T12", "arg2_id": "NCT00785213_exc_T13", "normalized": [] }, { "id": "NCT00785213_exc_R4", "type": "Has_temporal", "arg1_id": "NCT00785213_exc_T12", "arg2_id": "NCT00785213_exc_T14", "normalized": [] }, { "id": "NCT00785213_exc_R5", "type": "Subsumes", "arg1_id": "NCT00785213_exc_T22", "arg2_id": "NCT00785213_exc_T23", "normalized": [] }, { "id": "NCT00785213_exc_R6", "type": "Has_scope", "arg1_id": "NCT00785213_exc_T24", "arg2_id": "NCT00785213_exc_T25", "normalized": [] }, { "id": "NCT00785213_exc_R7", "type": "Has_temporal", "arg1_id": "NCT00785213_exc_T24", "arg2_id": "NCT00785213_exc_T22", "normalized": [] }, { "id": "NCT00785213_exc_R8", "type": "Has_temporal", "arg1_id": "NCT00785213_exc_T33", "arg2_id": "NCT00785213_exc_T31", "normalized": [] }, { "id": "NCT00785213_exc_R9", "type": "Has_temporal", "arg1_id": "NCT00785213_exc_T33", "arg2_id": "NCT00785213_exc_T32", "normalized": [] }, { "id": "NCT00785213_exc_R10", "type": "Has_scope", "arg1_id": "NCT00785213_exc_T34", "arg2_id": "NCT00785213_exc_T35", "normalized": [] } ]

[ { "id": "NCT00785213_inc_text", "type": "inclusion", "text": [ "Healthy adults 18-45 years of age \nNon-smoking \nNon-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) \nBody mass index (BMI) less than or equal to 32 \nMedically healthy on the basis of medical history and physical examination \nHemoglobin > or = to 11.5g/dL \nCompletion of the screening process within 28 days prior to dosing \nProvision of voluntary written informed consent \n" ], "offsets": [ [ 0, 414 ] ] } ]

[ { "id": "NCT00785213_inc_T1", "type": "Value", "text": [ "18-45 years of age" ], "offsets": [ [ 15, 33 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T2", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T3", "type": "Person", "text": [ "adults" ], "offsets": [ [ 8, 14 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T4", "type": "Person", "text": [ "of age" ], "offsets": [ [ 27, 33 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T5", "type": "Condition", "text": [ "smoking" ], "offsets": [ [ 39, 46 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T6", "type": "Negation", "text": [ "Non" ], "offsets": [ [ 35, 38 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T7", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 52, 60 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T8", "type": "Negation", "text": [ "Non" ], "offsets": [ [ 48, 51 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T9", "type": "Condition", "text": [ "surgically sterile" ], "offsets": [ [ 79, 97 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T10", "type": "Procedure", "text": [ "surgically" ], "offsets": [ [ 79, 89 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T11", "type": "Condition", "text": [ "post-menopausal" ], "offsets": [ [ 62, 77 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T12", "type": "Procedure", "text": [ "contraceptive measures" ], "offsets": [ [ 117, 139 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T13", "type": "Qualifier", "text": [ "effective" ], "offsets": [ [ 107, 116 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T15", "type": "Scope", "text": [ "post-menopausal, surgically sterile or using effective contraceptive measures" ], "offsets": [ [ 62, 139 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T16", "type": "Scope", "text": [ "Non-pregnant" ], "offsets": [ [ 48, 60 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T17", "type": "Measurement", "text": [ "Body mass index (BMI)" ], "offsets": [ [ 142, 163 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T18", "type": "Value", "text": [ "less than or equal to 32" ], "offsets": [ [ 164, 188 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T19", "type": "Observation", "text": [ "medical history" ], "offsets": [ [ 224, 239 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T20", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 244, 264 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T21", "type": "Condition", "text": [ "Medically healthy" ], "offsets": [ [ 190, 207 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T22", "type": "Scope", "text": [ "medical history and physical examination" ], "offsets": [ [ 224, 264 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T23", "type": "Measurement", "text": [ "Hemoglobin" ], "offsets": [ [ 266, 276 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T24", "type": "Value", "text": [ "> or = to 11.5g/dL" ], "offsets": [ [ 277, 295 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T25", "type": "Temporal", "text": [ "within 28 days prior to dosing" ], "offsets": [ [ 333, 363 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T26", "type": "Reference_point", "text": [ "dosing" ], "offsets": [ [ 357, 363 ] ], "normalized": [] }, { "id": "NCT00785213_inc_T27", "type": "Procedure", "text": [ "screening process" ], "offsets": [ [ 315, 332 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00785213_inc_R1", "type": "Has_value", "arg1_id": "NCT00785213_inc_T4", "arg2_id": "NCT00785213_inc_T1", "normalized": [] }, { "id": "NCT00785213_inc_R2", "type": "Has_negation", "arg1_id": "NCT00785213_inc_T5", "arg2_id": "NCT00785213_inc_T6", "normalized": [] }, { "id": "NCT00785213_inc_R3", "type": "Has_negation", "arg1_id": "NCT00785213_inc_T7", "arg2_id": "NCT00785213_inc_T8", "normalized": [] }, { "id": "NCT00785213_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT00785213_inc_T12", "arg2_id": "NCT00785213_inc_T13", "normalized": [] }, { "id": "NCT00785213_inc_R6", "type": "Subsumes", "arg1_id": "NCT00785213_inc_T16", "arg2_id": "NCT00785213_inc_T15", "normalized": [] }, { "id": "NCT00785213_inc_R7", "type": "Has_value", "arg1_id": "NCT00785213_inc_T17", "arg2_id": "NCT00785213_inc_T18", "normalized": [] }, { "id": "NCT00785213_inc_R8", "type": "Has_scope", "arg1_id": "NCT00785213_inc_T21", "arg2_id": "NCT00785213_inc_T22", "normalized": [] }, { "id": "NCT00785213_inc_R9", "type": "Has_value", "arg1_id": "NCT00785213_inc_T23", "arg2_id": "NCT00785213_inc_T24", "normalized": [] }, { "id": "NCT00785213_inc_R10", "type": "Has_index", "arg1_id": "NCT00785213_inc_T25", "arg2_id": "NCT00785213_inc_T26", "normalized": [] }, { "id": "NCT00785213_inc_R11", "type": "Has_temporal", "arg1_id": "NCT00785213_inc_T27", "arg2_id": "NCT00785213_inc_T25", "normalized": [] } ]

[ { "id": "NCT00787254_exc_text", "type": "exclusion", "text": [ "Endoscopically confirmed gastric and/or duodenal ulcers on Day 1. \nEndoscopically confirmed active upper gastrointestinal hemorrhage on Day 1. \nCurrent or past history of aspirin-induced asthma or hypersensitivity to NSAIDs. \nPast or planned surgery affecting gastric acid secretion. \nClinically significant hepatic or renal disorder. \nSerious cardiac dysfunction, hypertension, or hematological disorder. \n \n" ], "offsets": [ [ 0, 418 ] ] } ]

[ { "id": "NCT00787254_exc_T1", "type": "Qualifier", "text": [ "Endoscopically confirmed" ], "offsets": [ [ 0, 24 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T2", "type": "Procedure", "text": [ "Endoscopically" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T3", "type": "Qualifier", "text": [ "Endoscopically confirmed" ], "offsets": [ [ 67, 91 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T4", "type": "Procedure", "text": [ "Endoscopically" ], "offsets": [ [ 67, 81 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T5", "type": "Condition", "text": [ "upper gastrointestinal hemorrhage" ], "offsets": [ [ 99, 132 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T6", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 92, 98 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T7", "type": "Temporal", "text": [ "on Day 1" ], "offsets": [ [ 133, 141 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T8", "type": "Reference_point", "text": [ "Day 1" ], "offsets": [ [ 136, 141 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T9", "type": "Condition", "text": [ "gastric" ], "offsets": [ [ 25, 32 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T10", "type": "Condition", "text": [ "duodenal ulcers" ], "offsets": [ [ 40, 55 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T11", "type": "Temporal", "text": [ "on Day 1" ], "offsets": [ [ 56, 64 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T12", "type": "Reference_point", "text": [ "Day 1" ], "offsets": [ [ 59, 64 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T13", "type": "Scope", "text": [ "gastric and/or duodenal ulcers" ], "offsets": [ [ 25, 55 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T14", "type": "Qualifier", "text": [ "aspirin-induced" ], "offsets": [ [ 171, 186 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T15", "type": "Drug", "text": [ "aspirin" ], "offsets": [ [ 171, 178 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T16", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 187, 193 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T17", "type": "Condition", "text": [ "hypersensitivity to NSAIDs" ], "offsets": [ [ 197, 223 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T18", "type": "Drug", "text": [ "NSAIDs" ], "offsets": [ [ 217, 223 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T19", "type": "Observation", "text": [ "past history" ], "offsets": [ [ 155, 167 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T20", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 144, 151 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T21", "type": "Scope", "text": [ "Current or past history" ], "offsets": [ [ 144, 167 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T22", "type": "Scope", "text": [ "asthma or hypersensitivity to NSAIDs" ], "offsets": [ [ 187, 223 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T23", "type": "Qualifier", "text": [ "affecting gastric acid secretion" ], "offsets": [ [ 250, 282 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T24", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 242, 249 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T25", "type": "Mood", "text": [ "planned" ], "offsets": [ [ 234, 241 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T26", "type": "Temporal", "text": [ "Past" ], "offsets": [ [ 226, 230 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T27", "type": "Scope", "text": [ "Past or planned" ], "offsets": [ [ 226, 241 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T28", "type": "Condition", "text": [ "renal disorder" ], "offsets": [ [ 319, 333 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T29", "type": "Condition", "text": [ "hepatic", "disorder" ], "offsets": [ [ 308, 315 ], [ 325, 333 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T30", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 285, 307 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T32", "type": "Scope", "text": [ "hepatic or renal disorder" ], "offsets": [ [ 308, 333 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T33", "type": "Condition", "text": [ "cardiac dysfunction" ], "offsets": [ [ 344, 363 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T34", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 365, 377 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T35", "type": "Condition", "text": [ "hematological disorder" ], "offsets": [ [ 382, 404 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T36", "type": "Qualifier", "text": [ "Serious" ], "offsets": [ [ 336, 343 ] ], "normalized": [] }, { "id": "NCT00787254_exc_T38", "type": "Scope", "text": [ "cardiac dysfunction, hypertension, or hematological disorder" ], "offsets": [ [ 344, 404 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00787254_exc_R3", "type": "Has_temporal", "arg1_id": "NCT00787254_exc_T5", "arg2_id": "NCT00787254_exc_T6", "normalized": [] }, { "id": "NCT00787254_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT00787254_exc_T13", "arg2_id": "NCT00787254_exc_T1", "normalized": [] }, { "id": "NCT00787254_exc_R7", "type": "Has_temporal", "arg1_id": "NCT00787254_exc_T13", "arg2_id": "NCT00787254_exc_T11", "normalized": [] }, { "id": "NCT00787254_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT00787254_exc_T5", "arg2_id": "NCT00787254_exc_T3", "normalized": [] }, { "id": "NCT00787254_exc_R9", "type": "Has_temporal", "arg1_id": "NCT00787254_exc_T5", "arg2_id": "NCT00787254_exc_T7", "normalized": [] }, { "id": "NCT00787254_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT00787254_exc_T16", "arg2_id": "NCT00787254_exc_T14", "normalized": [] }, { "id": "NCT00787254_exc_R13", "type": "Has_scope", "arg1_id": "NCT00787254_exc_T22", "arg2_id": "NCT00787254_exc_T21", "normalized": [] }, { "id": "NCT00787254_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT00787254_exc_T24", "arg2_id": "NCT00787254_exc_T23", "normalized": [] }, { "id": "NCT00787254_exc_R15", "type": "Has_scope", "arg1_id": "NCT00787254_exc_T24", "arg2_id": "NCT00787254_exc_T27", "normalized": [] }, { "id": "NCT00787254_exc_R16", "type": "Has_qualifier", "arg1_id": "NCT00787254_exc_T32", "arg2_id": "NCT00787254_exc_T30", "normalized": [] }, { "id": "NCT00787254_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT00787254_exc_T38", "arg2_id": "NCT00787254_exc_T36", "normalized": [] } ]

[ { "id": "NCT00787254_inc_text", "type": "inclusion", "text": [ "The patient was on nonsteroid anti-inflammatory drug (NSAID) treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started. \nThe patient was confirmed to have a history of gastric ulcer or duodenal ulcer. \n" ], "offsets": [ [ 0, 302 ] ] } ]

[ { "id": "NCT00787254_inc_T1", "type": "Drug", "text": [ "nonsteroid anti-inflammatory drug (NSAID)" ], "offsets": [ [ 19, 60 ] ], "normalized": [] }, { "id": "NCT00787254_inc_T2", "type": "Temporal", "text": [ "on the day when consent was obtained" ], "offsets": [ [ 71, 107 ] ], "normalized": [] }, { "id": "NCT00787254_inc_T3", "type": "Reference_point", "text": [ "the day when consent was obtained" ], "offsets": [ [ 74, 107 ] ], "normalized": [] }, { "id": "NCT00787254_inc_T4", "type": "Condition", "text": [ "gastric ulcer" ], "offsets": [ [ 268, 281 ] ], "normalized": [] }, { "id": "NCT00787254_inc_T5", "type": "Condition", "text": [ "duodenal ulcer" ], "offsets": [ [ 285, 299 ] ], "normalized": [] }, { "id": "NCT00787254_inc_T6", "type": "Observation", "text": [ "history" ], "offsets": [ [ 257, 264 ] ], "normalized": [] }, { "id": "NCT00787254_inc_T7", "type": "Scope", "text": [ "gastric ulcer or duodenal ulcer" ], "offsets": [ [ 268, 299 ] ], "normalized": [] }, { "id": "NCT00787254_inc_T8", "type": "Observation", "text": [ "consent" ], "offsets": [ [ 87, 94 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00787254_inc_R1", "type": "Has_index", "arg1_id": "NCT00787254_inc_T2", "arg2_id": "NCT00787254_inc_T3", "normalized": [] }, { "id": "NCT00787254_inc_R2", "type": "Has_temporal", "arg1_id": "NCT00787254_inc_T7", "arg2_id": "NCT00787254_inc_T6", "normalized": [] }, { "id": "NCT00787254_inc_R3", "type": "Has_temporal", "arg1_id": "NCT00787254_inc_T1", "arg2_id": "NCT00787254_inc_T2", "normalized": [] } ]

[ { "id": "NCT00806273_exc_text", "type": "exclusion", "text": [ "ASA 3+ \nNo current treatment plan at OHSU \nSeverely carious teeth resulting in inability to isolate for procedure \nUnable to understand or sign consent form \n \n" ], "offsets": [ [ 0, 169 ] ] } ]

[ { "id": "NCT00806273_exc_T1", "type": "Condition", "text": [ "ASA 3+" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT00806273_exc_T2", "type": "Observation", "text": [ "treatment plan" ], "offsets": [ [ 19, 33 ] ], "normalized": [] }, { "id": "NCT00806273_exc_T3", "type": "Negation", "text": [ "No" ], "offsets": [ [ 8, 10 ] ], "normalized": [] }, { "id": "NCT00806273_exc_T4", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 11, 18 ] ], "normalized": [] }, { "id": "NCT00806273_exc_T5", "type": "Visit", "text": [ "OHSU" ], "offsets": [ [ 37, 41 ] ], "normalized": [] }, { "id": "NCT00806273_exc_T6", "type": "Condition", "text": [ "carious teeth" ], "offsets": [ [ 52, 65 ] ], "normalized": [] }, { "id": "NCT00806273_exc_T7", "type": "Qualifier", "text": [ "Severely" ], "offsets": [ [ 43, 51 ] ], "normalized": [] }, { "id": "NCT00806273_exc_T8", "type": "Condition", "text": [ "inability to isolate for procedure" ], "offsets": [ [ 79, 113 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00806273_exc_R1", "type": "Has_negation", "arg1_id": "NCT00806273_exc_T2", "arg2_id": "NCT00806273_exc_T3", "normalized": [] }, { "id": "NCT00806273_exc_R2", "type": "Has_temporal", "arg1_id": "NCT00806273_exc_T2", "arg2_id": "NCT00806273_exc_T4", "normalized": [] }, { "id": "NCT00806273_exc_R3", "type": "AND", "arg1_id": "NCT00806273_exc_T2", "arg2_id": "NCT00806273_exc_T5", "normalized": [] }, { "id": "NCT00806273_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT00806273_exc_T6", "arg2_id": "NCT00806273_exc_T7", "normalized": [] } ]

[ { "id": "NCT00806273_inc_text", "type": "inclusion", "text": [ "ASA 1 \nASA 2 \nPts have current treatment plan at OHSU for extraction of some or all of remaining teeth and scheduled for delivery of a removable appliance post extraction \nTeeth used are able to be isolated with rubber dam \nUnderstand and sign consent form \n" ], "offsets": [ [ 0, 258 ] ] } ]

[ { "id": "NCT00806273_inc_T1", "type": "Condition", "text": [ "ASA 1" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT00806273_inc_T2", "type": "Condition", "text": [ "ASA 2" ], "offsets": [ [ 7, 12 ] ], "normalized": [] }, { "id": "NCT00806273_inc_T3", "type": "Observation", "text": [ "treatment plan at OHSU" ], "offsets": [ [ 31, 53 ] ], "normalized": [] }, { "id": "NCT00806273_inc_T4", "type": "Mood", "text": [ "scheduled for" ], "offsets": [ [ 107, 120 ] ], "normalized": [] } ]

[]

[]

[]

[ { "id": "NCT00806936_exc_text", "type": "exclusion", "text": [ "Known or suspected allergy to trial product(s) or related products \nSubjects who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit \nSubjects who previously enrolled in this study \nFemales of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods \nThe receipt of any investigational product within 3 months prior to this trial \n \n" ], "offsets": [ [ 0, 486 ] ] } ]

[ { "id": "NCT00806936_exc_T1", "type": "Condition", "text": [ "allergy to trial product(s)" ], "offsets": [ [ 19, 46 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T2", "type": "Condition", "text": [ "allergy", "related products" ], "offsets": [ [ 19, 26 ], [ 50, 66 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T3", "type": "Drug", "text": [ "trial product(s)" ], "offsets": [ [ 30, 46 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T4", "type": "Drug", "text": [ "related products" ], "offsets": [ [ 50, 66 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T9", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 261, 283 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T10", "type": "Person", "text": [ "Females" ], "offsets": [ [ 250, 257 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T11", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 292, 300 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T12", "type": "Condition", "text": [ "breast-feeding" ], "offsets": [ [ 302, 316 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T13", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 337, 345 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T14", "type": "Mood", "text": [ "intend to become" ], "offsets": [ [ 320, 336 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T15", "type": "Procedure", "text": [ "contraceptive methods" ], "offsets": [ [ 372, 393 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T16", "type": "Qualifier", "text": [ "adequate" ], "offsets": [ [ 363, 371 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T17", "type": "Negation", "text": [ "not" ], "offsets": [ [ 353, 356 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T19", "type": "Drug", "text": [ "investigational product" ], "offsets": [ [ 414, 437 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T20", "type": "Temporal", "text": [ "within 3 months prior to this trial" ], "offsets": [ [ 438, 473 ] ], "normalized": [] }, { "id": "NCT00806936_exc_T21", "type": "Reference_point", "text": [ "this trial" ], "offsets": [ [ 463, 473 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00806936_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT00806936_exc_T15", "arg2_id": "NCT00806936_exc_T16", "normalized": [] }, { "id": "NCT00806936_exc_R2", "type": "Has_negation", "arg1_id": "NCT00806936_exc_T16", "arg2_id": "NCT00806936_exc_T17", "normalized": [] }, { "id": "NCT00806936_exc_R3", "type": "Has_temporal", "arg1_id": "NCT00806936_exc_T19", "arg2_id": "NCT00806936_exc_T20", "normalized": [] }, { "id": "NCT00806936_exc_R5", "type": "AND", "arg1_id": "NCT00806936_exc_T1", "arg2_id": "NCT00806936_exc_T3", "normalized": [] }, { "id": "NCT00806936_exc_R6", "type": "AND", "arg1_id": "NCT00806936_exc_T2", "arg2_id": "NCT00806936_exc_T4", "normalized": [] } ]

[ { "id": "NCT00806936_inc_text", "type": "inclusion", "text": [ "After the investigator has taken the decision to use human insulin or insulin analogues to treat the subject, any type 2 diabetic previously inadequately controlled with two or more OADs is eligible for the study \nThe selection of the subjects will be at the discretion of the individual investigator \n" ], "offsets": [ [ 0, 302 ] ] } ]

[ { "id": "NCT00806936_inc_T1", "type": "Condition", "text": [ "type 2 diabetic" ], "offsets": [ [ 114, 129 ] ], "normalized": [] }, { "id": "NCT00806936_inc_T2", "type": "Qualifier", "text": [ "inadequately controlled" ], "offsets": [ [ 141, 164 ] ], "normalized": [] }, { "id": "NCT00806936_inc_T3", "type": "Temporal", "text": [ "previously" ], "offsets": [ [ 130, 140 ] ], "normalized": [] }, { "id": "NCT00806936_inc_T4", "type": "Multiplier", "text": [ "two or more" ], "offsets": [ [ 170, 181 ] ], "normalized": [] }, { "id": "NCT00806936_inc_T5", "type": "Condition", "text": [ "OADs" ], "offsets": [ [ 182, 186 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00806936_inc_R1", "type": "Has_temporal", "arg1_id": "NCT00806936_inc_T2", "arg2_id": "NCT00806936_inc_T3", "normalized": [] }, { "id": "NCT00806936_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT00806936_inc_T1", "arg2_id": "NCT00806936_inc_T2", "normalized": [] }, { "id": "NCT00806936_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT00806936_inc_T5", "arg2_id": "NCT00806936_inc_T4", "normalized": [] } ]

[ { "id": "NCT00812344_exc_text", "type": "exclusion", "text": [ "Significant illness, trauma or surgical procedures. \nClinically significant laboratory abnormalities. \nClinically significant medical history \n \n" ], "offsets": [ [ 0, 154 ] ] } ]

[ { "id": "NCT00812344_exc_T1", "type": "Condition", "text": [ "illness" ], "offsets": [ [ 12, 19 ] ], "normalized": [] }, { "id": "NCT00812344_exc_T2", "type": "Condition", "text": [ "trauma" ], "offsets": [ [ 21, 27 ] ], "normalized": [] }, { "id": "NCT00812344_exc_T3", "type": "Procedure", "text": [ "surgical procedures" ], "offsets": [ [ 31, 50 ] ], "normalized": [] }, { "id": "NCT00812344_exc_T4", "type": "Qualifier", "text": [ "Significant" ], "offsets": [ [ 0, 11 ] ], "normalized": [] }, { "id": "NCT00812344_exc_T6", "type": "Scope", "text": [ "illness, trauma or surgical procedures" ], "offsets": [ [ 12, 50 ] ], "normalized": [] }, { "id": "NCT00812344_exc_T7", "type": "Condition", "text": [ "laboratory abnormalities" ], "offsets": [ [ 76, 100 ] ], "normalized": [] }, { "id": "NCT00812344_exc_T8", "type": "Procedure", "text": [ "laboratory" ], "offsets": [ [ 76, 86 ] ], "normalized": [] }, { "id": "NCT00812344_exc_T9", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 53, 75 ] ], "normalized": [] }, { "id": "NCT00812344_exc_T11", "type": "Observation", "text": [ "medical history" ], "offsets": [ [ 126, 141 ] ], "normalized": [] }, { "id": "NCT00812344_exc_T12", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 103, 125 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00812344_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT00812344_exc_T6", "arg2_id": "NCT00812344_exc_T4", "normalized": [] }, { "id": "NCT00812344_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT00812344_exc_T7", "arg2_id": "NCT00812344_exc_T9", "normalized": [] }, { "id": "NCT00812344_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT00812344_exc_T11", "arg2_id": "NCT00812344_exc_T12", "normalized": [] } ]

[ { "id": "NCT00812344_inc_text", "type": "inclusion", "text": [ "body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive \n" ], "offsets": [ [ 0, 93 ] ] } ]

[ { "id": "NCT00812344_inc_T1", "type": "Measurement", "text": [ "body mass index (BMI)" ], "offsets": [ [ 0, 21 ] ], "normalized": [] }, { "id": "NCT00812344_inc_T2", "type": "Value", "text": [ "between 19 to 30 kg/m2" ], "offsets": [ [ 22, 44 ] ], "normalized": [] }, { "id": "NCT00812344_inc_T3", "type": "Measurement", "text": [ "body weight" ], "offsets": [ [ 49, 60 ] ], "normalized": [] }, { "id": "NCT00812344_inc_T4", "type": "Value", "text": [ "50 to 100 kg inclusive" ], "offsets": [ [ 69, 91 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00812344_inc_R1", "type": "Has_value", "arg1_id": "NCT00812344_inc_T3", "arg2_id": "NCT00812344_inc_T4", "normalized": [] }, { "id": "NCT00812344_inc_R2", "type": "Has_value", "arg1_id": "NCT00812344_inc_T1", "arg2_id": "NCT00812344_inc_T2", "normalized": [] } ]

[ { "id": "NCT00846703_exc_text", "type": "exclusion", "text": [ "No Down syndrome\nNo other major disease that prohibits study treatment (e.g., severe congenital heart disease)\nNot requiring significant therapy modification owing to study therapy associated complications\nNo complications due to other interventions\nNo one with missing data that are needed for the differential diagnosis, or for selection of the proper therapy arm\n" ], "offsets": [ [ 0, 366 ] ] } ]

[ { "id": "NCT00846703_exc_T1", "type": "Negation", "text": [ "No" ], "offsets": [ [ 0, 2 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T2", "type": "Negation", "text": [ "No" ], "offsets": [ [ 17, 19 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T3", "type": "Negation", "text": [ "Not" ], "offsets": [ [ 111, 114 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T4", "type": "Negation", "text": [ "No" ], "offsets": [ [ 206, 208 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T5", "type": "Negation", "text": [ "No" ], "offsets": [ [ 250, 252 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T6", "type": "Condition", "text": [ "Down syndrome" ], "offsets": [ [ 3, 16 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T7", "type": "Condition", "text": [ "major disease" ], "offsets": [ [ 26, 39 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T8", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 20, 25 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T9", "type": "Condition", "text": [ "congenital heart disease" ], "offsets": [ [ 85, 109 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T10", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 78, 84 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T12", "type": "Procedure", "text": [ "study therapy" ], "offsets": [ [ 167, 180 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T13", "type": "Condition", "text": [ "complications" ], "offsets": [ [ 192, 205 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T16", "type": "Procedure", "text": [ "interventions" ], "offsets": [ [ 236, 249 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T17", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 230, 235 ] ], "normalized": [] }, { "id": "NCT00846703_exc_T18", "type": "Condition", "text": [ "complications" ], "offsets": [ [ 209, 222 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00846703_exc_R1", "type": "Has_negation", "arg1_id": "NCT00846703_exc_T6", "arg2_id": "NCT00846703_exc_T1", "normalized": [] }, { "id": "NCT00846703_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT00846703_exc_T7", "arg2_id": "NCT00846703_exc_T8", "normalized": [] }, { "id": "NCT00846703_exc_R3", "type": "Has_negation", "arg1_id": "NCT00846703_exc_T7", "arg2_id": "NCT00846703_exc_T2", "normalized": [] }, { "id": "NCT00846703_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT00846703_exc_T9", "arg2_id": "NCT00846703_exc_T10", "normalized": [] }, { "id": "NCT00846703_exc_R5", "type": "Subsumes", "arg1_id": "NCT00846703_exc_T7", "arg2_id": "NCT00846703_exc_T9", "normalized": [] }, { "id": "NCT00846703_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT00846703_exc_T16", "arg2_id": "NCT00846703_exc_T17", "normalized": [] }, { "id": "NCT00846703_exc_R7", "type": "AND", "arg1_id": "NCT00846703_exc_T18", "arg2_id": "NCT00846703_exc_T16", "normalized": [] }, { "id": "NCT00846703_exc_R8", "type": "Has_negation", "arg1_id": "NCT00846703_exc_T18", "arg2_id": "NCT00846703_exc_T4", "normalized": [] } ]

[ { "id": "NCT00846703_inc_text", "type": "inclusion", "text": [ "Cytologically proven acute lymphoblastic leukemia (ALL)\nNo relapse of a previously unrecognized ALL\nPatients must meet one of the following risk criteria:\nStandard-risk (SR) group meeting all of the following criteria:\nBlasts < 1,000/µL in peripheral blood (PB) on day 8\nAged 1 to < 6 years\nInitial WBC < 20,000/µL\nM1 (5%) or M2 (= 5% to < 25%) blasts in bone marrow on day 15;\nM1 marrow on day 33.\nAged < 1 or = 6 years and/or WBC = 20,000/µL\nBlasts < 1,000/µL in PB on day 8\nM1 or M2 marrow on day 15\nM3 (= 25%) marrow on day 15 OR meets SR criteria but M3 marrow on day 15 and *M1 marrow on day 33.\nMeets IR criteria and M3 marrow on day 15 (not SR and M3 on day 15)\nBlasts = 1,000/µL in PB on day 8\nM2 or M3 marrow on day 33\nTranslocation t(9;22) [BCR/ABL+] (Philadelphia chromosome-positive) or t(4;11) [MLL/AF4+].\n" ], "offsets": [ [ 0, 820 ] ] } ]

[ { "id": "NCT00846703_inc_T1", "type": "Condition", "text": [ "acute lymphoblastic leukemia" ], "offsets": [ [ 21, 49 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T2", "type": "Condition", "text": [ "ALL" ], "offsets": [ [ 51, 54 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T3", "type": "Qualifier", "text": [ "Cytologically proven" ], "offsets": [ [ 0, 20 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T4", "type": "Condition", "text": [ "ALL" ], "offsets": [ [ 96, 99 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T5", "type": "Qualifier", "text": [ "previously unrecognized" ], "offsets": [ [ 72, 95 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T6", "type": "Negation", "text": [ "No" ], "offsets": [ [ 56, 58 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T7", "type": "Condition", "text": [ "relapse" ], "offsets": [ [ 59, 66 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T22", "type": "Measurement", "text": [ "Standard-risk" ], "offsets": [ [ 155, 168 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T23", "type": "Measurement", "text": [ "SR" ], "offsets": [ [ 170, 172 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T24", "type": "Multiplier", "text": [ "all" ], "offsets": [ [ 188, 191 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T25", "type": "Measurement", "text": [ "criteria" ], "offsets": [ [ 209, 217 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T26", "type": "Measurement", "text": [ "Blasts" ], "offsets": [ [ 219, 225 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T27", "type": "Value", "text": [ "< 1,000/µL" ], "offsets": [ [ 226, 236 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T28", "type": "Qualifier", "text": [ "peripheral blood" ], "offsets": [ [ 240, 256 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T29", "type": "Qualifier", "text": [ "PB" ], "offsets": [ [ 258, 260 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T30", "type": "Temporal", "text": [ "on day 8" ], "offsets": [ [ 262, 270 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T31", "type": "Person", "text": [ "Aged" ], "offsets": [ [ 271, 275 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T32", "type": "Value", "text": [ "1 to < 6 years" ], "offsets": [ [ 276, 290 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T33", "type": "Measurement", "text": [ "WBC" ], "offsets": [ [ 299, 302 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T34", "type": "Qualifier", "text": [ "Initial" ], "offsets": [ [ 291, 298 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T35", "type": "Value", "text": [ "< 20,000/µL" ], "offsets": [ [ 303, 314 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T36", "type": "Measurement", "text": [ " ", "in bon" ], "offsets": [ [ 322, 323 ], [ 352, 358 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T37", "type": "Measurement", "text": [ "%", "in bon" ], "offsets": [ [ 333, 334 ], [ 352, 358 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T38", "type": "Qualifier", "text": [ "bone marrow" ], "offsets": [ [ 355, 366 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T39", "type": "Value", "text": [ "(5%" ], "offsets": [ [ 318, 321 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T40", "type": "Value", "text": [ "= 5% to < 25%" ], "offsets": [ [ 330, 343 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T41", "type": "Temporal", "text": [ "on day 15" ], "offsets": [ [ 367, 376 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T42", "type": "Scope", "text": [ "M1 (5%) or M2 (= 5% to < 25%) blasts" ], "offsets": [ [ 315, 351 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T43", "type": "Condition", "text": [ "M1 marrow" ], "offsets": [ [ 378, 387 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T44", "type": "Temporal", "text": [ "on day 33" ], "offsets": [ [ 388, 397 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T45", "type": "Person", "text": [ "Aged" ], "offsets": [ [ 399, 403 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T46", "type": "Value", "text": [ "< 1 or = 6 years" ], "offsets": [ [ 404, 420 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T47", "type": "Measurement", "text": [ "WBC" ], "offsets": [ [ 428, 431 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T48", "type": "Value", "text": [ "= 20,000/µL" ], "offsets": [ [ 432, 443 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T49", "type": "Measurement", "text": [ "Blasts" ], "offsets": [ [ 444, 450 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T50", "type": "Value", "text": [ "< 1,000/µL" ], "offsets": [ [ 451, 461 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T51", "type": "Condition", "text": [ "PB" ], "offsets": [ [ 465, 467 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T52", "type": "Temporal", "text": [ "on day 8" ], "offsets": [ [ 468, 476 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T53", "type": "Condition", "text": [ "M2 marrow" ], "offsets": [ [ 483, 492 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T54", "type": "Condition", "text": [ "rr", "ay 15" ], "offsets": [ [ 488, 490 ], [ 497, 502 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T55", "type": "Temporal", "text": [ "on day 15" ], "offsets": [ [ 493, 502 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T56", "type": "Scope", "text": [ "M1 or M2 marrow" ], "offsets": [ [ 477, 492 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T57", "type": "Condition", "text": [ "ar", "y 15 O" ], "offsets": [ [ 515, 517 ], [ 526, 532 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T58", "type": "Value", "text": [ "= 25%" ], "offsets": [ [ 507, 512 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T59", "type": "Temporal", "text": [ "on day 15" ], "offsets": [ [ 521, 530 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T60", "type": "Measurement", "text": [ "SR criteria" ], "offsets": [ [ 540, 551 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T61", "type": "Value", "text": [ "meets" ], "offsets": [ [ 534, 539 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T62", "type": "Condition", "text": [ "M3 marrow" ], "offsets": [ [ 556, 565 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T63", "type": "Temporal", "text": [ "on day 15" ], "offsets": [ [ 566, 575 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T64", "type": "Condition", "text": [ "M1 marrow" ], "offsets": [ [ 581, 590 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T65", "type": "Temporal", "text": [ "on day 33" ], "offsets": [ [ 591, 600 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T66", "type": "Scope", "text": [ "meets SR criteria but M3 marrow on day 15 and *M1 marrow on day 33" ], "offsets": [ [ 534, 600 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T67", "type": "Measurement", "text": [ "IR criteria" ], "offsets": [ [ 608, 619 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T68", "type": "Value", "text": [ "Meets" ], "offsets": [ [ 602, 607 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T69", "type": "Condition", "text": [ "M3 marrow" ], "offsets": [ [ 624, 633 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T70", "type": "Temporal", "text": [ "on day 15" ], "offsets": [ [ 659, 668 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T71", "type": "Value", "text": [ "not" ], "offsets": [ [ 645, 648 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T72", "type": "Measurement", "text": [ "SR" ], "offsets": [ [ 649, 651 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T73", "type": "Condition", "text": [ "M3" ], "offsets": [ [ 656, 658 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T74", "type": "Temporal", "text": [ "on day 15" ], "offsets": [ [ 659, 668 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T75", "type": "Measurement", "text": [ "Blasts" ], "offsets": [ [ 670, 676 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T76", "type": "Value", "text": [ "= 1,000/µL" ], "offsets": [ [ 677, 687 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T77", "type": "Qualifier", "text": [ "PB" ], "offsets": [ [ 691, 693 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T78", "type": "Temporal", "text": [ "on day 8" ], "offsets": [ [ 694, 702 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T79", "type": "Condition", "text": [ "M3 marrow" ], "offsets": [ [ 709, 718 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T80", "type": "Condition", "text": [ " ", "3\nTran" ], "offsets": [ [ 718, 719 ], [ 727, 733 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T81", "type": "Temporal", "text": [ "on day 33" ], "offsets": [ [ 719, 728 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T82", "type": "Scope", "text": [ "M2 or M3 marrow" ], "offsets": [ [ 703, 718 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T83", "type": "Measurement", "text": [ "Translocation t(9;22)" ], "offsets": [ [ 729, 750 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T84", "type": "Measurement", "text": [ "BCR/ABL" ], "offsets": [ [ 752, 759 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T85", "type": "Value", "text": [ "+" ], "offsets": [ [ 759, 760 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T86", "type": "Measurement", "text": [ "Philadelphia chromosome" ], "offsets": [ [ 763, 786 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T87", "type": "Value", "text": [ "positive" ], "offsets": [ [ 787, 795 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T88", "type": "Measurement", "text": [ "t(4;11)" ], "offsets": [ [ 800, 807 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T89", "type": "Measurement", "text": [ "MLL/AF4" ], "offsets": [ [ 809, 816 ] ], "normalized": [] }, { "id": "NCT00846703_inc_T90", "type": "Value", "text": [ "+" ], "offsets": [ [ 816, 817 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00846703_inc_R1", "type": "Subsumes", "arg1_id": "NCT00846703_inc_T1", "arg2_id": "NCT00846703_inc_T2", "normalized": [] }, { "id": "NCT00846703_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT00846703_inc_T1", "arg2_id": "NCT00846703_inc_T3", "normalized": [] }, { "id": "NCT00846703_inc_R3", "type": "Has_negation", "arg1_id": "NCT00846703_inc_T7", "arg2_id": "NCT00846703_inc_T6", "normalized": [] }, { "id": "NCT00846703_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT00846703_inc_T4", "arg2_id": "NCT00846703_inc_T5", "normalized": [] }, { "id": "NCT00846703_inc_R5", "type": "AND", "arg1_id": "NCT00846703_inc_T7", "arg2_id": "NCT00846703_inc_T4", "normalized": [] }, { "id": "NCT00846703_inc_R6", "type": "Subsumes", "arg1_id": "NCT00846703_inc_T22", "arg2_id": "NCT00846703_inc_T23", "normalized": [] }, { "id": "NCT00846703_inc_R7", "type": "Has_multiplier", "arg1_id": "NCT00846703_inc_T25", "arg2_id": "NCT00846703_inc_T24", "normalized": [] }, { "id": "NCT00846703_inc_R8", "type": "AND", "arg1_id": "NCT00846703_inc_T22", "arg2_id": "NCT00846703_inc_T25", "normalized": [] }, { "id": "NCT00846703_inc_R9", "type": "Subsumes", "arg1_id": "NCT00846703_inc_T28", "arg2_id": "NCT00846703_inc_T29", "normalized": [] }, { "id": "NCT00846703_inc_R10", "type": "Has_qualifier", "arg1_id": "NCT00846703_inc_T26", "arg2_id": "NCT00846703_inc_T28", "normalized": [] }, { "id": "NCT00846703_inc_R11", "type": "Has_temporal", "arg1_id": "NCT00846703_inc_T26", "arg2_id": "NCT00846703_inc_T30", "normalized": [] }, { "id": "NCT00846703_inc_R12", "type": "Has_value", "arg1_id": "NCT00846703_inc_T31", "arg2_id": "NCT00846703_inc_T32", "normalized": [] }, { "id": "NCT00846703_inc_R13", "type": "Has_value", "arg1_id": "NCT00846703_inc_T33", "arg2_id": "NCT00846703_inc_T35", "normalized": [] }, { "id": "NCT00846703_inc_R14", "type": "Has_qualifier", "arg1_id": "NCT00846703_inc_T33", "arg2_id": "NCT00846703_inc_T34", "normalized": [] }, { "id": "NCT00846703_inc_R15", "type": "Has_value", "arg1_id": "NCT00846703_inc_T37", "arg2_id": "NCT00846703_inc_T40", "normalized": [] }, { "id": "NCT00846703_inc_R16", "type": "Has_value", "arg1_id": "NCT00846703_inc_T36", "arg2_id": "NCT00846703_inc_T39", "normalized": [] }, { "id": "NCT00846703_inc_R17", "type": "Has_qualifier", "arg1_id": "NCT00846703_inc_T42", "arg2_id": "NCT00846703_inc_T38", "normalized": [] }, { "id": "NCT00846703_inc_R18", "type": "Has_temporal", "arg1_id": "NCT00846703_inc_T42", "arg2_id": "NCT00846703_inc_T41", "normalized": [] }, { "id": "NCT00846703_inc_R19", "type": "Has_temporal", "arg1_id": "NCT00846703_inc_T43", "arg2_id": "NCT00846703_inc_T44", "normalized": [] }, { "id": "NCT00846703_inc_R20", "type": "Has_value", "arg1_id": "NCT00846703_inc_T47", "arg2_id": "NCT00846703_inc_T48", "normalized": [] }, { "id": "NCT00846703_inc_R21", "type": "Has_value", "arg1_id": "NCT00846703_inc_T45", "arg2_id": "NCT00846703_inc_T46", "normalized": [] }, { "id": "NCT00846703_inc_R22", "type": "AND", "arg1_id": "NCT00846703_inc_T49", "arg2_id": "NCT00846703_inc_T51", "normalized": [] }, { "id": "NCT00846703_inc_R23", "type": "Has_value", "arg1_id": "NCT00846703_inc_T49", "arg2_id": "NCT00846703_inc_T50", "normalized": [] }, { "id": "NCT00846703_inc_R24", "type": "Has_temporal", "arg1_id": "NCT00846703_inc_T49", "arg2_id": "NCT00846703_inc_T52", "normalized": [] }, { "id": "NCT00846703_inc_R25", "type": "Has_temporal", "arg1_id": "NCT00846703_inc_T56", "arg2_id": "NCT00846703_inc_T55", "normalized": [] }, { "id": "NCT00846703_inc_R26", "type": "Has_value", "arg1_id": "NCT00846703_inc_T57", "arg2_id": "NCT00846703_inc_T58", "normalized": [] }, { "id": "NCT00846703_inc_R27", "type": "Has_value", "arg1_id": "NCT00846703_inc_T60", "arg2_id": "NCT00846703_inc_T61", "normalized": [] }, { "id": "NCT00846703_inc_R28", "type": "Has_temporal", "arg1_id": "NCT00846703_inc_T64", "arg2_id": "NCT00846703_inc_T65", "normalized": [] }, { "id": "NCT00846703_inc_R29", "type": "Has_temporal", "arg1_id": "NCT00846703_inc_T62", "arg2_id": "NCT00846703_inc_T63", "normalized": [] }, { "id": "NCT00846703_inc_R30", "type": "Has_temporal", "arg1_id": "NCT00846703_inc_T57", "arg2_id": "NCT00846703_inc_T59", "normalized": [] }, { "id": "NCT00846703_inc_R31", "type": "Has_value", "arg1_id": "NCT00846703_inc_T67", "arg2_id": "NCT00846703_inc_T68", "normalized": [] }, { "id": "NCT00846703_inc_R32", "type": "Has_temporal", "arg1_id": "NCT00846703_inc_T69", "arg2_id": "NCT00846703_inc_T70", "normalized": [] }, { "id": "NCT00846703_inc_R33", "type": "Has_value", "arg1_id": "NCT00846703_inc_T72", "arg2_id": "NCT00846703_inc_T71", "normalized": [] }, { "id": "NCT00846703_inc_R34", "type": "Has_temporal", "arg1_id": "NCT00846703_inc_T73", "arg2_id": "NCT00846703_inc_T74", "normalized": [] }, { "id": "NCT00846703_inc_R35", "type": "Has_value", "arg1_id": "NCT00846703_inc_T75", "arg2_id": "NCT00846703_inc_T76", "normalized": [] }, { "id": "NCT00846703_inc_R36", "type": "Has_qualifier", "arg1_id": "NCT00846703_inc_T75", "arg2_id": "NCT00846703_inc_T77", "normalized": [] }, { "id": "NCT00846703_inc_R37", "type": "Has_temporal", "arg1_id": "NCT00846703_inc_T75", "arg2_id": "NCT00846703_inc_T78", "normalized": [] }, { "id": "NCT00846703_inc_R38", "type": "Has_temporal", "arg1_id": "NCT00846703_inc_T82", "arg2_id": "NCT00846703_inc_T81", "normalized": [] }, { "id": "NCT00846703_inc_R39", "type": "Has_value", "arg1_id": "NCT00846703_inc_T84", "arg2_id": "NCT00846703_inc_T85", "normalized": [] }, { "id": "NCT00846703_inc_R40", "type": "Subsumes", "arg1_id": "NCT00846703_inc_T84", "arg2_id": "NCT00846703_inc_T83", "normalized": [] }, { "id": "NCT00846703_inc_R41", "type": "Has_value", "arg1_id": "NCT00846703_inc_T86", "arg2_id": "NCT00846703_inc_T87", "normalized": [] }, { "id": "NCT00846703_inc_R42", "type": "Subsumes", "arg1_id": "NCT00846703_inc_T89", "arg2_id": "NCT00846703_inc_T88", "normalized": [] }, { "id": "NCT00846703_inc_R43", "type": "Has_value", "arg1_id": "NCT00846703_inc_T89", "arg2_id": "NCT00846703_inc_T90", "normalized": [] }, { "id": "NCT00846703_inc_R44", "type": "Subsumes", "arg1_id": "NCT00846703_inc_T84", "arg2_id": "NCT00846703_inc_T86", "normalized": [] } ]

[ { "id": "NCT00862446_exc_text", "type": "exclusion", "text": [ "Enrollment in another trial\nLack of consent\n" ], "offsets": [ [ 0, 44 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT00862446_inc_text", "type": "inclusion", "text": [ "Infants in the newborn intensive care unit\nTPN cholestasis of at least 2.5 mg/dl\nAnticipated TPN treatment for at least one month\nsigned informed consent\n" ], "offsets": [ [ 0, 154 ] ] } ]

[ { "id": "NCT00862446_inc_T1", "type": "Visit", "text": [ "newborn intensive care unit" ], "offsets": [ [ 15, 42 ] ], "normalized": [] }, { "id": "NCT00862446_inc_T2", "type": "Person", "text": [ "Infants" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT00862446_inc_T3", "type": "Condition", "text": [ "TPN cholestasis" ], "offsets": [ [ 43, 58 ] ], "normalized": [] }, { "id": "NCT00862446_inc_T4", "type": "Multiplier", "text": [ "at least 2.5 mg/dl" ], "offsets": [ [ 62, 80 ] ], "normalized": [] }, { "id": "NCT00862446_inc_T5", "type": "Procedure", "text": [ "TPN treatment" ], "offsets": [ [ 93, 106 ] ], "normalized": [] }, { "id": "NCT00862446_inc_T6", "type": "Multiplier", "text": [ "for at least one month" ], "offsets": [ [ 107, 129 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00862446_inc_R1", "type": "Has_multiplier", "arg1_id": "NCT00862446_inc_T3", "arg2_id": "NCT00862446_inc_T4", "normalized": [] } ]

[ { "id": "NCT00867958_exc_text", "type": "exclusion", "text": [ "1. Patient has an allergy to nickel. \n2. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease. \n3. Patient is participating in another clinical trial which may affect this study's outcomes. \n4. Patient has been taking regular steroid medication. \n5. Patient has contraindications to general anesthesia. \n6. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis. \n \n" ], "offsets": [ [ 0, 571 ] ] } ]

[ { "id": "NCT00867958_exc_T1", "type": "Condition", "text": [ "allergy to nickel" ], "offsets": [ [ 18, 35 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T2", "type": "Drug", "text": [ "nickel" ], "offsets": [ [ 29, 35 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T3", "type": "Condition", "text": [ "bowel obstruction" ], "offsets": [ [ 68, 85 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T4", "type": "Condition", "text": [ "bowel strangulation" ], "offsets": [ [ 87, 106 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T5", "type": "Condition", "text": [ "peritonitis" ], "offsets": [ [ 108, 119 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T6", "type": "Condition", "text": [ "bowel perforation" ], "offsets": [ [ 121, 138 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T7", "type": "Condition", "text": [ "systemic infection" ], "offsets": [ [ 149, 167 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T8", "type": "Condition", "text": [ "local", "infection" ], "offsets": [ [ 140, 145 ], [ 158, 167 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T9", "type": "Condition", "text": [ "ischemic bowel" ], "offsets": [ [ 169, 183 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T10", "type": "Condition", "text": [ "carcinomatosis" ], "offsets": [ [ 185, 199 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T11", "type": "Condition", "text": [ "inflammatory bowel disease" ], "offsets": [ [ 222, 248 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T12", "type": "Qualifier", "text": [ "extensively spread" ], "offsets": [ [ 203, 221 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T15", "type": "Drug", "text": [ "steroid medication" ], "offsets": [ [ 381, 399 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T16", "type": "Multiplier", "text": [ "regular" ], "offsets": [ [ 373, 380 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T17", "type": "Condition", "text": [ "contraindications to general anesthesia" ], "offsets": [ [ 417, 456 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T18", "type": "Procedure", "text": [ "general anesthesia" ], "offsets": [ [ 438, 456 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T19", "type": "Condition", "text": [ "sphincter problems" ], "offsets": [ [ 486, 504 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T20", "type": "Condition", "text": [ "local disease in the pelvis" ], "offsets": [ [ 530, 557 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T21", "type": "Qualifier", "text": [ "extensive" ], "offsets": [ [ 520, 529 ] ], "normalized": [] }, { "id": "NCT00867958_exc_T22", "type": "Mood", "text": [ "evidence of" ], "offsets": [ [ 508, 519 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00867958_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT00867958_exc_T11", "arg2_id": "NCT00867958_exc_T12", "normalized": [] }, { "id": "NCT00867958_exc_R3", "type": "Has_multiplier", "arg1_id": "NCT00867958_exc_T15", "arg2_id": "NCT00867958_exc_T16", "normalized": [] }, { "id": "NCT00867958_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT00867958_exc_T20", "arg2_id": "NCT00867958_exc_T21", "normalized": [] }, { "id": "NCT00867958_exc_R6", "type": "Has_mood", "arg1_id": "NCT00867958_exc_T20", "arg2_id": "NCT00867958_exc_T22", "normalized": [] } ]

[ { "id": "NCT00867958_inc_text", "type": "inclusion", "text": [ "1. Patient is over 18 years old. \n2. Patient is scheduled for a non-emergency procedure. \n3. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures. \n" ], "offsets": [ [ 0, 212 ] ] } ]

[ { "id": "NCT00867958_inc_T1", "type": "Value", "text": [ "over 18 years old" ], "offsets": [ [ 14, 31 ] ], "normalized": [] }, { "id": "NCT00867958_inc_T2", "type": "Person", "text": [ "years old" ], "offsets": [ [ 22, 31 ] ], "normalized": [] }, { "id": "NCT00867958_inc_T3", "type": "Procedure", "text": [ "non-emergency procedure" ], "offsets": [ [ 64, 87 ] ], "normalized": [] }, { "id": "NCT00867958_inc_T4", "type": "Qualifier", "text": [ "non-emergency" ], "offsets": [ [ 64, 77 ] ], "normalized": [] }, { "id": "NCT00867958_inc_T5", "type": "Mood", "text": [ "scheduled" ], "offsets": [ [ 48, 57 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00867958_inc_R1", "type": "Has_value", "arg1_id": "NCT00867958_inc_T2", "arg2_id": "NCT00867958_inc_T1", "normalized": [] }, { "id": "NCT00867958_inc_R3", "type": "Has_mood", "arg1_id": "NCT00867958_inc_T3", "arg2_id": "NCT00867958_inc_T5", "normalized": [] } ]

[ { "id": "NCT00886158_exc_text", "type": "exclusion", "text": [ "Lack of consent \n \n" ], "offsets": [ [ 0, 28 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT00886158_inc_text", "type": "inclusion", "text": [ "Age from birth to 21 years \nAll solid organ transplant recipients receiving their care at Seattle Children's Hospital \nSigned consent, and when age appropriate, signed assent \n" ], "offsets": [ [ 0, 176 ] ] } ]

[ { "id": "NCT00886158_inc_T1", "type": "Value", "text": [ "from birth to 21 years" ], "offsets": [ [ 4, 26 ] ], "normalized": [] }, { "id": "NCT00886158_inc_T2", "type": "Person", "text": [ "Age" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT00886158_inc_T3", "type": "Visit", "text": [ "Seattle Children's Hospital" ], "offsets": [ [ 90, 117 ] ], "normalized": [] }, { "id": "NCT00886158_inc_T4", "type": "Procedure", "text": [ "solid organ transplant" ], "offsets": [ [ 32, 54 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00886158_inc_R1", "type": "Has_value", "arg1_id": "NCT00886158_inc_T2", "arg2_id": "NCT00886158_inc_T1", "normalized": [] }, { "id": "NCT00886158_inc_R2", "type": "AND", "arg1_id": "NCT00886158_inc_T4", "arg2_id": "NCT00886158_inc_T3", "normalized": [] } ]

[ { "id": "NCT00894712_exc_text", "type": "exclusion", "text": [ "Visible skin pathology, excessive freckles, or skin blemishes in the test area. \nHistory of skin disease or hypersensitivity and repeated contact allergies. \nSarcoma or squamous cell histology. \nMetastatic disease to the breast. \nCurrent tobacco use. \n \n" ], "offsets": [ [ 0, 263 ] ] } ]

[ { "id": "NCT00894712_exc_T1", "type": "Condition", "text": [ "skin pathology" ], "offsets": [ [ 8, 22 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T2", "type": "Condition", "text": [ "freckles" ], "offsets": [ [ 34, 42 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T3", "type": "Qualifier", "text": [ "excessive" ], "offsets": [ [ 24, 33 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T4", "type": "Condition", "text": [ "skin blemishes" ], "offsets": [ [ 47, 61 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T5", "type": "Condition", "text": [ "skin disease" ], "offsets": [ [ 92, 104 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T6", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 108, 124 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T7", "type": "Condition", "text": [ "contact allergies" ], "offsets": [ [ 138, 155 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T8", "type": "Condition", "text": [ "Sarcoma" ], "offsets": [ [ 158, 165 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T9", "type": "Condition", "text": [ "squamous cell" ], "offsets": [ [ 169, 182 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T10", "type": "Procedure", "text": [ "histology" ], "offsets": [ [ 183, 192 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T11", "type": "Scope", "text": [ "Sarcoma or squamous cell" ], "offsets": [ [ 158, 182 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T12", "type": "Condition", "text": [ "Metastatic disease" ], "offsets": [ [ 195, 213 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T13", "type": "Qualifier", "text": [ "to the breast" ], "offsets": [ [ 214, 227 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T14", "type": "Observation", "text": [ "tobacco use" ], "offsets": [ [ 238, 249 ] ], "normalized": [] }, { "id": "NCT00894712_exc_T15", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 230, 237 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00894712_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT00894712_exc_T2", "arg2_id": "NCT00894712_exc_T3", "normalized": [] }, { "id": "NCT00894712_exc_R2", "type": "Has_scope", "arg1_id": "NCT00894712_exc_T10", "arg2_id": "NCT00894712_exc_T11", "normalized": [] }, { "id": "NCT00894712_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT00894712_exc_T12", "arg2_id": "NCT00894712_exc_T13", "normalized": [] }, { "id": "NCT00894712_exc_R4", "type": "Has_temporal", "arg1_id": "NCT00894712_exc_T14", "arg2_id": "NCT00894712_exc_T15", "normalized": [] } ]

[ { "id": "NCT00894712_inc_text", "type": "inclusion", "text": [ "Must have pathologically confirmed invasive adenocarcinoma or ductal carcinoma in situ of the breast. \nPatients must have undergone segmental mastectomy (i.e., lumpectomy). \nPatients must not have received prior radiation therapy to the breast. \nPatients must not have active local-regional disease prior to registration. \nPatients must not be pregnant because of the potential for fetal harm as a result of radiation treatment. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. They will also be counseled on the importance of avoiding pregnancy and hormonal contraception while undergoing radiation therapy. \nPatients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment. \nAll patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines. \n" ], "offsets": [ [ 0, 972 ] ] } ]

[ { "id": "NCT00894712_inc_T2", "type": "Procedure", "text": [ "pathologically" ], "offsets": [ [ 10, 24 ] ], "normalized": [] }, { "id": "NCT00894712_inc_T3", "type": "Value", "text": [ "confirmed" ], "offsets": [ [ 25, 34 ] ], "normalized": [] }, { "id": "NCT00894712_inc_T4", "type": "Condition", "text": [ "invasive adenocarcinoma" ], "offsets": [ [ 35, 58 ] ], "normalized": [] }, { "id": "NCT00894712_inc_T5", "type": "Condition", "text": [ "ductal carcinoma in situ" ], "offsets": [ [ 62, 86 ] ], "normalized": [] }, { "id": "NCT00894712_inc_T1", "type": "Procedure", "text": [ "segmental mastectomy" ], "offsets": [ [ 132, 152 ] ], "normalized": [] }, { "id": "NCT00894712_inc_T6", "type": "Procedure", "text": [ "lumpectomy" ], "offsets": [ [ 160, 170 ] ], "normalized": [] }, { "id": "NCT00894712_inc_T7", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 212, 229 ] ], "normalized": [] }, { "id": "NCT00894712_inc_T8", "type": "Negation", "text": [ "not" ], "offsets": [ [ 188, 191 ] ], "normalized": [] }, { "id": "NCT00894712_inc_T9", "type": "Qualifier", "text": [ "of the breast" ], "offsets": [ [ 87, 100 ] ], "normalized": [] }, { "id": "NCT00894712_inc_T10", "type": "Condition", "text": [ "local-regional disease" ], "offsets": [ [ 276, 298 ] ], "normalized": [] }, { "id": "NCT00894712_inc_T12", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 269, 275 ] ], "normalized": [] }, { "id": "NCT00894712_inc_T13", "type": "Negation", "text": [ "not" ], "offsets": [ [ 260, 263 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00894712_inc_R2", "type": "Has_value", "arg1_id": "NCT00894712_inc_T2", "arg2_id": "NCT00894712_inc_T3", "normalized": [] }, { "id": "NCT00894712_inc_R1", "type": "AND", "arg1_id": "NCT00894712_inc_T4", "arg2_id": "NCT00894712_inc_T2", "normalized": [] }, { "id": "NCT00894712_inc_R3", "type": "AND", "arg1_id": "NCT00894712_inc_T5", "arg2_id": "NCT00894712_inc_T2", "normalized": [] }, { "id": "NCT00894712_inc_R4", "type": "Subsumes", "arg1_id": "NCT00894712_inc_T1", "arg2_id": "NCT00894712_inc_T6", "normalized": [] }, { "id": "NCT00894712_inc_R5", "type": "Has_negation", "arg1_id": "NCT00894712_inc_T7", "arg2_id": "NCT00894712_inc_T8", "normalized": [] }, { "id": "NCT00894712_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT00894712_inc_T4", "arg2_id": "NCT00894712_inc_T9", "normalized": [] }, { "id": "NCT00894712_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT00894712_inc_T5", "arg2_id": "NCT00894712_inc_T9", "normalized": [] }, { "id": "NCT00894712_inc_R8", "type": "Has_temporal", "arg1_id": "NCT00894712_inc_T10", "arg2_id": "NCT00894712_inc_T12", "normalized": [] }, { "id": "NCT00894712_inc_R9", "type": "Has_negation", "arg1_id": "NCT00894712_inc_T10", "arg2_id": "NCT00894712_inc_T13", "normalized": [] } ]

[ { "id": "NCT00904202_exc_text", "type": "exclusion", "text": [ "1. Had a neurological condition other than that associated with their pain diagnosis which, in the opinion of the investigator, would interfere with their ability to participate in the study \n2. Were taking a lidocaine-containing product that could not be discontinued while receiving lidocaine \n3. Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide) \n \n" ], "offsets": [ [ 0, 383 ] ] } ]

[ { "id": "NCT00904202_exc_T1", "type": "Condition", "text": [ "neurological condition" ], "offsets": [ [ 9, 31 ] ], "normalized": [] }, { "id": "NCT00904202_exc_T2", "type": "Condition", "text": [ "pain diagnosis" ], "offsets": [ [ 70, 84 ] ], "normalized": [] }, { "id": "NCT00904202_exc_T3", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 32, 42 ] ], "normalized": [] }, { "id": "NCT00904202_exc_T4", "type": "Qualifier", "text": [ "associated with their pain diagnosis" ], "offsets": [ [ 48, 84 ] ], "normalized": [] }, { "id": "NCT00904202_exc_T6", "type": "Drug", "text": [ "lidocaine-containing product" ], "offsets": [ [ 209, 237 ] ], "normalized": [] }, { "id": "NCT00904202_exc_T7", "type": "Qualifier", "text": [ "could not be discontinued" ], "offsets": [ [ 243, 268 ] ], "normalized": [] }, { "id": "NCT00904202_exc_T8", "type": "Temporal", "text": [ "while receiving lidocaine" ], "offsets": [ [ 269, 294 ] ], "normalized": [] }, { "id": "NCT00904202_exc_T9", "type": "Drug", "text": [ "lidocaine" ], "offsets": [ [ 285, 294 ] ], "normalized": [] }, { "id": "NCT00904202_exc_T10", "type": "Reference_point", "text": [ "receiving lidocaine" ], "offsets": [ [ 275, 294 ] ], "normalized": [] }, { "id": "NCT00904202_exc_T11", "type": "Drug", "text": [ "class 1 anti-arrhythmic drugs" ], "offsets": [ [ 311, 340 ] ], "normalized": [] }, { "id": "NCT00904202_exc_T12", "type": "Drug", "text": [ "mexiletine" ], "offsets": [ [ 348, 358 ] ], "normalized": [] }, { "id": "NCT00904202_exc_T13", "type": "Drug", "text": [ "tocainide" ], "offsets": [ [ 360, 369 ] ], "normalized": [] }, { "id": "NCT00904202_exc_T14", "type": "Scope", "text": [ "mexiletine, tocainide" ], "offsets": [ [ 348, 369 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00904202_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT00904202_exc_T3", "arg2_id": "NCT00904202_exc_T4", "normalized": [] }, { "id": "NCT00904202_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT00904202_exc_T1", "arg2_id": "NCT00904202_exc_T4", "normalized": [] }, { "id": "NCT00904202_exc_R5", "type": "AND", "arg1_id": "NCT00904202_exc_T10", "arg2_id": "NCT00904202_exc_T9", "normalized": [] }, { "id": "NCT00904202_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT00904202_exc_T6", "arg2_id": "NCT00904202_exc_T7", "normalized": [] }, { "id": "NCT00904202_exc_R7", "type": "Subsumes", "arg1_id": "NCT00904202_exc_T11", "arg2_id": "NCT00904202_exc_T14", "normalized": [] } ]

[ { "id": "NCT00904202_inc_text", "type": "inclusion", "text": [ "1. Had a diagnosis of PHN, DN, CRPS, carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy (upon mutual agreement of the sponsor and investigator) \n2. Patients with PHN must have had pain >3 months after rash healing \n3. Patients with DN must have had Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with or without dynamic allodynia of the lower extremities \n4. Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic criteria \n5. Patients with carpal tunnel syndrome must have had a diagnosis by combination clinical neurological examination (e.g., Phalen's and Tinel's signs), electrodiagnostic testing, and daily painful symptoms of at least 3 months' duration \n6. Patients with HIV neuropathy must have had HIV, subjective symptoms of painful peripheral neuropathy, and daily painful symptoms of at least 3 months' duration \n7. Patients with idiopathic sensory neuropathy must have had pain of at least 3 months' duration \n8. Reached an average daily pain rating during the baseline week of pain ratings greater than 4 on the 0-to-10 numerical pain rating scale (Question 5 of the BPI) \n9. Had never received an analgesic regimen that contained lidocaine or gabapentin \n" ], "offsets": [ [ 0, 1305 ] ] } ]

[ { "id": "NCT00904202_inc_T1", "type": "Condition", "text": [ "PHN" ], "offsets": [ [ 22, 25 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T2", "type": "Condition", "text": [ "DN" ], "offsets": [ [ 27, 29 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T3", "type": "Condition", "text": [ "CRPS" ], "offsets": [ [ 31, 35 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T4", "type": "Condition", "text": [ "carpal tunnel syndrome" ], "offsets": [ [ 37, 59 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T5", "type": "Condition", "text": [ "HIV neuropathy" ], "offsets": [ [ 61, 75 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T6", "type": "Condition", "text": [ "neuropathy" ], "offsets": [ [ 65, 75 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T7", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 61, 64 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T8", "type": "Condition", "text": [ "sensory neuropathy" ], "offsets": [ [ 88, 106 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T9", "type": "Qualifier", "text": [ "idiopathic" ], "offsets": [ [ 77, 87 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T10", "type": "Condition", "text": [ "peripheral neuropathy" ], "offsets": [ [ 117, 138 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T11", "type": "Condition", "text": [ "PHN" ], "offsets": [ [ 213, 216 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T12", "type": "Multiplier", "text": [ ">3 months" ], "offsets": [ [ 236, 245 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T13", "type": "Temporal", "text": [ "after rash healing" ], "offsets": [ [ 246, 264 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T14", "type": "Reference_point", "text": [ "rash healing" ], "offsets": [ [ 252, 264 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T15", "type": "Condition", "text": [ "rash healing" ], "offsets": [ [ 252, 264 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T16", "type": "Condition", "text": [ "pain" ], "offsets": [ [ 231, 235 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T17", "type": "Condition", "text": [ "DN" ], "offsets": [ [ 283, 285 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T18", "type": "Condition", "text": [ "Type I", "diabetes" ], "offsets": [ [ 300, 306 ], [ 313, 321 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T19", "type": "Condition", "text": [ "Type", "II diabetes" ], "offsets": [ [ 300, 304 ], [ 310, 321 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T20", "type": "Qualifier", "text": [ "painful" ], "offsets": [ [ 326, 333 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T21", "type": "Qualifier", "text": [ "distal" ], "offsets": [ [ 334, 340 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T22", "type": "Qualifier", "text": [ "symmetric" ], "offsets": [ [ 341, 350 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T23", "type": "Condition", "text": [ "sensorimotor polyneuropathy" ], "offsets": [ [ 351, 378 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T24", "type": "Condition", "text": [ "dynamic allodynia" ], "offsets": [ [ 395, 412 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T25", "type": "Scope", "text": [ "Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy" ], "offsets": [ [ 300, 378 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T27", "type": "Condition", "text": [ "CRPS" ], "offsets": [ [ 456, 460 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T28", "type": "Measurement", "text": [ "IASP (International Association for the Study of Pain) diagnostic criteria" ], "offsets": [ [ 483, 557 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T29", "type": "Value", "text": [ "met" ], "offsets": [ [ 471, 474 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T30", "type": "Condition", "text": [ "carpal tunnel syndrome" ], "offsets": [ [ 576, 598 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T31", "type": "Procedure", "text": [ "clinical neurological examination" ], "offsets": [ [ 640, 673 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T32", "type": "Condition", "text": [ "Phalen's", "signs" ], "offsets": [ [ 681, 689 ], [ 702, 707 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T33", "type": "Condition", "text": [ "Tinel's signs" ], "offsets": [ [ 694, 707 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T34", "type": "Scope", "text": [ "Phalen's and Tinel's signs" ], "offsets": [ [ 681, 707 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T35", "type": "Procedure", "text": [ "electrodiagnostic" ], "offsets": [ [ 710, 727 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T36", "type": "Multiplier", "text": [ "daily" ], "offsets": [ [ 741, 746 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T37", "type": "Temporal", "text": [ "at least 3 months' duration" ], "offsets": [ [ 767, 794 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T38", "type": "Condition", "text": [ "painful symptoms" ], "offsets": [ [ 747, 763 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T39", "type": "Condition", "text": [ "HIV neuropathy" ], "offsets": [ [ 813, 827 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T40", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 842, 845 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T41", "type": "Condition", "text": [ "subjective symptoms" ], "offsets": [ [ 847, 866 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T42", "type": "Condition", "text": [ "peripheral neuropathy" ], "offsets": [ [ 878, 899 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T43", "type": "Qualifier", "text": [ "painful" ], "offsets": [ [ 870, 877 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T44", "type": "Multiplier", "text": [ "daily" ], "offsets": [ [ 905, 910 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T45", "type": "Condition", "text": [ "painful symptoms" ], "offsets": [ [ 911, 927 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T46", "type": "Temporal", "text": [ "at least 3 months' duration" ], "offsets": [ [ 931, 958 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T47", "type": "Scope", "text": [ "HIV, subjective symptoms of painful peripheral neuropathy, and daily painful symptoms of at least 3 months' duration" ], "offsets": [ [ 842, 958 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T48", "type": "Condition", "text": [ "idiopathic sensory neuropathy" ], "offsets": [ [ 977, 1006 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T49", "type": "Condition", "text": [ "pain" ], "offsets": [ [ 1021, 1025 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T50", "type": "Temporal", "text": [ "at least 3 months' duration" ], "offsets": [ [ 1029, 1056 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T51", "type": "Measurement", "text": [ "daily pain rating" ], "offsets": [ [ 1080, 1097 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T52", "type": "Temporal", "text": [ "during the baseline week" ], "offsets": [ [ 1098, 1122 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T53", "type": "Reference_point", "text": [ "baseline week" ], "offsets": [ [ 1109, 1122 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T54", "type": "Qualifier", "text": [ "average" ], "offsets": [ [ 1072, 1079 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T55", "type": "Value", "text": [ "greater than 4" ], "offsets": [ [ 1139, 1153 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T56", "type": "Procedure", "text": [ "0-to-10 numerical pain rating scale" ], "offsets": [ [ 1161, 1196 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T57", "type": "Drug", "text": [ "analgesic regimen" ], "offsets": [ [ 1247, 1264 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T58", "type": "Drug", "text": [ "lidocaine" ], "offsets": [ [ 1280, 1289 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T59", "type": "Drug", "text": [ "gabapentin" ], "offsets": [ [ 1293, 1303 ] ], "normalized": [] }, { "id": "NCT00904202_inc_T60", "type": "Scope", "text": [ "lidocaine or gabapentin" ], "offsets": [ [ 1280, 1303 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00904202_inc_R5", "type": "Has_multiplier", "arg1_id": "NCT00904202_inc_T16", "arg2_id": "NCT00904202_inc_T12", "normalized": [] }, { "id": "NCT00904202_inc_R6", "type": "Has_temporal", "arg1_id": "NCT00904202_inc_T16", "arg2_id": "NCT00904202_inc_T13", "normalized": [] }, { "id": "NCT00904202_inc_R7", "type": "AND", "arg1_id": "NCT00904202_inc_T11", "arg2_id": "NCT00904202_inc_T16", "normalized": [] }, { "id": "NCT00904202_inc_R8", "type": "Has_qualifier", "arg1_id": "NCT00904202_inc_T23", "arg2_id": "NCT00904202_inc_T20", "normalized": [] }, { "id": "NCT00904202_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT00904202_inc_T23", "arg2_id": "NCT00904202_inc_T21", "normalized": [] }, { "id": "NCT00904202_inc_R10", "type": "Has_qualifier", "arg1_id": "NCT00904202_inc_T23", "arg2_id": "NCT00904202_inc_T22", "normalized": [] }, { "id": "NCT00904202_inc_R11", "type": "Has_scope", "arg1_id": "NCT00904202_inc_T17", "arg2_id": "NCT00904202_inc_T25", "normalized": [] }, { "id": "NCT00904202_inc_R12", "type": "Has_qualifier", "arg1_id": "NCT00904202_inc_T8", "arg2_id": "NCT00904202_inc_T9", "normalized": [] }, { "id": "NCT00904202_inc_R13", "type": "Has_value", "arg1_id": "NCT00904202_inc_T28", "arg2_id": "NCT00904202_inc_T29", "normalized": [] }, { "id": "NCT00904202_inc_R14", "type": "Subsumes", "arg1_id": "NCT00904202_inc_T31", "arg2_id": "NCT00904202_inc_T34", "normalized": [] }, { "id": "NCT00904202_inc_R15", "type": "Has_temporal", "arg1_id": "NCT00904202_inc_T38", "arg2_id": "NCT00904202_inc_T37", "normalized": [] }, { "id": "NCT00904202_inc_R16", "type": "Has_multiplier", "arg1_id": "NCT00904202_inc_T38", "arg2_id": "NCT00904202_inc_T36", "normalized": [] }, { "id": "NCT00904202_inc_R17", "type": "AND", "arg1_id": "NCT00904202_inc_T30", "arg2_id": "NCT00904202_inc_T31", "normalized": [] }, { "id": "NCT00904202_inc_R18", "type": "AND", "arg1_id": "NCT00904202_inc_T30", "arg2_id": "NCT00904202_inc_T35", "normalized": [] }, { "id": "NCT00904202_inc_R19", "type": "AND", "arg1_id": "NCT00904202_inc_T30", "arg2_id": "NCT00904202_inc_T38", "normalized": [] }, { "id": "NCT00904202_inc_R20", "type": "Has_qualifier", "arg1_id": "NCT00904202_inc_T42", "arg2_id": "NCT00904202_inc_T43", "normalized": [] }, { "id": "NCT00904202_inc_R21", "type": "Has_temporal", "arg1_id": "NCT00904202_inc_T45", "arg2_id": "NCT00904202_inc_T46", "normalized": [] }, { "id": "NCT00904202_inc_R22", "type": "Has_multiplier", "arg1_id": "NCT00904202_inc_T45", "arg2_id": "NCT00904202_inc_T44", "normalized": [] }, { "id": "NCT00904202_inc_R23", "type": "Has_scope", "arg1_id": "NCT00904202_inc_T39", "arg2_id": "NCT00904202_inc_T47", "normalized": [] }, { "id": "NCT00904202_inc_R24", "type": "Has_temporal", "arg1_id": "NCT00904202_inc_T49", "arg2_id": "NCT00904202_inc_T50", "normalized": [] }, { "id": "NCT00904202_inc_R25", "type": "AND", "arg1_id": "NCT00904202_inc_T48", "arg2_id": "NCT00904202_inc_T49", "normalized": [] }, { "id": "NCT00904202_inc_R27", "type": "Has_temporal", "arg1_id": "NCT00904202_inc_T51", "arg2_id": "NCT00904202_inc_T52", "normalized": [] }, { "id": "NCT00904202_inc_R28", "type": "Has_qualifier", "arg1_id": "NCT00904202_inc_T51", "arg2_id": "NCT00904202_inc_T54", "normalized": [] }, { "id": "NCT00904202_inc_R29", "type": "AND", "arg1_id": "NCT00904202_inc_T51", "arg2_id": "NCT00904202_inc_T56", "normalized": [] }, { "id": "NCT00904202_inc_R30", "type": "Has_value", "arg1_id": "NCT00904202_inc_T51", "arg2_id": "NCT00904202_inc_T55", "normalized": [] }, { "id": "NCT00904202_inc_R31", "type": "Has_scope", "arg1_id": "NCT00904202_inc_T57", "arg2_id": "NCT00904202_inc_T60", "normalized": [] } ]

[ { "id": "NCT00917891_exc_text", "type": "exclusion", "text": [ "1. Currently pregnant or last pregnancy outcome within 3 months prior to enrolment \n2. Currently breast-feeding \n3. Participated in any other research study within 60 days prior to screening \n4. Previously participated in any HIV vaccine study \n5. Untreated urogenital infections (either symptomatic or asymptomatic) within 2 weeks prior to enrollment \n6. Presence of abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy \n7. History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction \n8. Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation \n9. Any Grade 2, 3 or 4 baseline haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Experiences \n10. Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrollment \n11. Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex \n12. Any serious acute, chronic or progressive disease \n13. Any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives \n \n" ], "offsets": [ [ 0, 1400 ] ] } ]

[ { "id": "NCT00917891_exc_T1", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 13, 21 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T2", "type": "Condition", "text": [ "pregnancy outcome" ], "offsets": [ [ 30, 47 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T3", "type": "Temporal", "text": [ "within 3 months prior to enrolment" ], "offsets": [ [ 48, 82 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T4", "type": "Reference_point", "text": [ "enrolment" ], "offsets": [ [ 73, 82 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T6", "type": "Qualifier", "text": [ "last" ], "offsets": [ [ 25, 29 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T7", "type": "Temporal", "text": [ "last" ], "offsets": [ [ 25, 29 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T8", "type": "Condition", "text": [ "breast-feeding" ], "offsets": [ [ 97, 111 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T9", "type": "Temporal", "text": [ "Currently" ], "offsets": [ [ 87, 96 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T10", "type": "Temporal", "text": [ "Currently" ], "offsets": [ [ 3, 12 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T12", "type": "Condition", "text": [ "urogenital infections" ], "offsets": [ [ 258, 279 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T13", "type": "Qualifier", "text": [ "Untreated" ], "offsets": [ [ 248, 257 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T14", "type": "Condition", "text": [ "symptomatic" ], "offsets": [ [ 288, 299 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T15", "type": "Condition", "text": [ "asymptomatic" ], "offsets": [ [ 303, 315 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T16", "type": "Scope", "text": [ "symptomatic or asymptomatic" ], "offsets": [ [ 288, 315 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T17", "type": "Temporal", "text": [ "within 2 weeks prior to enrollment" ], "offsets": [ [ 317, 351 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T18", "type": "Reference_point", "text": [ "enrollment" ], "offsets": [ [ 341, 351 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T19", "type": "Condition", "text": [ "abnormal physical finding on the vulva" ], "offsets": [ [ 368, 406 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T20", "type": "Condition", "text": [ "abnormal physical finding on the", "vaginal walls" ], "offsets": [ [ 368, 400 ], [ 408, 421 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T21", "type": "Condition", "text": [ "abnormal physical finding on the", "cervix" ], "offsets": [ [ 368, 400 ], [ 425, 431 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T22", "type": "Procedure", "text": [ "speculum examination" ], "offsets": [ [ 446, 466 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T23", "type": "Procedure", "text": [ "pelvic", "examination" ], "offsets": [ [ 439, 445 ], [ 455, 466 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T24", "type": "Procedure", "text": [ "colposcopy" ], "offsets": [ [ 474, 484 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T25", "type": "Scope", "text": [ "pelvic/speculum examination and/or colposcopy" ], "offsets": [ [ 439, 484 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T26", "type": "Scope", "text": [ "abnormal physical finding on the vulva, vaginal walls or cervix" ], "offsets": [ [ 368, 431 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T27", "type": "Condition", "text": [ "urogenital", "prolapse" ], "offsets": [ [ 512, 522 ], [ 534, 542 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T28", "type": "Condition", "text": [ "uterine prolapse" ], "offsets": [ [ 526, 542 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T29", "type": "Condition", "text": [ "vaginal bleeding" ], "offsets": [ [ 556, 572 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T30", "type": "Qualifier", "text": [ "undiagnosed" ], "offsets": [ [ 544, 555 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T31", "type": "Condition", "text": [ "urethral obstruction" ], "offsets": [ [ 574, 594 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T32", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 500, 511 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T33", "type": "Observation", "text": [ "History" ], "offsets": [ [ 489, 496 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T34", "type": "Scope", "text": [ "urogenital or uterine prolapse" ], "offsets": [ [ 512, 542 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T36", "type": "Measurement", "text": [ "Pap smear" ], "offsets": [ [ 599, 608 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T37", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 616, 628 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T38", "type": "Value", "text": [ "requires cryotherapy" ], "offsets": [ [ 634, 654 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T39", "type": "Value", "text": [ "requires", "biopsy" ], "offsets": [ [ 634, 642 ], [ 656, 662 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T40", "type": "Value", "text": [ "requires", "treatment" ], "offsets": [ [ 634, 642 ], [ 664, 673 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T41", "type": "Procedure", "text": [ "cryotherapy" ], "offsets": [ [ 643, 654 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T42", "type": "Procedure", "text": [ "biopsy" ], "offsets": [ [ 656, 662 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T43", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 664, 673 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T44", "type": "Value", "text": [ "requires", "further evaluation" ], "offsets": [ [ 634, 642 ], [ 705, 723 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T45", "type": "Procedure", "text": [ "further evaluation" ], "offsets": [ [ 705, 723 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T46", "type": "Scope", "text": [ "requires cryotherapy, biopsy, treatment", "or further evaluation" ], "offsets": [ [ 634, 673 ], [ 702, 723 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T47", "type": "Condition", "text": [ "laboratory abnormality" ], "offsets": [ [ 794, 816 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T48", "type": "Condition", "text": [ "urinalysis", "abnormality" ], "offsets": [ [ 783, 793 ], [ 805, 816 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T49", "type": "Condition", "text": [ "chemistry", "abnormality" ], "offsets": [ [ 770, 779 ], [ 805, 816 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T50", "type": "Condition", "text": [ "haematology", "abnormality" ], "offsets": [ [ 757, 768 ], [ 805, 816 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T51", "type": "Value", "text": [ "Grade 2, 3 or 4" ], "offsets": [ [ 732, 747 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T52", "type": "Temporal", "text": [ "baseline" ], "offsets": [ [ 748, 756 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T53", "type": "Measurement", "text": [ "DAIDS Table for Grading Adverse Experiences" ], "offsets": [ [ 834, 877 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T54", "type": "Procedure", "text": [ "haematology" ], "offsets": [ [ 757, 768 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T55", "type": "Procedure", "text": [ "chemistry" ], "offsets": [ [ 770, 779 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T56", "type": "Procedure", "text": [ "urinalysis" ], "offsets": [ [ 783, 793 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T57", "type": "Procedure", "text": [ "laboratory" ], "offsets": [ [ 794, 804 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T58", "type": "Condition", "text": [ "bleeding per vagina" ], "offsets": [ [ 917, 936 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T59", "type": "Qualifier", "text": [ "undiagnosed" ], "offsets": [ [ 896, 907 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T60", "type": "Qualifier", "text": [ "Unexplained" ], "offsets": [ [ 883, 894 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T61", "type": "Qualifier", "text": [ "abnormal" ], "offsets": [ [ 908, 916 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T62", "type": "Condition", "text": [ "bleeding per vagina" ], "offsets": [ [ 938, 957 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T63", "type": "Temporal", "text": [ "during", "vaginal intercourse" ], "offsets": [ [ 958, 964 ], [ 978, 997 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T64", "type": "Temporal", "text": [ "following vaginal intercourse" ], "offsets": [ [ 968, 997 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T65", "type": "Procedure", "text": [ "gynaecologic surgery" ], "offsets": [ [ 1002, 1022 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T66", "type": "Temporal", "text": [ "within 90 days prior to enrollment" ], "offsets": [ [ 1023, 1057 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T67", "type": "Reference_point", "text": [ "enrollment" ], "offsets": [ [ 1047, 1057 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T68", "type": "Scope", "text": [ "during or following vaginal intercourse" ], "offsets": [ [ 958, 997 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T69", "type": "Scope", "text": [ "bleeding per vagina, bleeding per vagina" ], "offsets": [ [ 917, 957 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T70", "type": "Scope", "text": [ "Unexplained, undiagnosed abnormal" ], "offsets": [ [ 883, 916 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T71", "type": "Condition", "text": [ "anaphylaxis" ], "offsets": [ [ 1078, 1089 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T72", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1067, 1074 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T73", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 1100, 1107 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T74", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 1093, 1099 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T75", "type": "Condition", "text": [ "angioedema" ], "offsets": [ [ 1121, 1131 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T76", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1138, 1145 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T77", "type": "Condition", "text": [ "sensitivity", "to latex" ], "offsets": [ [ 1149, 1160 ], [ 1169, 1177 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T78", "type": "Condition", "text": [ "allergy to latex" ], "offsets": [ [ 1161, 1177 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T79", "type": "Scope", "text": [ "sensitivity/allergy to latex" ], "offsets": [ [ 1149, 1177 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T80", "type": "Scope", "text": [ "anaphylaxis or severe allergy" ], "offsets": [ [ 1078, 1107 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T81", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 1225, 1232 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T82", "type": "Qualifier", "text": [ "progressive" ], "offsets": [ [ 1213, 1224 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T83", "type": "Multiplier", "text": [ "chronic" ], "offsets": [ [ 1202, 1209 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T84", "type": "Temporal", "text": [ "acute" ], "offsets": [ [ 1195, 1200 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T85", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 1187, 1194 ] ], "normalized": [] }, { "id": "NCT00917891_exc_T86", "type": "Scope", "text": [ "serious acute, chronic or progressive" ], "offsets": [ [ 1187, 1224 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00917891_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT00917891_exc_T2", "arg2_id": "NCT00917891_exc_T6", "normalized": [] }, { "id": "NCT00917891_exc_R2", "type": "Has_temporal", "arg1_id": "NCT00917891_exc_T2", "arg2_id": "NCT00917891_exc_T3", "normalized": [] }, { "id": "NCT00917891_exc_R5", "type": "Has_temporal", "arg1_id": "NCT00917891_exc_T1", "arg2_id": "NCT00917891_exc_T10", "normalized": [] }, { "id": "NCT00917891_exc_R6", "type": "Has_temporal", "arg1_id": "NCT00917891_exc_T8", "arg2_id": "NCT00917891_exc_T9", "normalized": [] }, { "id": "NCT00917891_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT00917891_exc_T12", "arg2_id": "NCT00917891_exc_T13", "normalized": [] }, { "id": "NCT00917891_exc_R8", "type": "Has_scope", "arg1_id": "NCT00917891_exc_T12", "arg2_id": "NCT00917891_exc_T16", "normalized": [] }, { "id": "NCT00917891_exc_R9", "type": "Has_index", "arg1_id": "NCT00917891_exc_T17", "arg2_id": "NCT00917891_exc_T18", "normalized": [] }, { "id": "NCT00917891_exc_R10", "type": "Has_temporal", "arg1_id": "NCT00917891_exc_T12", "arg2_id": "NCT00917891_exc_T17", "normalized": [] }, { "id": "NCT00917891_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT00917891_exc_T29", "arg2_id": "NCT00917891_exc_T30", "normalized": [] }, { "id": "NCT00917891_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT00917891_exc_T34", "arg2_id": "NCT00917891_exc_T32", "normalized": [] }, { "id": "NCT00917891_exc_R14", "type": "Has_temporal", "arg1_id": "NCT00917891_exc_T34", "arg2_id": "NCT00917891_exc_T33", "normalized": [] }, { "id": "NCT00917891_exc_R15", "type": "Has_scope", "arg1_id": "NCT00917891_exc_T36", "arg2_id": "NCT00917891_exc_T46", "normalized": [] }, { "id": "NCT00917891_exc_R16", "type": "Has_temporal", "arg1_id": "NCT00917891_exc_T36", "arg2_id": "NCT00917891_exc_T37", "normalized": [] }, { "id": "NCT00917891_exc_R21", "type": "Has_temporal", "arg1_id": "NCT00917891_exc_T53", "arg2_id": "NCT00917891_exc_T52", "normalized": [] }, { "id": "NCT00917891_exc_R22", "type": "Has_value", "arg1_id": "NCT00917891_exc_T53", "arg2_id": "NCT00917891_exc_T51", "normalized": [] }, { "id": "NCT00917891_exc_R27", "type": "Has_index", "arg1_id": "NCT00917891_exc_T66", "arg2_id": "NCT00917891_exc_T67", "normalized": [] }, { "id": "NCT00917891_exc_R28", "type": "Has_temporal", "arg1_id": "NCT00917891_exc_T65", "arg2_id": "NCT00917891_exc_T66", "normalized": [] }, { "id": "NCT00917891_exc_R29", "type": "Has_scope", "arg1_id": "NCT00917891_exc_T62", "arg2_id": "NCT00917891_exc_T68", "normalized": [] }, { "id": "NCT00917891_exc_R30", "type": "Has_scope", "arg1_id": "NCT00917891_exc_T69", "arg2_id": "NCT00917891_exc_T70", "normalized": [] }, { "id": "NCT00917891_exc_R31", "type": "Has_qualifier", "arg1_id": "NCT00917891_exc_T73", "arg2_id": "NCT00917891_exc_T74", "normalized": [] }, { "id": "NCT00917891_exc_R32", "type": "Has_temporal", "arg1_id": "NCT00917891_exc_T79", "arg2_id": "NCT00917891_exc_T76", "normalized": [] }, { "id": "NCT00917891_exc_R34", "type": "Has_temporal", "arg1_id": "NCT00917891_exc_T80", "arg2_id": "NCT00917891_exc_T72", "normalized": [] }, { "id": "NCT00917891_exc_R35", "type": "Has_scope", "arg1_id": "NCT00917891_exc_T81", "arg2_id": "NCT00917891_exc_T86", "normalized": [] } ]

[ { "id": "NCT00917891_inc_text", "type": "inclusion", "text": [ "1. Women 18 to 40 years of age inclusive who can give written informed consent \n2. Available for all visits and consent to follow all procedures scheduled for the study \n3. Agree to daily application of gel and monitoring as per Daily Monitored Adherence (DMA) method \n4. Healthy and self-reported sexually active \n5. HIV-negative as determined by a HIV rapid test at time of enrollment \n6. On a stable form of contraception and willing to continue on this stable method of contraception, OR, Have undergone surgical sterilisation at least 3 months prior to enrollment \n7. In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses \n8. Upon pelvic/speculum examination and colposcopy at the time of enrollment, the cervix and vagina appear normal as determined by the investigator \n9. Asymptomatic for genital infections at the time of enrollment \n10. Willing to refrain from use of vaginal products or objects within 14 days prior to enrollment and for the duration of the study \n11. Willing to answer acceptability and adherence questionnaires throughout the study \n12. Willing to refrain from participation in any other research study for the duration of this study \n13. Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures \n" ], "offsets": [ [ 0, 1415 ] ] } ]

[ { "id": "NCT00917891_inc_T1", "type": "Person", "text": [ "Women" ], "offsets": [ [ 3, 8 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T2", "type": "Value", "text": [ "18 to 40 years" ], "offsets": [ [ 9, 23 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T3", "type": "Person", "text": [ "age" ], "offsets": [ [ 27, 30 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T4", "type": "Observation", "text": [ "can give written informed consent" ], "offsets": [ [ 45, 78 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T8", "type": "Drug", "text": [ "gel" ], "offsets": [ [ 203, 206 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T9", "type": "Multiplier", "text": [ "daily" ], "offsets": [ [ 182, 187 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T10", "type": "Procedure", "text": [ "monitoring" ], "offsets": [ [ 211, 221 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T11", "type": "Condition", "text": [ "Healthy" ], "offsets": [ [ 272, 279 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T12", "type": "Condition", "text": [ "sexually active" ], "offsets": [ [ 298, 313 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T13", "type": "Observation", "text": [ "self-reported" ], "offsets": [ [ 284, 297 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T14", "type": "Qualifier", "text": [ "self-reported" ], "offsets": [ [ 284, 297 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T15", "type": "Condition", "text": [ "HIV-negative" ], "offsets": [ [ 318, 330 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T16", "type": "Measurement", "text": [ "HIV" ], "offsets": [ [ 318, 321 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T17", "type": "Value", "text": [ "negative" ], "offsets": [ [ 322, 330 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T18", "type": "Measurement", "text": [ "HIV rapid test" ], "offsets": [ [ 350, 364 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T19", "type": "Temporal", "text": [ "at time of enrollment" ], "offsets": [ [ 365, 386 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T20", "type": "Reference_point", "text": [ "time of enrollment" ], "offsets": [ [ 368, 386 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T22", "type": "Drug", "text": [ "exogenous hormone" ], "offsets": [ [ 602, 619 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T23", "type": "Negation", "text": [ "absence" ], "offsets": [ [ 580, 587 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T24", "type": "Scope", "text": [ "absence of the use of exogenous hormone" ], "offsets": [ [ 580, 619 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T25", "type": "Value", "text": [ "regular" ], "offsets": [ [ 645, 652 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T26", "type": "Measurement", "text": [ "menstrual cycle" ], "offsets": [ [ 653, 668 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T27", "type": "Condition", "text": [ "regular menstrual cycle" ], "offsets": [ [ 645, 668 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T28", "type": "Value", "text": [ "minimum of 21 days" ], "offsets": [ [ 689, 707 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T29", "type": "Value", "text": [ "maximum of 36 days" ], "offsets": [ [ 714, 732 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T30", "type": "Scope", "text": [ "minimum of 21 days and a maximum of 36 days" ], "offsets": [ [ 689, 732 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T31", "type": "Procedure", "text": [ "speculum examination" ], "offsets": [ [ 764, 784 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T32", "type": "Procedure", "text": [ "pelvic", "examination" ], "offsets": [ [ 757, 763 ], [ 773, 784 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T33", "type": "Procedure", "text": [ "colposcopy" ], "offsets": [ [ 789, 799 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T34", "type": "Temporal", "text": [ "at the time of enrollment" ], "offsets": [ [ 800, 825 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T35", "type": "Scope", "text": [ "pelvic/speculum examination and colposcopy" ], "offsets": [ [ 757, 799 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T36", "type": "Observation", "text": [ "vagina" ], "offsets": [ [ 842, 848 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T37", "type": "Observation", "text": [ "cervix" ], "offsets": [ [ 831, 837 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T38", "type": "Value", "text": [ "normal" ], "offsets": [ [ 856, 862 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T39", "type": "Qualifier", "text": [ "normal" ], "offsets": [ [ 856, 862 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T41", "type": "Scope", "text": [ "cervix and vagina appear normal" ], "offsets": [ [ 831, 862 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T42", "type": "Condition", "text": [ "genital infections" ], "offsets": [ [ 918, 936 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T43", "type": "Mood", "text": [ "Asymptomatic" ], "offsets": [ [ 901, 913 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T44", "type": "Temporal", "text": [ "at the time of enrollment" ], "offsets": [ [ 937, 962 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T45", "type": "Mood", "text": [ "Willing" ], "offsets": [ [ 968, 975 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T46", "type": "Drug", "text": [ "vaginal products" ], "offsets": [ [ 999, 1015 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T47", "type": "Drug", "text": [ "objects", "vaginal" ], "offsets": [ [ 1019, 1026 ], [ 999, 1006 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T48", "type": "Temporal", "text": [ "within 14 days prior to enrollment" ], "offsets": [ [ 1027, 1061 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T49", "type": "Temporal", "text": [ "for the duration of the study" ], "offsets": [ [ 1066, 1095 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T50", "type": "Reference_point", "text": [ "enrollment" ], "offsets": [ [ 1051, 1061 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T51", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 1086, 1095 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T52", "type": "Scope", "text": [ "vaginal products or objects" ], "offsets": [ [ 999, 1026 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T53", "type": "Observation", "text": [ "adherence questionnaires" ], "offsets": [ [ 1137, 1161 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T54", "type": "Observation", "text": [ "acceptability", "questionnaires" ], "offsets": [ [ 1119, 1132 ], [ 1147, 1161 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T55", "type": "Temporal", "text": [ "throughout the study" ], "offsets": [ [ 1162, 1182 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T56", "type": "Negation", "text": [ "refrain" ], "offsets": [ [ 979, 986 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T57", "type": "Mood", "text": [ "Willing" ], "offsets": [ [ 1101, 1108 ] ], "normalized": [] }, { "id": "NCT00917891_inc_T58", "type": "Scope", "text": [ "acceptability and adherence questionnaires" ], "offsets": [ [ 1119, 1161 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00917891_inc_R1", "type": "Has_value", "arg1_id": "NCT00917891_inc_T3", "arg2_id": "NCT00917891_inc_T2", "normalized": [] }, { "id": "NCT00917891_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT00917891_inc_T8", "arg2_id": "NCT00917891_inc_T9", "normalized": [] }, { "id": "NCT00917891_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT00917891_inc_T10", "arg2_id": "NCT00917891_inc_T9", "normalized": [] }, { "id": "NCT00917891_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT00917891_inc_T12", "arg2_id": "NCT00917891_inc_T14", "normalized": [] }, { "id": "NCT00917891_inc_R6", "type": "Has_value", "arg1_id": "NCT00917891_inc_T16", "arg2_id": "NCT00917891_inc_T17", "normalized": [] }, { "id": "NCT00917891_inc_R8", "type": "Has_temporal", "arg1_id": "NCT00917891_inc_T18", "arg2_id": "NCT00917891_inc_T19", "normalized": [] }, { "id": "NCT00917891_inc_R9", "type": "AND", "arg1_id": "NCT00917891_inc_T15", "arg2_id": "NCT00917891_inc_T18", "normalized": [] }, { "id": "NCT00917891_inc_R10", "type": "Has_negation", "arg1_id": "NCT00917891_inc_T22", "arg2_id": "NCT00917891_inc_T23", "normalized": [] }, { "id": "NCT00917891_inc_R12", "type": "Has_value", "arg1_id": "NCT00917891_inc_T26", "arg2_id": "NCT00917891_inc_T25", "normalized": [] }, { "id": "NCT00917891_inc_R13", "type": "Subsumes", "arg1_id": "NCT00917891_inc_T25", "arg2_id": "NCT00917891_inc_T30", "normalized": [] }, { "id": "NCT00917891_inc_R14", "type": "AND", "arg1_id": "NCT00917891_inc_T24", "arg2_id": "NCT00917891_inc_T27", "normalized": [] }, { "id": "NCT00917891_inc_R15", "type": "Has_temporal", "arg1_id": "NCT00917891_inc_T35", "arg2_id": "NCT00917891_inc_T34", "normalized": [] }, { "id": "NCT00917891_inc_R16", "type": "Has_qualifier", "arg1_id": "NCT00917891_inc_T36", "arg2_id": "NCT00917891_inc_T39", "normalized": [] }, { "id": "NCT00917891_inc_R17", "type": "Has_qualifier", "arg1_id": "NCT00917891_inc_T37", "arg2_id": "NCT00917891_inc_T39", "normalized": [] }, { "id": "NCT00917891_inc_R18", "type": "Has_scope", "arg1_id": "NCT00917891_inc_T35", "arg2_id": "NCT00917891_inc_T41", "normalized": [] }, { "id": "NCT00917891_inc_R19", "type": "Has_mood", "arg1_id": "NCT00917891_inc_T42", "arg2_id": "NCT00917891_inc_T43", "normalized": [] }, { "id": "NCT00917891_inc_R20", "type": "Has_temporal", "arg1_id": "NCT00917891_inc_T42", "arg2_id": "NCT00917891_inc_T44", "normalized": [] }, { "id": "NCT00917891_inc_R23", "type": "Has_mood", "arg1_id": "NCT00917891_inc_T52", "arg2_id": "NCT00917891_inc_T45", "normalized": [] }, { "id": "NCT00917891_inc_R24", "type": "Has_temporal", "arg1_id": "NCT00917891_inc_T52", "arg2_id": "NCT00917891_inc_T48", "normalized": [] }, { "id": "NCT00917891_inc_R25", "type": "Has_temporal", "arg1_id": "NCT00917891_inc_T52", "arg2_id": "NCT00917891_inc_T49", "normalized": [] }, { "id": "NCT00917891_inc_R26", "type": "Has_negation", "arg1_id": "NCT00917891_inc_T52", "arg2_id": "NCT00917891_inc_T56", "normalized": [] }, { "id": "NCT00917891_inc_R27", "type": "Has_mood", "arg1_id": "NCT00917891_inc_T58", "arg2_id": "NCT00917891_inc_T57", "normalized": [] }, { "id": "NCT00917891_inc_R28", "type": "Has_temporal", "arg1_id": "NCT00917891_inc_T58", "arg2_id": "NCT00917891_inc_T55", "normalized": [] } ]

[ { "id": "NCT00926523_exc_text", "type": "exclusion", "text": [ "Subject are pregnant \nSubject is unable to perform tasks associated with study \n \n" ], "offsets": [ [ 0, 91 ] ] } ]

[ { "id": "NCT00926523_exc_T1", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 12, 20 ] ], "normalized": [] } ]

[]

[]

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[ { "id": "NCT00926523_inc_text", "type": "inclusion", "text": [ "Subject are at least 18 years of age \nSubject has confirmed Pulmonary Hypertension and Interstitial Lung Disease \nSubject are able to complete study procedures, such as spirometry, and Pulmonary Exercise test. \n" ], "offsets": [ [ 0, 211 ] ] } ]

[ { "id": "NCT00926523_inc_T1", "type": "Value", "text": [ "at least 18 years" ], "offsets": [ [ 12, 29 ] ], "normalized": [] }, { "id": "NCT00926523_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 33, 36 ] ], "normalized": [] }, { "id": "NCT00926523_inc_T3", "type": "Condition", "text": [ "Pulmonary Hypertension" ], "offsets": [ [ 60, 82 ] ], "normalized": [] }, { "id": "NCT00926523_inc_T4", "type": "Condition", "text": [ "Interstitial Lung Disease" ], "offsets": [ [ 87, 112 ] ], "normalized": [] }, { "id": "NCT00926523_inc_T5", "type": "Mood", "text": [ "confirmed" ], "offsets": [ [ 50, 59 ] ], "normalized": [] }, { "id": "NCT00926523_inc_T6", "type": "Procedure", "text": [ "Pulmonary Exercise test" ], "offsets": [ [ 185, 208 ] ], "normalized": [] }, { "id": "NCT00926523_inc_T7", "type": "Procedure", "text": [ "spirometry" ], "offsets": [ [ 169, 179 ] ], "normalized": [] }, { "id": "NCT00926523_inc_T8", "type": "Procedure", "text": [ "study procedures" ], "offsets": [ [ 143, 159 ] ], "normalized": [] }, { "id": "NCT00926523_inc_T10", "type": "Scope", "text": [ "spirometry, and Pulmonary Exercise test" ], "offsets": [ [ 169, 208 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00926523_inc_R1", "type": "Has_value", "arg1_id": "NCT00926523_inc_T2", "arg2_id": "NCT00926523_inc_T1", "normalized": [] }, { "id": "NCT00926523_inc_R2", "type": "Has_mood", "arg1_id": "NCT00926523_inc_T3", "arg2_id": "NCT00926523_inc_T5", "normalized": [] }, { "id": "NCT00926523_inc_R3", "type": "Has_mood", "arg1_id": "NCT00926523_inc_T4", "arg2_id": "NCT00926523_inc_T5", "normalized": [] }, { "id": "NCT00926523_inc_R4", "type": "Subsumes", "arg1_id": "NCT00926523_inc_T8", "arg2_id": "NCT00926523_inc_T10", "normalized": [] } ]

[ { "id": "NCT00931983_exc_text", "type": "exclusion", "text": [ "Other neuromuscular disease \nContraindication to weight bearing on lower extremities \nPressure sores where harness would be applied \nUncontrollable hypotension when upright \nLower limb contractures impeding range of motion necessary for ambulation \nPrior enrolment in a BWATT program \nUnable to commit to intervention for duration of protocol \n \n" ], "offsets": [ [ 0, 355 ] ] } ]

[ { "id": "NCT00931983_exc_T1", "type": "Condition", "text": [ "neuromuscular disease" ], "offsets": [ [ 6, 27 ] ], "normalized": [] }, { "id": "NCT00931983_exc_T2", "type": "Observation", "text": [ "weight bearing on lower extremities" ], "offsets": [ [ 49, 84 ] ], "normalized": [] }, { "id": "NCT00931983_exc_T3", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 29, 45 ] ], "normalized": [] }, { "id": "NCT00931983_exc_T4", "type": "Condition", "text": [ "Pressure sores" ], "offsets": [ [ 86, 100 ] ], "normalized": [] }, { "id": "NCT00931983_exc_T5", "type": "Device", "text": [ "harness" ], "offsets": [ [ 107, 114 ] ], "normalized": [] }, { "id": "NCT00931983_exc_T6", "type": "Condition", "text": [ "hypotension" ], "offsets": [ [ 148, 159 ] ], "normalized": [] }, { "id": "NCT00931983_exc_T7", "type": "Qualifier", "text": [ "Uncontrollable" ], "offsets": [ [ 133, 147 ] ], "normalized": [] }, { "id": "NCT00931983_exc_T8", "type": "Qualifier", "text": [ "when upright" ], "offsets": [ [ 160, 172 ] ], "normalized": [] }, { "id": "NCT00931983_exc_T9", "type": "Condition", "text": [ "Lower limb contractures" ], "offsets": [ [ 174, 197 ] ], "normalized": [] }, { "id": "NCT00931983_exc_T10", "type": "Mood", "text": [ "impeding" ], "offsets": [ [ 198, 206 ] ], "normalized": [] }, { "id": "NCT00931983_exc_T11", "type": "Observation", "text": [ "range of motion necessary for ambulation" ], "offsets": [ [ 207, 247 ] ], "normalized": [] } ]

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[]

[ { "id": "NCT00931983_exc_R2", "type": "AND", "arg1_id": "NCT00931983_exc_T4", "arg2_id": "NCT00931983_exc_T5", "normalized": [] }, { "id": "NCT00931983_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT00931983_exc_T6", "arg2_id": "NCT00931983_exc_T7", "normalized": [] }, { "id": "NCT00931983_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT00931983_exc_T6", "arg2_id": "NCT00931983_exc_T8", "normalized": [] }, { "id": "NCT00931983_exc_R5", "type": "Has_mood", "arg1_id": "NCT00931983_exc_T11", "arg2_id": "NCT00931983_exc_T10", "normalized": [] } ]

[ { "id": "NCT00931983_inc_text", "type": "inclusion", "text": [ "Children between the ages of 4-18 with incomplete ASIA C or D spinal cord injuries at least 12 months before study enrolment \nNon-ambulatory or 'exercise only' ambulators with or without assistive devices \nNormal motor and cognitive development up to time of injury \nMedical Stability \n" ], "offsets": [ [ 0, 286 ] ] } ]

[ { "id": "NCT00931983_inc_T1", "type": "Person", "text": [ "ages" ], "offsets": [ [ 21, 25 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T2", "type": "Value", "text": [ "4-18" ], "offsets": [ [ 29, 33 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T3", "type": "Person", "text": [ "Children" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T4", "type": "Condition", "text": [ "spinal cord injuries" ], "offsets": [ [ 62, 82 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T5", "type": "Measurement", "text": [ "ASIA" ], "offsets": [ [ 50, 54 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T6", "type": "Value", "text": [ "C or D" ], "offsets": [ [ 55, 61 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T7", "type": "Qualifier", "text": [ "incomplete" ], "offsets": [ [ 39, 49 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T8", "type": "Temporal", "text": [ "at least 12 months before study enrolment" ], "offsets": [ [ 83, 124 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T9", "type": "Reference_point", "text": [ "study enrolment" ], "offsets": [ [ 109, 124 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T10", "type": "Observation", "text": [ "Non-ambulatory" ], "offsets": [ [ 126, 140 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T11", "type": "Observation", "text": [ "'exercise only' ambulators" ], "offsets": [ [ 144, 170 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T12", "type": "Device", "text": [ "assistive devices" ], "offsets": [ [ 187, 204 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T13", "type": "Measurement", "text": [ "cognitive development" ], "offsets": [ [ 223, 244 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T14", "type": "Value", "text": [ "Normal" ], "offsets": [ [ 206, 212 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T15", "type": "Measurement", "text": [ "motor", "development" ], "offsets": [ [ 213, 218 ], [ 233, 244 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T16", "type": "Temporal", "text": [ "up to time of injury" ], "offsets": [ [ 245, 265 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T17", "type": "Reference_point", "text": [ "time of injury" ], "offsets": [ [ 251, 265 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T18", "type": "Scope", "text": [ "motor and cognitive development" ], "offsets": [ [ 213, 244 ] ], "normalized": [] }, { "id": "NCT00931983_inc_T19", "type": "Condition", "text": [ "Medical Stability" ], "offsets": [ [ 267, 284 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00931983_inc_R1", "type": "Has_value", "arg1_id": "NCT00931983_inc_T1", "arg2_id": "NCT00931983_inc_T2", "normalized": [] }, { "id": "NCT00931983_inc_R2", "type": "Has_value", "arg1_id": "NCT00931983_inc_T5", "arg2_id": "NCT00931983_inc_T6", "normalized": [] }, { "id": "NCT00931983_inc_R3", "type": "AND", "arg1_id": "NCT00931983_inc_T4", "arg2_id": "NCT00931983_inc_T5", "normalized": [] }, { "id": "NCT00931983_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT00931983_inc_T4", "arg2_id": "NCT00931983_inc_T7", "normalized": [] }, { "id": "NCT00931983_inc_R6", "type": "Has_temporal", "arg1_id": "NCT00931983_inc_T4", "arg2_id": "NCT00931983_inc_T8", "normalized": [] }, { "id": "NCT00931983_inc_R8", "type": "Has_value", "arg1_id": "NCT00931983_inc_T18", "arg2_id": "NCT00931983_inc_T14", "normalized": [] }, { "id": "NCT00931983_inc_R9", "type": "Has_temporal", "arg1_id": "NCT00931983_inc_T18", "arg2_id": "NCT00931983_inc_T16", "normalized": [] } ]

[ { "id": "NCT00943865_exc_text", "type": "exclusion", "text": [ "diabetes \nischemic heart disease or any abnormality on treadmill stress test \ninflammatory or chronic disorder \npregnancy \nlactation \ncreatinine level of 1,5 mg/dL or more \ngastrointestinal problems or musculoskeletal disorders that would prevent them to follow the test diets or exercise interventions \nliver dysfunction with a factor of at least 3 above the upper limit of normal in AST and ALT levels \nthyroid dysfunction, with serum TSH out of normal limits \nuse of immunosuppressive drugs, corticosteroids or anorexigen \n \n" ], "offsets": [ [ 0, 537 ] ] } ]

[ { "id": "NCT00943865_exc_T1", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T2", "type": "Condition", "text": [ "ischemic heart disease" ], "offsets": [ [ 10, 32 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T3", "type": "Measurement", "text": [ "treadmill stress test" ], "offsets": [ [ 55, 76 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T4", "type": "Value", "text": [ "abnormality" ], "offsets": [ [ 40, 51 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T5", "type": "Condition", "text": [ "disorder", "inflammatory" ], "offsets": [ [ 102, 110 ], [ 78, 90 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T6", "type": "Condition", "text": [ "chronic disorder" ], "offsets": [ [ 94, 110 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T7", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 112, 121 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T8", "type": "Condition", "text": [ "lactation" ], "offsets": [ [ 123, 132 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T9", "type": "Measurement", "text": [ "creatinine level" ], "offsets": [ [ 134, 150 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T10", "type": "Value", "text": [ "1,5 mg/dL or more" ], "offsets": [ [ 154, 171 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T11", "type": "Condition", "text": [ "gastrointestinal problems" ], "offsets": [ [ 173, 198 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T12", "type": "Condition", "text": [ "musculoskeletal disorders" ], "offsets": [ [ 202, 227 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T13", "type": "Mood", "text": [ "prevent" ], "offsets": [ [ 239, 246 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T14", "type": "Negation", "text": [ "prevent" ], "offsets": [ [ 239, 246 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T15", "type": "Procedure", "text": [ "test diets" ], "offsets": [ [ 266, 276 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T16", "type": "Procedure", "text": [ "exercise interventions" ], "offsets": [ [ 280, 302 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T17", "type": "Scope", "text": [ "test diets or exercise interventions" ], "offsets": [ [ 266, 302 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T18", "type": "Scope", "text": [ "gastrointestinal problems or musculoskeletal disorders" ], "offsets": [ [ 173, 227 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T19", "type": "Condition", "text": [ "liver dysfunction" ], "offsets": [ [ 304, 321 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T20", "type": "Value", "text": [ "factor of at least 3 above the upper limit of normal" ], "offsets": [ [ 329, 381 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T21", "type": "Measurement", "text": [ "AST", "levels" ], "offsets": [ [ 385, 388 ], [ 397, 403 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T22", "type": "Measurement", "text": [ "ALT levels" ], "offsets": [ [ 393, 403 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T23", "type": "Scope", "text": [ "AST and ALT levels" ], "offsets": [ [ 385, 403 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T24", "type": "Condition", "text": [ "thyroid dysfunction" ], "offsets": [ [ 405, 424 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T25", "type": "Measurement", "text": [ "serum TSH" ], "offsets": [ [ 431, 440 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T26", "type": "Value", "text": [ "out of normal limits" ], "offsets": [ [ 441, 461 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T27", "type": "Drug", "text": [ "immunosuppressive drugs" ], "offsets": [ [ 470, 493 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T28", "type": "Drug", "text": [ "corticosteroids" ], "offsets": [ [ 495, 510 ] ], "normalized": [] }, { "id": "NCT00943865_exc_T29", "type": "Drug", "text": [ "anorexigen" ], "offsets": [ [ 514, 524 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00943865_exc_R1", "type": "Has_value", "arg1_id": "NCT00943865_exc_T3", "arg2_id": "NCT00943865_exc_T4", "normalized": [] }, { "id": "NCT00943865_exc_R2", "type": "Has_value", "arg1_id": "NCT00943865_exc_T9", "arg2_id": "NCT00943865_exc_T10", "normalized": [] }, { "id": "NCT00943865_exc_R3", "type": "Has_negation", "arg1_id": "NCT00943865_exc_T17", "arg2_id": "NCT00943865_exc_T14", "normalized": [] }, { "id": "NCT00943865_exc_R5", "type": "Has_scope", "arg1_id": "NCT00943865_exc_T18", "arg2_id": "NCT00943865_exc_T17", "normalized": [] }, { "id": "NCT00943865_exc_R6", "type": "Has_scope", "arg1_id": "NCT00943865_exc_T19", "arg2_id": "NCT00943865_exc_T23", "normalized": [] }, { "id": "NCT00943865_exc_R7", "type": "Has_value", "arg1_id": "NCT00943865_exc_T23", "arg2_id": "NCT00943865_exc_T20", "normalized": [] }, { "id": "NCT00943865_exc_R8", "type": "Has_value", "arg1_id": "NCT00943865_exc_T25", "arg2_id": "NCT00943865_exc_T26", "normalized": [] }, { "id": "NCT00943865_exc_R9", "type": "AND", "arg1_id": "NCT00943865_exc_T24", "arg2_id": "NCT00943865_exc_T25", "normalized": [] } ]

[ { "id": "NCT00943865_inc_text", "type": "inclusion", "text": [ "men and women 30-55 years with BMI 30-40 and waist 95 cm or more \nnormal OGTT \nnormal treadmill stress test \nplus 2 of 4: \n1. low serum levels of HDL cholesterol (<40 mg⁄dL for men or < 50 mg ⁄dL for women); \n2. hypertriglyceridemia (triglyceride levels of 150 mg⁄dL or greater); \n3. impaired glucose homeostasis (fasting plasma glucose concentration of 110 mg⁄dL or greater or glucose of 140 mg⁄dL or greater after OGTT or \n4. hypertension (systolic blood pressure ≥ 140 or diastolic blood pressure ≥90 mmHg or treatment with antihypertensive drugs). \n" ], "offsets": [ [ 0, 553 ] ] } ]

[ { "id": "NCT00943865_inc_T1", "type": "Person", "text": [ "men" ], "offsets": [ [ 0, 3 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T2", "type": "Person", "text": [ "women" ], "offsets": [ [ 8, 13 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T3", "type": "Value", "text": [ "30-55 years" ], "offsets": [ [ 14, 25 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T4", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 31, 34 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T5", "type": "Value", "text": [ "30-40" ], "offsets": [ [ 35, 40 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T6", "type": "Measurement", "text": [ "waist" ], "offsets": [ [ 45, 50 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T7", "type": "Value", "text": [ "95 cm or more" ], "offsets": [ [ 51, 64 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T8", "type": "Person", "text": [ "30-55 years" ], "offsets": [ [ 14, 25 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T9", "type": "Measurement", "text": [ "OGTT" ], "offsets": [ [ 73, 77 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T10", "type": "Value", "text": [ "normal" ], "offsets": [ [ 66, 72 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T11", "type": "Measurement", "text": [ "treadmill stress test" ], "offsets": [ [ 86, 107 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T12", "type": "Value", "text": [ "normal" ], "offsets": [ [ 79, 85 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T13", "type": "Multiplier", "text": [ "2 of 4" ], "offsets": [ [ 114, 120 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T16", "type": "Measurement", "text": [ "serum levels of HDL cholesterol" ], "offsets": [ [ 130, 161 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T17", "type": "Value", "text": [ "low" ], "offsets": [ [ 126, 129 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T18", "type": "Value", "text": [ "<40 mg⁄dL" ], "offsets": [ [ 163, 172 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T19", "type": "Value", "text": [ "< 50 mg ⁄dL" ], "offsets": [ [ 184, 195 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T20", "type": "Person", "text": [ "men" ], "offsets": [ [ 177, 180 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T21", "type": "Person", "text": [ "women" ], "offsets": [ [ 200, 205 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T22", "type": "Scope", "text": [ "<40 mg⁄dL for men or < 50 mg ⁄dL for women" ], "offsets": [ [ 163, 205 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T23", "type": "Condition", "text": [ "hypertriglyceridemia" ], "offsets": [ [ 212, 232 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T24", "type": "Measurement", "text": [ "triglyceride levels" ], "offsets": [ [ 234, 253 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T25", "type": "Value", "text": [ "150 mg⁄dL or greater" ], "offsets": [ [ 257, 277 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T26", "type": "Scope", "text": [ "triglyceride levels of 150 mg⁄dL or greater" ], "offsets": [ [ 234, 277 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T27", "type": "Condition", "text": [ "impaired glucose homeostasis" ], "offsets": [ [ 284, 312 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T28", "type": "Measurement", "text": [ "fasting plasma glucose concentration" ], "offsets": [ [ 314, 350 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T29", "type": "Value", "text": [ "110 mg⁄dL or greater" ], "offsets": [ [ 354, 374 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T30", "type": "Measurement", "text": [ "glucose" ], "offsets": [ [ 378, 385 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T31", "type": "Value", "text": [ "140 mg⁄dL or greater" ], "offsets": [ [ 389, 409 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T32", "type": "Procedure", "text": [ "OGTT" ], "offsets": [ [ 416, 420 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T33", "type": "Temporal", "text": [ "after OGTT" ], "offsets": [ [ 410, 420 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T34", "type": "Reference_point", "text": [ "OGTT" ], "offsets": [ [ 416, 420 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T35", "type": "Scope", "text": [ "fasting plasma glucose concentration of 110 mg⁄dL or greater or glucose of 140 mg⁄dL or greater after OGTT" ], "offsets": [ [ 314, 420 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T36", "type": "Qualifier", "text": [ "after OGTT" ], "offsets": [ [ 410, 420 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T37", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 428, 440 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T38", "type": "Measurement", "text": [ "systolic blood pressure" ], "offsets": [ [ 442, 465 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T39", "type": "Value", "text": [ "≥ 140" ], "offsets": [ [ 466, 471 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T40", "type": "Measurement", "text": [ "diastolic blood pressure" ], "offsets": [ [ 475, 499 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T41", "type": "Value", "text": [ "≥90 mmHg" ], "offsets": [ [ 500, 508 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T42", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 512, 521 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T43", "type": "Drug", "text": [ "antihypertensive drugs" ], "offsets": [ [ 527, 549 ] ], "normalized": [] }, { "id": "NCT00943865_inc_T44", "type": "Scope", "text": [ "systolic blood pressure ≥ 140 or diastolic blood pressure ≥90 mmHg or treatment with antihypertensive drugs" ], "offsets": [ [ 442, 549 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00943865_inc_R1", "type": "Has_value", "arg1_id": "NCT00943865_inc_T4", "arg2_id": "NCT00943865_inc_T5", "normalized": [] }, { "id": "NCT00943865_inc_R2", "type": "Has_value", "arg1_id": "NCT00943865_inc_T6", "arg2_id": "NCT00943865_inc_T7", "normalized": [] }, { "id": "NCT00943865_inc_R3", "type": "Has_value", "arg1_id": "NCT00943865_inc_T8", "arg2_id": "NCT00943865_inc_T3", "normalized": [] }, { "id": "NCT00943865_inc_R5", "type": "Has_value", "arg1_id": "NCT00943865_inc_T9", "arg2_id": "NCT00943865_inc_T10", "normalized": [] }, { "id": "NCT00943865_inc_R6", "type": "Has_value", "arg1_id": "NCT00943865_inc_T11", "arg2_id": "NCT00943865_inc_T12", "normalized": [] }, { "id": "NCT00943865_inc_R7", "type": "Has_value", "arg1_id": "NCT00943865_inc_T16", "arg2_id": "NCT00943865_inc_T17", "normalized": [] }, { "id": "NCT00943865_inc_R8", "type": "Has_value", "arg1_id": "NCT00943865_inc_T20", "arg2_id": "NCT00943865_inc_T18", "normalized": [] }, { "id": "NCT00943865_inc_R9", "type": "Has_value", "arg1_id": "NCT00943865_inc_T21", "arg2_id": "NCT00943865_inc_T19", "normalized": [] }, { "id": "NCT00943865_inc_R10", "type": "Subsumes", "arg1_id": "NCT00943865_inc_T17", "arg2_id": "NCT00943865_inc_T22", "normalized": [] }, { "id": "NCT00943865_inc_R11", "type": "Has_value", "arg1_id": "NCT00943865_inc_T24", "arg2_id": "NCT00943865_inc_T25", "normalized": [] }, { "id": "NCT00943865_inc_R12", "type": "Subsumes", "arg1_id": "NCT00943865_inc_T23", "arg2_id": "NCT00943865_inc_T26", "normalized": [] }, { "id": "NCT00943865_inc_R13", "type": "Has_value", "arg1_id": "NCT00943865_inc_T28", "arg2_id": "NCT00943865_inc_T29", "normalized": [] }, { "id": "NCT00943865_inc_R16", "type": "Has_value", "arg1_id": "NCT00943865_inc_T30", "arg2_id": "NCT00943865_inc_T31", "normalized": [] }, { "id": "NCT00943865_inc_R18", "type": "Has_qualifier", "arg1_id": "NCT00943865_inc_T30", "arg2_id": "NCT00943865_inc_T36", "normalized": [] }, { "id": "NCT00943865_inc_R19", "type": "Subsumes", "arg1_id": "NCT00943865_inc_T27", "arg2_id": "NCT00943865_inc_T35", "normalized": [] }, { "id": "NCT00943865_inc_R20", "type": "AND", "arg1_id": "NCT00943865_inc_T42", "arg2_id": "NCT00943865_inc_T43", "normalized": [] }, { "id": "NCT00943865_inc_R21", "type": "Has_value", "arg1_id": "NCT00943865_inc_T40", "arg2_id": "NCT00943865_inc_T41", "normalized": [] }, { "id": "NCT00943865_inc_R22", "type": "Has_value", "arg1_id": "NCT00943865_inc_T38", "arg2_id": "NCT00943865_inc_T39", "normalized": [] }, { "id": "NCT00943865_inc_R23", "type": "Subsumes", "arg1_id": "NCT00943865_inc_T37", "arg2_id": "NCT00943865_inc_T44", "normalized": [] } ]

[ { "id": "NCT00954850_exc_text", "type": "exclusion", "text": [ "Malignancy and other significant medical conditions that will impact follow up within this program. \nThose less than 18 years of age. \nConcomitant interstitial lung disease, sarcoidosis, other significant lung disease. \nThose who have had a transplant. \nSignificant travel with work. \nUnable to make appointments (every three to six months over 2 years). \nThose residing in another country or planned absence for more than one month. \n \n" ], "offsets": [ [ 0, 446 ] ] } ]

[ { "id": "NCT00954850_exc_T1", "type": "Condition", "text": [ "Malignancy" ], "offsets": [ [ 0, 10 ] ], "normalized": [] }, { "id": "NCT00954850_exc_T2", "type": "Condition", "text": [ "medical conditions" ], "offsets": [ [ 33, 51 ] ], "normalized": [] }, { "id": "NCT00954850_exc_T3", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 21, 32 ] ], "normalized": [] }, { "id": "NCT00954850_exc_T4", "type": "Value", "text": [ "less than 18 years" ], "offsets": [ [ 107, 125 ] ], "normalized": [] }, { "id": "NCT00954850_exc_T5", "type": "Person", "text": [ "age" ], "offsets": [ [ 129, 132 ] ], "normalized": [] }, { "id": "NCT00954850_exc_T6", "type": "Condition", "text": [ "interstitial lung disease" ], "offsets": [ [ 147, 172 ] ], "normalized": [] }, { "id": "NCT00954850_exc_T7", "type": "Condition", "text": [ "sarcoidosis" ], "offsets": [ [ 174, 185 ] ], "normalized": [] }, { "id": "NCT00954850_exc_T8", "type": "Condition", "text": [ "lung disease" ], "offsets": [ [ 205, 217 ] ], "normalized": [] }, { "id": "NCT00954850_exc_T9", "type": "Temporal", "text": [ "Concomitant" ], "offsets": [ [ 135, 146 ] ], "normalized": [] }, { "id": "NCT00954850_exc_T10", "type": "Scope", "text": [ "interstitial lung disease, sarcoidosis, other significant lung disease" ], "offsets": [ [ 147, 217 ] ], "normalized": [] }, { "id": "NCT00954850_exc_T11", "type": "Procedure", "text": [ "transplant" ], "offsets": [ [ 241, 251 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00954850_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT00954850_exc_T2", "arg2_id": "NCT00954850_exc_T3", "normalized": [] }, { "id": "NCT00954850_exc_R2", "type": "Has_value", "arg1_id": "NCT00954850_exc_T5", "arg2_id": "NCT00954850_exc_T4", "normalized": [] }, { "id": "NCT00954850_exc_R3", "type": "Has_temporal", "arg1_id": "NCT00954850_exc_T10", "arg2_id": "NCT00954850_exc_T9", "normalized": [] } ]

[ { "id": "NCT00954850_inc_text", "type": "inclusion", "text": [ "Adults (18 and older) with physiologically confirmed SA or mild-moderate asthma and followed by an asthma specialist for at least 6 months. \nMust agree to have regular clinic visits (minimum 3-4 per year for SA, 1-2 for mild-moderate asthma). \nMust have good compliance with medications Patients with asthma and COPD. \n" ], "offsets": [ [ 0, 319 ] ] } ]

[ { "id": "NCT00954850_inc_T1", "type": "Value", "text": [ "18 and older" ], "offsets": [ [ 8, 20 ] ], "normalized": [] }, { "id": "NCT00954850_inc_T2", "type": "Person", "text": [ "Adults" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT00954850_inc_T3", "type": "Person", "text": [ "18 and older" ], "offsets": [ [ 8, 20 ] ], "normalized": [] }, { "id": "NCT00954850_inc_T4", "type": "Condition", "text": [ "SA" ], "offsets": [ [ 53, 55 ] ], "normalized": [] }, { "id": "NCT00954850_inc_T5", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 73, 79 ] ], "normalized": [] }, { "id": "NCT00954850_inc_T6", "type": "Qualifier", "text": [ "mild" ], "offsets": [ [ 59, 63 ] ], "normalized": [] }, { "id": "NCT00954850_inc_T7", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 64, 72 ] ], "normalized": [] }, { "id": "NCT00954850_inc_T8", "type": "Scope", "text": [ "mild-moderate" ], "offsets": [ [ 59, 72 ] ], "normalized": [] }, { "id": "NCT00954850_inc_T9", "type": "Observation", "text": [ "followed by an asthma specialist" ], "offsets": [ [ 84, 116 ] ], "normalized": [] }, { "id": "NCT00954850_inc_T10", "type": "Temporal", "text": [ "for at least 6 months" ], "offsets": [ [ 117, 138 ] ], "normalized": [] }, { "id": "NCT00954850_inc_T12", "type": "Condition", "text": [ "good compliance" ], "offsets": [ [ 254, 269 ] ], "normalized": [] }, { "id": "NCT00954850_inc_T13", "type": "Drug", "text": [ "medications" ], "offsets": [ [ 275, 286 ] ], "normalized": [] }, { "id": "NCT00954850_inc_T14", "type": "Condition", "text": [ "asthma" ], "offsets": [ [ 301, 307 ] ], "normalized": [] }, { "id": "NCT00954850_inc_T15", "type": "Condition", "text": [ "COPD" ], "offsets": [ [ 312, 316 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00954850_inc_R1", "type": "Has_value", "arg1_id": "NCT00954850_inc_T3", "arg2_id": "NCT00954850_inc_T1", "normalized": [] }, { "id": "NCT00954850_inc_R3", "type": "Subsumes", "arg1_id": "NCT00954850_inc_T2", "arg2_id": "NCT00954850_inc_T3", "normalized": [] }, { "id": "NCT00954850_inc_R4", "type": "Has_scope", "arg1_id": "NCT00954850_inc_T5", "arg2_id": "NCT00954850_inc_T8", "normalized": [] }, { "id": "NCT00954850_inc_R5", "type": "Has_temporal", "arg1_id": "NCT00954850_inc_T9", "arg2_id": "NCT00954850_inc_T10", "normalized": [] }, { "id": "NCT00954850_inc_R6", "type": "AND", "arg1_id": "NCT00954850_inc_T12", "arg2_id": "NCT00954850_inc_T13", "normalized": [] } ]

[ { "id": "NCT00959569_exc_text", "type": "exclusion", "text": [ "previous unusual response to esmolol\ninclusion in other randomized studies\nesmolol administration in the previous 30 days\nemergency operation\n" ], "offsets": [ [ 0, 142 ] ] } ]

[ { "id": "NCT00959569_exc_T1", "type": "Condition", "text": [ "unusual response" ], "offsets": [ [ 9, 25 ] ], "normalized": [] }, { "id": "NCT00959569_exc_T2", "type": "Drug", "text": [ "esmolol" ], "offsets": [ [ 29, 36 ] ], "normalized": [] }, { "id": "NCT00959569_exc_T4", "type": "Drug", "text": [ "esmolol" ], "offsets": [ [ 75, 82 ] ], "normalized": [] }, { "id": "NCT00959569_exc_T5", "type": "Temporal", "text": [ "in the previous 30 days" ], "offsets": [ [ 98, 121 ] ], "normalized": [] }, { "id": "NCT00959569_exc_T6", "type": "Procedure", "text": [ "operation" ], "offsets": [ [ 132, 141 ] ], "normalized": [] }, { "id": "NCT00959569_exc_T7", "type": "Qualifier", "text": [ "emergency" ], "offsets": [ [ 122, 131 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00959569_exc_R1", "type": "AND", "arg1_id": "NCT00959569_exc_T1", "arg2_id": "NCT00959569_exc_T2", "normalized": [] }, { "id": "NCT00959569_exc_R2", "type": "Has_temporal", "arg1_id": "NCT00959569_exc_T4", "arg2_id": "NCT00959569_exc_T5", "normalized": [] }, { "id": "NCT00959569_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT00959569_exc_T6", "arg2_id": "NCT00959569_exc_T7", "normalized": [] } ]

[ { "id": "NCT00959569_inc_text", "type": "inclusion", "text": [ "end diastolic diameter >60 mm and/or an ejection fraction <50%\nwritten informed consent\nage >18 years\n" ], "offsets": [ [ 0, 102 ] ] } ]

[ { "id": "NCT00959569_inc_T1", "type": "Measurement", "text": [ "end diastolic diameter" ], "offsets": [ [ 0, 22 ] ], "normalized": [] }, { "id": "NCT00959569_inc_T2", "type": "Value", "text": [ ">60 mm" ], "offsets": [ [ 23, 29 ] ], "normalized": [] }, { "id": "NCT00959569_inc_T3", "type": "Measurement", "text": [ "ejection fraction" ], "offsets": [ [ 40, 57 ] ], "normalized": [] }, { "id": "NCT00959569_inc_T4", "type": "Value", "text": [ "<50%" ], "offsets": [ [ 58, 62 ] ], "normalized": [] }, { "id": "NCT00959569_inc_T6", "type": "Person", "text": [ "age" ], "offsets": [ [ 88, 91 ] ], "normalized": [] }, { "id": "NCT00959569_inc_T7", "type": "Value", "text": [ ">18 years" ], "offsets": [ [ 92, 101 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00959569_inc_R1", "type": "Has_value", "arg1_id": "NCT00959569_inc_T1", "arg2_id": "NCT00959569_inc_T2", "normalized": [] }, { "id": "NCT00959569_inc_R2", "type": "Has_value", "arg1_id": "NCT00959569_inc_T3", "arg2_id": "NCT00959569_inc_T4", "normalized": [] }, { "id": "NCT00959569_inc_R3", "type": "Has_value", "arg1_id": "NCT00959569_inc_T6", "arg2_id": "NCT00959569_inc_T7", "normalized": [] } ]

[ { "id": "NCT00962364_exc_text", "type": "exclusion", "text": [ "none, all patients meeting the inclusion criteria will be eligible. \n \n" ], "offsets": [ [ 0, 80 ] ] } ]

[]

[]

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[ { "id": "NCT00962364_inc_text", "type": "inclusion", "text": [ "acute myocardial infarction or \nischemic cardiomyopathy with or without previous myocardial infarction or \ndilated cardiomyopathy due to valvular heart disease, hypertensive heart disease, history of myocarditis (no active myocardial infection present) \n" ], "offsets": [ [ 0, 254 ] ] } ]

[ { "id": "NCT00962364_inc_T1", "type": "Condition", "text": [ "acute myocardial infarction" ], "offsets": [ [ 0, 27 ] ], "normalized": [] }, { "id": "NCT00962364_inc_T2", "type": "Condition", "text": [ "ischemic cardiomyopathy" ], "offsets": [ [ 32, 55 ] ], "normalized": [] }, { "id": "NCT00962364_inc_T3", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 81, 102 ] ], "normalized": [] }, { "id": "NCT00962364_inc_T4", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 72, 80 ] ], "normalized": [] }, { "id": "NCT00962364_inc_T5", "type": "Scope", "text": [ "previous myocardial infarction" ], "offsets": [ [ 72, 102 ] ], "normalized": [] }, { "id": "NCT00962364_inc_T6", "type": "Condition", "text": [ "dilated cardiomyopathy" ], "offsets": [ [ 107, 129 ] ], "normalized": [] }, { "id": "NCT00962364_inc_T7", "type": "Condition", "text": [ "valvular heart disease" ], "offsets": [ [ 137, 159 ] ], "normalized": [] }, { "id": "NCT00962364_inc_T8", "type": "Condition", "text": [ "hypertensive heart disease" ], "offsets": [ [ 161, 187 ] ], "normalized": [] }, { "id": "NCT00962364_inc_T9", "type": "Condition", "text": [ "myocarditis" ], "offsets": [ [ 200, 211 ] ], "normalized": [] }, { "id": "NCT00962364_inc_T10", "type": "Observation", "text": [ "history" ], "offsets": [ [ 189, 196 ] ], "normalized": [] }, { "id": "NCT00962364_inc_T11", "type": "Condition", "text": [ "myocardial infection" ], "offsets": [ [ 223, 243 ] ], "normalized": [] }, { "id": "NCT00962364_inc_T12", "type": "Negation", "text": [ "no" ], "offsets": [ [ 213, 215 ] ], "normalized": [] }, { "id": "NCT00962364_inc_T13", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 216, 222 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT00962364_inc_R1", "type": "Has_temporal", "arg1_id": "NCT00962364_inc_T3", "arg2_id": "NCT00962364_inc_T4", "normalized": [] }, { "id": "NCT00962364_inc_R3", "type": "Has_temporal", "arg1_id": "NCT00962364_inc_T9", "arg2_id": "NCT00962364_inc_T10", "normalized": [] }, { "id": "NCT00962364_inc_R4", "type": "Has_temporal", "arg1_id": "NCT00962364_inc_T11", "arg2_id": "NCT00962364_inc_T13", "normalized": [] }, { "id": "NCT00962364_inc_R5", "type": "Has_negation", "arg1_id": "NCT00962364_inc_T11", "arg2_id": "NCT00962364_inc_T12", "normalized": [] }, { "id": "NCT00962364_inc_R6", "type": "AND", "arg1_id": "NCT00962364_inc_T9", "arg2_id": "NCT00962364_inc_T11", "normalized": [] } ]

[ { "id": "NCT00965900_exc_text", "type": "exclusion", "text": [ "Patients with systolic blood pressure <100 mmHg or basal heart rate <60/min\nPortal vein thrombosis\nUncontrolled ascites or hepatic encephalopathy\nSevere coagulation disorder: prothrombin time <40% (or INR >1.7) or platelet count <30,000/mm3\nMedium or large sized gastric or duodenal varices\nCoexisting malignancy\nSevere cardiovascular disorder, renal failure, peritonitis, sepsis\nSevere erosive esophagitis, severe esophageal stricture, active gastric or duodenal ulcer\nContraindication to beta-blocker\nPregnancy\nRefusal to give consent to participate in the trial\n" ], "offsets": [ [ 0, 565 ] ] } ]

[ { "id": "NCT00965900_exc_T1", "type": "Measurement", "text": [ "systolic blood pressure" ], "offsets": [ [ 14, 37 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T2", "type": "Value", "text": [ "<100 mmHg" ], "offsets": [ [ 38, 47 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T3", "type": "Measurement", "text": [ "heart rate" ], "offsets": [ [ 57, 67 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T4", "type": "Qualifier", "text": [ "basal" ], "offsets": [ [ 51, 56 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T5", "type": "Value", "text": [ "<60/min" ], "offsets": [ [ 68, 75 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T6", "type": "Condition", "text": [ "Portal vein thrombosis" ], "offsets": [ [ 76, 98 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T7", "type": "Condition", "text": [ "ascites" ], "offsets": [ [ 112, 119 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T8", "type": "Condition", "text": [ "hepatic encephalopathy" ], "offsets": [ [ 123, 145 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T9", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 99, 111 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T10", "type": "Condition", "text": [ "coagulation disorder" ], "offsets": [ [ 153, 173 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T11", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 146, 152 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T12", "type": "Measurement", "text": [ "prothrombin time" ], "offsets": [ [ 175, 191 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T13", "type": "Value", "text": [ "<40%" ], "offsets": [ [ 192, 196 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T14", "type": "Measurement", "text": [ "INR" ], "offsets": [ [ 201, 204 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T15", "type": "Value", "text": [ ">1.7" ], "offsets": [ [ 205, 209 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T16", "type": "Measurement", "text": [ "platelet count" ], "offsets": [ [ 214, 228 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T17", "type": "Value", "text": [ "<30,000/mm3" ], "offsets": [ [ 229, 240 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T18", "type": "Scope", "text": [ "prothrombin time <40% (or INR >1.7) or platelet count <30,000/mm3" ], "offsets": [ [ 175, 240 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T19", "type": "Condition", "text": [ "duodenal varices" ], "offsets": [ [ 274, 290 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T20", "type": "Condition", "text": [ "ric or", "C" ], "offsets": [ [ 267, 273 ], [ 291, 292 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T21", "type": "Qualifier", "text": [ "large" ], "offsets": [ [ 251, 256 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T22", "type": "Qualifier", "text": [ "Medium" ], "offsets": [ [ 241, 247 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T23", "type": "Scope", "text": [ "gastric or duodenal varices" ], "offsets": [ [ 263, 290 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T24", "type": "Scope", "text": [ "Medium or large" ], "offsets": [ [ 241, 256 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T25", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 302, 312 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T26", "type": "Qualifier", "text": [ "Coexisting" ], "offsets": [ [ 291, 301 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T27", "type": "Condition", "text": [ "cardiovascular disorder" ], "offsets": [ [ 320, 343 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T28", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 313, 319 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T29", "type": "Condition", "text": [ "renal failure" ], "offsets": [ [ 345, 358 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T30", "type": "Condition", "text": [ "peritonitis" ], "offsets": [ [ 360, 371 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T31", "type": "Condition", "text": [ "sepsis" ], "offsets": [ [ 373, 379 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T32", "type": "Condition", "text": [ "erosive esophagitis" ], "offsets": [ [ 387, 406 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T33", "type": "Condition", "text": [ "esophageal stricture" ], "offsets": [ [ 415, 435 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T34", "type": "Condition", "text": [ "duodenal ulcer" ], "offsets": [ [ 455, 469 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T35", "type": "Condition", "text": [ " or du", "ontra" ], "offsets": [ [ 451, 457 ], [ 471, 476 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T36", "type": "Qualifier", "text": [ "active" ], "offsets": [ [ 437, 443 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T37", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 408, 414 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T38", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 380, 386 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T39", "type": "Scope", "text": [ "gastric or duodenal ulcer" ], "offsets": [ [ 444, 469 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T40", "type": "Condition", "text": [ "Contraindication" ], "offsets": [ [ 470, 486 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T41", "type": "Drug", "text": [ "beta-blocker" ], "offsets": [ [ 490, 502 ] ], "normalized": [] }, { "id": "NCT00965900_exc_T42", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 503, 512 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00965900_exc_R1", "type": "Has_value", "arg1_id": "NCT00965900_exc_T1", "arg2_id": "NCT00965900_exc_T2", "normalized": [] }, { "id": "NCT00965900_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT00965900_exc_T3", "arg2_id": "NCT00965900_exc_T4", "normalized": [] }, { "id": "NCT00965900_exc_R3", "type": "Has_value", "arg1_id": "NCT00965900_exc_T3", "arg2_id": "NCT00965900_exc_T5", "normalized": [] }, { "id": "NCT00965900_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT00965900_exc_T7", "arg2_id": "NCT00965900_exc_T9", "normalized": [] }, { "id": "NCT00965900_exc_R5", "type": "Has_value", "arg1_id": "NCT00965900_exc_T14", "arg2_id": "NCT00965900_exc_T15", "normalized": [] }, { "id": "NCT00965900_exc_R6", "type": "Has_value", "arg1_id": "NCT00965900_exc_T16", "arg2_id": "NCT00965900_exc_T17", "normalized": [] }, { "id": "NCT00965900_exc_R7", "type": "Subsumes", "arg1_id": "NCT00965900_exc_T12", "arg2_id": "NCT00965900_exc_T14", "normalized": [] }, { "id": "NCT00965900_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT00965900_exc_T10", "arg2_id": "NCT00965900_exc_T11", "normalized": [] }, { "id": "NCT00965900_exc_R9", "type": "Has_scope", "arg1_id": "NCT00965900_exc_T10", "arg2_id": "NCT00965900_exc_T18", "normalized": [] }, { "id": "NCT00965900_exc_R10", "type": "Has_scope", "arg1_id": "NCT00965900_exc_T23", "arg2_id": "NCT00965900_exc_T24", "normalized": [] }, { "id": "NCT00965900_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT00965900_exc_T25", "arg2_id": "NCT00965900_exc_T26", "normalized": [] }, { "id": "NCT00965900_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT00965900_exc_T27", "arg2_id": "NCT00965900_exc_T28", "normalized": [] }, { "id": "NCT00965900_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT00965900_exc_T32", "arg2_id": "NCT00965900_exc_T38", "normalized": [] }, { "id": "NCT00965900_exc_R14", "type": "Has_qualifier", "arg1_id": "NCT00965900_exc_T33", "arg2_id": "NCT00965900_exc_T37", "normalized": [] }, { "id": "NCT00965900_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT00965900_exc_T39", "arg2_id": "NCT00965900_exc_T36", "normalized": [] }, { "id": "NCT00965900_exc_R16", "type": "AND", "arg1_id": "NCT00965900_exc_T40", "arg2_id": "NCT00965900_exc_T41", "normalized": [] }, { "id": "NCT00965900_exc_R17", "type": "Has_value", "arg1_id": "NCT00965900_exc_T12", "arg2_id": "NCT00965900_exc_T13", "normalized": [] } ]

[ { "id": "NCT00965900_inc_text", "type": "inclusion", "text": [ "Liver cirrhosis\nAge between 18 and 70 years\nEsophageal varices with high bleeding risk: more than F2 and red color sign\nNo previous history of upper gastrointestinal bleeding\nNo previous history of endoscopic, radiologic, or surgical therapy for varices or ascites\nDo not take beta-blocker, ACE inhibitor, or nitrate\nChild-Pugh score <12\n" ], "offsets": [ [ 0, 338 ] ] } ]

[ { "id": "NCT00965900_inc_T1", "type": "Condition", "text": [ "Liver cirrhosis" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T2", "type": "Person", "text": [ "Age" ], "offsets": [ [ 16, 19 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T3", "type": "Value", "text": [ "between 18 and 70 years" ], "offsets": [ [ 20, 43 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T4", "type": "Condition", "text": [ "Esophageal varices" ], "offsets": [ [ 44, 62 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T5", "type": "Observation", "text": [ "high bleeding risk" ], "offsets": [ [ 68, 86 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T6", "type": "Measurement", "text": [ "F2" ], "offsets": [ [ 98, 100 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T7", "type": "Multiplier", "text": [ "more than" ], "offsets": [ [ 88, 97 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T8", "type": "Condition", "text": [ "red color sign" ], "offsets": [ [ 105, 119 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T9", "type": "Scope", "text": [ "more than F2 and red color sign" ], "offsets": [ [ 88, 119 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T10", "type": "Negation", "text": [ "No" ], "offsets": [ [ 120, 122 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T11", "type": "Condition", "text": [ "upper gastrointestinal bleeding" ], "offsets": [ [ 143, 174 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T12", "type": "Negation", "text": [ "No" ], "offsets": [ [ 175, 177 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T13", "type": "Condition", "text": [ "varices" ], "offsets": [ [ 246, 253 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T14", "type": "Condition", "text": [ "ascites" ], "offsets": [ [ 257, 264 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T15", "type": "Procedure", "text": [ "surgical therapy" ], "offsets": [ [ 225, 241 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T16", "type": "Procedure", "text": [ "ologic, or", "apy for" ], "offsets": [ [ 214, 224 ], [ 238, 245 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T17", "type": "Procedure", "text": [ "scopic, ra", "apy for" ], "offsets": [ [ 202, 212 ], [ 238, 245 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T18", "type": "Scope", "text": [ "endoscopic, radiologic, or surgical therapy" ], "offsets": [ [ 198, 241 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T19", "type": "Negation", "text": [ "Do not" ], "offsets": [ [ 265, 271 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T20", "type": "Drug", "text": [ "beta-blocker" ], "offsets": [ [ 277, 289 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T21", "type": "Drug", "text": [ "ACE inhibitor" ], "offsets": [ [ 291, 304 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T22", "type": "Drug", "text": [ "nitrate" ], "offsets": [ [ 309, 316 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T23", "type": "Scope", "text": [ "beta-blocker, ACE inhibitor, or nitrate" ], "offsets": [ [ 277, 316 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T24", "type": "Measurement", "text": [ "Child-Pugh score" ], "offsets": [ [ 317, 333 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T25", "type": "Value", "text": [ "<12" ], "offsets": [ [ 334, 337 ] ], "normalized": [] }, { "id": "NCT00965900_inc_T26", "type": "Scope", "text": [ "varices or ascites" ], "offsets": [ [ 246, 264 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00965900_inc_R2", "type": "Has_multiplier", "arg1_id": "NCT00965900_inc_T6", "arg2_id": "NCT00965900_inc_T7", "normalized": [] }, { "id": "NCT00965900_inc_R3", "type": "Has_scope", "arg1_id": "NCT00965900_inc_T5", "arg2_id": "NCT00965900_inc_T9", "normalized": [] }, { "id": "NCT00965900_inc_R4", "type": "Has_negation", "arg1_id": "NCT00965900_inc_T23", "arg2_id": "NCT00965900_inc_T19", "normalized": [] }, { "id": "NCT00965900_inc_R5", "type": "Has_value", "arg1_id": "NCT00965900_inc_T24", "arg2_id": "NCT00965900_inc_T25", "normalized": [] }, { "id": "NCT00965900_inc_R6", "type": "Has_scope", "arg1_id": "NCT00965900_inc_T18", "arg2_id": "NCT00965900_inc_T26", "normalized": [] }, { "id": "NCT00965900_inc_R7", "type": "Has_negation", "arg1_id": "NCT00965900_inc_T18", "arg2_id": "NCT00965900_inc_T12", "normalized": [] }, { "id": "NCT00965900_inc_R8", "type": "Has_negation", "arg1_id": "NCT00965900_inc_T11", "arg2_id": "NCT00965900_inc_T10", "normalized": [] } ]

[ { "id": "NCT00970866_exc_text", "type": "exclusion", "text": [ "Known asthmatic or history of allergy towards peanut or milk products \nConcurrent participation in another clinical trial \nSevere illness warranting hospital referral \n \n" ], "offsets": [ [ 0, 179 ] ] } ]

[ { "id": "NCT00970866_exc_T1", "type": "Condition", "text": [ "asthmatic" ], "offsets": [ [ 6, 15 ] ], "normalized": [] }, { "id": "NCT00970866_exc_T2", "type": "Observation", "text": [ "history" ], "offsets": [ [ 19, 26 ] ], "normalized": [] }, { "id": "NCT00970866_exc_T3", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 30, 37 ] ], "normalized": [] }, { "id": "NCT00970866_exc_T4", "type": "Drug", "text": [ "peanut" ], "offsets": [ [ 46, 52 ] ], "normalized": [] }, { "id": "NCT00970866_exc_T5", "type": "Drug", "text": [ "milk products" ], "offsets": [ [ 56, 69 ] ], "normalized": [] }, { "id": "NCT00970866_exc_T6", "type": "Scope", "text": [ "peanut or milk products" ], "offsets": [ [ 46, 69 ] ], "normalized": [] }, { "id": "NCT00970866_exc_T8", "type": "Condition", "text": [ "illness" ], "offsets": [ [ 130, 137 ] ], "normalized": [] }, { "id": "NCT00970866_exc_T9", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 123, 129 ] ], "normalized": [] }, { "id": "NCT00970866_exc_T10", "type": "Procedure", "text": [ "hospital referral" ], "offsets": [ [ 149, 166 ] ], "normalized": [] }, { "id": "NCT00970866_exc_T11", "type": "Mood", "text": [ "warranting" ], "offsets": [ [ 138, 148 ] ], "normalized": [] }, { "id": "NCT00970866_exc_T7", "type": "Observation", "text": [ "participation in another clinical trial" ], "offsets": [ [ 82, 121 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00970866_exc_R2", "type": "Has_temporal", "arg1_id": "NCT00970866_exc_T3", "arg2_id": "NCT00970866_exc_T2", "normalized": [] }, { "id": "NCT00970866_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT00970866_exc_T8", "arg2_id": "NCT00970866_exc_T9", "normalized": [] }, { "id": "NCT00970866_exc_R4", "type": "Has_mood", "arg1_id": "NCT00970866_exc_T10", "arg2_id": "NCT00970866_exc_T11", "normalized": [] } ]

[ { "id": "NCT00970866_inc_text", "type": "inclusion", "text": [ "At least 18 years of age \nNo more than 20 wk of gestation \nGiven Ante-natal Cards of the Ghana Health Service \nCompleted the initial routine ante-natal examination at the clinics \nHIV negative or status unknown (as from the Ante-natal card) \nFree from chronic disease e.g. malignancy requiring frequent medical attention (as from the Ante-natal card) \nResiding in the Manya Krobo or Yilo Krobo district \nPrepared to sign an informed consent \nLiving in the area throughout the duration of the study \nAcceptance of home visitors \n" ], "offsets": [ [ 0, 528 ] ] } ]

[ { "id": "NCT00970866_inc_T1", "type": "Value", "text": [ "At least 18 years" ], "offsets": [ [ 0, 17 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 21, 24 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T3", "type": "Value", "text": [ "No more than 20 wk" ], "offsets": [ [ 26, 44 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T4", "type": "Measurement", "text": [ "gestation" ], "offsets": [ [ 48, 57 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T5", "type": "Condition", "text": [ "gestation" ], "offsets": [ [ 48, 57 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T7", "type": "Condition", "text": [ "routine ante-natal examination" ], "offsets": [ [ 133, 163 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T8", "type": "Visit", "text": [ "clinics" ], "offsets": [ [ 171, 178 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T9", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 180, 183 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T10", "type": "Negation", "text": [ "negative" ], "offsets": [ [ 184, 192 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T11", "type": "Qualifier", "text": [ "status unknown" ], "offsets": [ [ 196, 210 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T12", "type": "Scope", "text": [ "negative or status unknown" ], "offsets": [ [ 184, 210 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T13", "type": "Condition", "text": [ "chronic disease" ], "offsets": [ [ 252, 267 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T14", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 273, 283 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T15", "type": "Visit", "text": [ "Manya Krobo", "district" ], "offsets": [ [ 368, 379 ], [ 394, 402 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T16", "type": "Visit", "text": [ "Yilo Krobo district" ], "offsets": [ [ 383, 402 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T17", "type": "Observation", "text": [ "Residing" ], "offsets": [ [ 352, 360 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T18", "type": "Scope", "text": [ "Manya Krobo or Yilo Krobo district" ], "offsets": [ [ 368, 402 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T20", "type": "Observation", "text": [ "Living in the area" ], "offsets": [ [ 442, 460 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T21", "type": "Temporal", "text": [ "throughout the duration of the study" ], "offsets": [ [ 461, 497 ] ], "normalized": [] }, { "id": "NCT00970866_inc_T22", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 488, 497 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00970866_inc_R1", "type": "Has_value", "arg1_id": "NCT00970866_inc_T2", "arg2_id": "NCT00970866_inc_T1", "normalized": [] }, { "id": "NCT00970866_inc_R2", "type": "Has_value", "arg1_id": "NCT00970866_inc_T4", "arg2_id": "NCT00970866_inc_T3", "normalized": [] }, { "id": "NCT00970866_inc_R4", "type": "AND", "arg1_id": "NCT00970866_inc_T7", "arg2_id": "NCT00970866_inc_T8", "normalized": [] }, { "id": "NCT00970866_inc_R5", "type": "Has_scope", "arg1_id": "NCT00970866_inc_T9", "arg2_id": "NCT00970866_inc_T12", "normalized": [] }, { "id": "NCT00970866_inc_R6", "type": "Has_scope", "arg1_id": "NCT00970866_inc_T17", "arg2_id": "NCT00970866_inc_T18", "normalized": [] }, { "id": "NCT00970866_inc_R8", "type": "Has_temporal", "arg1_id": "NCT00970866_inc_T20", "arg2_id": "NCT00970866_inc_T21", "normalized": [] }, { "id": "NCT00970866_inc_R9", "type": "Subsumes", "arg1_id": "NCT00970866_inc_T13", "arg2_id": "NCT00970866_inc_T14", "normalized": [] } ]

[ { "id": "NCT00989261_exc_text", "type": "exclusion", "text": [ "1. Patients over the age of 85 years except at the discretion of the Investigator and with agreement of the Sponsor. \n2. Diagnosis of acute promyelocytic leukemia \n3. Diagnosis of chronic myelogenous leukemia (CML) in blast crisis \n4. AML in relapse or refractory after 3 or more previous lines of chemotherapy (and/or HSCT) treatment \n5. AML or antecedent MDS secondary to prior chemotherapy \n6. Persistent clinically significant non-hematological toxicity that is Grade >1 by NCI CTCAE v4 from prior chemotherapy \n7. Patients who have had HSCT and are within 100 days of transplant and/or are still taking immunosuppressive drugs and/or have clinically significant graft-versus-host disease requiring treatment and/or have >Grade 1 persistent non hematological toxicity related to the transplant \n8. Clinically active central nervous system (CNS) leukemia. Patients with CNS leukemia, which is controlled, but who are still receiving IT therapy at study entry may be considered eligible and continue receive IT therapy at the discretion of the Investigator and with agreement of the Sponsor. \n9. Patients who have previously received AC220 \n10. Disseminated intravascular coagulation (DIC) (diagnosis by laboratory or clinical assessment) \n11. Major surgery within 4 weeks prior to enrollment in the study \n12. Radiation therapy within 4 weeks prior to, or concurrent with study \n13. Use of concomitant drugs that prolong QT/QTc interval and/or are CYP3A4 inhibitors are prohibited with the exception of antibiotics, antifungals, and other antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient. \n14. Uncontrolled or significant cardiovascular disease \n15. Women who are pregnant, lactating, or unwilling to use contraception if of childbearing potential \n16. Men who are unwilling to use contraception if their partners are of childbearing potential \n17. Active, uncontrolled infection \n18. Human immunodeficiency virus positivity \n19. Active hepatitis B or C or other active liver disease \n20. History of cancer, except Stage 1 cervix or nonmelanotic skin cancer, with the possible exception of patients in complete remission \n \n" ], "offsets": [ [ 0, 2257 ] ] } ]

[ { "id": "NCT00989261_exc_T1", "type": "Value", "text": [ "over the age of 85 years" ], "offsets": [ [ 12, 36 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 21, 24 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T5", "type": "Condition", "text": [ "acute promyelocytic leukemia" ], "offsets": [ [ 134, 162 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T6", "type": "Condition", "text": [ "chronic myelogenous leukemia (CML)" ], "offsets": [ [ 180, 214 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T7", "type": "Condition", "text": [ "blast crisis" ], "offsets": [ [ 218, 230 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T8", "type": "Condition", "text": [ "AML" ], "offsets": [ [ 235, 238 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T9", "type": "Qualifier", "text": [ "in relapse" ], "offsets": [ [ 239, 249 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T10", "type": "Qualifier", "text": [ "refractory" ], "offsets": [ [ 253, 263 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T11", "type": "Temporal", "text": [ "after 3 or more previous lines of chemotherapy" ], "offsets": [ [ 264, 310 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T12", "type": "Multiplier", "text": [ "3 or more" ], "offsets": [ [ 270, 279 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T13", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 280, 288 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T14", "type": "Procedure", "text": [ "lines of chemotherapy" ], "offsets": [ [ 289, 310 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T15", "type": "Scope", "text": [ "in relapse or refractory" ], "offsets": [ [ 239, 263 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T16", "type": "Condition", "text": [ "AML" ], "offsets": [ [ 339, 342 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T17", "type": "Condition", "text": [ "MDS" ], "offsets": [ [ 357, 360 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T18", "type": "Temporal", "text": [ "antecedent" ], "offsets": [ [ 346, 356 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T20", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 374, 379 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T21", "type": "Condition", "text": [ "chemotherapy" ], "offsets": [ [ 380, 392 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T19", "type": "Scope", "text": [ "AML or antecedent MDS" ], "offsets": [ [ 339, 360 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T22", "type": "Condition", "text": [ "toxicity" ], "offsets": [ [ 449, 457 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T23", "type": "Qualifier", "text": [ "non-hematological" ], "offsets": [ [ 431, 448 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T24", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 408, 430 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T26", "type": "Value", "text": [ "Grade >1" ], "offsets": [ [ 466, 474 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T27", "type": "Measurement", "text": [ "NCI CTCAE v4" ], "offsets": [ [ 478, 490 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T28", "type": "Qualifier", "text": [ "Grade >1 by NCI CTCAE v4" ], "offsets": [ [ 466, 490 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T29", "type": "Procedure", "text": [ "chemotherapy" ], "offsets": [ [ 502, 514 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T30", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 496, 501 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T31", "type": "Temporal", "text": [ "within 100 days of transplant" ], "offsets": [ [ 554, 583 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T32", "type": "Condition", "text": [ "HSCT" ], "offsets": [ [ 541, 545 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T33", "type": "Temporal", "text": [ "have had" ], "offsets": [ [ 532, 540 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T34", "type": "Procedure", "text": [ "transplant" ], "offsets": [ [ 573, 583 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T35", "type": "Reference_point", "text": [ "transplant" ], "offsets": [ [ 573, 583 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T36", "type": "Drug", "text": [ "immunosuppressive drugs" ], "offsets": [ [ 608, 631 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T37", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 644, 666 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T39", "type": "Condition", "text": [ "graft-versus-host disease" ], "offsets": [ [ 667, 692 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T40", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 703, 712 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T41", "type": "Mood", "text": [ "requiring" ], "offsets": [ [ 693, 702 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T42", "type": "Qualifier", "text": [ ">Grade 1" ], "offsets": [ [ 725, 733 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T43", "type": "Qualifier", "text": [ "non hematological" ], "offsets": [ [ 745, 762 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T44", "type": "Qualifier", "text": [ "persistent" ], "offsets": [ [ 734, 744 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T45", "type": "Multiplier", "text": [ "persistent" ], "offsets": [ [ 734, 744 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T46", "type": "Condition", "text": [ "toxicity" ], "offsets": [ [ 763, 771 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T47", "type": "Procedure", "text": [ "transplant" ], "offsets": [ [ 787, 797 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T48", "type": "Temporal", "text": [ "still" ], "offsets": [ [ 595, 600 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T49", "type": "Condition", "text": [ "central nervous system (CNS) leukemia" ], "offsets": [ [ 820, 857 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T51", "type": "Drug", "text": [ "AC220" ], "offsets": [ [ 1136, 1141 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T52", "type": "Condition", "text": [ "Disseminated intravascular coagulation (DIC)" ], "offsets": [ [ 1147, 1191 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T53", "type": "Procedure", "text": [ "Major surgery" ], "offsets": [ [ 1246, 1259 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T54", "type": "Temporal", "text": [ "within 4 weeks prior to enrollment" ], "offsets": [ [ 1260, 1294 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T55", "type": "Reference_point", "text": [ "enrollment" ], "offsets": [ [ 1284, 1294 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T56", "type": "Procedure", "text": [ "Radiation therapy" ], "offsets": [ [ 1313, 1330 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T57", "type": "Temporal", "text": [ "within 4 weeks prior to", "study" ], "offsets": [ [ 1331, 1354 ], [ 1375, 1380 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T58", "type": "Temporal", "text": [ "concurrent with study" ], "offsets": [ [ 1359, 1380 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T59", "type": "Reference_point", "text": [ "study" ], "offsets": [ [ 1375, 1380 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T60", "type": "Scope", "text": [ "within 4 weeks prior to, or concurrent with study" ], "offsets": [ [ 1331, 1380 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T61", "type": "Condition", "text": [ "prolong QT/QTc interval" ], "offsets": [ [ 1416, 1439 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T62", "type": "Drug", "text": [ "drugs that prolong QT/QTc interval" ], "offsets": [ [ 1405, 1439 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T63", "type": "Drug", "text": [ "CYP3A4 inhibitors" ], "offsets": [ [ 1451, 1468 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T64", "type": "Drug", "text": [ "antibiotics" ], "offsets": [ [ 1506, 1517 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T65", "type": "Drug", "text": [ "antifungals" ], "offsets": [ [ 1519, 1530 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T66", "type": "Drug", "text": [ "antimicrobials" ], "offsets": [ [ 1542, 1556 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T67", "type": "Qualifier", "text": [ "that prolong QT/QTc interval" ], "offsets": [ [ 1411, 1439 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T68", "type": "Negation", "text": [ "with the exception of" ], "offsets": [ [ 1484, 1505 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T69", "type": "Scope", "text": [ "antibiotics, antifungals, and other antimicrobials" ], "offsets": [ [ 1506, 1556 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T70", "type": "Scope", "text": [ "drugs that prolong QT/QTc interval and/or are CYP3A4 inhibitors" ], "offsets": [ [ 1405, 1468 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T71", "type": "Condition", "text": [ "cardiovascular disease" ], "offsets": [ [ 1746, 1768 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T72", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 1718, 1730 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T73", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 1734, 1745 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T74", "type": "Scope", "text": [ "Uncontrolled or significant" ], "offsets": [ [ 1718, 1745 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T75", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 1788, 1796 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T76", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 1798, 1807 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T77", "type": "Mood", "text": [ "unwilling" ], "offsets": [ [ 1812, 1821 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T78", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 1849, 1871 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T79", "type": "Condition", "text": [ "contraception" ], "offsets": [ [ 1829, 1842 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T80", "type": "Person", "text": [ "Men" ], "offsets": [ [ 1877, 1880 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T81", "type": "Mood", "text": [ "unwilling" ], "offsets": [ [ 1889, 1898 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T82", "type": "Drug", "text": [ "contraception" ], "offsets": [ [ 1906, 1919 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T83", "type": "Observation", "text": [ "their partners are of childbearing potential" ], "offsets": [ [ 1923, 1967 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T85", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 1994, 2003 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T86", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 1981, 1993 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T87", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 1973, 1979 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T88", "type": "Condition", "text": [ "Human immunodeficiency virus" ], "offsets": [ [ 2009, 2037 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T89", "type": "Measurement", "text": [ "Human immunodeficiency virus" ], "offsets": [ [ 2009, 2037 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T90", "type": "Value", "text": [ "positivity" ], "offsets": [ [ 2038, 2048 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T91", "type": "Condition", "text": [ "hepatitis B" ], "offsets": [ [ 2061, 2072 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T92", "type": "Condition", "text": [ "hepatitis", "C" ], "offsets": [ [ 2061, 2070 ], [ 2076, 2077 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T93", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 2054, 2060 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T94", "type": "Condition", "text": [ "liver disease" ], "offsets": [ [ 2094, 2107 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T95", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 2087, 2093 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T96", "type": "Scope", "text": [ "hepatitis B or C" ], "offsets": [ [ 2061, 2077 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T97", "type": "Condition", "text": [ "cancer" ], "offsets": [ [ 2124, 2130 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T98", "type": "Observation", "text": [ "History" ], "offsets": [ [ 2113, 2120 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T99", "type": "Condition", "text": [ "skin cancer" ], "offsets": [ [ 2170, 2181 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T100", "type": "Qualifier", "text": [ "nonmelanotic" ], "offsets": [ [ 2157, 2169 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T101", "type": "Qualifier", "text": [ "Stage 1 cervix" ], "offsets": [ [ 2139, 2153 ] ], "normalized": [] }, { "id": "NCT00989261_exc_T102", "type": "Negation", "text": [ "except" ], "offsets": [ [ 2132, 2138 ] ], "normalized": [] } ]

[]

[]

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"NCT00989261_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT00989261_exc_T22", "arg2_id": "NCT00989261_exc_T23", "normalized": [] }, { "id": "NCT00989261_exc_R11", "type": "Has_qualifier", "arg1_id": "NCT00989261_exc_T22", "arg2_id": "NCT00989261_exc_T24", "normalized": [] }, { "id": "NCT00989261_exc_R12", "type": "Has_value", "arg1_id": "NCT00989261_exc_T27", "arg2_id": "NCT00989261_exc_T26", "normalized": [] }, { "id": "NCT00989261_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT00989261_exc_T22", "arg2_id": "NCT00989261_exc_T28", "normalized": [] }, { "id": "NCT00989261_exc_R14", "type": "Has_temporal", "arg1_id": "NCT00989261_exc_T29", "arg2_id": "NCT00989261_exc_T30", "normalized": [] }, { "id": "NCT00989261_exc_R17", "type": "Has_temporal", "arg1_id": "NCT00989261_exc_T32", "arg2_id": "NCT00989261_exc_T33", "normalized": [] }, { "id": "NCT00989261_exc_R20", "type": "Has_mood", "arg1_id": "NCT00989261_exc_T40", "arg2_id": "NCT00989261_exc_T41", "normalized": [] }, { "id": "NCT00989261_exc_R21", "type": "AND", "arg1_id": "NCT00989261_exc_T39", "arg2_id": "NCT00989261_exc_T40", "normalized": [] }, { "id": "NCT00989261_exc_R22", "type": "Has_qualifier", "arg1_id": "NCT00989261_exc_T39", "arg2_id": "NCT00989261_exc_T37", "normalized": [] }, { "id": "NCT00989261_exc_R24", "type": "Has_qualifier", "arg1_id": "NCT00989261_exc_T46", "arg2_id": "NCT00989261_exc_T43", "normalized": [] }, { "id": "NCT00989261_exc_R25", "type": "Has_qualifier", "arg1_id": "NCT00989261_exc_T46", "arg2_id": "NCT00989261_exc_T44", "normalized": [] }, { "id": "NCT00989261_exc_R27", "type": "Has_qualifier", "arg1_id": "NCT00989261_exc_T46", "arg2_id": "NCT00989261_exc_T42", "normalized": [] }, { "id": "NCT00989261_exc_R28", "type": "Has_temporal", "arg1_id": "NCT00989261_exc_T36", "arg2_id": "NCT00989261_exc_T48", "normalized": [] }, { "id": "NCT00989261_exc_R33", "type": "Has_temporal", "arg1_id": "NCT00989261_exc_T53", "arg2_id": "NCT00989261_exc_T54", "normalized": [] }, { "id": "NCT00989261_exc_R36", "type": "Has_scope", "arg1_id": "NCT00989261_exc_T56", "arg2_id": "NCT00989261_exc_T60", "normalized": [] }, { "id": "NCT00989261_exc_R39", "type": "Has_negation", "arg1_id": "NCT00989261_exc_T69", "arg2_id": "NCT00989261_exc_T68", "normalized": [] }, { "id": "NCT00989261_exc_R40", "type": "Has_scope", "arg1_id": "NCT00989261_exc_T70", "arg2_id": "NCT00989261_exc_T69", "normalized": [] }, { "id": "NCT00989261_exc_R41", "type": "Has_scope", "arg1_id": "NCT00989261_exc_T71", "arg2_id": "NCT00989261_exc_T74", "normalized": [] }, { "id": "NCT00989261_exc_R42", "type": "Has_mood", "arg1_id": "NCT00989261_exc_T79", "arg2_id": "NCT00989261_exc_T77", "normalized": [] }, { "id": "NCT00989261_exc_R43", "type": "AND", "arg1_id": "NCT00989261_exc_T78", "arg2_id": "NCT00989261_exc_T79", "normalized": [] }, { "id": "NCT00989261_exc_R44", "type": "Has_mood", "arg1_id": "NCT00989261_exc_T82", "arg2_id": "NCT00989261_exc_T81", "normalized": [] }, { "id": "NCT00989261_exc_R45", "type": "AND", "arg1_id": "NCT00989261_exc_T83", "arg2_id": "NCT00989261_exc_T82", "normalized": [] }, { "id": "NCT00989261_exc_R46", "type": "Has_qualifier", "arg1_id": "NCT00989261_exc_T85", "arg2_id": "NCT00989261_exc_T86", "normalized": [] }, { "id": "NCT00989261_exc_R47", "type": "Has_temporal", "arg1_id": "NCT00989261_exc_T85", "arg2_id": "NCT00989261_exc_T87", "normalized": [] }, { "id": "NCT00989261_exc_R48", "type": "Has_value", "arg1_id": "NCT00989261_exc_T89", "arg2_id": "NCT00989261_exc_T90", "normalized": [] }, { "id": "NCT00989261_exc_R50", "type": "Has_temporal", "arg1_id": "NCT00989261_exc_T94", "arg2_id": "NCT00989261_exc_T95", "normalized": [] }, { "id": "NCT00989261_exc_R51", "type": "Has_temporal", "arg1_id": "NCT00989261_exc_T96", "arg2_id": "NCT00989261_exc_T93", "normalized": [] }, { "id": "NCT00989261_exc_R52", "type": "Has_temporal", "arg1_id": "NCT00989261_exc_T97", "arg2_id": "NCT00989261_exc_T98", "normalized": [] }, { "id": "NCT00989261_exc_R53", "type": "Has_qualifier", "arg1_id": "NCT00989261_exc_T99", "arg2_id": "NCT00989261_exc_T100", "normalized": [] }, { "id": "NCT00989261_exc_R54", "type": "Has_qualifier", "arg1_id": "NCT00989261_exc_T99", "arg2_id": "NCT00989261_exc_T101", "normalized": [] }, { "id": "NCT00989261_exc_R55", "type": "Has_negation", "arg1_id": "NCT00989261_exc_T99", "arg2_id": "NCT00989261_exc_T102", "normalized": [] }, { "id": "NCT00989261_exc_R56", "type": "AND", "arg1_id": "NCT00989261_exc_T97", "arg2_id": "NCT00989261_exc_T99", "normalized": [] } ]

[ { "id": "NCT00989261_inc_text", "type": "inclusion", "text": [ "1. Males and females age ≥18 years in second relapse or refractory. \n2. Males and females age ≥60 years in first relapse or refractory. \n3. Must have baseline bone marrow sample taken. \n4. Morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS with ≥20% bone marrow or peripheral blasts), as defined by the World Health Organization (WHO) criteria, confirmed by pathology review at treating institution. \n5. Able to swallow the liquid study drug. \n6. ECOG performance status of 0 to 2 \n7. In the absence of rapidly progressing disease, the interval from prior treatment to time of AC220 administration will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. The use of chemotherapeutic or antileukemic agents other than hydroxyurea is not permitted during the study with the possible exception of intrathecal (IT) therapy at the discretion of the Investigator and with the agreement of the Sponsor. \n8. Persistent chronic clinically significant non-hematological toxicities from prior treatment must be ≤Grade 1. \n9. Prior therapy with FLT3 inhibitors is permitted, except previous treatment with AC220. \n10. Serum creatinine ≤1.5 × ULN and glomerular filtration rate (GFR) > 30 mL/min \n11. Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits. \n12. Total serum bilirubin ≤1.5 × ULN \n13. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5 × ULN \n14. Females of childbearing potential must have a negative pregnancy test (urine β-hCG). \n15. Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study. \n16. Written informed consent must be provided. \n" ], "offsets": [ [ 0, 1779 ] ] } ]

[ { "id": "NCT00989261_inc_T1", "type": "Person", "text": [ "Males" ], "offsets": [ [ 3, 8 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T2", "type": "Person", "text": [ "females" ], "offsets": [ [ 13, 20 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T3", "type": "Person", "text": [ "age" ], "offsets": [ [ 21, 24 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T4", "type": "Value", "text": [ "≥18 years" ], "offsets": [ [ 25, 34 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T5", "type": "Condition", "text": [ "relapse" ], "offsets": [ [ 45, 52 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T6", "type": "Condition", "text": [ "refractory" ], "offsets": [ [ 56, 66 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T7", "type": "Scope", "text": [ "relapse or refractory" ], "offsets": [ [ 45, 66 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T8", "type": "Multiplier", "text": [ "second" ], "offsets": [ [ 38, 44 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T9", "type": "Person", "text": [ "Males" ], "offsets": [ [ 72, 77 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T10", "type": "Person", "text": [ "females" ], "offsets": [ [ 82, 89 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T11", "type": "Person", "text": [ "age" ], "offsets": [ [ 90, 93 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T12", "type": "Value", "text": [ "≥60 years" ], "offsets": [ [ 94, 103 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T13", "type": "Multiplier", "text": [ "first" ], "offsets": [ [ 107, 112 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T14", "type": "Condition", "text": [ "relapse" ], "offsets": [ [ 113, 120 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T15", "type": "Condition", "text": [ "refractory" ], "offsets": [ [ 124, 134 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T16", "type": "Scope", "text": [ "relapse or refractory" ], "offsets": [ [ 113, 134 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T17", "type": "Procedure", "text": [ "bone marrow sample" ], "offsets": [ [ 159, 177 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T18", "type": "Temporal", "text": [ "baseline" ], "offsets": [ [ 150, 158 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T19", "type": "Qualifier", "text": [ "Morphologically documented" ], "offsets": [ [ 189, 215 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T20", "type": "Qualifier", "text": [ "primary" ], "offsets": [ [ 216, 223 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T21", "type": "Condition", "text": [ "AML" ], "offsets": [ [ 224, 227 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T22", "type": "Condition", "text": [ "AML" ], "offsets": [ [ 231, 234 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T23", "type": "Condition", "text": [ "myelodysplastic syndrome" ], "offsets": [ [ 248, 272 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T24", "type": "Condition", "text": [ "MDS" ], "offsets": [ [ 274, 277 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T25", "type": "Value", "text": [ "≥20%" ], "offsets": [ [ 283, 287 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T26", "type": "Measurement", "text": [ "bone marrow" ], "offsets": [ [ 288, 299 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T27", "type": "Measurement", "text": [ "peripheral blasts" ], "offsets": [ [ 303, 320 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T28", "type": "Scope", "text": [ "bone marrow or peripheral blasts" ], "offsets": [ [ 288, 320 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T29", "type": "Procedure", "text": [ "World Health Organization (WHO) criteria" ], "offsets": [ [ 341, 381 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T30", "type": "Procedure", "text": [ "pathology review" ], "offsets": [ [ 396, 412 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T33", "type": "Measurement", "text": [ "ECOG performance status" ], "offsets": [ [ 485, 508 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T34", "type": "Value", "text": [ "0 to 2" ], "offsets": [ [ 512, 518 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T36", "type": "Condition", "text": [ "toxicities" ], "offsets": [ [ 1037, 1047 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T37", "type": "Qualifier", "text": [ "non-hematological" ], "offsets": [ [ 1019, 1036 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T38", "type": "Qualifier", "text": [ "clinically significant" ], "offsets": [ [ 996, 1018 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T39", "type": "Temporal", "text": [ "prior" ], "offsets": [ [ 1053, 1058 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T40", "type": "Qualifier", "text": [ "≤Grade 1" ], "offsets": [ [ 1077, 1085 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T41", "type": "Value", "text": [ "≤Grade 1" ], "offsets": [ [ 1077, 1085 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T42", "type": "Qualifier", "text": [ "from prior treatment" ], "offsets": [ [ 1048, 1068 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T43", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1059, 1068 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T44", "type": "Drug", "text": [ "FLT3 inhibitors" ], "offsets": [ [ 1110, 1125 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T45", "type": "Mood", "text": [ "permitted" ], "offsets": [ [ 1129, 1138 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T46", "type": "Procedure", "text": [ "therapy" ], "offsets": [ [ 1097, 1104 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T47", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1156, 1165 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T48", "type": "Drug", "text": [ "AC220" ], "offsets": [ [ 1171, 1176 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T49", "type": "Negation", "text": [ "except" ], "offsets": [ [ 1140, 1146 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T50", "type": "Measurement", "text": [ "Serum creatinine" ], "offsets": [ [ 1183, 1199 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T51", "type": "Value", "text": [ "≤1.5 × ULN" ], "offsets": [ [ 1200, 1210 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T52", "type": "Measurement", "text": [ "glomerular filtration rate (GFR)" ], "offsets": [ [ 1215, 1247 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T53", "type": "Value", "text": [ "> 30 mL/min" ], "offsets": [ [ 1248, 1259 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T54", "type": "Measurement", "text": [ "Serum potassium" ], "offsets": [ [ 1265, 1280 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T55", "type": "Measurement", "text": [ "Serum", "magnesium" ], "offsets": [ [ 1265, 1270 ], [ 1282, 1291 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T56", "type": "Measurement", "text": [ "Serum", "calcium" ], "offsets": [ [ 1265, 1270 ], [ 1297, 1304 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T57", "type": "Value", "text": [ "at least within institutional normal limits" ], "offsets": [ [ 1322, 1365 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T58", "type": "Scope", "text": [ "Serum potassium, magnesium, and calcium" ], "offsets": [ [ 1265, 1304 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T59", "type": "Measurement", "text": [ "Total serum bilirubin" ], "offsets": [ [ 1372, 1393 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T60", "type": "Value", "text": [ "≤1.5 × ULN" ], "offsets": [ [ 1394, 1404 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T61", "type": "Measurement", "text": [ "Serum aspartate transaminase (AST)" ], "offsets": [ [ 1410, 1444 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T62", "type": "Measurement", "text": [ "alanine transaminase (ALT)" ], "offsets": [ [ 1452, 1478 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T63", "type": "Value", "text": [ "≤2.5 × ULN" ], "offsets": [ [ 1479, 1489 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T64", "type": "Measurement", "text": [ "pregnancy test" ], "offsets": [ [ 1550, 1564 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T65", "type": "Value", "text": [ "negative" ], "offsets": [ [ 1541, 1549 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T66", "type": "Procedure", "text": [ "urine β-hCG" ], "offsets": [ [ 1566, 1577 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T67", "type": "Person", "text": [ "Females" ], "offsets": [ [ 1495, 1502 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T68", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 1506, 1528 ] ], "normalized": [] }, { "id": "NCT00989261_inc_T69", "type": "Scope", "text": [ "Females of childbearing potential" ], "offsets": [ [ 1495, 1528 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00989261_inc_R1", "type": "Has_multiplier", "arg1_id": "NCT00989261_inc_T7", "arg2_id": "NCT00989261_inc_T8", "normalized": [] }, { "id": "NCT00989261_inc_R2", "type": "Has_value", "arg1_id": "NCT00989261_inc_T3", "arg2_id": "NCT00989261_inc_T4", "normalized": [] }, { "id": "NCT00989261_inc_R3", "type": "Has_value", "arg1_id": "NCT00989261_inc_T11", "arg2_id": "NCT00989261_inc_T12", "normalized": [] }, { "id": "NCT00989261_inc_R4", "type": "Has_multiplier", "arg1_id": "NCT00989261_inc_T16", "arg2_id": "NCT00989261_inc_T13", "normalized": [] }, { "id": "NCT00989261_inc_R5", "type": "Has_temporal", "arg1_id": "NCT00989261_inc_T17", "arg2_id": "NCT00989261_inc_T18", "normalized": [] }, { "id": "NCT00989261_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT00989261_inc_T21", "arg2_id": "NCT00989261_inc_T20", "normalized": [] }, { "id": "NCT00989261_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT00989261_inc_T22", "arg2_id": "NCT00989261_inc_T20", "normalized": [] }, { "id": "NCT00989261_inc_R10", "type": "Has_qualifier", "arg1_id": "NCT00989261_inc_T21", "arg2_id": "NCT00989261_inc_T19", "normalized": [] }, { "id": "NCT00989261_inc_R11", "type": "Has_qualifier", "arg1_id": "NCT00989261_inc_T22", "arg2_id": "NCT00989261_inc_T19", "normalized": [] }, { "id": "NCT00989261_inc_R12", "type": "Has_value", "arg1_id": "NCT00989261_inc_T28", "arg2_id": "NCT00989261_inc_T25", "normalized": [] }, { "id": "NCT00989261_inc_R13", "type": "Has_scope", "arg1_id": "NCT00989261_inc_T24", "arg2_id": "NCT00989261_inc_T28", "normalized": [] }, { "id": "NCT00989261_inc_R14", "type": "Subsumes", "arg1_id": "NCT00989261_inc_T23", "arg2_id": "NCT00989261_inc_T24", "normalized": [] }, { "id": "NCT00989261_inc_R15", "type": "AND", "arg1_id": "NCT00989261_inc_T23", "arg2_id": "NCT00989261_inc_T29", "normalized": [] }, { "id": "NCT00989261_inc_R16", "type": "AND", "arg1_id": "NCT00989261_inc_T23", "arg2_id": "NCT00989261_inc_T30", "normalized": [] }, { "id": "NCT00989261_inc_R17", "type": "Has_value", "arg1_id": "NCT00989261_inc_T33", "arg2_id": "NCT00989261_inc_T34", "normalized": [] }, { "id": "NCT00989261_inc_R19", "type": "Has_qualifier", "arg1_id": "NCT00989261_inc_T36", "arg2_id": "NCT00989261_inc_T40", "normalized": [] }, { "id": "NCT00989261_inc_R20", "type": "Has_qualifier", "arg1_id": "NCT00989261_inc_T36", "arg2_id": "NCT00989261_inc_T37", "normalized": [] }, { "id": "NCT00989261_inc_R21", "type": "Has_qualifier", "arg1_id": "NCT00989261_inc_T36", "arg2_id": "NCT00989261_inc_T38", "normalized": [] }, { "id": "NCT00989261_inc_R22", "type": "Has_temporal", "arg1_id": "NCT00989261_inc_T43", "arg2_id": "NCT00989261_inc_T39", "normalized": [] }, { "id": "NCT00989261_inc_R24", "type": "Has_qualifier", "arg1_id": "NCT00989261_inc_T36", "arg2_id": "NCT00989261_inc_T42", "normalized": [] }, { "id": "NCT00989261_inc_R25", "type": "AND", "arg1_id": "NCT00989261_inc_T46", "arg2_id": "NCT00989261_inc_T44", "normalized": [] }, { "id": "NCT00989261_inc_R26", "type": "Has_mood", "arg1_id": "NCT00989261_inc_T46", "arg2_id": "NCT00989261_inc_T45", "normalized": [] }, { "id": "NCT00989261_inc_R27", "type": "AND", "arg1_id": "NCT00989261_inc_T47", "arg2_id": "NCT00989261_inc_T48", "normalized": [] }, { "id": "NCT00989261_inc_R28", "type": "Has_negation", "arg1_id": "NCT00989261_inc_T47", "arg2_id": "NCT00989261_inc_T49", "normalized": [] }, { "id": "NCT00989261_inc_R29", "type": "AND", "arg1_id": "NCT00989261_inc_T46", "arg2_id": "NCT00989261_inc_T47", "normalized": [] }, { "id": "NCT00989261_inc_R30", "type": "Has_value", "arg1_id": "NCT00989261_inc_T52", "arg2_id": "NCT00989261_inc_T53", "normalized": [] }, { "id": "NCT00989261_inc_R31", "type": "Has_value", "arg1_id": "NCT00989261_inc_T50", "arg2_id": "NCT00989261_inc_T51", "normalized": [] }, { "id": "NCT00989261_inc_R32", "type": "Has_value", "arg1_id": "NCT00989261_inc_T58", "arg2_id": "NCT00989261_inc_T57", "normalized": [] }, { "id": "NCT00989261_inc_R33", "type": "Has_value", "arg1_id": "NCT00989261_inc_T59", "arg2_id": "NCT00989261_inc_T60", "normalized": [] }, { "id": "NCT00989261_inc_R34", "type": "Has_value", "arg1_id": "NCT00989261_inc_T62", "arg2_id": "NCT00989261_inc_T63", "normalized": [] }, { "id": "NCT00989261_inc_R35", "type": "Has_value", "arg1_id": "NCT00989261_inc_T61", "arg2_id": "NCT00989261_inc_T63", "normalized": [] }, { "id": "NCT00989261_inc_R36", "type": "Subsumes", "arg1_id": "NCT00989261_inc_T64", "arg2_id": "NCT00989261_inc_T66", "normalized": [] }, { "id": "NCT00989261_inc_R37", "type": "Has_value", "arg1_id": "NCT00989261_inc_T64", "arg2_id": "NCT00989261_inc_T65", "normalized": [] }, { "id": "NCT00989261_inc_R38", "type": "AND", "arg1_id": "NCT00989261_inc_T69", "arg2_id": "NCT00989261_inc_T64", "normalized": [] } ]

[ { "id": "NCT00994786_exc_text", "type": "exclusion", "text": [ "Patients with any other primary DSM-IV psychiatric diagnosis in addition to Obsessive Compulsive Disorder.\nPatients who currently fulfil criteria for DSM-IV eating disorder, body dysmorphic disorder, current alcohol or substance abuse, or who have a lifetime history of bipolar disorder. Patients with a history of Schizophrenia and other psychotic disorders, Delirium, Dementia, and Amnestic and other cognitive disorders.\nSubjects with a concurrent Axis II Cluster A Personality Disorder\nBorderline or Antisocial Personality Disorder.\nSubjects who based on history or mental status examination have a significant risk of committing suicide, in the investigator's opinion.\nSubjects with a history of more than three adequate trials with an SSRI.\nSubjects who have had an adequate trial of pregabalin.\nSubjects who have initiated psychotherapy in the last 4 months prior to the first visit.\nSubjects who, during the course of the study, would be likely to require treatment with prohibited concomitant therapy .\nPrior use of or a known allergy or hypersensitivity to pregabalin.\nSubjects who have participated in any clinical trial within 30 days prior to entering the study, or in a clinical trial involving a psychotropic medication within the 6 months prior to entering the study.\nAny subject who has been taking benzodiazepines before entering the study who: 1) cannot tolerate being free of benzodiazepines for 4 weeks, or 2) has signs or symptoms of benzodiazepine withdrawal or rebound at the end of those 4 weeks. Should a patient entering the study, who is currently on benzodiazepines develop discontinuation symptoms with discontinuation of their benzodiazepine, we will treat these symptoms with a more gradual benzodiazepine taper. Study will be delayed until the patient is able to tolerate the discontinuation for 4 weeks.\nPatients with a current seizure disorder, organic brain disorder or a history of seizure disorders (except for febrile seizures in childhood).\nPatients with thyroid pathology, the treatment of which has not been stabilized for at least three months.\nPatients on neuroleptic drugs in the two months prior to study entry or cognitive behavioural therapy specific to OCD within four weeks of study entry\nPregnant or lactating females, or if sexually active and of childbearing potential, not using adequate methods of birth control.\nPatients with a history or evidence of a medical condition that would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the trial.\nPatients receiving psychotropics of any kind, including betablockers and other anticonvulsants. Sleep medication such as oral chloral-hydrate or zopiclone are acceptable.\nPatients using any herbal psychoactive treatments, e.g. St John's Wort, Valerian, Kava Kava, L-tryptophan.\nPatients with any condition or on any therapy that, in the investigator's opinion, or as indicated in the pregabalin product label, may pose a risk to the subject.\nPatients who have had a major life event in the past three months, which in the judgement of the investigator is influencing their current condition.\nPatients having clinically significant abnormal laboratory, or ECG findings not resolved by further examinations.\n" ], "offsets": [ [ 0, 3279 ] ] } ]

[ { "id": "NCT00994786_exc_T1", "type": "Qualifier", "text": [ "any other" ], "offsets": [ [ 14, 23 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T2", "type": "Negation", "text": [ "in addition to" ], "offsets": [ [ 61, 75 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T3", "type": "Condition", "text": [ "Obsessive Compulsive Disorder" ], "offsets": [ [ 76, 105 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T4", "type": "Condition", "text": [ "psychiatric diagnosis" ], "offsets": [ [ 39, 60 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T5", "type": "Qualifier", "text": [ "primary" ], "offsets": [ [ 24, 31 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T6", "type": "Qualifier", "text": [ "DSM-IV" ], "offsets": [ [ 32, 38 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T7", "type": "Scope", "text": [ "any other primary DSM-IV" ], "offsets": [ [ 14, 38 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T8", "type": "Condition", "text": [ "eating disorder" ], "offsets": [ [ 157, 172 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T9", "type": "Condition", "text": [ "body dysmorphic disorder" ], "offsets": [ [ 174, 198 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T10", "type": "Condition", "text": [ "substance abuse" ], "offsets": [ [ 219, 234 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T11", "type": "Condition", "text": [ "lcohol", "buse," ], "offsets": [ [ 209, 215 ], [ 230, 235 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T12", "type": "Condition", "text": [ "bipolar disorder" ], "offsets": [ [ 270, 286 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T13", "type": "Condition", "text": [ "Schizophrenia" ], "offsets": [ [ 315, 328 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T14", "type": "Condition", "text": [ "psychotic disorders" ], "offsets": [ [ 339, 358 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T15", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 333, 338 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T16", "type": "Condition", "text": [ "Delirium" ], "offsets": [ [ 360, 368 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T17", "type": "Condition", "text": [ "Dementia" ], "offsets": [ [ 370, 378 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T18", "type": "Condition", "text": [ "Amnestic" ], "offsets": [ [ 384, 392 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T19", "type": "Condition", "text": [ "cognitive disorders" ], "offsets": [ [ 403, 422 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T20", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 397, 402 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T21", "type": "Qualifier", "text": [ "DSM-IV" ], "offsets": [ [ 150, 156 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T22", "type": "Scope", "text": [ "eating disorder, body dysmorphic disorder, current alcohol or substance abuse" ], "offsets": [ [ 157, 234 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T23", "type": "Condition", "text": [ "Personality Disorder" ], "offsets": [ [ 469, 489 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T24", "type": "Qualifier", "text": [ "Axis II Cluster A" ], "offsets": [ [ 451, 468 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T25", "type": "Condition", "text": [ "Antisocial Personality Disorder" ], "offsets": [ [ 504, 535 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T26", "type": "Condition", "text": [ "derline or", "sonality Disorder.\nS" ], "offsets": [ [ 493, 503 ], [ 518, 538 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T27", "type": "Procedure", "text": [ "mental status examination" ], "offsets": [ [ 570, 595 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T28", "type": "Observation", "text": [ "risk of committing suicide" ], "offsets": [ [ 615, 641 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T29", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 603, 614 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T33", "type": "Procedure", "text": [ "psychotherapy" ], "offsets": [ [ 830, 843 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T34", "type": "Temporal", "text": [ "in the last 4 months prior to the first visit" ], "offsets": [ [ 844, 889 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T35", "type": "Reference_point", "text": [ "first visit" ], "offsets": [ [ 878, 889 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T37", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 1036, 1043 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T38", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 1047, 1063 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T39", "type": "Drug", "text": [ "pregabalin" ], "offsets": [ [ 1067, 1077 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T40", "type": "Scope", "text": [ "allergy or hypersensitivity" ], "offsets": [ [ 1036, 1063 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T43", "type": "Condition", "text": [ "seizure disorder" ], "offsets": [ [ 1862, 1878 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T44", "type": "Condition", "text": [ "organic brain disorder" ], "offsets": [ [ 1880, 1902 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T45", "type": "Condition", "text": [ "history of seizure disorders" ], "offsets": [ [ 1908, 1936 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T46", "type": "Negation", "text": [ "except" ], "offsets": [ [ 1938, 1944 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T47", "type": "Condition", "text": [ "febrile seizures" ], "offsets": [ [ 1949, 1965 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T48", "type": "Qualifier", "text": [ "childhood" ], "offsets": [ [ 1969, 1978 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T49", "type": "Condition", "text": [ "thyroid pathology" ], "offsets": [ [ 1995, 2012 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T50", "type": "Temporal", "text": [ "at least three months" ], "offsets": [ [ 2065, 2086 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T51", "type": "Negation", "text": [ "not" ], "offsets": [ [ 2041, 2044 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T52", "type": "Qualifier", "text": [ "stabilized" ], "offsets": [ [ 2050, 2060 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T53", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 2018, 2027 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T54", "type": "Drug", "text": [ "neuroleptic drugs" ], "offsets": [ [ 2100, 2117 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T55", "type": "Temporal", "text": [ "in the two months prior to study entry" ], "offsets": [ [ 2118, 2156 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T56", "type": "Reference_point", "text": [ "study entry" ], "offsets": [ [ 2145, 2156 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T57", "type": "Procedure", "text": [ "cognitive behavioural therapy" ], "offsets": [ [ 2160, 2189 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T58", "type": "Condition", "text": [ "OCD" ], "offsets": [ [ 2202, 2205 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T59", "type": "Temporal", "text": [ "within four weeks of study entry" ], "offsets": [ [ 2206, 2238 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T60", "type": "Reference_point", "text": [ "study entry" ], "offsets": [ [ 2227, 2238 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T63", "type": "Drug", "text": [ "psychotropics" ], "offsets": [ [ 2592, 2605 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T64", "type": "Drug", "text": [ "betablockers" ], "offsets": [ [ 2629, 2641 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T65", "type": "Drug", "text": [ "anticonvulsants" ], "offsets": [ [ 2652, 2667 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T66", "type": "Scope", "text": [ "betablockers and other anticonvulsants" ], "offsets": [ [ 2629, 2667 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T67", "type": "Drug", "text": [ "Sleep medication" ], "offsets": [ [ 2669, 2685 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T68", "type": "Negation", "text": [ "acceptable" ], "offsets": [ [ 2732, 2742 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T69", "type": "Drug", "text": [ "zopiclone" ], "offsets": [ [ 2718, 2727 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T70", "type": "Drug", "text": [ "chloral-hydrate" ], "offsets": [ [ 2699, 2714 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T71", "type": "Qualifier", "text": [ "oral" ], "offsets": [ [ 2702, 2706 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T72", "type": "Scope", "text": [ "oral chloral-hydrate or zopiclone" ], "offsets": [ [ 2694, 2727 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T73", "type": "Procedure", "text": [ "herbal psychoactive treatments" ], "offsets": [ [ 2763, 2793 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T74", "type": "Drug", "text": [ "St John's Wort" ], "offsets": [ [ 2800, 2814 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T75", "type": "Drug", "text": [ "Valerian" ], "offsets": [ [ 2816, 2824 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T76", "type": "Drug", "text": [ "Kava Kava" ], "offsets": [ [ 2826, 2835 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T77", "type": "Drug", "text": [ "L-tryptophan" ], "offsets": [ [ 2837, 2849 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T78", "type": "Scope", "text": [ "St John's Wort, Valerian, Kava Kava, L-tryptophan" ], "offsets": [ [ 2800, 2849 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T81", "type": "Measurement", "text": [ "ndings not", " by fur" ], "offsets": [ [ 3234, 3244 ], [ 3253, 3260 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T82", "type": "Measurement", "text": [ "ECG findings" ], "offsets": [ [ 3228, 3240 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T83", "type": "Value", "text": [ "significant abnormal" ], "offsets": [ [ 3192, 3212 ] ], "normalized": [] }, { "id": "NCT00994786_exc_T84", "type": "Scope", "text": [ "laboratory, or ECG findings" ], "offsets": [ [ 3213, 3240 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00994786_exc_R1", "type": "Has_negation", "arg1_id": "NCT00994786_exc_T3", "arg2_id": "NCT00994786_exc_T2", "normalized": [] }, { "id": "NCT00994786_exc_R2", "type": "AND", "arg1_id": "NCT00994786_exc_T4", "arg2_id": "NCT00994786_exc_T3", "normalized": [] }, { "id": "NCT00994786_exc_R3", "type": "Has_scope", "arg1_id": "NCT00994786_exc_T4", "arg2_id": "NCT00994786_exc_T7", "normalized": [] }, { "id": "NCT00994786_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT00994786_exc_T22", "arg2_id": "NCT00994786_exc_T21", "normalized": [] }, { "id": "NCT00994786_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT00994786_exc_T14", "arg2_id": "NCT00994786_exc_T15", "normalized": [] }, { "id": "NCT00994786_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT00994786_exc_T19", "arg2_id": "NCT00994786_exc_T20", "normalized": [] }, { "id": "NCT00994786_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT00994786_exc_T23", "arg2_id": "NCT00994786_exc_T24", "normalized": [] }, { "id": "NCT00994786_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT00994786_exc_T28", "arg2_id": "NCT00994786_exc_T29", "normalized": [] }, { "id": "NCT00994786_exc_R9", "type": "Has_index", "arg1_id": "NCT00994786_exc_T34", "arg2_id": "NCT00994786_exc_T35", "normalized": [] }, { "id": "NCT00994786_exc_R10", "type": "Has_temporal", "arg1_id": "NCT00994786_exc_T33", "arg2_id": "NCT00994786_exc_T34", "normalized": [] }, { "id": "NCT00994786_exc_R11", "type": "AND", "arg1_id": "NCT00994786_exc_T40", "arg2_id": "NCT00994786_exc_T39", "normalized": [] }, { "id": "NCT00994786_exc_R12", "type": "Has_qualifier", "arg1_id": "NCT00994786_exc_T47", "arg2_id": "NCT00994786_exc_T48", "normalized": [] }, { "id": "NCT00994786_exc_R13", "type": "Has_negation", "arg1_id": "NCT00994786_exc_T47", "arg2_id": "NCT00994786_exc_T46", "normalized": [] }, { "id": "NCT00994786_exc_R14", "type": "AND", "arg1_id": "NCT00994786_exc_T45", "arg2_id": "NCT00994786_exc_T47", "normalized": [] }, { "id": "NCT00994786_exc_R15", "type": "AND", "arg1_id": "NCT00994786_exc_T49", "arg2_id": "NCT00994786_exc_T53", "normalized": [] }, { "id": "NCT00994786_exc_R16", "type": "Has_qualifier", "arg1_id": "NCT00994786_exc_T53", "arg2_id": "NCT00994786_exc_T52", "normalized": [] }, { "id": "NCT00994786_exc_R17", "type": "Has_negation", "arg1_id": "NCT00994786_exc_T52", "arg2_id": "NCT00994786_exc_T51", "normalized": [] }, { "id": "NCT00994786_exc_R18", "type": "Has_temporal", "arg1_id": "NCT00994786_exc_T53", "arg2_id": "NCT00994786_exc_T50", "normalized": [] }, { "id": "NCT00994786_exc_R19", "type": "Has_index", "arg1_id": "NCT00994786_exc_T55", "arg2_id": "NCT00994786_exc_T56", "normalized": [] }, { "id": "NCT00994786_exc_R20", "type": "Has_temporal", "arg1_id": "NCT00994786_exc_T54", "arg2_id": "NCT00994786_exc_T55", "normalized": [] }, { "id": "NCT00994786_exc_R21", "type": "Has_index", "arg1_id": "NCT00994786_exc_T59", "arg2_id": "NCT00994786_exc_T60", "normalized": [] }, { "id": "NCT00994786_exc_R22", "type": "AND", "arg1_id": "NCT00994786_exc_T57", "arg2_id": "NCT00994786_exc_T58", "normalized": [] }, { "id": "NCT00994786_exc_R23", "type": "Has_temporal", "arg1_id": "NCT00994786_exc_T57", "arg2_id": "NCT00994786_exc_T59", "normalized": [] }, { "id": "NCT00994786_exc_R24", "type": "Subsumes", "arg1_id": "NCT00994786_exc_T63", "arg2_id": "NCT00994786_exc_T66", "normalized": [] }, { "id": "NCT00994786_exc_R25", "type": "Has_qualifier", "arg1_id": "NCT00994786_exc_T70", "arg2_id": "NCT00994786_exc_T71", "normalized": [] }, { "id": "NCT00994786_exc_R26", "type": "Subsumes", "arg1_id": "NCT00994786_exc_T67", "arg2_id": "NCT00994786_exc_T72", "normalized": [] }, { "id": "NCT00994786_exc_R27", "type": "Has_negation", "arg1_id": "NCT00994786_exc_T67", "arg2_id": "NCT00994786_exc_T68", "normalized": [] }, { "id": "NCT00994786_exc_R28", "type": "Subsumes", "arg1_id": "NCT00994786_exc_T73", "arg2_id": "NCT00994786_exc_T78", "normalized": [] }, { "id": "NCT00994786_exc_R29", "type": "Has_value", "arg1_id": "NCT00994786_exc_T84", "arg2_id": "NCT00994786_exc_T83", "normalized": [] } ]

[ { "id": "NCT00994786_inc_text", "type": "inclusion", "text": [ "Must be an outpatient with a primary DSM-IV Obsessive-Compulsive Disorder. Patients must have a score of greater than 20 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS; Goodman et al., 1989b).\nDiagnosis of comorbid DSM-IV major depressive episode will be allowed in the study provided that the diagnosis is secondary to OCD, they have a baseline Montgomery Depression Rating Scale (MADRS) score of less than or equal to 19, and the onset of OCD predates the onset of the current episode of depression by five or more years.\nThe ability to comprehend and comply with protocol requirements.\nWritten consent must be provided prior to study entry.\nAll women of childbearing potential (WOCBP) must be practicing a medically acceptable method of birth control\nAll female subjects of childbearing potential (WOCBP), including those who are practicing a medically acceptable method of birth control, must have a negative serum pregnancy test within 72 hours prior to the start of study medication.\n" ], "offsets": [ [ 0, 996 ] ] } ]

[ { "id": "NCT00994786_inc_T1", "type": "Condition", "text": [ "Obsessive-Compulsive Disorder" ], "offsets": [ [ 44, 73 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T2", "type": "Qualifier", "text": [ "primary" ], "offsets": [ [ 29, 36 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T3", "type": "Qualifier", "text": [ "DSM-IV" ], "offsets": [ [ 37, 43 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T4", "type": "Scope", "text": [ "primary DSM-IV" ], "offsets": [ [ 29, 43 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T5", "type": "Visit", "text": [ "outpatient" ], "offsets": [ [ 11, 21 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T6", "type": "Measurement", "text": [ "Yale-Brown Obsessive Compulsive Scale" ], "offsets": [ [ 128, 165 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T7", "type": "Value", "text": [ "score of greater than 20" ], "offsets": [ [ 96, 120 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T8", "type": "Measurement", "text": [ "Y-BOCS" ], "offsets": [ [ 167, 173 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T9", "type": "Condition", "text": [ "major depressive episode" ], "offsets": [ [ 228, 252 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T10", "type": "Qualifier", "text": [ "DSM-IV" ], "offsets": [ [ 221, 227 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T11", "type": "Qualifier", "text": [ "comorbid" ], "offsets": [ [ 212, 220 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T12", "type": "Scope", "text": [ "comorbid DSM-IV" ], "offsets": [ [ 212, 227 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T13", "type": "Condition", "text": [ "OCD" ], "offsets": [ [ 326, 329 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T14", "type": "Measurement", "text": [ "Montgomery Depression Rating Scale" ], "offsets": [ [ 352, 386 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T15", "type": "Qualifier", "text": [ "baseline" ], "offsets": [ [ 343, 351 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T16", "type": "Measurement", "text": [ "MADRS" ], "offsets": [ [ 388, 393 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T17", "type": "Value", "text": [ "score of less than or equal to 19" ], "offsets": [ [ 395, 428 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T18", "type": "Condition", "text": [ "onset of OCD" ], "offsets": [ [ 438, 450 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T19", "type": "Temporal", "text": [ "predates the onset of the current episode of depression by five or more years" ], "offsets": [ [ 451, 528 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T20", "type": "Reference_point", "text": [ "onset of the current episode of depression" ], "offsets": [ [ 464, 506 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T23", "type": "Person", "text": [ "women" ], "offsets": [ [ 654, 659 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T25", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 663, 685 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T26", "type": "Condition", "text": [ "WOCBP" ], "offsets": [ [ 687, 692 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T27", "type": "Scope", "text": [ "women of childbearing potential" ], "offsets": [ [ 654, 685 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T28", "type": "Qualifier", "text": [ "medically acceptable" ], "offsets": [ [ 715, 735 ] ], "normalized": [] }, { "id": "NCT00994786_inc_T29", "type": "Procedure", "text": [ "birth control" ], "offsets": [ [ 746, 759 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT00994786_inc_R1", "type": "Has_scope", "arg1_id": "NCT00994786_inc_T1", "arg2_id": "NCT00994786_inc_T4", "normalized": [] }, { "id": "NCT00994786_inc_R2", "type": "AND", "arg1_id": "NCT00994786_inc_T5", "arg2_id": "NCT00994786_inc_T1", "normalized": [] }, { "id": "NCT00994786_inc_R3", "type": "Has_value", "arg1_id": "NCT00994786_inc_T6", "arg2_id": "NCT00994786_inc_T7", "normalized": [] }, { "id": "NCT00994786_inc_R4", "type": "Subsumes", "arg1_id": "NCT00994786_inc_T6", "arg2_id": "NCT00994786_inc_T8", "normalized": [] }, { "id": "NCT00994786_inc_R5", "type": "Has_scope", "arg1_id": "NCT00994786_inc_T9", "arg2_id": "NCT00994786_inc_T12", "normalized": [] }, { "id": "NCT00994786_inc_R6", "type": "AND", "arg1_id": "NCT00994786_inc_T9", "arg2_id": "NCT00994786_inc_T13", "normalized": [] }, { "id": "NCT00994786_inc_R7", "type": "Has_qualifier", "arg1_id": "NCT00994786_inc_T14", "arg2_id": "NCT00994786_inc_T15", "normalized": [] }, { "id": "NCT00994786_inc_R8", "type": "Subsumes", "arg1_id": "NCT00994786_inc_T14", "arg2_id": "NCT00994786_inc_T16", "normalized": [] }, { "id": "NCT00994786_inc_R9", "type": "Has_value", "arg1_id": "NCT00994786_inc_T14", "arg2_id": "NCT00994786_inc_T17", "normalized": [] }, { "id": "NCT00994786_inc_R10", "type": "Has_index", "arg1_id": "NCT00994786_inc_T19", "arg2_id": "NCT00994786_inc_T20", "normalized": [] }, { "id": "NCT00994786_inc_R11", "type": "Subsumes", "arg1_id": "NCT00994786_inc_T26", "arg2_id": "NCT00994786_inc_T27", "normalized": [] }, { "id": "NCT00994786_inc_R12", "type": "Has_qualifier", "arg1_id": "NCT00994786_inc_T29", "arg2_id": "NCT00994786_inc_T28", "normalized": [] }, { "id": "NCT00994786_inc_R13", "type": "AND", "arg1_id": "NCT00994786_inc_T26", "arg2_id": "NCT00994786_inc_T29", "normalized": [] } ]

[ { "id": "NCT01000155_exc_text", "type": "exclusion", "text": [ "Subjects with hemoglobin SC or SB+ thalassemia \nSubjects on chronic transfusion program \nSubjects who have received RBC transfusions cannot have >15% adult hemoglobin \nKnown positive status for HIV, active hepatitis B or hepatitis C \nPregnant or breast feeding women \nIndividuals with a history of malignancy are ineligible except for the following circumstances. Individuals with a history of malignancy are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancer are eligible if diagnosed and adequately treated within the past 5 years: cervical or breast cancer in situ, and basal cell or squamous cell carcinoma of the skin \nSubjects with a history of thrombosis or other reason (other than sickle cell disease) for enhanced thrombotic risk \nSubjects with unresolved infections \nSevere or uncontrolled medical conditions that could compromise study participation \nSubjects on fetal hemoglobin inducing agents \nSubjects on any other experimental treatment within 90 days of the first dose of study drug or who have not recovered from the side effects of such therapy \nKnown allergic reaction to a histone deacetylase inhibitor \nSubjects who have received valproic acid for treatment of epilepsy within 30 days of enrollment \nSubjects who have received any HDAC inhibitors other than valproic acid \n \n" ], "offsets": [ [ 0, 1443 ] ] } ]

[ { "id": "NCT01000155_exc_T1", "type": "Condition", "text": [ "hemoglobin SC" ], "offsets": [ [ 14, 27 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T2", "type": "Condition", "text": [ "SB+ thalassemia" ], "offsets": [ [ 31, 46 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T3", "type": "Procedure", "text": [ "transfusion program" ], "offsets": [ [ 68, 87 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T4", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 60, 67 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T5", "type": "Multiplier", "text": [ "chronic" ], "offsets": [ [ 60, 67 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T6", "type": "Procedure", "text": [ "RBC transfusions" ], "offsets": [ [ 116, 132 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T7", "type": "Negation", "text": [ "cannot have" ], "offsets": [ [ 133, 144 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T8", "type": "Value", "text": [ ">15% adult hemoglobin" ], "offsets": [ [ 145, 166 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T9", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 194, 197 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T10", "type": "Condition", "text": [ "hepatitis B" ], "offsets": [ [ 206, 217 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T11", "type": "Condition", "text": [ "hepatitis C" ], "offsets": [ [ 221, 232 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T12", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 199, 205 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T13", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 234, 242 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T14", "type": "Observation", "text": [ "breast feeding" ], "offsets": [ [ 246, 260 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T15", "type": "Person", "text": [ "women" ], "offsets": [ [ 261, 266 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T16", "type": "Condition", "text": [ "malignancy" ], "offsets": [ [ 298, 308 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T17", "type": "Observation", "text": [ "history" ], "offsets": [ [ 287, 294 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T18", "type": "Condition", "text": [ "disease-free" ], "offsets": [ [ 436, 448 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T19", "type": "Temporal", "text": [ "for at least 5 years" ], "offsets": [ [ 449, 469 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T20", "type": "Mood", "text": [ "low risk" ], "offsets": [ [ 514, 522 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T21", "type": "Condition", "text": [ "recurrence of that malignancy" ], "offsets": [ [ 527, 556 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T22", "type": "Condition", "text": [ "that malignancy" ], "offsets": [ [ 541, 556 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T24", "type": "Condition", "text": [ "breast cancer in situ" ], "offsets": [ [ 682, 703 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T25", "type": "Condition", "text": [ "cervical", "cancer in situ" ], "offsets": [ [ 670, 678 ], [ 689, 703 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T26", "type": "Temporal", "text": [ "within the past 5 years" ], "offsets": [ [ 645, 668 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T27", "type": "Condition", "text": [ "squamous cell carcinoma of the skin" ], "offsets": [ [ 723, 758 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T28", "type": "Condition", "text": [ "basal cell", "carcinoma of the skin" ], "offsets": [ [ 709, 719 ], [ 737, 758 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T30", "type": "Negation", "text": [ "are eligible" ], "offsets": [ [ 596, 608 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T31", "type": "Mood", "text": [ "diagnosed" ], "offsets": [ [ 612, 621 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T32", "type": "Mood", "text": [ "adequately treated" ], "offsets": [ [ 626, 644 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T33", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 637, 644 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T34", "type": "Qualifier", "text": [ "adequately" ], "offsets": [ [ 626, 636 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T35", "type": "Condition", "text": [ "thrombosis" ], "offsets": [ [ 787, 797 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T36", "type": "Condition", "text": [ "sickle cell disease" ], "offsets": [ [ 826, 845 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T37", "type": "Condition", "text": [ "thrombotic risk" ], "offsets": [ [ 860, 875 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T38", "type": "Mood", "text": [ "enhanced", "risk" ], "offsets": [ [ 851, 859 ], [ 871, 875 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T39", "type": "Observation", "text": [ "history" ], "offsets": [ [ 776, 783 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T40", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 815, 825 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T41", "type": "Condition", "text": [ "thrombotic" ], "offsets": [ [ 860, 870 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T42", "type": "Condition", "text": [ "infections" ], "offsets": [ [ 902, 912 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T43", "type": "Qualifier", "text": [ "unresolved" ], "offsets": [ [ 891, 901 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T44", "type": "Condition", "text": [ "medical conditions" ], "offsets": [ [ 937, 955 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T45", "type": "Qualifier", "text": [ "compromise study participation" ], "offsets": [ [ 967, 997 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T47", "type": "Drug", "text": [ "fetal hemoglobin inducing agents" ], "offsets": [ [ 1011, 1043 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T48", "type": "Qualifier", "text": [ "fetal" ], "offsets": [ [ 1011, 1016 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T51", "type": "Condition", "text": [ "allergic reaction" ], "offsets": [ [ 1208, 1225 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T52", "type": "Drug", "text": [ "histone deacetylase inhibitor" ], "offsets": [ [ 1231, 1260 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T53", "type": "Drug", "text": [ "valproic acid" ], "offsets": [ [ 1289, 1302 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T54", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1307, 1316 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T55", "type": "Condition", "text": [ "epilepsy" ], "offsets": [ [ 1320, 1328 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T56", "type": "Temporal", "text": [ "within 30 days of enrollment" ], "offsets": [ [ 1329, 1357 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T57", "type": "Reference_point", "text": [ "enrollment" ], "offsets": [ [ 1347, 1357 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T58", "type": "Drug", "text": [ "HDAC inhibitors" ], "offsets": [ [ 1390, 1405 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T59", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 1406, 1416 ] ], "normalized": [] }, { "id": "NCT01000155_exc_T60", "type": "Drug", "text": [ "valproic acid" ], "offsets": [ [ 1417, 1430 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01000155_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01000155_exc_T3", "arg2_id": "NCT01000155_exc_T4", "normalized": [] }, { "id": "NCT01000155_exc_R3", "type": "Has_value", "arg1_id": "NCT01000155_exc_T6", "arg2_id": "NCT01000155_exc_T8", "normalized": [] }, { "id": "NCT01000155_exc_R4", "type": "Has_negation", "arg1_id": "NCT01000155_exc_T6", "arg2_id": "NCT01000155_exc_T7", "normalized": [] }, { "id": "NCT01000155_exc_R5", "type": "Has_temporal", "arg1_id": "NCT01000155_exc_T10", "arg2_id": "NCT01000155_exc_T12", "normalized": [] }, { "id": "NCT01000155_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01000155_exc_T11", "arg2_id": "NCT01000155_exc_T12", "normalized": [] }, { "id": "NCT01000155_exc_R7", "type": "Has_temporal", "arg1_id": "NCT01000155_exc_T16", "arg2_id": "NCT01000155_exc_T17", "normalized": [] }, { "id": "NCT01000155_exc_R9", "type": "Has_mood", "arg1_id": "NCT01000155_exc_T21", "arg2_id": "NCT01000155_exc_T20", "normalized": [] }, { "id": "NCT01000155_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT01000155_exc_T33", "arg2_id": "NCT01000155_exc_T34", "normalized": [] }, { "id": "NCT01000155_exc_R11", "type": "Has_temporal", "arg1_id": "NCT01000155_exc_T33", "arg2_id": "NCT01000155_exc_T26", "normalized": [] }, { "id": "NCT01000155_exc_R12", "type": "Has_mood", "arg1_id": "NCT01000155_exc_T37", "arg2_id": "NCT01000155_exc_T38", "normalized": [] }, { "id": "NCT01000155_exc_R13", "type": "Has_temporal", "arg1_id": "NCT01000155_exc_T35", "arg2_id": "NCT01000155_exc_T39", "normalized": [] }, { "id": "NCT01000155_exc_R14", "type": "Has_negation", "arg1_id": "NCT01000155_exc_T36", "arg2_id": "NCT01000155_exc_T40", "normalized": [] }, { "id": "NCT01000155_exc_R16", "type": "AND", "arg1_id": "NCT01000155_exc_T35", "arg2_id": "NCT01000155_exc_T36", "normalized": [] }, { "id": "NCT01000155_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT01000155_exc_T42", "arg2_id": "NCT01000155_exc_T43", "normalized": [] }, { "id": "NCT01000155_exc_R21", "type": "Has_index", "arg1_id": "NCT01000155_exc_T56", "arg2_id": "NCT01000155_exc_T57", "normalized": [] }, { "id": "NCT01000155_exc_R22", "type": "Has_temporal", "arg1_id": "NCT01000155_exc_T55", "arg2_id": "NCT01000155_exc_T56", "normalized": [] }, { "id": "NCT01000155_exc_R24", "type": "Has_negation", "arg1_id": "NCT01000155_exc_T60", "arg2_id": "NCT01000155_exc_T59", "normalized": [] }, { "id": "NCT01000155_exc_R25", "type": "AND", "arg1_id": "NCT01000155_exc_T58", "arg2_id": "NCT01000155_exc_T60", "normalized": [] } ]

[ { "id": "NCT01000155_inc_text", "type": "inclusion", "text": [ "Diagnosis of sickle cell disease \nClinically significant disease defined as at least 1 painful episode per year averaged over the previous 3 years or a history of priapism, stroke, acute chest syndrome, avascular necrosis, multi-organ failure or the need for chronic narcotic medications for pain from sickle cell disease \nMust have failed a previous attempt at treatment with hydroxyurea defined as the inability to achieve a significant absolute increase in % fetal hemoglobin or the inability to tolerate hydroxyurea treatment due to severe side effects such as but not limited to myelosuppression, gastrointestinal symptoms, edema or hepatic enzyme elevations or have contraindications to hydroxyurea \n18 years of age or older \nHematologic laboratory values as outlined in the protocol \nNon-hematologic laboratory values as outlined in the protocol \nMust agree not to donate blood or other bodily fluid while taking the study drug and for 28 days thereafter \nWomen of child-bearing potential (WCBP) must have a negative serum pregnancy test 72 hours or less prior to starting treatment \nWomen of child-bearing potential and men must agree to use 2 forms of adequate contraception prior to study entry and for the duration of study participation \n" ], "offsets": [ [ 0, 1250 ] ] } ]

[ { "id": "NCT01000155_inc_T1", "type": "Condition", "text": [ "sickle cell disease" ], "offsets": [ [ 13, 32 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T2", "type": "Mood", "text": [ "Diagnosis" ], "offsets": [ [ 0, 9 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T3", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 34, 56 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T4", "type": "Condition", "text": [ "Clinically significant disease" ], "offsets": [ [ 34, 64 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T5", "type": "Multiplier", "text": [ "per year averaged over the previous 3 years", "at least 1" ], "offsets": [ [ 103, 146 ], [ 76, 86 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T6", "type": "Condition", "text": [ "painful episode" ], "offsets": [ [ 87, 102 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T7", "type": "Temporal", "text": [ "the previous 3 years" ], "offsets": [ [ 126, 146 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T8", "type": "Qualifier", "text": [ "averaged over the previous 3 years" ], "offsets": [ [ 112, 146 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T9", "type": "Observation", "text": [ "history" ], "offsets": [ [ 152, 159 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T10", "type": "Condition", "text": [ "priapism" ], "offsets": [ [ 163, 171 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T11", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 173, 179 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T12", "type": "Condition", "text": [ "acute chest syndrome" ], "offsets": [ [ 181, 201 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T13", "type": "Condition", "text": [ "avascular necrosis" ], "offsets": [ [ 203, 221 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T14", "type": "Condition", "text": [ "multi-organ failure" ], "offsets": [ [ 223, 242 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T15", "type": "Mood", "text": [ "need for" ], "offsets": [ [ 250, 258 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T16", "type": "Multiplier", "text": [ "chronic" ], "offsets": [ [ 259, 266 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T17", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 259, 266 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T18", "type": "Drug", "text": [ "narcotic medications" ], "offsets": [ [ 267, 287 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T19", "type": "Condition", "text": [ "pain" ], "offsets": [ [ 292, 296 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T20", "type": "Condition", "text": [ "sickle cell disease" ], "offsets": [ [ 302, 321 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T21", "type": "Scope", "text": [ "at least 1 painful episode per year averaged over the previous 3 years or a history of priapism, stroke, acute chest syndrome, avascular necrosis, multi-organ failure or the need for chronic narcotic medications for pain from sickle cell disease" ], "offsets": [ [ 76, 321 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T23", "type": "Value", "text": [ "18 years", "or older" ], "offsets": [ [ 706, 714 ], [ 722, 730 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T24", "type": "Person", "text": [ "age" ], "offsets": [ [ 718, 721 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T29", "type": "Procedure", "text": [ "donate blood" ], "offsets": [ [ 872, 884 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T30", "type": "Negation", "text": [ "not" ], "offsets": [ [ 865, 868 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T31", "type": "Mood", "text": [ "Must agree", "to" ], "offsets": [ [ 854, 864 ], [ 869, 871 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T32", "type": "Procedure", "text": [ "donate", "bodily fluid" ], "offsets": [ [ 872, 878 ], [ 894, 906 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T33", "type": "Temporal", "text": [ "while taking the study drug" ], "offsets": [ [ 907, 934 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T34", "type": "Reference_point", "text": [ "taking the study drug" ], "offsets": [ [ 913, 934 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T35", "type": "Drug", "text": [ "study drug" ], "offsets": [ [ 924, 934 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T36", "type": "Temporal", "text": [ "for 28 days thereafter" ], "offsets": [ [ 939, 961 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T37", "type": "Scope", "text": [ "while taking the study drug and for 28 days thereafter" ], "offsets": [ [ 907, 961 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T38", "type": "Scope", "text": [ "donate blood or other bodily fluid" ], "offsets": [ [ 872, 906 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T39", "type": "Condition", "text": [ "child-bearing potential" ], "offsets": [ [ 972, 995 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T40", "type": "Person", "text": [ "Women" ], "offsets": [ [ 963, 968 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T41", "type": "Scope", "text": [ "Women of child-bearing potential" ], "offsets": [ [ 963, 995 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T42", "type": "Person", "text": [ "WCBP" ], "offsets": [ [ 997, 1001 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T43", "type": "Measurement", "text": [ "serum pregnancy test" ], "offsets": [ [ 1024, 1044 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T44", "type": "Value", "text": [ "negative" ], "offsets": [ [ 1015, 1023 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T45", "type": "Temporal", "text": [ "72 hours or less prior to starting treatment" ], "offsets": [ [ 1045, 1089 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T46", "type": "Reference_point", "text": [ "starting treatment" ], "offsets": [ [ 1071, 1089 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T47", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 1080, 1089 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T48", "type": "Scope", "text": [ "Women of child-bearing potential (WCBP)" ], "offsets": [ [ 963, 1002 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T50", "type": "Condition", "text": [ "child-bearing potential" ], "offsets": [ [ 1100, 1123 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T51", "type": "Person", "text": [ "Women" ], "offsets": [ [ 1091, 1096 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T52", "type": "Person", "text": [ "men" ], "offsets": [ [ 1128, 1131 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T53", "type": "Mood", "text": [ "must agree to" ], "offsets": [ [ 1132, 1145 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T54", "type": "Multiplier", "text": [ "2 forms" ], "offsets": [ [ 1150, 1157 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T55", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 1170, 1183 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T56", "type": "Qualifier", "text": [ "adequate" ], "offsets": [ [ 1161, 1169 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T57", "type": "Scope", "text": [ "Women of child-bearing potential and men" ], "offsets": [ [ 1091, 1131 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T58", "type": "Temporal", "text": [ "prior to study entry" ], "offsets": [ [ 1184, 1204 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T59", "type": "Temporal", "text": [ "for the duration of study participation" ], "offsets": [ [ 1209, 1248 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T60", "type": "Reference_point", "text": [ "study participation" ], "offsets": [ [ 1229, 1248 ] ], "normalized": [] }, { "id": "NCT01000155_inc_T61", "type": "Reference_point", "text": [ "study entry" ], "offsets": [ [ 1193, 1204 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01000155_inc_R1", "type": "Has_mood", "arg1_id": "NCT01000155_inc_T1", "arg2_id": "NCT01000155_inc_T2", "normalized": [] }, { "id": "NCT01000155_inc_R8", "type": "Has_qualifier", "arg1_id": "NCT01000155_inc_T18", "arg2_id": "NCT01000155_inc_T17", "normalized": [] }, { "id": "NCT01000155_inc_R9", "type": "Has_temporal", "arg1_id": "NCT01000155_inc_T10", "arg2_id": "NCT01000155_inc_T9", "normalized": [] }, { "id": "NCT01000155_inc_R10", "type": "Has_multiplier", "arg1_id": "NCT01000155_inc_T6", "arg2_id": "NCT01000155_inc_T5", "normalized": [] }, { "id": "NCT01000155_inc_R11", "type": "Subsumes", "arg1_id": "NCT01000155_inc_T4", "arg2_id": "NCT01000155_inc_T21", "normalized": [] }, { "id": "NCT01000155_inc_R12", "type": "Has_value", "arg1_id": "NCT01000155_inc_T24", "arg2_id": "NCT01000155_inc_T23", "normalized": [] }, { "id": "NCT01000155_inc_R13", "type": "Has_negation", "arg1_id": "NCT01000155_inc_T31", "arg2_id": "NCT01000155_inc_T30", "normalized": [] }, { "id": "NCT01000155_inc_R14", "type": "Has_mood", "arg1_id": "NCT01000155_inc_T29", "arg2_id": "NCT01000155_inc_T31", "normalized": [] }, { "id": "NCT01000155_inc_R15", "type": "Has_mood", "arg1_id": "NCT01000155_inc_T32", "arg2_id": "NCT01000155_inc_T31", "normalized": [] }, { "id": "NCT01000155_inc_R18", "type": "Subsumes", "arg1_id": "NCT01000155_inc_T38", "arg2_id": "NCT01000155_inc_T37", "normalized": [] }, { "id": "NCT01000155_inc_R19", "type": "Subsumes", "arg1_id": "NCT01000155_inc_T41", "arg2_id": "NCT01000155_inc_T42", "normalized": [] }, { "id": "NCT01000155_inc_R22", "type": "Has_temporal", "arg1_id": "NCT01000155_inc_T43", "arg2_id": "NCT01000155_inc_T45", "normalized": [] }, { "id": "NCT01000155_inc_R23", "type": "Has_value", "arg1_id": "NCT01000155_inc_T43", "arg2_id": "NCT01000155_inc_T44", "normalized": [] }, { "id": "NCT01000155_inc_R24", "type": "AND", "arg1_id": "NCT01000155_inc_T48", "arg2_id": "NCT01000155_inc_T43", "normalized": [] }, { "id": "NCT01000155_inc_R25", "type": "Has_qualifier", "arg1_id": "NCT01000155_inc_T55", "arg2_id": "NCT01000155_inc_T56", "normalized": [] }, { "id": "NCT01000155_inc_R26", "type": "Has_multiplier", "arg1_id": "NCT01000155_inc_T55", "arg2_id": "NCT01000155_inc_T54", "normalized": [] }, { "id": "NCT01000155_inc_R27", "type": "Has_mood", "arg1_id": "NCT01000155_inc_T55", "arg2_id": "NCT01000155_inc_T53", "normalized": [] }, { "id": "NCT01000155_inc_R28", "type": "AND", "arg1_id": "NCT01000155_inc_T51", "arg2_id": "NCT01000155_inc_T50", "normalized": [] }, { "id": "NCT01000155_inc_R29", "type": "AND", "arg1_id": "NCT01000155_inc_T57", "arg2_id": "NCT01000155_inc_T55", "normalized": [] }, { "id": "NCT01000155_inc_R32", "type": "Has_temporal", "arg1_id": "NCT01000155_inc_T55", "arg2_id": "NCT01000155_inc_T58", "normalized": [] }, { "id": "NCT01000155_inc_R33", "type": "Has_temporal", "arg1_id": "NCT01000155_inc_T55", "arg2_id": "NCT01000155_inc_T59", "normalized": [] } ]

[ { "id": "NCT01009359_exc_text", "type": "exclusion", "text": [ "Current unstable medical condition (e.g. unstable angina, myocardial infarction or coronary revascularization in the preceding 12 months, cardiac failure, chronic renal failure, chronic hepatic disease, severe pulmonary disease, blood disorders, poorly controlled diabetes, chronic infection) \n \n" ], "offsets": [ [ 0, 305 ] ] } ]

[ { "id": "NCT01009359_exc_T1", "type": "Condition", "text": [ "unstable medical condition" ], "offsets": [ [ 8, 34 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T2", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 8, 16 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T3", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T4", "type": "Condition", "text": [ "unstable angina" ], "offsets": [ [ 41, 56 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T5", "type": "Condition", "text": [ "myocardial infarction" ], "offsets": [ [ 58, 79 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T6", "type": "Procedure", "text": [ "coronary revascularization" ], "offsets": [ [ 83, 109 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T7", "type": "Temporal", "text": [ "in the preceding 12 months" ], "offsets": [ [ 110, 136 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T8", "type": "Condition", "text": [ "cardiac failure" ], "offsets": [ [ 138, 153 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T9", "type": "Condition", "text": [ "chronic renal failure" ], "offsets": [ [ 155, 176 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T10", "type": "Condition", "text": [ "chronic hepatic disease" ], "offsets": [ [ 178, 201 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T11", "type": "Condition", "text": [ "pulmonary disease" ], "offsets": [ [ 210, 227 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T12", "type": "Condition", "text": [ "blood disorders" ], "offsets": [ [ 229, 244 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T13", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 264, 272 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T14", "type": "Qualifier", "text": [ "controlled" ], "offsets": [ [ 253, 263 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T15", "type": "Negation", "text": [ "poorly" ], "offsets": [ [ 246, 252 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T16", "type": "Condition", "text": [ "chronic infection" ], "offsets": [ [ 274, 291 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T17", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 274, 281 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T18", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 203, 209 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T19", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 178, 185 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T20", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 155, 162 ] ], "normalized": [] }, { "id": "NCT01009359_exc_T21", "type": "Scope", "text": [ "unstable angina, myocardial infarction or coronary revascularization in the preceding 12 months, cardiac failure, chronic renal failure, chronic hepatic disease, severe pulmonary disease, blood disorders, poorly controlled diabetes, chronic infection" ], "offsets": [ [ 41, 291 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT01009359_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01009359_exc_T1", "arg2_id": "NCT01009359_exc_T3", "normalized": [] }, { "id": "NCT01009359_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01009359_exc_T6", "arg2_id": "NCT01009359_exc_T7", "normalized": [] }, { "id": "NCT01009359_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01009359_exc_T5", "arg2_id": "NCT01009359_exc_T7", "normalized": [] }, { "id": "NCT01009359_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT01009359_exc_T13", "arg2_id": "NCT01009359_exc_T14", "normalized": [] }, { "id": "NCT01009359_exc_R6", "type": "Has_negation", "arg1_id": "NCT01009359_exc_T14", "arg2_id": "NCT01009359_exc_T15", "normalized": [] }, { "id": "NCT01009359_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT01009359_exc_T11", "arg2_id": "NCT01009359_exc_T18", "normalized": [] }, { "id": "NCT01009359_exc_R11", "type": "Subsumes", "arg1_id": "NCT01009359_exc_T1", "arg2_id": "NCT01009359_exc_T21", "normalized": [] } ]

[ { "id": "NCT01009359_inc_text", "type": "inclusion", "text": [ "Able to give fully informed consent in writing \nMales or females aged >/= 50 years \nNo significant disease or drug use \nAbsence of any sign of dementia/cognitive impairment in neuropsychological examinationsPatients for brain imaging: \nPatient and designee capable of giving fully informed consent in writing \nPatient fulfils DSM-IV and NINCDS-ADRA criteria for probable Alzheimers disease \n" ], "offsets": [ [ 0, 391 ] ] } ]

[ { "id": "NCT01009359_inc_T2", "type": "Person", "text": [ "Males" ], "offsets": [ [ 48, 53 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T3", "type": "Person", "text": [ "females" ], "offsets": [ [ 57, 64 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T4", "type": "Person", "text": [ "aged" ], "offsets": [ [ 65, 69 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T5", "type": "Value", "text": [ ">/= 50 years" ], "offsets": [ [ 70, 82 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T6", "type": "Condition", "text": [ "drug use" ], "offsets": [ [ 110, 118 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T7", "type": "Condition", "text": [ "disease" ], "offsets": [ [ 99, 106 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T8", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 87, 98 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T10", "type": "Negation", "text": [ "No" ], "offsets": [ [ 84, 86 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T11", "type": "Scope", "text": [ "significant disease or drug use" ], "offsets": [ [ 87, 118 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T12", "type": "Condition", "text": [ "dementia" ], "offsets": [ [ 143, 151 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T13", "type": "Condition", "text": [ "sign of dementia" ], "offsets": [ [ 135, 151 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T14", "type": "Condition", "text": [ "sign of", "cognitive impairment" ], "offsets": [ [ 135, 142 ], [ 152, 172 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T15", "type": "Condition", "text": [ "cognitive impairment" ], "offsets": [ [ 152, 172 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T16", "type": "Negation", "text": [ "Absence of" ], "offsets": [ [ 120, 130 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T17", "type": "Scope", "text": [ "sign of dementia/cognitive impairment" ], "offsets": [ [ 135, 172 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T18", "type": "Procedure", "text": [ "neuropsychological examinations" ], "offsets": [ [ 176, 207 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T21", "type": "Measurement", "text": [ "DSM-IV", "criteria" ], "offsets": [ [ 326, 332 ], [ 349, 357 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T22", "type": "Measurement", "text": [ "NINCDS-ADRA criteria" ], "offsets": [ [ 337, 357 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T23", "type": "Condition", "text": [ "Alzheimers disease" ], "offsets": [ [ 371, 389 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T24", "type": "Mood", "text": [ "probable" ], "offsets": [ [ 362, 370 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T25", "type": "Value", "text": [ "fulfils" ], "offsets": [ [ 318, 325 ] ], "normalized": [] }, { "id": "NCT01009359_inc_T26", "type": "Scope", "text": [ "fulfils DSM-IV and NINCDS-ADRA criteria" ], "offsets": [ [ 318, 357 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT01009359_inc_R1", "type": "Has_value", "arg1_id": "NCT01009359_inc_T4", "arg2_id": "NCT01009359_inc_T5", "normalized": [] }, { "id": "NCT01009359_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01009359_inc_T7", "arg2_id": "NCT01009359_inc_T8", "normalized": [] }, { "id": "NCT01009359_inc_R3", "type": "Has_negation", "arg1_id": "NCT01009359_inc_T11", "arg2_id": "NCT01009359_inc_T10", "normalized": [] }, { "id": "NCT01009359_inc_R7", "type": "Has_negation", "arg1_id": "NCT01009359_inc_T17", "arg2_id": "NCT01009359_inc_T16", "normalized": [] }, { "id": "NCT01009359_inc_R8", "type": "Has_mood", "arg1_id": "NCT01009359_inc_T23", "arg2_id": "NCT01009359_inc_T24", "normalized": [] }, { "id": "NCT01009359_inc_R9", "type": "Has_value", "arg1_id": "NCT01009359_inc_T21", "arg2_id": "NCT01009359_inc_T25", "normalized": [] }, { "id": "NCT01009359_inc_R10", "type": "Has_value", "arg1_id": "NCT01009359_inc_T22", "arg2_id": "NCT01009359_inc_T25", "normalized": [] } ]

[ { "id": "NCT01032109_exc_text", "type": "exclusion", "text": [ "choroidal neovascularization caused by other eye diseases \nocular surgery within the past 3 mouths \nhistory of uveitis \nintraocular pressure higher than 25 mmHg, or glaucoma \nhistory of systemic or ocular thromboembolic events. \n \n" ], "offsets": [ [ 0, 240 ] ] } ]

[ { "id": "NCT01032109_exc_T1", "type": "Condition", "text": [ "choroidal neovascularization" ], "offsets": [ [ 0, 28 ] ], "normalized": [] }, { "id": "NCT01032109_exc_T2", "type": "Condition", "text": [ "other eye diseases" ], "offsets": [ [ 39, 57 ] ], "normalized": [] }, { "id": "NCT01032109_exc_T3", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 39, 44 ] ], "normalized": [] }, { "id": "NCT01032109_exc_T4", "type": "Procedure", "text": [ "ocular surgery" ], "offsets": [ [ 59, 73 ] ], "normalized": [] }, { "id": "NCT01032109_exc_T5", "type": "Temporal", "text": [ "within the past 3 mouths" ], "offsets": [ [ 74, 98 ] ], "normalized": [] }, { "id": "NCT01032109_exc_T6", "type": "Condition", "text": [ "uveitis" ], "offsets": [ [ 111, 118 ] ], "normalized": [] }, { "id": "NCT01032109_exc_T7", "type": "Observation", "text": [ "history" ], "offsets": [ [ 100, 107 ] ], "normalized": [] }, { "id": "NCT01032109_exc_T8", "type": "Measurement", "text": [ "intraocular pressure" ], "offsets": [ [ 120, 140 ] ], "normalized": [] }, { "id": "NCT01032109_exc_T9", "type": "Value", "text": [ "higher than 25 mmHg" ], "offsets": [ [ 141, 160 ] ], "normalized": [] }, { "id": "NCT01032109_exc_T10", "type": "Condition", "text": [ "glaucoma" ], "offsets": [ [ 165, 173 ] ], "normalized": [] }, { "id": "NCT01032109_exc_T11", "type": "Condition", "text": [ "thromboembolic events" ], "offsets": [ [ 205, 226 ] ], "normalized": [] }, { "id": "NCT01032109_exc_T13", "type": "Qualifier", "text": [ "ocular" ], "offsets": [ [ 198, 204 ] ], "normalized": [] }, { "id": "NCT01032109_exc_T14", "type": "Qualifier", "text": [ "systemic" ], "offsets": [ [ 186, 194 ] ], "normalized": [] }, { "id": "NCT01032109_exc_T12", "type": "Scope", "text": [ "systemic or ocular" ], "offsets": [ [ 186, 204 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01032109_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01032109_exc_T4", "arg2_id": "NCT01032109_exc_T5", "normalized": [] }, { "id": "NCT01032109_exc_R4", "type": "Has_temporal", "arg1_id": "NCT01032109_exc_T6", "arg2_id": "NCT01032109_exc_T7", "normalized": [] }, { "id": "NCT01032109_exc_R5", "type": "Has_value", "arg1_id": "NCT01032109_exc_T8", "arg2_id": "NCT01032109_exc_T9", "normalized": [] }, { "id": "NCT01032109_exc_R6", "type": "Has_scope", "arg1_id": "NCT01032109_exc_T11", "arg2_id": "NCT01032109_exc_T12", "normalized": [] } ]

[ { "id": "NCT01032109_inc_text", "type": "inclusion", "text": [ "choroidal neovascularization caused by age-related macula degeneration \nno previous treatment \na follow-up at least 12 months \na baseline visual acuity ranging from a letter score of 0 to 70 on the Early Treatment Diabetic Retinopathy Study chart \n" ], "offsets": [ [ 0, 248 ] ] } ]

[ { "id": "NCT01032109_inc_T1", "type": "Condition", "text": [ "choroidal neovascularization" ], "offsets": [ [ 0, 28 ] ], "normalized": [] }, { "id": "NCT01032109_inc_T2", "type": "Qualifier", "text": [ "age-related" ], "offsets": [ [ 39, 50 ] ], "normalized": [] }, { "id": "NCT01032109_inc_T3", "type": "Condition", "text": [ "macula degeneration" ], "offsets": [ [ 51, 70 ] ], "normalized": [] }, { "id": "NCT01032109_inc_T4", "type": "Negation", "text": [ "no" ], "offsets": [ [ 72, 74 ] ], "normalized": [] }, { "id": "NCT01032109_inc_T5", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 75, 83 ] ], "normalized": [] }, { "id": "NCT01032109_inc_T6", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 84, 93 ] ], "normalized": [] }, { "id": "NCT01032109_inc_T8", "type": "Observation", "text": [ "follow-up" ], "offsets": [ [ 97, 106 ] ], "normalized": [] }, { "id": "NCT01032109_inc_T9", "type": "Temporal", "text": [ "at least 12 months" ], "offsets": [ [ 107, 125 ] ], "normalized": [] }, { "id": "NCT01032109_inc_T10", "type": "Measurement", "text": [ "visual acuity" ], "offsets": [ [ 138, 151 ] ], "normalized": [] }, { "id": "NCT01032109_inc_T11", "type": "Temporal", "text": [ "baseline" ], "offsets": [ [ 129, 137 ] ], "normalized": [] }, { "id": "NCT01032109_inc_T12", "type": "Value", "text": [ "letter score of 0 to 70" ], "offsets": [ [ 167, 190 ] ], "normalized": [] }, { "id": "NCT01032109_inc_T13", "type": "Procedure", "text": [ "Early Treatment Diabetic Retinopathy Study chart" ], "offsets": [ [ 198, 246 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT01032109_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01032109_inc_T3", "arg2_id": "NCT01032109_inc_T2", "normalized": [] }, { "id": "NCT01032109_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01032109_inc_T6", "arg2_id": "NCT01032109_inc_T5", "normalized": [] }, { "id": "NCT01032109_inc_R4", "type": "Has_negation", "arg1_id": "NCT01032109_inc_T6", "arg2_id": "NCT01032109_inc_T4", "normalized": [] }, { "id": "NCT01032109_inc_R5", "type": "Has_temporal", "arg1_id": "NCT01032109_inc_T8", "arg2_id": "NCT01032109_inc_T9", "normalized": [] }, { "id": "NCT01032109_inc_R6", "type": "Has_temporal", "arg1_id": "NCT01032109_inc_T10", "arg2_id": "NCT01032109_inc_T11", "normalized": [] }, { "id": "NCT01032109_inc_R7", "type": "Has_value", "arg1_id": "NCT01032109_inc_T10", "arg2_id": "NCT01032109_inc_T12", "normalized": [] } ]

[ { "id": "NCT01051414_exc_text", "type": "exclusion", "text": [ "Subjects with evidence of liver cirrhosis \nEvidence of HCC \nCo-infection with hepatitis B virus, HIV \n \n" ], "offsets": [ [ 0, 113 ] ] } ]

[ { "id": "NCT01051414_exc_T1", "type": "Condition", "text": [ "liver cirrhosis" ], "offsets": [ [ 26, 41 ] ], "normalized": [] }, { "id": "NCT01051414_exc_T2", "type": "Mood", "text": [ "evidence" ], "offsets": [ [ 14, 22 ] ], "normalized": [] }, { "id": "NCT01051414_exc_T3", "type": "Condition", "text": [ "HCC" ], "offsets": [ [ 55, 58 ] ], "normalized": [] }, { "id": "NCT01051414_exc_T4", "type": "Mood", "text": [ "Evidence" ], "offsets": [ [ 43, 51 ] ], "normalized": [] }, { "id": "NCT01051414_exc_T5", "type": "Condition", "text": [ "hepatitis B virus" ], "offsets": [ [ 78, 95 ] ], "normalized": [] }, { "id": "NCT01051414_exc_T6", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 97, 100 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT01051414_exc_R1", "type": "Has_mood", "arg1_id": "NCT01051414_exc_T1", "arg2_id": "NCT01051414_exc_T2", "normalized": [] }, { "id": "NCT01051414_exc_R2", "type": "Has_mood", "arg1_id": "NCT01051414_exc_T3", "arg2_id": "NCT01051414_exc_T4", "normalized": [] } ]

[ { "id": "NCT01051414_inc_text", "type": "inclusion", "text": [ "Subjects chronically infected with HCV Genotype 1 \nHCV RNA viral load of ≥ 10*5* IU/mL (100,000 IU/mL) at screening \n" ], "offsets": [ [ 0, 117 ] ] } ]

[ { "id": "NCT01051414_inc_T1", "type": "Condition", "text": [ "HCV" ], "offsets": [ [ 35, 38 ] ], "normalized": [] }, { "id": "NCT01051414_inc_T2", "type": "Qualifier", "text": [ "Genotype 1" ], "offsets": [ [ 39, 49 ] ], "normalized": [] }, { "id": "NCT01051414_inc_T3", "type": "Temporal", "text": [ "chronically" ], "offsets": [ [ 9, 20 ] ], "normalized": [] }, { "id": "NCT01051414_inc_T4", "type": "Multiplier", "text": [ "chronically" ], "offsets": [ [ 9, 20 ] ], "normalized": [] }, { "id": "NCT01051414_inc_T5", "type": "Measurement", "text": [ "HCV RNA viral load" ], "offsets": [ [ 51, 69 ] ], "normalized": [] }, { "id": "NCT01051414_inc_T6", "type": "Value", "text": [ "≥ 10*5* IU/mL" ], "offsets": [ [ 73, 86 ] ], "normalized": [] }, { "id": "NCT01051414_inc_T7", "type": "Value", "text": [ "100,000 IU/mL" ], "offsets": [ [ 88, 101 ] ], "normalized": [] }, { "id": "NCT01051414_inc_T8", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 103, 115 ] ], "normalized": [] }, { "id": "NCT01051414_inc_T9", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 106, 115 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01051414_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01051414_inc_T1", "arg2_id": "NCT01051414_inc_T2", "normalized": [] }, { "id": "NCT01051414_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01051414_inc_T1", "arg2_id": "NCT01051414_inc_T3", "normalized": [] }, { "id": "NCT01051414_inc_R4", "type": "Subsumes", "arg1_id": "NCT01051414_inc_T6", "arg2_id": "NCT01051414_inc_T7", "normalized": [] }, { "id": "NCT01051414_inc_R5", "type": "Has_value", "arg1_id": "NCT01051414_inc_T5", "arg2_id": "NCT01051414_inc_T6", "normalized": [] }, { "id": "NCT01051414_inc_R7", "type": "Has_temporal", "arg1_id": "NCT01051414_inc_T5", "arg2_id": "NCT01051414_inc_T8", "normalized": [] } ]

[ { "id": "NCT01064752_exc_text", "type": "exclusion", "text": [ "1. Taking a tetracycline within 6 months or history of adverse reaction to minocycline or another tetracycline. \n2. Enhanced risk from lumbar puncture, including documented or suspected cerebral mass lesion predisposing to brain herniation or bleeding diathesis. \n3. Pregnancy or expectation of pregnancy during the study. \n4. Active opportunistic infection or active neurological disease that might confound evaluation. \n5. ADC Stage > 1. \n6. Hemoglobin < 10 Gms/dL. \n7. BUN or creatine above the normal limits. \n8. Taking other drugs known to reduce the metabolism of minocycline and thus increase the probability of toxicity. \n \n" ], "offsets": [ [ 0, 641 ] ] } ]

[ { "id": "NCT01064752_exc_T1", "type": "Drug", "text": [ "tetracycline" ], "offsets": [ [ 12, 24 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T2", "type": "Temporal", "text": [ "within 6 months" ], "offsets": [ [ 25, 40 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T3", "type": "Observation", "text": [ "history" ], "offsets": [ [ 44, 51 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T4", "type": "Condition", "text": [ "adverse reaction" ], "offsets": [ [ 55, 71 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T5", "type": "Drug", "text": [ "minocycline" ], "offsets": [ [ 75, 86 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T6", "type": "Drug", "text": [ "tetracycline" ], "offsets": [ [ 98, 110 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T7", "type": "Scope", "text": [ "minocycline or another tetracycline" ], "offsets": [ [ 75, 110 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T8", "type": "Procedure", "text": [ "lumbar puncture" ], "offsets": [ [ 135, 150 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T9", "type": "Mood", "text": [ "Enhanced risk" ], "offsets": [ [ 116, 129 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T10", "type": "Condition", "text": [ "cerebral mass lesion" ], "offsets": [ [ 186, 206 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T11", "type": "Qualifier", "text": [ "predisposing to brain herniation or bleeding diathesis" ], "offsets": [ [ 207, 261 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T12", "type": "Mood", "text": [ "predisposing to" ], "offsets": [ [ 207, 222 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T13", "type": "Condition", "text": [ "brain herniation" ], "offsets": [ [ 223, 239 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T14", "type": "Condition", "text": [ "bleeding diathesis" ], "offsets": [ [ 243, 261 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T15", "type": "Scope", "text": [ "brain herniation or bleeding diathesis" ], "offsets": [ [ 223, 261 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T16", "type": "Mood", "text": [ "documented" ], "offsets": [ [ 162, 172 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T17", "type": "Mood", "text": [ "suspected" ], "offsets": [ [ 176, 185 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T18", "type": "Scope", "text": [ "documented or suspected" ], "offsets": [ [ 162, 185 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T19", "type": "Scope", "text": [ "documented or suspected cerebral mass lesion predisposing to brain herniation or bleeding diathesis" ], "offsets": [ [ 162, 261 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T20", "type": "Scope", "text": [ "Enhanced risk from lumbar puncture" ], "offsets": [ [ 116, 150 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T21", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 267, 276 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T22", "type": "Mood", "text": [ "expectation" ], "offsets": [ [ 280, 291 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T23", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 295, 304 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T24", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 305, 321 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T25", "type": "Scope", "text": [ "Pregnancy or expectation of pregnancy" ], "offsets": [ [ 267, 304 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T26", "type": "Condition", "text": [ "opportunistic infection" ], "offsets": [ [ 334, 357 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T27", "type": "Qualifier", "text": [ "opportunistic" ], "offsets": [ [ 334, 347 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T28", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 327, 333 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T29", "type": "Condition", "text": [ "neurological disease" ], "offsets": [ [ 368, 388 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T30", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 361, 367 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T31", "type": "Measurement", "text": [ "ADC Stage" ], "offsets": [ [ 425, 434 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T32", "type": "Value", "text": [ "> 1" ], "offsets": [ [ 435, 438 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T33", "type": "Measurement", "text": [ "Hemoglobin" ], "offsets": [ [ 444, 454 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T34", "type": "Value", "text": [ "< 10 Gms/dL" ], "offsets": [ [ 455, 466 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T35", "type": "Measurement", "text": [ "BUN" ], "offsets": [ [ 472, 475 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T36", "type": "Measurement", "text": [ "creatine" ], "offsets": [ [ 479, 487 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T37", "type": "Value", "text": [ "above the normal limits" ], "offsets": [ [ 488, 511 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T38", "type": "Scope", "text": [ "BUN or creatine" ], "offsets": [ [ 472, 487 ] ], "normalized": [] }, { "id": "NCT01064752_exc_T39", "type": "Drug", "text": [ "minocycline" ], "offsets": [ [ 570, 581 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01064752_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01064752_exc_T1", "arg2_id": "NCT01064752_exc_T2", "normalized": [] }, { "id": "NCT01064752_exc_R2", "type": "Has_scope", "arg1_id": "NCT01064752_exc_T4", "arg2_id": "NCT01064752_exc_T7", "normalized": [] }, { "id": "NCT01064752_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01064752_exc_T4", "arg2_id": "NCT01064752_exc_T3", "normalized": [] }, { "id": "NCT01064752_exc_R4", "type": "Has_mood", "arg1_id": "NCT01064752_exc_T8", "arg2_id": "NCT01064752_exc_T9", "normalized": [] }, { "id": "NCT01064752_exc_R5", "type": "Has_mood", "arg1_id": "NCT01064752_exc_T15", "arg2_id": "NCT01064752_exc_T12", "normalized": [] }, { "id": "NCT01064752_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT01064752_exc_T10", "arg2_id": "NCT01064752_exc_T11", "normalized": [] }, { "id": "NCT01064752_exc_R8", "type": "Has_scope", "arg1_id": "NCT01064752_exc_T10", "arg2_id": "NCT01064752_exc_T18", "normalized": [] }, { "id": "NCT01064752_exc_R9", "type": "Subsumes", "arg1_id": "NCT01064752_exc_T20", "arg2_id": "NCT01064752_exc_T19", "normalized": [] }, { "id": "NCT01064752_exc_R10", "type": "Has_mood", "arg1_id": "NCT01064752_exc_T23", "arg2_id": "NCT01064752_exc_T22", "normalized": [] }, { "id": "NCT01064752_exc_R11", "type": "Has_temporal", "arg1_id": "NCT01064752_exc_T25", "arg2_id": "NCT01064752_exc_T24", "normalized": [] }, { "id": "NCT01064752_exc_R13", "type": "Has_temporal", "arg1_id": "NCT01064752_exc_T26", "arg2_id": "NCT01064752_exc_T28", "normalized": [] }, { "id": "NCT01064752_exc_R14", "type": "Has_temporal", "arg1_id": "NCT01064752_exc_T29", "arg2_id": "NCT01064752_exc_T30", "normalized": [] }, { "id": "NCT01064752_exc_R15", "type": "Has_value", "arg1_id": "NCT01064752_exc_T31", "arg2_id": "NCT01064752_exc_T32", "normalized": [] }, { "id": "NCT01064752_exc_R16", "type": "Has_value", "arg1_id": "NCT01064752_exc_T33", "arg2_id": "NCT01064752_exc_T34", "normalized": [] }, { "id": "NCT01064752_exc_R17", "type": "Has_value", "arg1_id": "NCT01064752_exc_T38", "arg2_id": "NCT01064752_exc_T37", "normalized": [] } ]

[ { "id": "NCT01064752_inc_text", "type": "inclusion", "text": [ "1. HIV infection with plasma and CSF HIV RNA concentrations (using Roche Amplicor assay) > 1,000 copies/ mL (available after baseline LP). \n2. Off antiretroviral therapy (ART) for > 6 weeks before the study and no plans to begin treatment for the study duration. (The decision of whether or not a subject takes antiretroviral therapy will be made by the subject in consultation with his/her primary care provider prior to screening for this study.) \n3. Predicted adherence to the medication. \n4. Capable of providing informed consent. \n5. > 18 years old \n6. CD4 cell counts >150 cells/μL (though likely most, if not all, will be >250 cells/μL). \n7. When available, subjects will be screened for stability of blood CD4 and HIV RNA levels. \n" ], "offsets": [ [ 0, 739 ] ] } ]

[ { "id": "NCT01064752_inc_T1", "type": "Condition", "text": [ "HIV infection" ], "offsets": [ [ 3, 16 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T2", "type": "Measurement", "text": [ "plasma", "concentration" ], "offsets": [ [ 22, 28 ], [ 45, 58 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T3", "type": "Measurement", "text": [ "CSF HIV RNA concentration" ], "offsets": [ [ 33, 58 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T4", "type": "Procedure", "text": [ "Roche Amplicor assay" ], "offsets": [ [ 67, 87 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T5", "type": "Value", "text": [ "> 1,000 copies/ mL" ], "offsets": [ [ 89, 107 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T6", "type": "Procedure", "text": [ "antiretroviral therapy (ART)" ], "offsets": [ [ 147, 175 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T7", "type": "Condition", "text": [ "Off antiretroviral therapy (ART)" ], "offsets": [ [ 143, 175 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T8", "type": "Temporal", "text": [ "> 6 weeks before the study" ], "offsets": [ [ 180, 206 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T9", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 197, 206 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T10", "type": "Mood", "text": [ "plans to begin" ], "offsets": [ [ 214, 228 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T11", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 229, 238 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T12", "type": "Temporal", "text": [ "for the study duration" ], "offsets": [ [ 239, 261 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T13", "type": "Reference_point", "text": [ "study" ], "offsets": [ [ 247, 252 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T14", "type": "Negation", "text": [ "no" ], "offsets": [ [ 211, 213 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T18", "type": "Value", "text": [ "18 years" ], "offsets": [ [ 541, 549 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T19", "type": "Person", "text": [ "old" ], "offsets": [ [ 550, 553 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T20", "type": "Measurement", "text": [ "CD4 cell counts" ], "offsets": [ [ 558, 573 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T21", "type": "Value", "text": [ ">150 cells/μL" ], "offsets": [ [ 574, 587 ] ], "normalized": [] }, { "id": "NCT01064752_inc_T22", "type": "Value", "text": [ ">250 cells/μL" ], "offsets": [ [ 629, 642 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01064752_inc_R1", "type": "AND", "arg1_id": "NCT01064752_inc_T3", "arg2_id": "NCT01064752_inc_T4", "normalized": [] }, { "id": "NCT01064752_inc_R2", "type": "AND", "arg1_id": "NCT01064752_inc_T2", "arg2_id": "NCT01064752_inc_T4", "normalized": [] }, { "id": "NCT01064752_inc_R3", "type": "Has_value", "arg1_id": "NCT01064752_inc_T2", "arg2_id": "NCT01064752_inc_T5", "normalized": [] }, { "id": "NCT01064752_inc_R4", "type": "Has_value", "arg1_id": "NCT01064752_inc_T3", "arg2_id": "NCT01064752_inc_T5", "normalized": [] }, { "id": "NCT01064752_inc_R6", "type": "Has_index", "arg1_id": "NCT01064752_inc_T8", "arg2_id": "NCT01064752_inc_T9", "normalized": [] }, { "id": "NCT01064752_inc_R8", "type": "Has_temporal", "arg1_id": "NCT01064752_inc_T11", "arg2_id": "NCT01064752_inc_T12", "normalized": [] }, { "id": "NCT01064752_inc_R9", "type": "Has_mood", "arg1_id": "NCT01064752_inc_T11", "arg2_id": "NCT01064752_inc_T10", "normalized": [] }, { "id": "NCT01064752_inc_R10", "type": "Has_negation", "arg1_id": "NCT01064752_inc_T10", "arg2_id": "NCT01064752_inc_T14", "normalized": [] }, { "id": "NCT01064752_inc_R11", "type": "Has_temporal", "arg1_id": "NCT01064752_inc_T7", "arg2_id": "NCT01064752_inc_T8", "normalized": [] }, { "id": "NCT01064752_inc_R12", "type": "Has_value", "arg1_id": "NCT01064752_inc_T19", "arg2_id": "NCT01064752_inc_T18", "normalized": [] }, { "id": "NCT01064752_inc_R13", "type": "Has_value", "arg1_id": "NCT01064752_inc_T20", "arg2_id": "NCT01064752_inc_T21", "normalized": [] }, { "id": "NCT01064752_inc_R14", "type": "Subsumes", "arg1_id": "NCT01064752_inc_T21", "arg2_id": "NCT01064752_inc_T22", "normalized": [] } ]

[ { "id": "NCT01078051_exc_text", "type": "exclusion", "text": [ "NA\n\n" ], "offsets": [ [ 0, 4 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT01078051_inc_text", "type": "inclusion", "text": [ "Patients with angina or silent ischemia and documented ischemia\nPatients who are eligible for intracoronary stenting\nAge > 18 years\nDe novo lesion CTO\nReference vessel size 2.5 mm by visual estimation\nAt least one CTO lesions located in proximal or mid epicardial coronary artery. (If the patient has two CTO lesions, one CTO lesion should be located in proximal or mid epicardial coronary artery)\nAngiographically defined total occlusion over 3 months\nIf no definite symptom with total occlusion, two experienced operators decide CTO in consideration of angiographical morphology (degree of calcification, bridging collaterals, non-tapered stump, angiographic filling from collaterals)\n" ], "offsets": [ [ 0, 687 ] ] } ]

[ { "id": "NCT01078051_inc_T1", "type": "Condition", "text": [ "angina" ], "offsets": [ [ 14, 20 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T2", "type": "Condition", "text": [ "ischemia" ], "offsets": [ [ 31, 39 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T3", "type": "Qualifier", "text": [ "silent" ], "offsets": [ [ 24, 30 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T4", "type": "Qualifier", "text": [ "documented" ], "offsets": [ [ 44, 54 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T5", "type": "Condition", "text": [ "ischemia" ], "offsets": [ [ 55, 63 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T7", "type": "Procedure", "text": [ "intracoronary stenting" ], "offsets": [ [ 94, 116 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T8", "type": "Person", "text": [ "Age" ], "offsets": [ [ 117, 120 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T9", "type": "Value", "text": [ "> 18 years" ], "offsets": [ [ 121, 131 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T10", "type": "Condition", "text": [ "CTO" ], "offsets": [ [ 147, 150 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T11", "type": "Qualifier", "text": [ "De novo lesion" ], "offsets": [ [ 132, 146 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T12", "type": "Value", "text": [ "2.5 mm" ], "offsets": [ [ 173, 179 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T13", "type": "Measurement", "text": [ "rence vessel size 2.5", "isual estimation\nAt" ], "offsets": [ [ 155, 176 ], [ 184, 203 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T14", "type": "Multiplier", "text": [ "At least one" ], "offsets": [ [ 201, 213 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T15", "type": "Condition", "text": [ "CTO lesions" ], "offsets": [ [ 214, 225 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T16", "type": "Qualifier", "text": [ "oximal or m", "ary artery. (If" ], "offsets": [ [ 239, 250 ], [ 269, 284 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T17", "type": "Qualifier", "text": [ "mid epicardial coronary artery" ], "offsets": [ [ 249, 279 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T18", "type": "Condition", "text": [ "coronary artery" ], "offsets": [ [ 264, 279 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T19", "type": "Scope", "text": [ "in proximal or mid epicardial coronary artery" ], "offsets": [ [ 234, 279 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T21", "type": "Condition", "text": [ "total occlusion" ], "offsets": [ [ 423, 438 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T22", "type": "Qualifier", "text": [ "Angiographically defined" ], "offsets": [ [ 398, 422 ] ], "normalized": [] }, { "id": "NCT01078051_inc_T23", "type": "Temporal", "text": [ "3 months" ], "offsets": [ [ 444, 452 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01078051_inc_R1", "type": "Has_qualifier", "arg1_id": "NCT01078051_inc_T2", "arg2_id": "NCT01078051_inc_T3", "normalized": [] }, { "id": "NCT01078051_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01078051_inc_T5", "arg2_id": "NCT01078051_inc_T4", "normalized": [] }, { "id": "NCT01078051_inc_R3", "type": "Has_value", "arg1_id": "NCT01078051_inc_T8", "arg2_id": "NCT01078051_inc_T9", "normalized": [] }, { "id": "NCT01078051_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT01078051_inc_T10", "arg2_id": "NCT01078051_inc_T11", "normalized": [] }, { "id": "NCT01078051_inc_R5", "type": "Has_value", "arg1_id": "NCT01078051_inc_T13", "arg2_id": "NCT01078051_inc_T12", "normalized": [] }, { "id": "NCT01078051_inc_R6", "type": "Has_multiplier", "arg1_id": "NCT01078051_inc_T15", "arg2_id": "NCT01078051_inc_T14", "normalized": [] }, { "id": "NCT01078051_inc_R9", "type": "Has_scope", "arg1_id": "NCT01078051_inc_T15", "arg2_id": "NCT01078051_inc_T19", "normalized": [] }, { "id": "NCT01078051_inc_R10", "type": "Has_qualifier", "arg1_id": "NCT01078051_inc_T21", "arg2_id": "NCT01078051_inc_T22", "normalized": [] }, { "id": "NCT01078051_inc_R11", "type": "Has_temporal", "arg1_id": "NCT01078051_inc_T21", "arg2_id": "NCT01078051_inc_T23", "normalized": [] } ]

[ { "id": "NCT01082549_exc_text", "type": "exclusion", "text": [ "1. Prior treatment with gemcitabine, carboplatin (except in the adjuvant setting), or Iniparib. \n2. Past or current history of neoplasm other than the entry diagnosis, with the exception of treated non-melanoma skin cancer or carcinoma in-situ of any primary site, or invasive cancers treated definitively, with treatment ending >5 years previously and no evidence of recurrences. \n3. A history of cardiac disease, as defined by: \nMalignant hypertension \nUnstable angina \nCongestive heart failure \nMyocardial infarction within the previous 6 months \nSymptomatic, unstable or uncontrolled, cardiac arrhythmias. Patients who have stable, rate-controlled atrial fibrillation are eligible for study enrollment. \n4. Active brain metastases. Patients with treated brain metastases are eligible, if (1) radiation therapy was completed at least 2 weeks prior to study entry; (2) follow-up scan shows no disease progression; and (3) patient does not require steroids. \n5. Women who are pregnant or lactating. \n6. Any serious, active infection (> Grade 2) at the time of treatment. \n7. A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment. \n8. A major surgical procedure, or significant traumatic injury ≤28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study. \n9. Uncontrolled or intercurrent illness including, that in the opinion of the investigator may increase the risks associated with study participation or administration of the investigational products, or that may interfere with the interpretation of the results. \n10. History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results. \n11. Known or suspected allergy/hypersensitivity to any agent given in the course of this trial. \nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. \n \n" ], "offsets": [ [ 0, 2174 ] ] } ]

[ { "id": "NCT01082549_exc_T1", "type": "Drug", "text": [ "gemcitabine" ], "offsets": [ [ 24, 35 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T2", "type": "Drug", "text": [ "carboplatin" ], "offsets": [ [ 37, 48 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T3", "type": "Drug", "text": [ "Iniparib" ], "offsets": [ [ 86, 94 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T4", "type": "Temporal", "text": [ "Prior" ], "offsets": [ [ 3, 8 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T5", "type": "Scope", "text": [ "gemcitabine, carboplatin (except in the adjuvant setting), or Iniparib" ], "offsets": [ [ 24, 94 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T6", "type": "Condition", "text": [ "neoplasm" ], "offsets": [ [ 127, 135 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T7", "type": "Condition", "text": [ "non-melanoma skin cancer" ], "offsets": [ [ 198, 222 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T8", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 190, 197 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T9", "type": "Qualifier", "text": [ "treated" ], "offsets": [ [ 190, 197 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T10", "type": "Condition", "text": [ "carcinoma in-situ" ], "offsets": [ [ 226, 243 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T11", "type": "Condition", "text": [ "cancers" ], "offsets": [ [ 277, 284 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T12", "type": "Qualifier", "text": [ "invasive" ], "offsets": [ [ 268, 276 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T13", "type": "Qualifier", "text": [ "treated definitively" ], "offsets": [ [ 285, 305 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T14", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 285, 292 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T15", "type": "Negation", "text": [ "with the exception of" ], "offsets": [ [ 168, 189 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T16", "type": "Temporal", "text": [ ">5 years previously" ], "offsets": [ [ 329, 348 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T17", "type": "Observation", "text": [ "evidence of recurrences" ], "offsets": [ [ 356, 379 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T18", "type": "Negation", "text": [ "no" ], "offsets": [ [ 353, 355 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T19", "type": "Observation", "text": [ "history" ], "offsets": [ [ 116, 123 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T20", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 108, 115 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T21", "type": "Temporal", "text": [ "Past" ], "offsets": [ [ 100, 104 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T22", "type": "Scope", "text": [ "Past or current" ], "offsets": [ [ 100, 115 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T23", "type": "Qualifier", "text": [ "other than the entry diagnosis" ], "offsets": [ [ 136, 166 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T24", "type": "Condition", "text": [ "entry diagnosis" ], "offsets": [ [ 151, 166 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T25", "type": "Scope", "text": [ "treated non-melanoma skin cancer or carcinoma in-situ of any primary site, or invasive cancers treated definitively, with treatment ending >5 years previously and no evidence of recurrences" ], "offsets": [ [ 190, 379 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T26", "type": "Condition", "text": [ "cardiac disease" ], "offsets": [ [ 398, 413 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T27", "type": "Observation", "text": [ "history" ], "offsets": [ [ 387, 394 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T29", "type": "Condition", "text": [ "Malignant hypertension" ], "offsets": [ [ 431, 453 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T30", "type": "Condition", "text": [ "Unstable angina" ], "offsets": [ [ 455, 470 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T31", "type": "Condition", "text": [ "Congestive heart failure" ], "offsets": [ [ 472, 496 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T32", "type": "Condition", "text": [ "Myocardial infarction" ], "offsets": [ [ 498, 519 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T33", "type": "Temporal", "text": [ "within the previous 6 months" ], "offsets": [ [ 520, 548 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T34", "type": "Condition", "text": [ "cardiac arrhythmias" ], "offsets": [ [ 589, 608 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T35", "type": "Qualifier", "text": [ "uncontrolled" ], "offsets": [ [ 575, 587 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T36", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 563, 571 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T37", "type": "Qualifier", "text": [ "Symptomatic" ], "offsets": [ [ 550, 561 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T38", "type": "Scope", "text": [ "Symptomatic, unstable or uncontrolled" ], "offsets": [ [ 550, 587 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T39", "type": "Condition", "text": [ "atrial fibrillation" ], "offsets": [ [ 652, 671 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T41", "type": "Negation", "text": [ "are eligible" ], "offsets": [ [ 672, 684 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T42", "type": "Qualifier", "text": [ "rate-controlled" ], "offsets": [ [ 636, 651 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T43", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 628, 634 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T44", "type": "Condition", "text": [ "brain metastases" ], "offsets": [ [ 718, 734 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T45", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 711, 717 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T46", "type": "Condition", "text": [ "brain metastases" ], "offsets": [ [ 758, 774 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T47", "type": "Procedure", "text": [ "treated" ], "offsets": [ [ 750, 757 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T48", "type": "Qualifier", "text": [ "treated" ], "offsets": [ [ 750, 757 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T49", "type": "Negation", "text": [ "are eligible" ], "offsets": [ [ 775, 787 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T51", "type": "Procedure", "text": [ "radiation therapy" ], "offsets": [ [ 796, 813 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T52", "type": "Temporal", "text": [ "at least 2 weeks prior to study entry" ], "offsets": [ [ 828, 865 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T53", "type": "Reference_point", "text": [ "study entry" ], "offsets": [ [ 854, 865 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T54", "type": "Condition", "text": [ "disease progression" ], "offsets": [ [ 895, 914 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T55", "type": "Procedure", "text": [ "follow-up scan" ], "offsets": [ [ 871, 885 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T56", "type": "Negation", "text": [ "no" ], "offsets": [ [ 892, 894 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T57", "type": "Drug", "text": [ "steroids" ], "offsets": [ [ 949, 957 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T58", "type": "Negation", "text": [ "not" ], "offsets": [ [ 937, 940 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T59", "type": "Mood", "text": [ "require" ], "offsets": [ [ 941, 948 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T60", "type": "Scope", "text": [ "radiation therapy was completed at least 2 weeks prior to study entry; (2) follow-up scan shows no disease progression; and (3) patient does not require steroids" ], "offsets": [ [ 796, 957 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T61", "type": "Scope", "text": [ "treated brain metastases" ], "offsets": [ [ 750, 774 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T62", "type": "Scope", "text": [ "treated brain metastases are eligible, if (1) radiation therapy was completed at least 2 weeks prior to study entry; (2) follow-up scan shows no disease progression; and (3) patient does not require steroids" ], "offsets": [ [ 750, 957 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T63", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 977, 985 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T64", "type": "Person", "text": [ "Women" ], "offsets": [ [ 963, 968 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T65", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 989, 998 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T67", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 1024, 1033 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T68", "type": "Value", "text": [ "> Grade 2" ], "offsets": [ [ 1035, 1044 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T69", "type": "Qualifier", "text": [ "> Grade 2" ], "offsets": [ [ 1035, 1044 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T70", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 1008, 1015 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T71", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 1017, 1023 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T72", "type": "Condition", "text": [ "medical condition" ], "offsets": [ [ 1097, 1114 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T73", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 1078, 1085 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T77", "type": "Condition", "text": [ "impair the ability of the patient to receive protocol treatment" ], "offsets": [ [ 1126, 1189 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T78", "type": "Mood", "text": [ "would" ], "offsets": [ [ 1120, 1125 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T79", "type": "Procedure", "text": [ "surgical procedure" ], "offsets": [ [ 1203, 1221 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T80", "type": "Qualifier", "text": [ "major" ], "offsets": [ [ 1197, 1202 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T82", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 1226, 1237 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T84", "type": "Condition", "text": [ "traumatic injury" ], "offsets": [ [ 1238, 1254 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T85", "type": "Temporal", "text": [ "≤28 days of beginning treatment" ], "offsets": [ [ 1255, 1286 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T86", "type": "Reference_point", "text": [ "beginning treatment" ], "offsets": [ [ 1267, 1286 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T87", "type": "Procedure", "text": [ "major surgery" ], "offsets": [ [ 1320, 1333 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T88", "type": "Mood", "text": [ "need for" ], "offsets": [ [ 1311, 1319 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T89", "type": "Temporal", "text": [ "during the course of the study" ], "offsets": [ [ 1334, 1364 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T90", "type": "Reference_point", "text": [ "the course of the study" ], "offsets": [ [ 1341, 1364 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T91", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 1370, 1382 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T92", "type": "Temporal", "text": [ "intercurrent" ], "offsets": [ [ 1386, 1398 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T93", "type": "Condition", "text": [ "illness" ], "offsets": [ [ 1399, 1406 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T94", "type": "Qualifier", "text": [ "in the opinion of the investigator may increase the risks" ], "offsets": [ [ 1423, 1480 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T96", "type": "Scope", "text": [ "Uncontrolled or intercurrent" ], "offsets": [ [ 1370, 1398 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T98", "type": "Condition", "text": [ "psychiatric condition" ], "offsets": [ [ 1661, 1682 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T99", "type": "Condition", "text": [ "laboratory abnormality" ], "offsets": [ [ 1686, 1708 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T100", "type": "Procedure", "text": [ "laboratory" ], "offsets": [ [ 1686, 1696 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T102", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 1959, 1975 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T103", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 1951, 1958 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T104", "type": "Mood", "text": [ "Known" ], "offsets": [ [ 1932, 1937 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T105", "type": "Mood", "text": [ "suspected" ], "offsets": [ [ 1941, 1950 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T106", "type": "Scope", "text": [ "Known or suspected" ], "offsets": [ [ 1932, 1950 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T107", "type": "Drug", "text": [ "agent given in the course of this trial" ], "offsets": [ [ 1983, 2022 ] ], "normalized": [] }, { "id": "NCT01082549_exc_T108", "type": "Scope", "text": [ "allergy/hypersensitivity" ], "offsets": [ [ 1951, 1975 ] ], "normalized": [] } ]

[]

[]

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"id": "NCT01082549_exc_R11", "type": "Has_temporal", "arg1_id": "NCT01082549_exc_T14", "arg2_id": "NCT01082549_exc_T16", "normalized": [] }, { "id": "NCT01082549_exc_R12", "type": "Has_negation", "arg1_id": "NCT01082549_exc_T25", "arg2_id": "NCT01082549_exc_T15", "normalized": [] }, { "id": "NCT01082549_exc_R13", "type": "Has_temporal", "arg1_id": "NCT01082549_exc_T26", "arg2_id": "NCT01082549_exc_T27", "normalized": [] }, { "id": "NCT01082549_exc_R14", "type": "Has_temporal", "arg1_id": "NCT01082549_exc_T32", "arg2_id": "NCT01082549_exc_T33", "normalized": [] }, { "id": "NCT01082549_exc_R15", "type": "Has_scope", "arg1_id": "NCT01082549_exc_T34", "arg2_id": "NCT01082549_exc_T38", "normalized": [] }, { "id": "NCT01082549_exc_R16", "type": "Has_negation", "arg1_id": "NCT01082549_exc_T39", "arg2_id": "NCT01082549_exc_T41", "normalized": [] }, { "id": "NCT01082549_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT01082549_exc_T39", "arg2_id": "NCT01082549_exc_T42", "normalized": [] }, { "id": "NCT01082549_exc_R18", "type": "Has_qualifier", "arg1_id": "NCT01082549_exc_T39", "arg2_id": "NCT01082549_exc_T43", "normalized": [] }, { "id": "NCT01082549_exc_R19", "type": "Has_temporal", "arg1_id": "NCT01082549_exc_T44", "arg2_id": "NCT01082549_exc_T45", "normalized": [] }, { "id": "NCT01082549_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT01082549_exc_T46", "arg2_id": "NCT01082549_exc_T48", "normalized": [] }, { "id": "NCT01082549_exc_R23", "type": "Has_index", "arg1_id": "NCT01082549_exc_T52", "arg2_id": "NCT01082549_exc_T53", "normalized": [] }, { "id": "NCT01082549_exc_R24", "type": "Has_negation", "arg1_id": "NCT01082549_exc_T54", "arg2_id": "NCT01082549_exc_T56", "normalized": [] }, { "id": "NCT01082549_exc_R25", "type": "AND", "arg1_id": "NCT01082549_exc_T55", "arg2_id": "NCT01082549_exc_T54", "normalized": [] }, { "id": "NCT01082549_exc_R26", "type": "Has_mood", "arg1_id": "NCT01082549_exc_T57", "arg2_id": "NCT01082549_exc_T59", "normalized": [] }, { "id": "NCT01082549_exc_R27", "type": "Has_negation", "arg1_id": "NCT01082549_exc_T57", "arg2_id": "NCT01082549_exc_T58", "normalized": [] }, { "id": "NCT01082549_exc_R28", "type": "Has_temporal", "arg1_id": "NCT01082549_exc_T51", "arg2_id": "NCT01082549_exc_T52", "normalized": [] }, { "id": "NCT01082549_exc_R22", "type": "Has_scope", "arg1_id": "NCT01082549_exc_T61", "arg2_id": "NCT01082549_exc_T60", "normalized": [] }, { "id": "NCT01082549_exc_R29", "type": "Has_negation", "arg1_id": "NCT01082549_exc_T62", "arg2_id": "NCT01082549_exc_T49", "normalized": [] }, { "id": "NCT01082549_exc_R31", "type": "Has_qualifier", "arg1_id": "NCT01082549_exc_T67", "arg2_id": "NCT01082549_exc_T69", "normalized": [] }, { "id": "NCT01082549_exc_R32", "type": "Has_temporal", "arg1_id": "NCT01082549_exc_T67", "arg2_id": "NCT01082549_exc_T71", "normalized": [] }, { "id": "NCT01082549_exc_R33", "type": "Has_qualifier", "arg1_id": "NCT01082549_exc_T67", "arg2_id": "NCT01082549_exc_T70", "normalized": [] }, { "id": "NCT01082549_exc_R34", "type": "Has_qualifier", "arg1_id": "NCT01082549_exc_T72", "arg2_id": "NCT01082549_exc_T73", "normalized": [] }, { "id": "NCT01082549_exc_R35", "type": "Has_mood", "arg1_id": "NCT01082549_exc_T77", "arg2_id": "NCT01082549_exc_T78", "normalized": [] }, { "id": "NCT01082549_exc_R36", "type": "AND", "arg1_id": "NCT01082549_exc_T72", "arg2_id": "NCT01082549_exc_T77", "normalized": [] }, { "id": "NCT01082549_exc_R37", "type": "Has_qualifier", "arg1_id": "NCT01082549_exc_T79", "arg2_id": "NCT01082549_exc_T80", "normalized": [] }, { "id": "NCT01082549_exc_R39", "type": "Has_qualifier", "arg1_id": "NCT01082549_exc_T84", "arg2_id": "NCT01082549_exc_T82", "normalized": [] }, { "id": "NCT01082549_exc_R40", "type": "Has_temporal", "arg1_id": "NCT01082549_exc_T84", "arg2_id": "NCT01082549_exc_T85", "normalized": [] }, { "id": "NCT01082549_exc_R41", "type": "Has_mood", "arg1_id": "NCT01082549_exc_T87", "arg2_id": "NCT01082549_exc_T88", "normalized": [] }, { "id": "NCT01082549_exc_R43", "type": "Has_temporal", "arg1_id": "NCT01082549_exc_T87", "arg2_id": "NCT01082549_exc_T89", "normalized": [] }, { "id": "NCT01082549_exc_R44", "type": "Has_qualifier", "arg1_id": "NCT01082549_exc_T93", "arg2_id": "NCT01082549_exc_T94", "normalized": [] }, { "id": "NCT01082549_exc_R45", "type": "Has_scope", "arg1_id": "NCT01082549_exc_T93", "arg2_id": "NCT01082549_exc_T96", "normalized": [] }, { "id": "NCT01082549_exc_R47", "type": "AND", "arg1_id": "NCT01082549_exc_T108", "arg2_id": "NCT01082549_exc_T107", "normalized": [] }, { "id": "NCT01082549_exc_R48", "type": "Has_scope", "arg1_id": "NCT01082549_exc_T108", "arg2_id": "NCT01082549_exc_T106", "normalized": [] } ]

[ { "id": "NCT01082549_inc_text", "type": "inclusion", "text": [ "Eligible patients must meet the following criteria to be enrolled in the study: \n1. Newly diagnosed, stage IV squamous cell lung cancer. This includes patients who present with disseminated metastases, and those with a malignant pleural or pericardial effusion (i.e., formerly stage IIIB in the 6th TNM staging system). \n2. Patients who have received prior adjuvant therapy for early-stage lung cancer are eligible if at least 12 months have elapsed from that treatment. \n3. Histologically confirmed squamous cell bronchogenic carcinoma. Patients whose tumors contain mixed non-small cell histologies are eligible, as long as squamous carcinoma is the predominant histology. Mixed tumors with small cell anaplastic elements are not eligible. Cytologic specimens obtained by brushings, washings, or needle aspiration of the defined lesion are acceptable. \n4. Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the recurrence is outside the original radiation therapy port. Radiation therapy must have been completed >4 weeks prior to the initiation of study treatment. Patients who have received chemo/radiation for locally advanced NSCLC are not eligible. Patients who have received palliative radiation therapy for symptomatic metastases must have completed treatment >14 days prior the initiation of the study treatment. \n5. Presence of evaluable (measureable or non-measurable) disease. \n6. ECOG Performance Status of 0 or 1. \n7. Laboratory values as follows: \nAbsolute neutrophil count (ANC) >1,500/microL and platelets >100,000/microL (≤72 hours prior to initial treatment). \nHemoglobin >9 g/dL (Note: Patients may be transfused or receive erythropoietin to maintain or exceed this level). \nBilirubin < ULN. \nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal if no liver involvement or ≤5 times the upper limit of normal with liver involvement. \nCreatinine <2.0 mg/dL, or creatinine clearance >40 mL/min (as calculated by the Cockcroft-Gault method. \n8. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and at least 6 months after the last dose of the study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. Sexually active men must agree to use a medically acceptable form of birth control during treatment and at least 6 months after the last dose. If a female partner becomes pregnant during the course of the study the treating physician should be informed immediately. \n9. >18 years of age. \n10. Ability to understand the nature of this study, give written informed consent, and comply with study requirements. \n11. Patients entering this study must be willing to provide tissue from a previous tumor biopsy (if available) for correlative testing. An exception to this is when the national/local regulations prohibits some of the key activities of this research like the export of samples to third countries, storage of coded samples or global gene expression profiling without a pre-specified list of target genes. If tissue is not available, a patient will still be eligible for enrollment into the study. \n" ], "offsets": [ [ 0, 3483 ] ] } ]

[ { "id": "NCT01082549_inc_T2", "type": "Mood", "text": [ "Newly diagnosed" ], "offsets": [ [ 84, 99 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T3", "type": "Temporal", "text": [ "Newly" ], "offsets": [ [ 84, 89 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T4", "type": "Qualifier", "text": [ "stage IV" ], "offsets": [ [ 101, 109 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T5", "type": "Measurement", "text": [ "stage" ], "offsets": [ [ 101, 106 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T6", "type": "Value", "text": [ "IV" ], "offsets": [ [ 107, 109 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T7", "type": "Condition", "text": [ "squamous cell lung cancer" ], "offsets": [ [ 110, 135 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T8", "type": "Condition", "text": [ "metastases" ], "offsets": [ [ 190, 200 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T9", "type": "Qualifier", "text": [ "disseminated" ], "offsets": [ [ 177, 189 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T10", "type": "Condition", "text": [ "pericardial effusion" ], "offsets": [ [ 240, 260 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T11", "type": "Condition", "text": [ "pleural", "effusion" ], "offsets": [ [ 229, 236 ], [ 252, 260 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T12", "type": "Qualifier", "text": [ "malignant" ], "offsets": [ [ 219, 228 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T13", "type": "Scope", "text": [ "pleural or pericardial effusion" ], "offsets": [ [ 229, 260 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T15", "type": "Measurement", "text": [ "6th TNM staging system" ], "offsets": [ [ 295, 317 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T16", "type": "Value", "text": [ "stage IIIB" ], "offsets": [ [ 277, 287 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T17", "type": "Scope", "text": [ "stage IIIB in the 6th TNM staging system" ], "offsets": [ [ 277, 317 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T14", "type": "Procedure", "text": [ "adjuvant therapy" ], "offsets": [ [ 357, 373 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T18", "type": "Condition", "text": [ "early-stage lung cancer" ], "offsets": [ [ 378, 401 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T19", "type": "Temporal", "text": [ "at least 12 months have elapsed from that treatment" ], "offsets": [ [ 418, 469 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T20", "type": "Reference_point", "text": [ "that treatment" ], "offsets": [ [ 455, 469 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T21", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 460, 469 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T22", "type": "Scope", "text": [ "adjuvant therapy for early-stage lung cancer" ], "offsets": [ [ 357, 401 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T23", "type": "Condition", "text": [ "squamous cell bronchogenic carcinoma" ], "offsets": [ [ 500, 536 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T25", "type": "Procedure", "text": [ "Histologically" ], "offsets": [ [ 475, 489 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T26", "type": "Value", "text": [ "confirmed" ], "offsets": [ [ 490, 499 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T24", "type": "Condition", "text": [ "mixed non-small cell histologies" ], "offsets": [ [ 568, 600 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T27", "type": "Condition", "text": [ "squamous carcinoma" ], "offsets": [ [ 626, 644 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T28", "type": "Qualifier", "text": [ "predominant histology" ], "offsets": [ [ 652, 673 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T29", "type": "Observation", "text": [ "small cell anaplastic elements" ], "offsets": [ [ 693, 723 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T30", "type": "Negation", "text": [ "not" ], "offsets": [ [ 728, 731 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T31", "type": "Condition", "text": [ "Mixed tumors" ], "offsets": [ [ 675, 687 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T32", "type": "Qualifier", "text": [ "small cell anaplastic elements" ], "offsets": [ [ 693, 723 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T33", "type": "Procedure", "text": [ "radiotherapy" ], "offsets": [ [ 881, 893 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T34", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 872, 880 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T35", "type": "Qualifier", "text": [ "locally advanced" ], "offsets": [ [ 920, 936 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T36", "type": "Condition", "text": [ "non-small cell lung cancer" ], "offsets": [ [ 937, 963 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T38", "type": "Procedure", "text": [ "Radiation therapy" ], "offsets": [ [ 1052, 1069 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T39", "type": "Temporal", "text": [ ">4 weeks prior to the initiation of study treatment" ], "offsets": [ [ 1095, 1146 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T40", "type": "Reference_point", "text": [ "the initiation of study treatment" ], "offsets": [ [ 1113, 1146 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T41", "type": "Qualifier", "text": [ "locally advanced" ], "offsets": [ [ 1195, 1211 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T42", "type": "Condition", "text": [ "NSCLC" ], "offsets": [ [ 1212, 1217 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T43", "type": "Procedure", "text": [ "chemo" ], "offsets": [ [ 1175, 1180 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T44", "type": "Procedure", "text": [ "radiation" ], "offsets": [ [ 1181, 1190 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T45", "type": "Scope", "text": [ "chemo/radiation" ], "offsets": [ [ 1175, 1190 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T46", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1222, 1225 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T47", "type": "Procedure", "text": [ "palliative radiation therapy" ], "offsets": [ [ 1263, 1291 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T48", "type": "Condition", "text": [ "symptomatic metastases" ], "offsets": [ [ 1296, 1318 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T49", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 1296, 1307 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T50", "type": "Temporal", "text": [ ">14 days prior the initiation of the study treatment" ], "offsets": [ [ 1349, 1401 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T51", "type": "Reference_point", "text": [ "the initiation of the study treatment" ], "offsets": [ [ 1364, 1401 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T53", "type": "Measurement", "text": [ "ECOG Performance Status" ], "offsets": [ [ 1474, 1497 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T54", "type": "Value", "text": [ "0 or 1" ], "offsets": [ [ 1501, 1507 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T55", "type": "Measurement", "text": [ "Absolute neutrophil count (ANC)" ], "offsets": [ [ 1544, 1575 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T56", "type": "Value", "text": [ ">1,500/microL" ], "offsets": [ [ 1576, 1589 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T57", "type": "Measurement", "text": [ "platelets" ], "offsets": [ [ 1594, 1603 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T58", "type": "Value", "text": [ ">100,000/microL" ], "offsets": [ [ 1604, 1619 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T59", "type": "Temporal", "text": [ "≤72 hours prior to initial treatment" ], "offsets": [ [ 1621, 1657 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T60", "type": "Reference_point", "text": [ "initial treatment" ], "offsets": [ [ 1640, 1657 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T61", "type": "Scope", "text": [ "Absolute neutrophil count (ANC) >1,500/microL and platelets >100,000/microL" ], "offsets": [ [ 1544, 1619 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T62", "type": "Measurement", "text": [ "Hemoglobin" ], "offsets": [ [ 1661, 1671 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T63", "type": "Value", "text": [ ">9 g/dL" ], "offsets": [ [ 1672, 1679 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T65", "type": "Measurement", "text": [ "Bilirubin" ], "offsets": [ [ 1776, 1785 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T66", "type": "Value", "text": [ "< ULN" ], "offsets": [ [ 1786, 1791 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T67", "type": "Measurement", "text": [ "Alanine aminotransferase (ALT)" ], "offsets": [ [ 1794, 1824 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T68", "type": "Measurement", "text": [ "aspartate aminotransferase (AST)" ], "offsets": [ [ 1829, 1861 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T69", "type": "Value", "text": [ "≤2.5 times the upper limit of normal" ], "offsets": [ [ 1862, 1898 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T70", "type": "Condition", "text": [ "liver involvement" ], "offsets": [ [ 1905, 1922 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T71", "type": "Negation", "text": [ "no" ], "offsets": [ [ 1902, 1904 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T73", "type": "Scope", "text": [ "no liver involvement" ], "offsets": [ [ 1902, 1922 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T74", "type": "Value", "text": [ "≤5 times the upper limit of normal" ], "offsets": [ [ 1926, 1960 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T75", "type": "Condition", "text": [ "liver involvement." ], "offsets": [ [ 1966, 1984 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T76", "type": "Scope", "text": [ "≤2.5 times the upper limit of normal if no liver involvement or ≤5 times the upper limit of normal with liver involvement" ], "offsets": [ [ 1862, 1983 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T77", "type": "Measurement", "text": [ "Creatinine" ], "offsets": [ [ 1986, 1996 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T78", "type": "Value", "text": [ "<2.0 mg/dL" ], "offsets": [ [ 1997, 2007 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T79", "type": "Measurement", "text": [ "creatinine clearance" ], "offsets": [ [ 2012, 2032 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T80", "type": "Value", "text": [ ">40 mL/min" ], "offsets": [ [ 2033, 2043 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T81", "type": "Qualifier", "text": [ "Cockcroft-Gault method" ], "offsets": [ [ 2066, 2088 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T83", "type": "Value", "text": [ ">18 years" ], "offsets": [ [ 2847, 2856 ] ], "normalized": [] }, { "id": "NCT01082549_inc_T84", "type": "Person", "text": [ "age" ], "offsets": [ [ 2860, 2863 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01082549_inc_R2", "type": "Has_value", "arg1_id": "NCT01082549_inc_T5", "arg2_id": "NCT01082549_inc_T6", "normalized": [] }, { "id": "NCT01082549_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT01082549_inc_T7", "arg2_id": "NCT01082549_inc_T4", "normalized": [] }, { "id": "NCT01082549_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT01082549_inc_T8", "arg2_id": "NCT01082549_inc_T9", "normalized": [] }, { "id": "NCT01082549_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT01082549_inc_T13", "arg2_id": "NCT01082549_inc_T12", "normalized": [] }, { "id": "NCT01082549_inc_R7", "type": "Has_value", "arg1_id": "NCT01082549_inc_T15", "arg2_id": "NCT01082549_inc_T16", "normalized": [] }, { "id": "NCT01082549_inc_R8", "type": "Subsumes", "arg1_id": "NCT01082549_inc_T12", "arg2_id": "NCT01082549_inc_T15", "normalized": [] }, { "id": "NCT01082549_inc_R12", "type": "AND", "arg1_id": "NCT01082549_inc_T22", "arg2_id": "NCT01082549_inc_T21", "normalized": [] }, { "id": "NCT01082549_inc_R13", "type": "Has_value", "arg1_id": "NCT01082549_inc_T25", "arg2_id": "NCT01082549_inc_T26", "normalized": [] }, { "id": "NCT01082549_inc_R14", "type": "AND", "arg1_id": "NCT01082549_inc_T23", "arg2_id": "NCT01082549_inc_T25", "normalized": [] }, { "id": "NCT01082549_inc_R15", "type": "Has_qualifier", "arg1_id": "NCT01082549_inc_T27", "arg2_id": "NCT01082549_inc_T28", "normalized": [] }, { "id": "NCT01082549_inc_R16", "type": "AND", "arg1_id": "NCT01082549_inc_T24", "arg2_id": "NCT01082549_inc_T27", "normalized": [] }, { "id": "NCT01082549_inc_R17", "type": "Has_qualifier", "arg1_id": "NCT01082549_inc_T31", "arg2_id": "NCT01082549_inc_T32", "normalized": [] }, { "id": "NCT01082549_inc_R19", "type": "Has_negation", "arg1_id": "NCT01082549_inc_T32", "arg2_id": "NCT01082549_inc_T30", "normalized": [] }, { "id": "NCT01082549_inc_R20", "type": "Has_temporal", "arg1_id": "NCT01082549_inc_T33", "arg2_id": "NCT01082549_inc_T34", "normalized": [] }, { "id": "NCT01082549_inc_R21", "type": "Has_qualifier", "arg1_id": "NCT01082549_inc_T36", "arg2_id": "NCT01082549_inc_T35", "normalized": [] }, { "id": "NCT01082549_inc_R22", "type": "AND", "arg1_id": "NCT01082549_inc_T33", "arg2_id": "NCT01082549_inc_T36", "normalized": [] }, { "id": "NCT01082549_inc_R24", "type": "Has_temporal", "arg1_id": "NCT01082549_inc_T38", "arg2_id": "NCT01082549_inc_T39", "normalized": [] }, { "id": "NCT01082549_inc_R25", "type": "Has_qualifier", "arg1_id": "NCT01082549_inc_T42", "arg2_id": "NCT01082549_inc_T41", "normalized": [] }, { "id": "NCT01082549_inc_R26", "type": "AND", "arg1_id": "NCT01082549_inc_T45", "arg2_id": "NCT01082549_inc_T42", "normalized": [] }, { "id": "NCT01082549_inc_R27", "type": "Has_negation", "arg1_id": "NCT01082549_inc_T45", "arg2_id": "NCT01082549_inc_T46", "normalized": [] }, { "id": "NCT01082549_inc_R29", "type": "AND", "arg1_id": "NCT01082549_inc_T47", "arg2_id": "NCT01082549_inc_T48", "normalized": [] }, { "id": "NCT01082549_inc_R31", "type": "Has_value", "arg1_id": "NCT01082549_inc_T53", "arg2_id": "NCT01082549_inc_T54", "normalized": [] }, { "id": "NCT01082549_inc_R33", "type": "Has_value", "arg1_id": "NCT01082549_inc_T57", "arg2_id": "NCT01082549_inc_T58", "normalized": [] }, { "id": "NCT01082549_inc_R34", "type": "Has_value", "arg1_id": "NCT01082549_inc_T55", "arg2_id": "NCT01082549_inc_T56", "normalized": [] }, { "id": "NCT01082549_inc_R35", "type": "Has_temporal", "arg1_id": "NCT01082549_inc_T61", "arg2_id": "NCT01082549_inc_T59", "normalized": [] }, { "id": "NCT01082549_inc_R36", "type": "Has_value", "arg1_id": "NCT01082549_inc_T62", "arg2_id": "NCT01082549_inc_T63", "normalized": [] }, { "id": "NCT01082549_inc_R37", "type": "Has_value", "arg1_id": "NCT01082549_inc_T65", "arg2_id": "NCT01082549_inc_T66", "normalized": [] }, { "id": "NCT01082549_inc_R40", "type": "Has_negation", "arg1_id": "NCT01082549_inc_T70", "arg2_id": "NCT01082549_inc_T71", "normalized": [] }, { "id": "NCT01082549_inc_R41", "type": "Has_value", "arg1_id": "NCT01082549_inc_T75", "arg2_id": "NCT01082549_inc_T74", "normalized": [] }, { "id": "NCT01082549_inc_R38", "type": "Has_value", "arg1_id": "NCT01082549_inc_T73", "arg2_id": "NCT01082549_inc_T69", "normalized": [] }, { "id": "NCT01082549_inc_R39", "type": "Has_scope", "arg1_id": "NCT01082549_inc_T68", "arg2_id": "NCT01082549_inc_T76", "normalized": [] }, { "id": "NCT01082549_inc_R42", "type": "Has_scope", "arg1_id": "NCT01082549_inc_T67", "arg2_id": "NCT01082549_inc_T76", "normalized": [] }, { "id": "NCT01082549_inc_R43", "type": "Has_value", "arg1_id": "NCT01082549_inc_T79", "arg2_id": "NCT01082549_inc_T80", "normalized": [] }, { "id": "NCT01082549_inc_R44", "type": "Has_value", "arg1_id": "NCT01082549_inc_T77", "arg2_id": "NCT01082549_inc_T78", "normalized": [] }, { "id": "NCT01082549_inc_R45", "type": "Has_qualifier", "arg1_id": "NCT01082549_inc_T79", "arg2_id": "NCT01082549_inc_T81", "normalized": [] }, { "id": "NCT01082549_inc_R46", "type": "Has_qualifier", "arg1_id": "NCT01082549_inc_T77", "arg2_id": "NCT01082549_inc_T81", "normalized": [] }, { "id": "NCT01082549_inc_R47", "type": "Has_value", "arg1_id": "NCT01082549_inc_T84", "arg2_id": "NCT01082549_inc_T83", "normalized": [] } ]

[ { "id": "NCT01084993_exc_text", "type": "exclusion", "text": [ "Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12 months\nConcurrent participation in other investigational study\nFemoral sheath (artery)\n" ], "offsets": [ [ 0, 173 ] ] } ]

[ { "id": "NCT01084993_exc_T1", "type": "Condition", "text": [ "Intolerance" ], "offsets": [ [ 0, 11 ] ], "normalized": [] }, { "id": "NCT01084993_exc_T2", "type": "Condition", "text": [ "allergy" ], "offsets": [ [ 15, 22 ] ], "normalized": [] }, { "id": "NCT01084993_exc_T3", "type": "Drug", "text": [ "ASA" ], "offsets": [ [ 26, 29 ] ], "normalized": [] }, { "id": "NCT01084993_exc_T4", "type": "Scope", "text": [ "Intolerance or allergy" ], "offsets": [ [ 0, 22 ] ], "normalized": [] }, { "id": "NCT01084993_exc_T5", "type": "Drug", "text": [ "clopidogrel" ], "offsets": [ [ 31, 42 ] ], "normalized": [] }, { "id": "NCT01084993_exc_T6", "type": "Drug", "text": [ "ticlopidine" ], "offsets": [ [ 46, 57 ] ], "normalized": [] }, { "id": "NCT01084993_exc_T7", "type": "Temporal", "text": [ "for 12 months" ], "offsets": [ [ 79, 92 ] ], "normalized": [] }, { "id": "NCT01084993_exc_T8", "type": "Negation", "text": [ "precluding" ], "offsets": [ [ 58, 68 ] ], "normalized": [] }, { "id": "NCT01084993_exc_T9", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 69, 78 ] ], "normalized": [] }, { "id": "NCT01084993_exc_T10", "type": "Scope", "text": [ "precluding treatment for 12 months" ], "offsets": [ [ 58, 92 ] ], "normalized": [] }, { "id": "NCT01084993_exc_T11", "type": "Scope", "text": [ "ASA, clopidogrel or ticlopidine" ], "offsets": [ [ 26, 57 ] ], "normalized": [] }, { "id": "NCT01084993_exc_T13", "type": "Condition", "text": [ "Femoral sheath (artery)" ], "offsets": [ [ 149, 172 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01084993_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01084993_exc_T9", "arg2_id": "NCT01084993_exc_T7", "normalized": [] }, { "id": "NCT01084993_exc_R2", "type": "Has_negation", "arg1_id": "NCT01084993_exc_T9", "arg2_id": "NCT01084993_exc_T8", "normalized": [] }, { "id": "NCT01084993_exc_R3", "type": "Has_scope", "arg1_id": "NCT01084993_exc_T11", "arg2_id": "NCT01084993_exc_T10", "normalized": [] }, { "id": "NCT01084993_exc_R4", "type": "Has_scope", "arg1_id": "NCT01084993_exc_T4", "arg2_id": "NCT01084993_exc_T11", "normalized": [] } ]

[ { "id": "NCT01084993_inc_text", "type": "inclusion", "text": [ "At least two of the following additional criteria\nAt least 70 yrs old\nFemale gender\nDiabetes\nCreatinine clearance <60mL/min\nHistory of gastro-intestinal or other organ bleeding\nBaseline anemia\nCurrent treatment with glycoproteins IIb-IIIa inhibitors\n" ], "offsets": [ [ 0, 250 ] ] } ]

[ { "id": "NCT01084993_inc_T1", "type": "Multiplier", "text": [ "At least two" ], "offsets": [ [ 0, 12 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T3", "type": "Value", "text": [ "At least 70 yrs" ], "offsets": [ [ 50, 65 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T4", "type": "Person", "text": [ "old" ], "offsets": [ [ 66, 69 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T5", "type": "Person", "text": [ "Female" ], "offsets": [ [ 70, 76 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T6", "type": "Condition", "text": [ "Diabetes" ], "offsets": [ [ 84, 92 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T7", "type": "Measurement", "text": [ "Creatinine clearance" ], "offsets": [ [ 93, 113 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T8", "type": "Value", "text": [ "<60mL/min" ], "offsets": [ [ 114, 123 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T9", "type": "Condition", "text": [ "organ bleeding" ], "offsets": [ [ 162, 176 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T10", "type": "Condition", "text": [ "o-intestinal or o", "ing\nBase" ], "offsets": [ [ 140, 157 ], [ 173, 181 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T11", "type": "Qualifier", "text": [ "other" ], "offsets": [ [ 156, 161 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T12", "type": "Observation", "text": [ "History" ], "offsets": [ [ 124, 131 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T13", "type": "Scope", "text": [ "gastro-intestinal or other organ bleeding" ], "offsets": [ [ 135, 176 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T14", "type": "Condition", "text": [ "anemia" ], "offsets": [ [ 186, 192 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T15", "type": "Temporal", "text": [ "Baseline" ], "offsets": [ [ 177, 185 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T16", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 201, 210 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T17", "type": "Drug", "text": [ "glycoproteins IIb-IIIa inhibitors" ], "offsets": [ [ 216, 249 ] ], "normalized": [] }, { "id": "NCT01084993_inc_T18", "type": "Temporal", "text": [ "Current" ], "offsets": [ [ 193, 200 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01084993_inc_R1", "type": "Has_value", "arg1_id": "NCT01084993_inc_T4", "arg2_id": "NCT01084993_inc_T3", "normalized": [] }, { "id": "NCT01084993_inc_R2", "type": "Has_value", "arg1_id": "NCT01084993_inc_T7", "arg2_id": "NCT01084993_inc_T8", "normalized": [] }, { "id": "NCT01084993_inc_R3", "type": "Has_qualifier", "arg1_id": "NCT01084993_inc_T9", "arg2_id": "NCT01084993_inc_T11", "normalized": [] }, { "id": "NCT01084993_inc_R4", "type": "Has_temporal", "arg1_id": "NCT01084993_inc_T13", "arg2_id": "NCT01084993_inc_T12", "normalized": [] }, { "id": "NCT01084993_inc_R5", "type": "Has_temporal", "arg1_id": "NCT01084993_inc_T14", "arg2_id": "NCT01084993_inc_T15", "normalized": [] }, { "id": "NCT01084993_inc_R6", "type": "Has_temporal", "arg1_id": "NCT01084993_inc_T16", "arg2_id": "NCT01084993_inc_T18", "normalized": [] }, { "id": "NCT01084993_inc_R7", "type": "AND", "arg1_id": "NCT01084993_inc_T16", "arg2_id": "NCT01084993_inc_T17", "normalized": [] } ]

[ { "id": "NCT01088750_exc_text", "type": "exclusion", "text": [ "NA\n" ], "offsets": [ [ 0, 3 ] ] } ]

[]

[]

[]

[]

[ { "id": "NCT01088750_inc_text", "type": "inclusion", "text": [ "Stage IA or IIA disease\nNot specified\nNo prior therapy\n" ], "offsets": [ [ 0, 55 ] ] } ]

[]

[]

[]

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[ { "id": "NCT01098383_exc_text", "type": "exclusion", "text": [ "an underlying infectious disease\nchromosomal abnormality\nmetabolic disorder\nspecific brain related disorder (such as tuberous sclerosis)\nhistory of fetal cytomegalovirus infection\nbirth asphyxia\na history of major head injury\na chronic use of non-steroidal anti-inflammatory drugs, (NSAID)\nknown brain damage\nEpilepsy\nAbnormal Electro-cardiogram (ECG)\nEpileptiform EEG\nUse of psychostimulants, anti-depressants, neuroleptics or anti-convulsive agents within the past month.\nLack of cooperation in the screening phase\n" ], "offsets": [ [ 0, 517 ] ] } ]

[ { "id": "NCT01098383_exc_T1", "type": "Condition", "text": [ "infectious disease" ], "offsets": [ [ 14, 32 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T2", "type": "Qualifier", "text": [ "underlying" ], "offsets": [ [ 3, 13 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T3", "type": "Condition", "text": [ "chromosomal abnormality" ], "offsets": [ [ 33, 56 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T4", "type": "Condition", "text": [ "metabolic disorder" ], "offsets": [ [ 57, 75 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T5", "type": "Condition", "text": [ "disorder" ], "offsets": [ [ 99, 107 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T6", "type": "Qualifier", "text": [ "brain" ], "offsets": [ [ 85, 90 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T7", "type": "Condition", "text": [ "tuberous sclerosis" ], "offsets": [ [ 117, 135 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T8", "type": "Condition", "text": [ "cytomegalovirus infection" ], "offsets": [ [ 154, 179 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T9", "type": "Qualifier", "text": [ "fetal" ], "offsets": [ [ 148, 153 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T10", "type": "Condition", "text": [ "birth asphyxia" ], "offsets": [ [ 180, 194 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T11", "type": "Condition", "text": [ "major head injury" ], "offsets": [ [ 208, 225 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T12", "type": "Condition", "text": [ "chronic use" ], "offsets": [ [ 228, 239 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T13", "type": "Drug", "text": [ "non-steroidal anti-inflammatory drugs" ], "offsets": [ [ 243, 280 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T14", "type": "Drug", "text": [ "NSAID" ], "offsets": [ [ 283, 288 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T15", "type": "Condition", "text": [ "brain damage" ], "offsets": [ [ 296, 308 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T16", "type": "Condition", "text": [ "Epilepsy" ], "offsets": [ [ 309, 317 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T17", "type": "Measurement", "text": [ "Electro-cardiogram" ], "offsets": [ [ 327, 345 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T18", "type": "Measurement", "text": [ "ECG" ], "offsets": [ [ 347, 350 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T19", "type": "Value", "text": [ "Abnormal" ], "offsets": [ [ 318, 326 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T20", "type": "Measurement", "text": [ "EEG" ], "offsets": [ [ 365, 368 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T21", "type": "Value", "text": [ "Epileptiform" ], "offsets": [ [ 352, 364 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T22", "type": "Drug", "text": [ "psychostimulants" ], "offsets": [ [ 376, 392 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T23", "type": "Drug", "text": [ "anti-depressants" ], "offsets": [ [ 394, 410 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T24", "type": "Drug", "text": [ "neuroleptics" ], "offsets": [ [ 412, 424 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T25", "type": "Drug", "text": [ "anti-convulsive agents" ], "offsets": [ [ 428, 450 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T26", "type": "Temporal", "text": [ "within the past month" ], "offsets": [ [ 451, 472 ] ], "normalized": [] }, { "id": "NCT01098383_exc_T27", "type": "Scope", "text": [ "psychostimulants, anti-depressants, neuroleptics or anti-convulsive agents" ], "offsets": [ [ 376, 450 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01098383_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01098383_exc_T1", "arg2_id": "NCT01098383_exc_T2", "normalized": [] }, { "id": "NCT01098383_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01098383_exc_T5", "arg2_id": "NCT01098383_exc_T6", "normalized": [] }, { "id": "NCT01098383_exc_R3", "type": "Subsumes", "arg1_id": "NCT01098383_exc_T5", "arg2_id": "NCT01098383_exc_T7", "normalized": [] }, { "id": "NCT01098383_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01098383_exc_T8", "arg2_id": "NCT01098383_exc_T9", "normalized": [] }, { "id": "NCT01098383_exc_R5", "type": "Subsumes", "arg1_id": "NCT01098383_exc_T13", "arg2_id": "NCT01098383_exc_T14", "normalized": [] }, { "id": "NCT01098383_exc_R6", "type": "AND", "arg1_id": "NCT01098383_exc_T12", "arg2_id": "NCT01098383_exc_T13", "normalized": [] }, { "id": "NCT01098383_exc_R7", "type": "Subsumes", "arg1_id": "NCT01098383_exc_T17", "arg2_id": "NCT01098383_exc_T18", "normalized": [] }, { "id": "NCT01098383_exc_R8", "type": "Has_value", "arg1_id": "NCT01098383_exc_T17", "arg2_id": "NCT01098383_exc_T19", "normalized": [] }, { "id": "NCT01098383_exc_R9", "type": "Has_value", "arg1_id": "NCT01098383_exc_T20", "arg2_id": "NCT01098383_exc_T21", "normalized": [] }, { "id": "NCT01098383_exc_R10", "type": "Has_temporal", "arg1_id": "NCT01098383_exc_T27", "arg2_id": "NCT01098383_exc_T26", "normalized": [] } ]

[ { "id": "NCT01098383_inc_text", "type": "inclusion", "text": [ "A formal diagnosis of Autism or Pervasive Developmental Disorder not otherwise specified (PDD-NOS), given by a child neurologist.\nAge: 10-18 years.\nA signed parental consent form.\n" ], "offsets": [ [ 0, 180 ] ] } ]

[ { "id": "NCT01098383_inc_T1", "type": "Condition", "text": [ "Autism" ], "offsets": [ [ 22, 28 ] ], "normalized": [] }, { "id": "NCT01098383_inc_T2", "type": "Condition", "text": [ "Pervasive Developmental Disorder not otherwise specified" ], "offsets": [ [ 32, 88 ] ], "normalized": [] }, { "id": "NCT01098383_inc_T3", "type": "Condition", "text": [ "PDD-NOS" ], "offsets": [ [ 90, 97 ] ], "normalized": [] }, { "id": "NCT01098383_inc_T5", "type": "Person", "text": [ "Age" ], "offsets": [ [ 130, 133 ] ], "normalized": [] }, { "id": "NCT01098383_inc_T6", "type": "Value", "text": [ "10-18 years" ], "offsets": [ [ 135, 146 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01098383_inc_R1", "type": "Subsumes", "arg1_id": "NCT01098383_inc_T2", "arg2_id": "NCT01098383_inc_T3", "normalized": [] }, { "id": "NCT01098383_inc_R2", "type": "Has_value", "arg1_id": "NCT01098383_inc_T5", "arg2_id": "NCT01098383_inc_T6", "normalized": [] } ]

[ { "id": "NCT01116882_exc_text", "type": "exclusion", "text": [ "1. The patient is pregnant or breastfeeding. \n2. Evidence of STEMI within 72 hours of the intended treatment on infarct related or non-infarct related artery. \n3. Cardiogenic shock on presentation or during current hospitalization. \n4. Left ventricular ejection fraction less than 20%. \n5. Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated). \n6. A platelet count less than 75,000 cells/mm3 or greater than 700,000 cells/mm3 or a WBC less than 3,000 cells/mm3. \n7. Acute or chronic renal dysfunction (creatinine greater than 2.5 mg/dl or less than 150µmol/L). \n8. Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials). \n9. Prior participation in this study. \n10. Within 30 days prior to the index study procedure, the subject has undergone a previous coronary interventional procedure of any kind. Note: This exclusion criterion does not apply to post-STEMI patients. \n11. Stroke or transient ischemic attack within the prior 3 months. \n12. Active peptic ulcer or upper gastrointestinal bleeding within the prior 3 months. \n13. Subject has active sepsis. \n14. Unprotected left main coronary artery disease (stenosis greater than 50%). \n15. In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study. \n16. Subject has normal or insignificant coronaries (i.e. coronary lesion(s) less than 50% stenosis). \n17. Any target vessel has evidence of: \nexcessive thrombus (e.g. requires target vessel thrombectomy) \ntortuousity (greater than 60 degree angle) that makes it unsuitable for proper stent delivery and deployment, \nheavy calcification. \n18. Any target lesion requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.). \n19. Any lesion that is located in a saphenous vein graft, however, lesions located within the native vessel but accessed through the graft are eligible. \n20. The target vessel is in a \"last remaining\" epicardial vessel (e.g. greater than 2 non-target epicardial vessels and the bypass grafts to these territories [if present] are totally occluded). \n \n" ], "offsets": [ [ 0, 2793 ] ] } ]

[ { "id": "NCT01116882_exc_T1", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 18, 26 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T2", "type": "Observation", "text": [ "breastfeeding" ], "offsets": [ [ 30, 43 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T3", "type": "Condition", "text": [ "STEMI" ], "offsets": [ [ 61, 66 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T4", "type": "Temporal", "text": [ "within 72 hours" ], "offsets": [ [ 67, 82 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T5", "type": "Qualifier", "text": [ "infarct related", "artery" ], "offsets": [ [ 112, 127 ], [ 151, 157 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T6", "type": "Qualifier", "text": [ "non-infarct related artery" ], "offsets": [ [ 131, 157 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T7", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 99, 108 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T8", "type": "Scope", "text": [ "infarct related or non-infarct related artery" ], "offsets": [ [ 112, 157 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T9", "type": "Condition", "text": [ "Cardiogenic shock" ], "offsets": [ [ 163, 180 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T10", "type": "Procedure", "text": [ "hospitalization" ], "offsets": [ [ 215, 230 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T11", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 207, 214 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T12", "type": "Measurement", "text": [ "Left ventricular ejection fraction" ], "offsets": [ [ 236, 270 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T13", "type": "Value", "text": [ "less than 20%" ], "offsets": [ [ 271, 284 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T14", "type": "Drug", "text": [ "aspirin" ], "offsets": [ [ 310, 317 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T15", "type": "Drug", "text": [ "clopidogrel" ], "offsets": [ [ 319, 330 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T16", "type": "Drug", "text": [ "Plavix" ], "offsets": [ [ 332, 338 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T17", "type": "Drug", "text": [ "ticlopidine" ], "offsets": [ [ 344, 355 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T18", "type": "Drug", "text": [ "Ticlid" ], "offsets": [ [ 357, 363 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T19", "type": "Drug", "text": [ "heparin" ], "offsets": [ [ 366, 373 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T20", "type": "Drug", "text": [ "bivalirudin" ], "offsets": [ [ 375, 386 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T21", "type": "Observation", "text": [ "stainless steel" ], "offsets": [ [ 388, 403 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T22", "type": "Drug", "text": [ "contrast agent" ], "offsets": [ [ 408, 422 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T23", "type": "Condition", "text": [ "allergies" ], "offsets": [ [ 296, 305 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T24", "type": "Scope", "text": [ "aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent" ], "offsets": [ [ 310, 422 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T25", "type": "Measurement", "text": [ "platelet count" ], "offsets": [ [ 472, 486 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T26", "type": "Value", "text": [ "less than 75,000 cells/mm3" ], "offsets": [ [ 487, 513 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T27", "type": "Value", "text": [ "greater than 700,000 cells/mm3" ], "offsets": [ [ 517, 547 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T28", "type": "Measurement", "text": [ "WBC" ], "offsets": [ [ 553, 556 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T29", "type": "Value", "text": [ "less than 3,000 cells/mm3" ], "offsets": [ [ 557, 582 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T30", "type": "Scope", "text": [ "less than 75,000 cells/mm3 or greater than 700,000 cells/mm3" ], "offsets": [ [ 487, 547 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T31", "type": "Condition", "text": [ "chronic renal dysfunction" ], "offsets": [ [ 597, 622 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T32", "type": "Condition", "text": [ "Acute", "renal dysfunction" ], "offsets": [ [ 588, 593 ], [ 605, 622 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T33", "type": "Measurement", "text": [ "creatinine" ], "offsets": [ [ 624, 634 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T34", "type": "Value", "text": [ "greater than 2.5 mg/dl" ], "offsets": [ [ 635, 657 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T35", "type": "Value", "text": [ "less than 150µmol/L" ], "offsets": [ [ 661, 680 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T36", "type": "Scope", "text": [ "greater than 2.5 mg/dl or less than 150µmol/L" ], "offsets": [ [ 635, 680 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T40", "type": "Temporal", "text": [ "Within 30 days prior to the index study procedure" ], "offsets": [ [ 1090, 1139 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T41", "type": "Reference_point", "text": [ "the index study procedure" ], "offsets": [ [ 1114, 1139 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T42", "type": "Procedure", "text": [ "coronary interventional procedure" ], "offsets": [ [ 1178, 1211 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T43", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 1169, 1177 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T45", "type": "Condition", "text": [ "STEMI" ], "offsets": [ [ 1279, 1284 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T44", "type": "Condition", "text": [ "Stroke" ], "offsets": [ [ 1300, 1306 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T46", "type": "Condition", "text": [ "transient ischemic attack" ], "offsets": [ [ 1310, 1335 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T47", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1261, 1264 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T48", "type": "Temporal", "text": [ "within the prior 3 months" ], "offsets": [ [ 1336, 1361 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T49", "type": "Scope", "text": [ "Stroke or transient ischemic attack" ], "offsets": [ [ 1300, 1335 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T50", "type": "Condition", "text": [ "peptic ulcer" ], "offsets": [ [ 1375, 1387 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T51", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 1368, 1374 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T52", "type": "Condition", "text": [ "upper gastrointestinal bleeding" ], "offsets": [ [ 1391, 1422 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T53", "type": "Temporal", "text": [ "within the prior 3 months" ], "offsets": [ [ 1423, 1448 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T54", "type": "Scope", "text": [ "peptic ulcer or upper gastrointestinal bleeding" ], "offsets": [ [ 1375, 1422 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T55", "type": "Condition", "text": [ "sepsis" ], "offsets": [ [ 1474, 1480 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T56", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 1467, 1473 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T57", "type": "Condition", "text": [ "left main coronary artery disease" ], "offsets": [ [ 1499, 1532 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T58", "type": "Qualifier", "text": [ "Unprotected" ], "offsets": [ [ 1487, 1498 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T59", "type": "Measurement", "text": [ "stenosis" ], "offsets": [ [ 1534, 1542 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T60", "type": "Condition", "text": [ "stenosis" ], "offsets": [ [ 1534, 1542 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T61", "type": "Value", "text": [ "greater than 50%" ], "offsets": [ [ 1543, 1559 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T63", "type": "Measurement", "text": [ "life expectancy" ], "offsets": [ [ 1656, 1671 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T64", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 1656, 1671 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T65", "type": "Value", "text": [ "less than one year" ], "offsets": [ [ 1675, 1693 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T67", "type": "Condition", "text": [ "coronary lesion" ], "offsets": [ [ 1899, 1914 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T68", "type": "Measurement", "text": [ "coronary lesion" ], "offsets": [ [ 1899, 1914 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T69", "type": "Value", "text": [ "less than 50% stenosis" ], "offsets": [ [ 1918, 1940 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T70", "type": "Condition", "text": [ "stenosis" ], "offsets": [ [ 1932, 1940 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T71", "type": "Condition", "text": [ "thrombus" ], "offsets": [ [ 1994, 2002 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T72", "type": "Procedure", "text": [ "target vessel thrombectomy" ], "offsets": [ [ 2018, 2044 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T73", "type": "Condition", "text": [ "tortuousity" ], "offsets": [ [ 2047, 2058 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T74", "type": "Value", "text": [ "greater than 60 degree" ], "offsets": [ [ 2060, 2082 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T75", "type": "Measurement", "text": [ "angle" ], "offsets": [ [ 2083, 2088 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T76", "type": "Procedure", "text": [ "stent delivery and deployment" ], "offsets": [ [ 2126, 2155 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T77", "type": "Qualifier", "text": [ "unsuitable for proper" ], "offsets": [ [ 2104, 2125 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T79", "type": "Condition", "text": [ "calcification" ], "offsets": [ [ 2164, 2177 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T80", "type": "Qualifier", "text": [ "heavy" ], "offsets": [ [ 2158, 2163 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T81", "type": "Device", "text": [ "device other than percutaneous transluminal coronary angioplasty (PTCA)" ], "offsets": [ [ 2228, 2299 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T82", "type": "Procedure", "text": [ "percutaneous transluminal coronary angioplasty (PTCA)" ], "offsets": [ [ 2246, 2299 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T83", "type": "Negation", "text": [ "other than" ], "offsets": [ [ 2235, 2245 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T84", "type": "Procedure", "text": [ "stent placement" ], "offsets": [ [ 2309, 2324 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T85", "type": "Temporal", "text": [ "prior to stent placement" ], "offsets": [ [ 2300, 2324 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T86", "type": "Reference_point", "text": [ "stent placement" ], "offsets": [ [ 2309, 2324 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T87", "type": "Procedure", "text": [ "directional coronary atherectomy" ], "offsets": [ [ 2351, 2383 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T88", "type": "Procedure", "text": [ "excimer laser" ], "offsets": [ [ 2385, 2398 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T89", "type": "Procedure", "text": [ "rotational atherectomy" ], "offsets": [ [ 2400, 2422 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T90", "type": "Scope", "text": [ "directional coronary atherectomy, excimer laser, rotational atherectomy" ], "offsets": [ [ 2351, 2422 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T91", "type": "Mood", "text": [ "requires" ], "offsets": [ [ 2202, 2210 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T92", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 2211, 2220 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T93", "type": "Condition", "text": [ "target lesion" ], "offsets": [ [ 2188, 2201 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T94", "type": "Device", "text": [ "saphenous vein graft" ], "offsets": [ [ 2468, 2488 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T95", "type": "Condition", "text": [ "lesion" ], "offsets": [ [ 2440, 2446 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T96", "type": "Qualifier", "text": [ "located in a saphenous vein graft" ], "offsets": [ [ 2455, 2488 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T97", "type": "Qualifier", "text": [ "within the native vessel" ], "offsets": [ [ 2515, 2539 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T99", "type": "Qualifier", "text": [ "accessed through the graft" ], "offsets": [ [ 2544, 2570 ] ], "normalized": [] }, { "id": "NCT01116882_exc_T100", "type": "Scope", "text": [ "within the native vessel but accessed through the graft" ], "offsets": [ [ 2515, 2570 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01116882_exc_R1", "type": "Has_scope", "arg1_id": "NCT01116882_exc_T7", "arg2_id": "NCT01116882_exc_T8", "normalized": [] }, { "id": "NCT01116882_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01116882_exc_T3", "arg2_id": "NCT01116882_exc_T4", "normalized": [] }, { "id": "NCT01116882_exc_R3", "type": "AND", "arg1_id": "NCT01116882_exc_T3", "arg2_id": "NCT01116882_exc_T7", "normalized": [] }, { "id": "NCT01116882_exc_R4", "type": "Has_value", "arg1_id": "NCT01116882_exc_T12", "arg2_id": "NCT01116882_exc_T13", "normalized": [] }, { "id": "NCT01116882_exc_R5", "type": "Has_scope", "arg1_id": "NCT01116882_exc_T23", "arg2_id": "NCT01116882_exc_T24", "normalized": [] }, { "id": "NCT01116882_exc_R6", "type": "Has_value", "arg1_id": "NCT01116882_exc_T28", "arg2_id": "NCT01116882_exc_T29", "normalized": [] }, { "id": "NCT01116882_exc_R7", "type": "Has_scope", "arg1_id": "NCT01116882_exc_T25", "arg2_id": "NCT01116882_exc_T30", "normalized": [] }, { "id": "NCT01116882_exc_R8", "type": "Has_scope", "arg1_id": "NCT01116882_exc_T33", "arg2_id": "NCT01116882_exc_T36", "normalized": [] }, { "id": "NCT01116882_exc_R9", "type": "Has_temporal", "arg1_id": "NCT01116882_exc_T42", "arg2_id": "NCT01116882_exc_T43", "normalized": [] }, { "id": "NCT01116882_exc_R11", "type": "Has_temporal", "arg1_id": "NCT01116882_exc_T42", "arg2_id": "NCT01116882_exc_T40", "normalized": [] }, { "id": "NCT01116882_exc_R12", "type": "Has_negation", "arg1_id": "NCT01116882_exc_T45", "arg2_id": "NCT01116882_exc_T47", "normalized": [] }, { "id": "NCT01116882_exc_R13", "type": "Has_temporal", "arg1_id": "NCT01116882_exc_T49", "arg2_id": "NCT01116882_exc_T48", "normalized": [] }, { "id": "NCT01116882_exc_R14", "type": "Has_temporal", "arg1_id": "NCT01116882_exc_T54", "arg2_id": "NCT01116882_exc_T51", "normalized": [] }, { "id": "NCT01116882_exc_R15", "type": "Has_temporal", "arg1_id": "NCT01116882_exc_T54", "arg2_id": "NCT01116882_exc_T53", "normalized": [] }, { "id": "NCT01116882_exc_R16", "type": "Has_temporal", "arg1_id": "NCT01116882_exc_T55", "arg2_id": "NCT01116882_exc_T56", "normalized": [] }, { "id": "NCT01116882_exc_R17", "type": "Has_qualifier", "arg1_id": "NCT01116882_exc_T57", "arg2_id": "NCT01116882_exc_T58", "normalized": [] }, { "id": "NCT01116882_exc_R19", "type": "Has_value", "arg1_id": "NCT01116882_exc_T59", "arg2_id": "NCT01116882_exc_T61", "normalized": [] }, { "id": "NCT01116882_exc_R20", "type": "AND", "arg1_id": "NCT01116882_exc_T57", "arg2_id": "NCT01116882_exc_T60", "normalized": [] }, { "id": "NCT01116882_exc_R22", "type": "Has_value", "arg1_id": "NCT01116882_exc_T63", "arg2_id": "NCT01116882_exc_T65", "normalized": [] }, { "id": "NCT01116882_exc_R25", "type": "Has_value", "arg1_id": "NCT01116882_exc_T68", "arg2_id": "NCT01116882_exc_T69", "normalized": [] }, { "id": "NCT01116882_exc_R26", "type": "Has_value", "arg1_id": "NCT01116882_exc_T75", "arg2_id": "NCT01116882_exc_T74", "normalized": [] }, { "id": "NCT01116882_exc_R27", "type": "Subsumes", "arg1_id": "NCT01116882_exc_T73", "arg2_id": "NCT01116882_exc_T75", "normalized": [] }, { "id": "NCT01116882_exc_R28", "type": "Has_qualifier", "arg1_id": "NCT01116882_exc_T76", "arg2_id": "NCT01116882_exc_T77", "normalized": [] }, { "id": "NCT01116882_exc_R30", "type": "Has_qualifier", "arg1_id": "NCT01116882_exc_T79", "arg2_id": "NCT01116882_exc_T80", "normalized": [] }, { "id": "NCT01116882_exc_R32", "type": "Has_negation", "arg1_id": "NCT01116882_exc_T82", "arg2_id": "NCT01116882_exc_T83", "normalized": [] }, { "id": "NCT01116882_exc_R35", "type": "Subsumes", "arg1_id": "NCT01116882_exc_T84", "arg2_id": "NCT01116882_exc_T90", "normalized": [] }, { "id": "NCT01116882_exc_R36", "type": "AND", "arg1_id": "NCT01116882_exc_T92", "arg2_id": "NCT01116882_exc_T81", "normalized": [] }, { "id": "NCT01116882_exc_R37", "type": "Has_temporal", "arg1_id": "NCT01116882_exc_T92", "arg2_id": "NCT01116882_exc_T85", "normalized": [] }, { "id": "NCT01116882_exc_R38", "type": "Has_mood", "arg1_id": "NCT01116882_exc_T92", "arg2_id": "NCT01116882_exc_T91", "normalized": [] }, { "id": "NCT01116882_exc_R39", "type": "AND", "arg1_id": "NCT01116882_exc_T93", "arg2_id": "NCT01116882_exc_T92", "normalized": [] }, { "id": "NCT01116882_exc_R41", "type": "Has_qualifier", "arg1_id": "NCT01116882_exc_T95", "arg2_id": "NCT01116882_exc_T96", "normalized": [] } ]

[ { "id": "NCT01116882_inc_text", "type": "inclusion", "text": [ "1. Subject is at least 18 years old. \n2. Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions). \n3. Subject's lesion(s) is (are) amenable to stent treatment with currently available FDA-approved bare metal or drug eluting stents. \n4. Subject is an acceptable candidate for elective, urgent or emergency coronary artery bypass graft (CABG). \n5. Subject has clinical evidence of ischemic heart disease in terms of a positive functional study, or documented symptoms. \n6. Documented stable angina pectoris [Canadian Cardiovascular Society Classification (CCS) 1, 2, 3, or 4], unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), non-ST segment elevation myocardial infarction, or documented silent ischemia. \n7. Subject is willing and able to undergo percutaneous intervention at SOS hospital, if randomized to SOS study arm. \n8. Subject and the treating physician agree that the subject will comply with all follow-up evaluations. \n9. Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site. \n10. The target lesion(s) is (are) de novo or restenotic (including in-stent restenotic) native coronary artery lesion(s) with greater than 50 and less than 100% stenosis (visual estimate), or the target lesion is an acute (less than 1 month) total occlusion as evidenced by clinical symptoms. \n11. Target lesions(s) is (are) located in an infarct (if not treated with primary PCI) or non-infarct-related artery with a 70% or greater stenosis (by visual estimate) more than 72 hours following the ST segment elevation myocardial infarction (STEMI). \nLesions treated with PCI more than 72 hours following STEMI would be subject to the same protocol inclusion/exclusion criteria listed above and below with the exception that a target lesion of 70% or greater stenosis may be treated with or without symptoms or abnormal stress test). \n" ], "offsets": [ [ 0, 2133 ] ] } ]

[ { "id": "NCT01116882_inc_T1", "type": "Value", "text": [ "at least 18 years" ], "offsets": [ [ 14, 31 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T2", "type": "Person", "text": [ "old" ], "offsets": [ [ 32, 35 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T3", "type": "Procedure", "text": [ "percutaneous coronary intervention (PCI)" ], "offsets": [ [ 82, 122 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T4", "type": "Qualifier", "text": [ "single-", "vessel" ], "offsets": [ [ 58, 65 ], [ 75, 81 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T5", "type": "Qualifier", "text": [ "multi-vessel" ], "offsets": [ [ 69, 81 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T6", "type": "Scope", "text": [ "single- or multi-vessel" ], "offsets": [ [ 58, 81 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T8", "type": "Condition", "text": [ "target lesion" ], "offsets": [ [ 148, 161 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T9", "type": "Condition", "text": [ "in-stent restenotic lesions" ], "offsets": [ [ 173, 200 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T10", "type": "Qualifier", "text": [ "de novo" ], "offsets": [ [ 126, 133 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T11", "type": "Qualifier", "text": [ "restenotic" ], "offsets": [ [ 137, 147 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T12", "type": "Qualifier", "text": [ "in-stent" ], "offsets": [ [ 173, 181 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T13", "type": "Qualifier", "text": [ "restenotic" ], "offsets": [ [ 182, 192 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T14", "type": "Scope", "text": [ "de novo or restenotic target lesion" ], "offsets": [ [ 126, 161 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T15", "type": "Scope", "text": [ "de novo or restenotic target lesion (including in-stent restenotic lesions)" ], "offsets": [ [ 126, 201 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T16", "type": "Device", "text": [ "drug eluting stents" ], "offsets": [ [ 316, 335 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T17", "type": "Condition", "text": [ "amenable to stent treatment" ], "offsets": [ [ 236, 263 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T18", "type": "Device", "text": [ "bare metal", "stents" ], "offsets": [ [ 302, 312 ], [ 329, 335 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T19", "type": "Scope", "text": [ "bare metal or drug eluting stents" ], "offsets": [ [ 302, 335 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T20", "type": "Condition", "text": [ "coronary artery bypass graft (CABG)" ], "offsets": [ [ 410, 445 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T21", "type": "Qualifier", "text": [ "emergency" ], "offsets": [ [ 400, 409 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T22", "type": "Qualifier", "text": [ "urgent" ], "offsets": [ [ 390, 396 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T23", "type": "Qualifier", "text": [ "elective" ], "offsets": [ [ 380, 388 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T24", "type": "Scope", "text": [ "elective, urgent or emergency" ], "offsets": [ [ 380, 409 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T25", "type": "Condition", "text": [ "ischemic heart disease" ], "offsets": [ [ 484, 506 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T26", "type": "Observation", "text": [ "clinical evidence" ], "offsets": [ [ 463, 480 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T27", "type": "Procedure", "text": [ "functional study" ], "offsets": [ [ 530, 546 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T28", "type": "Value", "text": [ "positive" ], "offsets": [ [ 521, 529 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T29", "type": "Condition", "text": [ "stable angina pectoris" ], "offsets": [ [ 587, 609 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T30", "type": "Measurement", "text": [ "Canadian Cardiovascular Society Classification (CCS)" ], "offsets": [ [ 611, 663 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T31", "type": "Value", "text": [ "1, 2, 3, or 4" ], "offsets": [ [ 664, 677 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T32", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 587, 593 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T33", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 680, 688 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T34", "type": "Condition", "text": [ "unstable angina pectoris" ], "offsets": [ [ 680, 704 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T35", "type": "Condition", "text": [ "ischemia" ], "offsets": [ [ 721, 729 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T36", "type": "Observation", "text": [ "documented" ], "offsets": [ [ 710, 720 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T37", "type": "Measurement", "text": [ "Braunwald Class" ], "offsets": [ [ 731, 746 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T38", "type": "Value", "text": [ "IB-C, IIB-C, or IIIB-C" ], "offsets": [ [ 747, 769 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T39", "type": "Condition", "text": [ "non-ST segment elevation myocardial infarction" ], "offsets": [ [ 772, 818 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T40", "type": "Condition", "text": [ "silent ischemia" ], "offsets": [ [ 834, 849 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T41", "type": "Qualifier", "text": [ "silent" ], "offsets": [ [ 834, 840 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T42", "type": "Observation", "text": [ "documented" ], "offsets": [ [ 823, 833 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T43", "type": "Procedure", "text": [ "percutaneous intervention" ], "offsets": [ [ 894, 919 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T44", "type": "Observation", "text": [ "willing" ], "offsets": [ [ 866, 873 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T45", "type": "Observation", "text": [ "able" ], "offsets": [ [ 878, 882 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T46", "type": "Visit", "text": [ "SOS hospital" ], "offsets": [ [ 923, 935 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T50", "type": "Qualifier", "text": [ "de novo" ], "offsets": [ [ 1334, 1341 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T51", "type": "Condition", "text": [ "target lesion" ], "offsets": [ [ 1308, 1321 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T7", "type": "Scope", "text": [ "de novo or restenotic" ], "offsets": [ [ 126, 147 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T52", "type": "Qualifier", "text": [ "restenotic" ], "offsets": [ [ 1345, 1355 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T53", "type": "Qualifier", "text": [ "in-stent restenotic" ], "offsets": [ [ 1367, 1386 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T54", "type": "Scope", "text": [ "de novo or restenotic" ], "offsets": [ [ 1334, 1355 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T55", "type": "Scope", "text": [ "de novo or restenotic (including in-stent restenotic)" ], "offsets": [ [ 1334, 1387 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T56", "type": "Condition", "text": [ "coronary artery lesion" ], "offsets": [ [ 1395, 1417 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T57", "type": "Value", "text": [ "greater than 50 and less than 100%" ], "offsets": [ [ 1426, 1460 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T58", "type": "Measurement", "text": [ "stenosis" ], "offsets": [ [ 1461, 1469 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T59", "type": "Condition", "text": [ "stenosis" ], "offsets": [ [ 1461, 1469 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T60", "type": "Condition", "text": [ "target lesion" ], "offsets": [ [ 1496, 1509 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T61", "type": "Temporal", "text": [ "acute" ], "offsets": [ [ 1516, 1521 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T62", "type": "Temporal", "text": [ "less than 1 month" ], "offsets": [ [ 1523, 1540 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T63", "type": "Condition", "text": [ "total occlusion" ], "offsets": [ [ 1542, 1557 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T64", "type": "Observation", "text": [ "clinical symptoms" ], "offsets": [ [ 1574, 1591 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T65", "type": "Condition", "text": [ "Target lesions" ], "offsets": [ [ 1598, 1612 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T66", "type": "Condition", "text": [ "infarct" ], "offsets": [ [ 1639, 1646 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T67", "type": "Qualifier", "text": [ "in an infarct", "-related artery" ], "offsets": [ [ 1633, 1646 ], [ 1695, 1710 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T68", "type": "Procedure", "text": [ "primary PCI" ], "offsets": [ [ 1668, 1679 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T69", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1651, 1654 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T70", "type": "Qualifier", "text": [ "non-infarct-related artery" ], "offsets": [ [ 1684, 1710 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T71", "type": "Value", "text": [ "70% or greater" ], "offsets": [ [ 1718, 1732 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T72", "type": "Measurement", "text": [ "stenosis" ], "offsets": [ [ 1733, 1741 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T73", "type": "Condition", "text": [ "stenosis" ], "offsets": [ [ 1733, 1741 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T74", "type": "Scope", "text": [ "in an infarct (if not treated with primary PCI) or non-infarct-related artery" ], "offsets": [ [ 1633, 1710 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T75", "type": "Temporal", "text": [ "more than 72 hours following the ST segment elevation myocardial infarction (STEMI)" ], "offsets": [ [ 1763, 1846 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T76", "type": "Reference_point", "text": [ "the ST segment elevation myocardial infarction (STEMI)" ], "offsets": [ [ 1792, 1846 ] ], "normalized": [] }, { "id": "NCT01116882_inc_T77", "type": "Condition", "text": [ "ST segment elevation myocardial infarction (STEMI)" ], "offsets": [ [ 1796, 1846 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01116882_inc_R1", "type": "Has_value", "arg1_id": "NCT01116882_inc_T2", "arg2_id": "NCT01116882_inc_T1", "normalized": [] }, { "id": "NCT01116882_inc_R2", "type": "Has_scope", "arg1_id": "NCT01116882_inc_T3", "arg2_id": "NCT01116882_inc_T6", "normalized": [] }, { "id": "NCT01116882_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT01116882_inc_T9", "arg2_id": "NCT01116882_inc_T13", "normalized": [] }, { "id": "NCT01116882_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT01116882_inc_T9", "arg2_id": "NCT01116882_inc_T12", "normalized": [] }, { "id": "NCT01116882_inc_R8", "type": "Has_scope", "arg1_id": "NCT01116882_inc_T3", "arg2_id": "NCT01116882_inc_T15", "normalized": [] }, { "id": "NCT01116882_inc_R9", "type": "Has_scope", "arg1_id": "NCT01116882_inc_T17", "arg2_id": "NCT01116882_inc_T19", "normalized": [] }, { "id": "NCT01116882_inc_R10", "type": "Has_scope", "arg1_id": "NCT01116882_inc_T20", "arg2_id": "NCT01116882_inc_T24", "normalized": [] }, { "id": "NCT01116882_inc_R12", "type": "Has_value", "arg1_id": "NCT01116882_inc_T27", "arg2_id": "NCT01116882_inc_T28", "normalized": [] }, { "id": "NCT01116882_inc_R13", "type": "AND", "arg1_id": "NCT01116882_inc_T25", "arg2_id": "NCT01116882_inc_T27", "normalized": [] }, { "id": "NCT01116882_inc_R14", "type": "Has_value", "arg1_id": "NCT01116882_inc_T30", "arg2_id": "NCT01116882_inc_T31", "normalized": [] }, { "id": "NCT01116882_inc_R15", "type": "Has_qualifier", "arg1_id": "NCT01116882_inc_T29", "arg2_id": "NCT01116882_inc_T32", "normalized": [] }, { "id": "NCT01116882_inc_R16", "type": "Subsumes", "arg1_id": "NCT01116882_inc_T32", "arg2_id": "NCT01116882_inc_T30", "normalized": [] }, { "id": "NCT01116882_inc_R17", "type": "Has_qualifier", "arg1_id": "NCT01116882_inc_T34", "arg2_id": "NCT01116882_inc_T33", "normalized": [] }, { "id": "NCT01116882_inc_R18", "type": "Has_value", "arg1_id": "NCT01116882_inc_T37", "arg2_id": "NCT01116882_inc_T38", "normalized": [] }, { "id": "NCT01116882_inc_R19", "type": "Has_qualifier", "arg1_id": "NCT01116882_inc_T40", "arg2_id": "NCT01116882_inc_T41", "normalized": [] }, { "id": "NCT01116882_inc_R22", "type": "Subsumes", "arg1_id": "NCT01116882_inc_T35", "arg2_id": "NCT01116882_inc_T37", "normalized": [] }, { "id": "NCT01116882_inc_R23", "type": "AND", "arg1_id": "NCT01116882_inc_T34", "arg2_id": "NCT01116882_inc_T35", "normalized": [] }, { "id": "NCT01116882_inc_R26", "type": "AND", "arg1_id": "NCT01116882_inc_T43", "arg2_id": "NCT01116882_inc_T46", "normalized": [] }, { "id": "NCT01116882_inc_R3", "type": "Has_scope", "arg1_id": "NCT01116882_inc_T8", "arg2_id": "NCT01116882_inc_T7", "normalized": [] }, { "id": "NCT01116882_inc_R4", "type": "Subsumes", "arg1_id": "NCT01116882_inc_T14", "arg2_id": "NCT01116882_inc_T9", "normalized": [] }, { "id": "NCT01116882_inc_R7", "type": "Subsumes", "arg1_id": "NCT01116882_inc_T54", "arg2_id": "NCT01116882_inc_T53", "normalized": [] }, { "id": "NCT01116882_inc_R27", "type": "Has_scope", "arg1_id": "NCT01116882_inc_T51", "arg2_id": "NCT01116882_inc_T55", "normalized": [] }, { "id": "NCT01116882_inc_R28", "type": "Subsumes", "arg1_id": "NCT01116882_inc_T51", "arg2_id": "NCT01116882_inc_T56", "normalized": [] }, { "id": "NCT01116882_inc_R29", "type": "Has_value", "arg1_id": "NCT01116882_inc_T58", "arg2_id": "NCT01116882_inc_T57", "normalized": [] }, { "id": "NCT01116882_inc_R30", "type": "Subsumes", "arg1_id": "NCT01116882_inc_T61", "arg2_id": "NCT01116882_inc_T62", "normalized": [] }, { "id": "NCT01116882_inc_R31", "type": "Has_temporal", "arg1_id": "NCT01116882_inc_T60", "arg2_id": "NCT01116882_inc_T61", "normalized": [] }, { "id": "NCT01116882_inc_R33", "type": "Subsumes", "arg1_id": "NCT01116882_inc_T60", "arg2_id": "NCT01116882_inc_T63", "normalized": [] }, { "id": "NCT01116882_inc_R34", "type": "AND", "arg1_id": "NCT01116882_inc_T56", "arg2_id": "NCT01116882_inc_T59", "normalized": [] }, { "id": "NCT01116882_inc_R35", "type": "AND", "arg1_id": "NCT01116882_inc_T67", "arg2_id": "NCT01116882_inc_T66", "normalized": [] }, { "id": "NCT01116882_inc_R36", "type": "Has_negation", "arg1_id": "NCT01116882_inc_T68", "arg2_id": "NCT01116882_inc_T69", "normalized": [] }, { "id": "NCT01116882_inc_R37", "type": "Has_value", "arg1_id": "NCT01116882_inc_T72", "arg2_id": "NCT01116882_inc_T71", "normalized": [] }, { "id": "NCT01116882_inc_R38", "type": "AND", "arg1_id": "NCT01116882_inc_T65", "arg2_id": "NCT01116882_inc_T73", "normalized": [] }, { "id": "NCT01116882_inc_R39", "type": "Has_scope", "arg1_id": "NCT01116882_inc_T65", "arg2_id": "NCT01116882_inc_T74", "normalized": [] }, { "id": "NCT01116882_inc_R40", "type": "Has_index", "arg1_id": "NCT01116882_inc_T75", "arg2_id": "NCT01116882_inc_T76", "normalized": [] }, { "id": "NCT01116882_inc_R41", "type": "AND", "arg1_id": "NCT01116882_inc_T76", "arg2_id": "NCT01116882_inc_T77", "normalized": [] }, { "id": "NCT01116882_inc_R42", "type": "Has_temporal", "arg1_id": "NCT01116882_inc_T73", "arg2_id": "NCT01116882_inc_T75", "normalized": [] } ]

[ { "id": "NCT01116973_exc_text", "type": "exclusion", "text": [ "Inability to obtain consent \nSubjects under 18 years of age \nNon-English speaking subjects \nSubjects that are unable to lay flat due to pulmonary complications, increased intracranial pressure (ICP), or unstable spinal cord injuries \nSubjects with known cardiac abnormalities (atrial septal defects or ventricular septal defects, severe tricuspid valve disease, severe pulmonary hypertension, Ejection fraction < 15%) \nPrisoners \nSubjects with known upper extremity deep vein thromboses (subclavian or distal) \nSubjects with non-functional CICC or PICC distal ports \nSubjects with femoral CICCs \nPregnant women \n \n" ], "offsets": [ [ 0, 623 ] ] } ]

[ { "id": "NCT01116973_exc_T2", "type": "Value", "text": [ "under 18 years" ], "offsets": [ [ 38, 52 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T3", "type": "Person", "text": [ "age" ], "offsets": [ [ 56, 59 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T5", "type": "Condition", "text": [ "unable to lay flat" ], "offsets": [ [ 110, 128 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T6", "type": "Condition", "text": [ "pulmonary complications" ], "offsets": [ [ 136, 159 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T7", "type": "Qualifier", "text": [ "due to pulmonary complications" ], "offsets": [ [ 129, 159 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T8", "type": "Condition", "text": [ "increased intracranial pressure (ICP)" ], "offsets": [ [ 161, 198 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T9", "type": "Condition", "text": [ "spinal cord injuries" ], "offsets": [ [ 212, 232 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T10", "type": "Qualifier", "text": [ "unstable" ], "offsets": [ [ 203, 211 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T11", "type": "Condition", "text": [ "cardiac abnormalities" ], "offsets": [ [ 254, 275 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T12", "type": "Condition", "text": [ "atrial septal defects" ], "offsets": [ [ 277, 298 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T13", "type": "Condition", "text": [ "ventricular septal defects" ], "offsets": [ [ 302, 328 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T14", "type": "Condition", "text": [ "tricuspid valve disease" ], "offsets": [ [ 337, 360 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T15", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 330, 336 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T16", "type": "Condition", "text": [ "pulmonary hypertension" ], "offsets": [ [ 369, 391 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T17", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 362, 368 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T18", "type": "Measurement", "text": [ "Ejection fraction" ], "offsets": [ [ 393, 410 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T19", "type": "Value", "text": [ "< 15%" ], "offsets": [ [ 411, 416 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T20", "type": "Scope", "text": [ "atrial septal defects or ventricular septal defects, severe tricuspid valve disease, severe pulmonary hypertension, Ejection fraction < 15%" ], "offsets": [ [ 277, 416 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T21", "type": "Person", "text": [ "Prisoners" ], "offsets": [ [ 419, 428 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T23", "type": "Condition", "text": [ "upper extremity deep vein thromboses" ], "offsets": [ [ 450, 486 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T24", "type": "Qualifier", "text": [ "subclavian" ], "offsets": [ [ 488, 498 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T25", "type": "Qualifier", "text": [ "distal" ], "offsets": [ [ 502, 508 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T26", "type": "Scope", "text": [ "subclavian or distal" ], "offsets": [ [ 488, 508 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T27", "type": "Device", "text": [ "CICC", "distal ports" ], "offsets": [ [ 540, 544 ], [ 553, 565 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T28", "type": "Device", "text": [ "PICC distal ports" ], "offsets": [ [ 548, 565 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T29", "type": "Qualifier", "text": [ "non-functional" ], "offsets": [ [ 525, 539 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T30", "type": "Scope", "text": [ "CICC or PICC distal ports" ], "offsets": [ [ 540, 565 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T31", "type": "Device", "text": [ "femoral CICCs" ], "offsets": [ [ 581, 594 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T32", "type": "Person", "text": [ "women" ], "offsets": [ [ 605, 610 ] ], "normalized": [] }, { "id": "NCT01116973_exc_T33", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 596, 604 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01116973_exc_R1", "type": "Has_value", "arg1_id": "NCT01116973_exc_T3", "arg2_id": "NCT01116973_exc_T2", "normalized": [] }, { "id": "NCT01116973_exc_R2", "type": "AND", "arg1_id": "NCT01116973_exc_T7", "arg2_id": "NCT01116973_exc_T6", "normalized": [] }, { "id": "NCT01116973_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT01116973_exc_T9", "arg2_id": "NCT01116973_exc_T10", "normalized": [] }, { "id": "NCT01116973_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01116973_exc_T5", "arg2_id": "NCT01116973_exc_T7", "normalized": [] }, { "id": "NCT01116973_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT01116973_exc_T14", "arg2_id": "NCT01116973_exc_T15", "normalized": [] }, { "id": "NCT01116973_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT01116973_exc_T16", "arg2_id": "NCT01116973_exc_T17", "normalized": [] }, { "id": "NCT01116973_exc_R7", "type": "Has_value", "arg1_id": "NCT01116973_exc_T18", "arg2_id": "NCT01116973_exc_T19", "normalized": [] }, { "id": "NCT01116973_exc_R8", "type": "Subsumes", "arg1_id": "NCT01116973_exc_T11", "arg2_id": "NCT01116973_exc_T20", "normalized": [] }, { "id": "NCT01116973_exc_R9", "type": "Has_scope", "arg1_id": "NCT01116973_exc_T23", "arg2_id": "NCT01116973_exc_T26", "normalized": [] }, { "id": "NCT01116973_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT01116973_exc_T30", "arg2_id": "NCT01116973_exc_T29", "normalized": [] } ]

[ { "id": "NCT01116973_inc_text", "type": "inclusion", "text": [ "Subject's ability to lay in a supine position with their hands at their sides during CVP measurements \nA consent form signed by the patient or patient's representative \nSubjects that are age 18-90 \nSubjects that have an indwelling CICC and are transitioning to a PICC for long-term IV access \nCICC placed in the internal jugular vein or subclavian vein position \n" ], "offsets": [ [ 0, 363 ] ] } ]

[ { "id": "NCT01116973_inc_T1", "type": "Observation", "text": [ "ability to lay in a supine position with their hands at their sides" ], "offsets": [ [ 10, 77 ] ], "normalized": [] }, { "id": "NCT01116973_inc_T2", "type": "Temporal", "text": [ "during CVP measurements" ], "offsets": [ [ 78, 101 ] ], "normalized": [] }, { "id": "NCT01116973_inc_T3", "type": "Procedure", "text": [ "CVP measurements" ], "offsets": [ [ 85, 101 ] ], "normalized": [] }, { "id": "NCT01116973_inc_T4", "type": "Reference_point", "text": [ "CVP measurements" ], "offsets": [ [ 85, 101 ] ], "normalized": [] }, { "id": "NCT01116973_inc_T6", "type": "Person", "text": [ "age" ], "offsets": [ [ 187, 190 ] ], "normalized": [] }, { "id": "NCT01116973_inc_T7", "type": "Value", "text": [ "18-90" ], "offsets": [ [ 191, 196 ] ], "normalized": [] }, { "id": "NCT01116973_inc_T8", "type": "Device", "text": [ "indwelling CICC" ], "offsets": [ [ 220, 235 ] ], "normalized": [] }, { "id": "NCT01116973_inc_T9", "type": "Observation", "text": [ "transitioning to a PICC" ], "offsets": [ [ 244, 267 ] ], "normalized": [] }, { "id": "NCT01116973_inc_T10", "type": "Device", "text": [ "PICC" ], "offsets": [ [ 263, 267 ] ], "normalized": [] }, { "id": "NCT01116973_inc_T11", "type": "Device", "text": [ "CICC placed" ], "offsets": [ [ 293, 304 ] ], "normalized": [] }, { "id": "NCT01116973_inc_T12", "type": "Qualifier", "text": [ "in the internal jugular vein", "position" ], "offsets": [ [ 305, 333 ], [ 353, 361 ] ], "normalized": [] }, { "id": "NCT01116973_inc_T13", "type": "Qualifier", "text": [ "in the", "subclavian vein position" ], "offsets": [ [ 305, 311 ], [ 337, 361 ] ], "normalized": [] }, { "id": "NCT01116973_inc_T14", "type": "Scope", "text": [ "in the internal jugular vein or subclavian vein position" ], "offsets": [ [ 305, 361 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01116973_inc_R1", "type": "Has_index", "arg1_id": "NCT01116973_inc_T2", "arg2_id": "NCT01116973_inc_T4", "normalized": [] }, { "id": "NCT01116973_inc_R2", "type": "Has_temporal", "arg1_id": "NCT01116973_inc_T1", "arg2_id": "NCT01116973_inc_T2", "normalized": [] }, { "id": "NCT01116973_inc_R3", "type": "Has_value", "arg1_id": "NCT01116973_inc_T6", "arg2_id": "NCT01116973_inc_T7", "normalized": [] }, { "id": "NCT01116973_inc_R4", "type": "Has_scope", "arg1_id": "NCT01116973_inc_T11", "arg2_id": "NCT01116973_inc_T14", "normalized": [] } ]

[ { "id": "NCT01117181_exc_text", "type": "exclusion", "text": [ "Meets criteria for Major Depressive Episode, by Diagnostic Statistical Manual of Mental Disorder - IV (TR) criteria \nClinically significant agitation /aggression for which either 1) the frequency of agitation /aggression as assessed by the NPI is 'Very frequently', or 2) the frequency of agitation /aggression as assessed by the NPI is 'Frequently' AND the severity of the agitation as assessed by the NPI is 'Moderate', or 'Marked' \nClinically significant delusions for which either 1) the frequency of delusions as assessed by the NPI is 'Very frequently', or 2) the frequency of delusions as assessed by the NPI is 'Frequently' AND the severity of the delusions as assessed by the NPI is 'Moderate', or 'Marked' \nClinically significant hallucinations for which either 1) the frequency of hallucinations as assessed by the NPI is 'Very frequently', or 2) the frequency of hallucinations as assessed by the NPI is 'Frequently' AND the severity of the hallucinations as assessed by the NPI is 'Moderate', or 'Marked' \nTreatment with psychotropic medications in the 2 weeks prior to randomization with the exception of approved treatments for dementia (ChEIs and memantine), selective serotonin reuptake inhibitor antidepressants, and trazodone (if used as an aid to facilitate sleep and not as an antidepressant); other psychotropics (with the exclusion of antipsychotics), if stable for 3 months, may be allowed only with Steering Committee approval on a case by case basis. Note that antipsychotics are expressly prohibited. \nTreatment with methylphenidate is contraindicated in the opinion of the study physician \nFailure of treatment with methylphenidate in the past for apathy after convincing evidence of an adequate trial as judged by study physician \nTreatment with a medication that would prohibit the safe concurrent use of methylphenidate such as monoamine oxidase inhibitors and tricyclic antidepressants \nNeed for acute psychiatric hospitalization or is suicidal \nUncontrolled hypertension (medication non-compliance or past 3 months with a diastolic reading of 105 as verified by compartment pressure of the rectus sheath (CPRS)) \nSymptomatic coronary artery disease deemed to be significant by study physician at the time of screening \nLack of appetite that results in significant unintentional weight loss as determined by the study physician in the last three months \nSignificant communicative impairments \nCurrent participation in a clinical trial or in any study that may add significant burden or affect study outcomes \nHyperthyroidism, advanced arteriosclerosis, symptomatic cardiovascular disease, serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or a family history of sudden death or death related to heart problems \nGlaucoma, pheochromocytoma, or known or suspected hypersensitivity to methylphenidate or its excipients \nCentral Nervous System (CNS) abnormalities (e.g., cerebral aneurysm) and/or other vascular abnormalities such as vasculitis or pre-existing stroke, motor tics or a family history or diagnosis of Tourette's syndrome, seizures (convulsions, epilepsy), or abnormal EEGs \nAny condition that, in the opinion of the study physician, makes it medically inappropriate or risky for the patient to enroll in the trial \n \n" ], "offsets": [ [ 0, 3312 ] ] } ]

[ { "id": "NCT01117181_exc_T1", "type": "Condition", "text": [ "Major Depressive Episode" ], "offsets": [ [ 19, 43 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T2", "type": "Measurement", "text": [ "Diagnostic Statistical Manual of Mental Disorder - IV (TR) criteria" ], "offsets": [ [ 48, 115 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T3", "type": "Value", "text": [ "Meets" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T4", "type": "Condition", "text": [ "agitation /aggression" ], "offsets": [ [ 140, 161 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T5", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 117, 139 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T8", "type": "Multiplier", "text": [ "frequency of agitation /aggression" ], "offsets": [ [ 186, 220 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T7", "type": "Condition", "text": [ "agitation /aggression" ], "offsets": [ [ 199, 220 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T9", "type": "Measurement", "text": [ "NPI" ], "offsets": [ [ 240, 243 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T10", "type": "Value", "text": [ "Very frequently" ], "offsets": [ [ 248, 263 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T11", "type": "Multiplier", "text": [ "frequency of agitation /aggression" ], "offsets": [ [ 276, 310 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T12", "type": "Condition", "text": [ "agitation /aggression" ], "offsets": [ [ 289, 310 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T13", "type": "Measurement", "text": [ "NPI" ], "offsets": [ [ 330, 333 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T14", "type": "Value", "text": [ "Frequently" ], "offsets": [ [ 338, 348 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T15", "type": "Measurement", "text": [ "NPI" ], "offsets": [ [ 403, 406 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T16", "type": "Value", "text": [ "Moderate" ], "offsets": [ [ 411, 419 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T17", "type": "Value", "text": [ "Marked" ], "offsets": [ [ 426, 432 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T18", "type": "Scope", "text": [ "'Moderate', or 'Marked'" ], "offsets": [ [ 410, 433 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T19", "type": "Qualifier", "text": [ "severity of the agitation" ], "offsets": [ [ 358, 383 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T20", "type": "Condition", "text": [ "agitation" ], "offsets": [ [ 374, 383 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T21", "type": "Condition", "text": [ "delusions" ], "offsets": [ [ 458, 467 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T22", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 435, 457 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T23", "type": "Multiplier", "text": [ "frequency of delusions" ], "offsets": [ [ 492, 514 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T24", "type": "Condition", "text": [ "delusions" ], "offsets": [ [ 505, 514 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T25", "type": "Measurement", "text": [ "NPI" ], "offsets": [ [ 534, 537 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T26", "type": "Value", "text": [ "Very frequently" ], "offsets": [ [ 542, 557 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T27", "type": "Multiplier", "text": [ "frequency of delusions" ], "offsets": [ [ 570, 592 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T28", "type": "Condition", "text": [ "delusions" ], "offsets": [ [ 583, 592 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T29", "type": "Measurement", "text": [ "NPI" ], "offsets": [ [ 612, 615 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T30", "type": "Value", "text": [ "Frequently" ], "offsets": [ [ 620, 630 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T31", "type": "Qualifier", "text": [ "severity of the delusions" ], "offsets": [ [ 640, 665 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T32", "type": "Condition", "text": [ "delusions" ], "offsets": [ [ 656, 665 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T33", "type": "Measurement", "text": [ "NPI" ], "offsets": [ [ 685, 688 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T34", "type": "Value", "text": [ "Moderate" ], "offsets": [ [ 693, 701 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T35", "type": "Value", "text": [ "Marked" ], "offsets": [ [ 708, 714 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T36", "type": "Scope", "text": [ "'Moderate', or 'Marked'" ], "offsets": [ [ 692, 715 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T37", "type": "Condition", "text": [ "hallucinations" ], "offsets": [ [ 740, 754 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T38", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 717, 739 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T39", "type": "Multiplier", "text": [ "frequency of hallucinations" ], "offsets": [ [ 779, 806 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T40", "type": "Condition", "text": [ "hallucinations" ], "offsets": [ [ 792, 806 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T41", "type": "Measurement", "text": [ "NPI" ], "offsets": [ [ 826, 829 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T42", "type": "Value", "text": [ "Very frequently" ], "offsets": [ [ 834, 849 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T43", "type": "Multiplier", "text": [ "frequency of hallucinations" ], "offsets": [ [ 862, 889 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T44", "type": "Condition", "text": [ "hallucinations" ], "offsets": [ [ 875, 889 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T45", "type": "Measurement", "text": [ "NPI" ], "offsets": [ [ 909, 912 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T46", "type": "Value", "text": [ "Frequently" ], "offsets": [ [ 917, 927 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T47", "type": "Qualifier", "text": [ "severity of the hallucinations" ], "offsets": [ [ 937, 967 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T48", "type": "Condition", "text": [ "hallucinations" ], "offsets": [ [ 953, 967 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T49", "type": "Measurement", "text": [ "NPI" ], "offsets": [ [ 987, 990 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T50", "type": "Value", "text": [ "Moderate" ], "offsets": [ [ 995, 1003 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T51", "type": "Value", "text": [ "Marked" ], "offsets": [ [ 1010, 1016 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T52", "type": "Scope", "text": [ "'Moderate', or 'Marked'" ], "offsets": [ [ 994, 1017 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T53", "type": "Scope", "text": [ "frequency of agitation /aggression as assessed by the NPI is 'Very frequently', or 2) the frequency of agitation /aggression as assessed by the NPI is 'Frequently' AND the severity of the agitation as assessed by the NPI is 'Moderate', or 'Marked'" ], "offsets": [ [ 186, 433 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T54", "type": "Scope", "text": [ "frequency of delusions as assessed by the NPI is 'Very frequently', or 2) the frequency of delusions as assessed by the NPI is 'Frequently' AND the severity of the delusions as assessed by the NPI is 'Moderate', or 'Marked'" ], "offsets": [ [ 492, 715 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T55", "type": "Scope", "text": [ "frequency of hallucinations as assessed by the NPI is 'Very frequently', or 2) the frequency of hallucinations as assessed by the NPI is 'Frequently' AND the severity of the hallucinations as assessed by the NPI is 'Moderate', or 'Marked'" ], "offsets": [ [ 779, 1017 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T56", "type": "Drug", "text": [ "psychotropic medications" ], "offsets": [ [ 1034, 1058 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T57", "type": "Temporal", "text": [ "in the 2 weeks prior to randomization" ], "offsets": [ [ 1059, 1096 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T58", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 1083, 1096 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T59", "type": "Condition", "text": [ "dementia" ], "offsets": [ [ 1143, 1151 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T60", "type": "Procedure", "text": [ "treatments for dementia" ], "offsets": [ [ 1128, 1151 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T61", "type": "Drug", "text": [ "ChEIs" ], "offsets": [ [ 1153, 1158 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T62", "type": "Drug", "text": [ "memantine" ], "offsets": [ [ 1163, 1172 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T63", "type": "Scope", "text": [ "ChEIs and memantine" ], "offsets": [ [ 1153, 1172 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T64", "type": "Drug", "text": [ "selective serotonin reuptake inhibitor antidepressants" ], "offsets": [ [ 1175, 1229 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T65", "type": "Drug", "text": [ "trazodone" ], "offsets": [ [ 1235, 1244 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T66", "type": "Negation", "text": [ "with the exception of" ], "offsets": [ [ 1097, 1118 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T67", "type": "Scope", "text": [ "treatments for dementia (ChEIs and memantine), selective serotonin reuptake inhibitor antidepressants, and trazodone" ], "offsets": [ [ 1128, 1244 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T69", "type": "Drug", "text": [ "other psychotropics" ], "offsets": [ [ 1315, 1334 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T70", "type": "Drug", "text": [ "antipsychotics" ], "offsets": [ [ 1358, 1372 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T71", "type": "Negation", "text": [ "with the exclusion of" ], "offsets": [ [ 1336, 1357 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T72", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 1378, 1384 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T73", "type": "Temporal", "text": [ "for 3 months" ], "offsets": [ [ 1385, 1397 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T74", "type": "Drug", "text": [ "methylphenidate" ], "offsets": [ [ 1544, 1559 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T75", "type": "Drug", "text": [ "methylphenidate" ], "offsets": [ [ 1644, 1659 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T77", "type": "Drug", "text": [ "medication that would prohibit the safe concurrent use of methylphenidate" ], "offsets": [ [ 1777, 1850 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T78", "type": "Drug", "text": [ "methylphenidate" ], "offsets": [ [ 1835, 1850 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T79", "type": "Temporal", "text": [ "concurrent" ], "offsets": [ [ 1817, 1827 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T80", "type": "Observation", "text": [ "prohibit" ], "offsets": [ [ 1799, 1807 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T81", "type": "Drug", "text": [ "monoamine oxidase inhibitors" ], "offsets": [ [ 1859, 1887 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T82", "type": "Drug", "text": [ "tricyclic antidepressants" ], "offsets": [ [ 1892, 1917 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T83", "type": "Scope", "text": [ "monoamine oxidase inhibitors and tricyclic antidepressants" ], "offsets": [ [ 1859, 1917 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T84", "type": "Procedure", "text": [ "psychiatric hospitalization" ], "offsets": [ [ 1934, 1961 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T85", "type": "Observation", "text": [ "Need for" ], "offsets": [ [ 1919, 1927 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T86", "type": "Temporal", "text": [ "acute" ], "offsets": [ [ 1928, 1933 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T87", "type": "Condition", "text": [ "suicidal" ], "offsets": [ [ 1968, 1976 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T88", "type": "Condition", "text": [ "Uncontrolled hypertension" ], "offsets": [ [ 1978, 2003 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T89", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 1978, 1990 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T90", "type": "Condition", "text": [ "medication non-compliance" ], "offsets": [ [ 2005, 2030 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T91", "type": "Temporal", "text": [ "past 3 months" ], "offsets": [ [ 2034, 2047 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T92", "type": "Measurement", "text": [ "diastolic reading" ], "offsets": [ [ 2055, 2072 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T93", "type": "Value", "text": [ "105" ], "offsets": [ [ 2076, 2079 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T95", "type": "Measurement", "text": [ "compartment pressure of the rectus sheath (CPRS)" ], "offsets": [ [ 2095, 2143 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T96", "type": "Qualifier", "text": [ "as verified by compartment pressure of the rectus sheath (CPRS)" ], "offsets": [ [ 2080, 2143 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T97", "type": "Scope", "text": [ "medication non-compliance or past 3 months with a diastolic reading of 105 as verified by compartment pressure of the rectus sheath (CPRS)" ], "offsets": [ [ 2005, 2143 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T98", "type": "Condition", "text": [ "coronary artery disease" ], "offsets": [ [ 2158, 2181 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T99", "type": "Qualifier", "text": [ "Symptomatic" ], "offsets": [ [ 2146, 2157 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T100", "type": "Temporal", "text": [ "at the time of screening" ], "offsets": [ [ 2226, 2250 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T101", "type": "Reference_point", "text": [ "time of screening" ], "offsets": [ [ 2233, 2250 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T102", "type": "Condition", "text": [ "unintentional weight loss" ], "offsets": [ [ 2297, 2322 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T103", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 2285, 2296 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T105", "type": "Condition", "text": [ "Lack of appetite" ], "offsets": [ [ 2252, 2268 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T106", "type": "Qualifier", "text": [ "as determined by the study physician" ], "offsets": [ [ 2323, 2359 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T107", "type": "Temporal", "text": [ "in the last three months" ], "offsets": [ [ 2360, 2384 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T108", "type": "Qualifier", "text": [ "Significant" ], "offsets": [ [ 2386, 2397 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T110", "type": "Condition", "text": [ "communicative impairments" ], "offsets": [ [ 2398, 2423 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T113", "type": "Condition", "text": [ "Hyperthyroidism" ], "offsets": [ [ 2541, 2556 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T114", "type": "Condition", "text": [ "arteriosclerosis" ], "offsets": [ [ 2567, 2583 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T115", "type": "Qualifier", "text": [ "advanced" ], "offsets": [ [ 2558, 2566 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T116", "type": "Condition", "text": [ "cardiovascular disease" ], "offsets": [ [ 2597, 2619 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T117", "type": "Qualifier", "text": [ "symptomatic" ], "offsets": [ [ 2585, 2596 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T118", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 2621, 2628 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T119", "type": "Condition", "text": [ "structural cardiac abnormalities" ], "offsets": [ [ 2629, 2661 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T120", "type": "Condition", "text": [ "cardiomyopathy" ], "offsets": [ [ 2663, 2677 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T121", "type": "Condition", "text": [ "heart rhythm abnormalities" ], "offsets": [ [ 2687, 2713 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T122", "type": "Qualifier", "text": [ "serious" ], "offsets": [ [ 2679, 2686 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T123", "type": "Observation", "text": [ "family history" ], "offsets": [ [ 2720, 2734 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T124", "type": "Condition", "text": [ "sudden death" ], "offsets": [ [ 2738, 2750 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T125", "type": "Condition", "text": [ "death related to heart problems" ], "offsets": [ [ 2754, 2785 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T126", "type": "Qualifier", "text": [ "related to heart problems" ], "offsets": [ [ 2760, 2785 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T127", "type": "Scope", "text": [ "sudden death or death related to heart problems" ], "offsets": [ [ 2738, 2785 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T128", "type": "Condition", "text": [ "Glaucoma" ], "offsets": [ [ 2787, 2795 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T129", "type": "Condition", "text": [ "pheochromocytoma" ], "offsets": [ [ 2797, 2813 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T130", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 2837, 2853 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T131", "type": "Drug", "text": [ "methylphenidate or its excipients" ], "offsets": [ [ 2857, 2890 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T132", "type": "Drug", "text": [ "its excipients" ], "offsets": [ [ 2876, 2890 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T133", "type": "Observation", "text": [ "suspected" ], "offsets": [ [ 2827, 2836 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T134", "type": "Observation", "text": [ "known" ], "offsets": [ [ 2818, 2823 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T135", "type": "Scope", "text": [ "known or suspected" ], "offsets": [ [ 2818, 2836 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T136", "type": "Condition", "text": [ "Central Nervous System (CNS) abnormalities" ], "offsets": [ [ 2892, 2934 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T137", "type": "Condition", "text": [ "cerebral aneurysm" ], "offsets": [ [ 2942, 2959 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T138", "type": "Condition", "text": [ "vascular abnormalities" ], "offsets": [ [ 2974, 2996 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T139", "type": "Condition", "text": [ "vasculitis" ], "offsets": [ [ 3005, 3015 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T140", "type": "Condition", "text": [ "stroke" ], "offsets": [ [ 3032, 3038 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T141", "type": "Temporal", "text": [ "pre-existing" ], "offsets": [ [ 3019, 3031 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T142", "type": "Condition", "text": [ "motor tics" ], "offsets": [ [ 3040, 3050 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T143", "type": "Observation", "text": [ "family history" ], "offsets": [ [ 3056, 3070 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T144", "type": "Condition", "text": [ "Tourette's syndrome" ], "offsets": [ [ 3087, 3106 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T145", "type": "Condition", "text": [ "seizures" ], "offsets": [ [ 3108, 3116 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T146", "type": "Condition", "text": [ "convulsions" ], "offsets": [ [ 3118, 3129 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T147", "type": "Observation", "text": [ "diagnosis" ], "offsets": [ [ 3074, 3083 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T148", "type": "Scope", "text": [ "family history or diagnosis" ], "offsets": [ [ 3056, 3083 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T149", "type": "Condition", "text": [ "epilepsy" ], "offsets": [ [ 3131, 3139 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T150", "type": "Scope", "text": [ "convulsions, epilepsy" ], "offsets": [ [ 3118, 3139 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T151", "type": "Qualifier", "text": [ "abnormal" ], "offsets": [ [ 3145, 3153 ] ], "normalized": [] }, { "id": "NCT01117181_exc_T152", "type": "Condition", "text": [ "EEGs" ], "offsets": [ [ 3154, 3158 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01117181_exc_R1", "type": "Has_value", "arg1_id": "NCT01117181_exc_T2", "arg2_id": "NCT01117181_exc_T3", "normalized": [] }, { "id": "NCT01117181_exc_R2", "type": "AND", "arg1_id": "NCT01117181_exc_T1", "arg2_id": "NCT01117181_exc_T2", "normalized": [] }, { "id": "NCT01117181_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T4", "arg2_id": "NCT01117181_exc_T5", "normalized": [] }, { "id": "NCT01117181_exc_R4", "type": "AND", "arg1_id": "NCT01117181_exc_T8", "arg2_id": "NCT01117181_exc_T7", "normalized": [] }, { "id": "NCT01117181_exc_R5", "type": "AND", "arg1_id": "NCT01117181_exc_T8", "arg2_id": "NCT01117181_exc_T9", "normalized": [] }, { "id": "NCT01117181_exc_R6", "type": "Has_value", "arg1_id": "NCT01117181_exc_T9", "arg2_id": "NCT01117181_exc_T10", "normalized": [] }, { "id": "NCT01117181_exc_R7", "type": "AND", "arg1_id": "NCT01117181_exc_T11", "arg2_id": "NCT01117181_exc_T12", "normalized": [] }, { "id": "NCT01117181_exc_R8", "type": "Has_value", "arg1_id": "NCT01117181_exc_T13", "arg2_id": "NCT01117181_exc_T14", "normalized": [] }, { "id": "NCT01117181_exc_R9", "type": "Has_scope", "arg1_id": "NCT01117181_exc_T15", "arg2_id": "NCT01117181_exc_T18", "normalized": [] }, { "id": "NCT01117181_exc_R10", "type": "AND", "arg1_id": "NCT01117181_exc_T19", "arg2_id": "NCT01117181_exc_T20", "normalized": [] }, { "id": "NCT01117181_exc_R11", "type": "AND", "arg1_id": "NCT01117181_exc_T19", "arg2_id": "NCT01117181_exc_T15", "normalized": [] }, { "id": "NCT01117181_exc_R12", "type": "AND", "arg1_id": "NCT01117181_exc_T23", "arg2_id": "NCT01117181_exc_T24", "normalized": [] }, { "id": "NCT01117181_exc_R13", "type": "Has_value", "arg1_id": "NCT01117181_exc_T25", "arg2_id": "NCT01117181_exc_T26", "normalized": [] }, { "id": "NCT01117181_exc_R14", "type": "AND", "arg1_id": "NCT01117181_exc_T23", "arg2_id": "NCT01117181_exc_T25", "normalized": [] }, { "id": "NCT01117181_exc_R15", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T21", "arg2_id": "NCT01117181_exc_T22", "normalized": [] }, { "id": "NCT01117181_exc_R16", "type": "AND", "arg1_id": "NCT01117181_exc_T31", "arg2_id": "NCT01117181_exc_T32", "normalized": [] }, { "id": "NCT01117181_exc_R17", "type": "Has_scope", "arg1_id": "NCT01117181_exc_T33", "arg2_id": "NCT01117181_exc_T36", "normalized": [] }, { "id": "NCT01117181_exc_R18", "type": "Has_value", "arg1_id": "NCT01117181_exc_T29", "arg2_id": "NCT01117181_exc_T30", "normalized": [] }, { "id": "NCT01117181_exc_R19", "type": "AND", "arg1_id": "NCT01117181_exc_T27", "arg2_id": "NCT01117181_exc_T29", "normalized": [] }, { "id": "NCT01117181_exc_R20", "type": "AND", "arg1_id": "NCT01117181_exc_T31", "arg2_id": "NCT01117181_exc_T33", "normalized": [] }, { "id": "NCT01117181_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T37", "arg2_id": "NCT01117181_exc_T38", "normalized": [] }, { "id": "NCT01117181_exc_R22", "type": "AND", "arg1_id": "NCT01117181_exc_T39", "arg2_id": "NCT01117181_exc_T40", "normalized": [] }, { "id": "NCT01117181_exc_R23", "type": "Has_value", "arg1_id": "NCT01117181_exc_T41", "arg2_id": "NCT01117181_exc_T42", "normalized": [] }, { "id": "NCT01117181_exc_R24", "type": "AND", "arg1_id": "NCT01117181_exc_T43", "arg2_id": "NCT01117181_exc_T44", "normalized": [] }, { "id": "NCT01117181_exc_R25", "type": "AND", "arg1_id": "NCT01117181_exc_T47", "arg2_id": "NCT01117181_exc_T48", "normalized": [] }, { "id": "NCT01117181_exc_R26", "type": "Has_scope", "arg1_id": "NCT01117181_exc_T49", "arg2_id": "NCT01117181_exc_T52", "normalized": [] }, { "id": "NCT01117181_exc_R27", "type": "AND", "arg1_id": "NCT01117181_exc_T47", "arg2_id": "NCT01117181_exc_T49", "normalized": [] }, { "id": "NCT01117181_exc_R28", "type": "Has_value", "arg1_id": "NCT01117181_exc_T45", "arg2_id": "NCT01117181_exc_T46", "normalized": [] }, { "id": "NCT01117181_exc_R29", "type": "AND", "arg1_id": "NCT01117181_exc_T43", "arg2_id": "NCT01117181_exc_T45", "normalized": [] }, { "id": "NCT01117181_exc_R30", "type": "AND", "arg1_id": "NCT01117181_exc_T39", "arg2_id": "NCT01117181_exc_T41", "normalized": [] }, { "id": "NCT01117181_exc_R31", "type": "AND", "arg1_id": "NCT01117181_exc_T11", "arg2_id": "NCT01117181_exc_T13", "normalized": [] }, { "id": "NCT01117181_exc_R32", "type": "Has_scope", "arg1_id": "NCT01117181_exc_T4", "arg2_id": "NCT01117181_exc_T53", "normalized": [] }, { "id": "NCT01117181_exc_R33", "type": "Has_scope", "arg1_id": "NCT01117181_exc_T21", "arg2_id": "NCT01117181_exc_T54", "normalized": [] }, { "id": "NCT01117181_exc_R34", "type": "Has_scope", "arg1_id": "NCT01117181_exc_T37", "arg2_id": "NCT01117181_exc_T55", "normalized": [] }, { "id": "NCT01117181_exc_R35", "type": "Has_index", "arg1_id": "NCT01117181_exc_T57", "arg2_id": "NCT01117181_exc_T58", "normalized": [] }, { "id": "NCT01117181_exc_R36", "type": "AND", "arg1_id": "NCT01117181_exc_T60", "arg2_id": "NCT01117181_exc_T59", "normalized": [] }, { "id": "NCT01117181_exc_R37", "type": "Has_scope", "arg1_id": "NCT01117181_exc_T60", "arg2_id": "NCT01117181_exc_T63", "normalized": [] }, { "id": "NCT01117181_exc_R38", "type": "Has_temporal", "arg1_id": "NCT01117181_exc_T56", "arg2_id": "NCT01117181_exc_T57", "normalized": [] }, { "id": "NCT01117181_exc_R39", "type": "Has_negation", "arg1_id": "NCT01117181_exc_T67", "arg2_id": "NCT01117181_exc_T66", "normalized": [] }, { "id": "NCT01117181_exc_R40", "type": "Has_scope", "arg1_id": "NCT01117181_exc_T56", "arg2_id": "NCT01117181_exc_T67", "normalized": [] }, { "id": "NCT01117181_exc_R41", "type": "Has_negation", "arg1_id": "NCT01117181_exc_T70", "arg2_id": "NCT01117181_exc_T71", "normalized": [] }, { "id": "NCT01117181_exc_R42", "type": "AND", "arg1_id": "NCT01117181_exc_T69", "arg2_id": "NCT01117181_exc_T70", "normalized": [] }, { "id": "NCT01117181_exc_R43", "type": "Has_temporal", "arg1_id": "NCT01117181_exc_T72", "arg2_id": "NCT01117181_exc_T73", "normalized": [] }, { "id": "NCT01117181_exc_R44", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T69", "arg2_id": "NCT01117181_exc_T72", "normalized": [] }, { "id": "NCT01117181_exc_R45", "type": "Has_temporal", "arg1_id": "NCT01117181_exc_T78", "arg2_id": "NCT01117181_exc_T79", "normalized": [] }, { "id": "NCT01117181_exc_R47", "type": "Subsumes", "arg1_id": "NCT01117181_exc_T77", "arg2_id": "NCT01117181_exc_T83", "normalized": [] }, { "id": "NCT01117181_exc_R48", "type": "Has_temporal", "arg1_id": "NCT01117181_exc_T84", "arg2_id": "NCT01117181_exc_T86", "normalized": [] }, { "id": "NCT01117181_exc_R50", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T88", "arg2_id": "NCT01117181_exc_T89", "normalized": [] }, { "id": "NCT01117181_exc_R51", "type": "Has_value", "arg1_id": "NCT01117181_exc_T92", "arg2_id": "NCT01117181_exc_T93", "normalized": [] }, { "id": "NCT01117181_exc_R52", "type": "AND", "arg1_id": "NCT01117181_exc_T96", "arg2_id": "NCT01117181_exc_T95", "normalized": [] }, { "id": "NCT01117181_exc_R53", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T92", "arg2_id": "NCT01117181_exc_T96", "normalized": [] }, { "id": "NCT01117181_exc_R54", "type": "Has_temporal", "arg1_id": "NCT01117181_exc_T90", "arg2_id": "NCT01117181_exc_T91", "normalized": [] }, { "id": "NCT01117181_exc_R55", "type": "Has_scope", "arg1_id": "NCT01117181_exc_T88", "arg2_id": "NCT01117181_exc_T97", "normalized": [] }, { "id": "NCT01117181_exc_R56", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T98", "arg2_id": "NCT01117181_exc_T99", "normalized": [] }, { "id": "NCT01117181_exc_R57", "type": "Has_index", "arg1_id": "NCT01117181_exc_T100", "arg2_id": "NCT01117181_exc_T101", "normalized": [] }, { "id": "NCT01117181_exc_R58", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T102", "arg2_id": "NCT01117181_exc_T103", "normalized": [] }, { "id": "NCT01117181_exc_R59", "type": "AND", "arg1_id": "NCT01117181_exc_T105", "arg2_id": "NCT01117181_exc_T102", "normalized": [] }, { "id": "NCT01117181_exc_R60", "type": "Has_temporal", "arg1_id": "NCT01117181_exc_T105", "arg2_id": "NCT01117181_exc_T107", "normalized": [] }, { "id": "NCT01117181_exc_R61", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T102", "arg2_id": "NCT01117181_exc_T106", "normalized": [] }, { "id": "NCT01117181_exc_R62", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T110", "arg2_id": "NCT01117181_exc_T108", "normalized": [] }, { "id": "NCT01117181_exc_R63", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T114", "arg2_id": "NCT01117181_exc_T115", "normalized": [] }, { "id": "NCT01117181_exc_R64", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T116", "arg2_id": "NCT01117181_exc_T117", "normalized": [] }, { "id": "NCT01117181_exc_R65", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T119", "arg2_id": "NCT01117181_exc_T118", "normalized": [] }, { "id": "NCT01117181_exc_R66", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T121", "arg2_id": "NCT01117181_exc_T122", "normalized": [] }, { "id": "NCT01117181_exc_R67", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T125", "arg2_id": "NCT01117181_exc_T126", "normalized": [] }, { "id": "NCT01117181_exc_R69", "type": "AND", "arg1_id": "NCT01117181_exc_T130", "arg2_id": "NCT01117181_exc_T131", "normalized": [] }, { "id": "NCT01117181_exc_R70", "type": "AND", "arg1_id": "NCT01117181_exc_T131", "arg2_id": "NCT01117181_exc_T132", "normalized": [] }, { "id": "NCT01117181_exc_R71", "type": "Has_scope", "arg1_id": "NCT01117181_exc_T130", "arg2_id": "NCT01117181_exc_T135", "normalized": [] }, { "id": "NCT01117181_exc_R72", "type": "Subsumes", "arg1_id": "NCT01117181_exc_T136", "arg2_id": "NCT01117181_exc_T137", "normalized": [] }, { "id": "NCT01117181_exc_R73", "type": "Subsumes", "arg1_id": "NCT01117181_exc_T138", "arg2_id": "NCT01117181_exc_T139", "normalized": [] }, { "id": "NCT01117181_exc_R74", "type": "Has_temporal", "arg1_id": "NCT01117181_exc_T140", "arg2_id": "NCT01117181_exc_T141", "normalized": [] }, { "id": "NCT01117181_exc_R75", "type": "Has_scope", "arg1_id": "NCT01117181_exc_T144", "arg2_id": "NCT01117181_exc_T148", "normalized": [] }, { "id": "NCT01117181_exc_R76", "type": "Subsumes", "arg1_id": "NCT01117181_exc_T145", "arg2_id": "NCT01117181_exc_T150", "normalized": [] }, { "id": "NCT01117181_exc_R77", "type": "Has_qualifier", "arg1_id": "NCT01117181_exc_T152", "arg2_id": "NCT01117181_exc_T151", "normalized": [] } ]

[ { "id": "NCT01117181_inc_text", "type": "inclusion", "text": [ "Possible or probable Alzheimer's disease (National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria), with Mini-Mental State Exam (MMSE) score of 10-26 inclusive; MMSE scores above 26 in those who nevertheless meet criteria for AD may be allowed with Steering Committee approval on a case by case basis \nClinically significant apathy for at least four weeks for which either 1) the frequency of apathy as assessed by the Neuropsychiatric Inventory (NPI) is 'Very frequently', or 2) the frequency of apathy as assessed by the NPI is 'Frequently' or 'Often' AND the severity of apathy as assessed by the NPI is 'Moderate' or 'Marked' \nA medication for apathy is appropriate, in the opinion of the study physician \nProvision of informed consent for participation in the study by patient or surrogate (if the patient is unable to provide informed consent) and caregiver \nAvailability of primary caregiver, who spends greater than ten hours a week with the patient and supervises his/her care, to accompany the patient to study visits and to participate in the study \nSufficient fluency, of both the patient and caregiver, in written and spoken English to participate in study visits, physical exams, and outcome assessments \nNo change to AD medications within the month preceding randomization, including starting, stopping, or dosage modifications \nTreatment with stable doses of selective serotonin reuptake inhibitor antidepressants(SSRIs) is appropriate if stable for 3 months prior to randomization. Other psychotropics(with the exclusion of antipsychotics), if stable for 3 months, may be allowed only with Steering Committee approval on a case by case basis. \n" ], "offsets": [ [ 0, 1759 ] ] } ]

[ { "id": "NCT01117181_inc_T1", "type": "Condition", "text": [ "Alzheimer's disease" ], "offsets": [ [ 21, 40 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T2", "type": "Measurement", "text": [ "National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria" ], "offsets": [ [ 42, 195 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T3", "type": "Value", "text": [ "probable" ], "offsets": [ [ 12, 20 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T4", "type": "Value", "text": [ "Possible" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T5", "type": "Scope", "text": [ "Possible or probable" ], "offsets": [ [ 0, 20 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T6", "type": "Measurement", "text": [ "Mini-Mental State Exam (MMSE)" ], "offsets": [ [ 203, 232 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T7", "type": "Value", "text": [ "score of 10-26 inclusive" ], "offsets": [ [ 233, 257 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T8", "type": "Measurement", "text": [ "MMSE" ], "offsets": [ [ 259, 263 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T9", "type": "Value", "text": [ "scores above 26" ], "offsets": [ [ 264, 279 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T10", "type": "Condition", "text": [ "AD" ], "offsets": [ [ 324, 326 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T11", "type": "Condition", "text": [ "apathy" ], "offsets": [ [ 423, 429 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T12", "type": "Person", "text": [ "at least four weeks" ], "offsets": [ [ 434, 453 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T13", "type": "Measurement", "text": [ "Neuropsychiatric Inventory (NPI)" ], "offsets": [ [ 517, 549 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T14", "type": "Value", "text": [ "Very frequently" ], "offsets": [ [ 554, 569 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T15", "type": "Measurement", "text": [ "NPI" ], "offsets": [ [ 621, 624 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T16", "type": "Value", "text": [ "Frequently" ], "offsets": [ [ 629, 639 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T17", "type": "Value", "text": [ "Often" ], "offsets": [ [ 645, 650 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T18", "type": "Measurement", "text": [ "NPI" ], "offsets": [ [ 698, 701 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T19", "type": "Observation", "text": [ "severity of apathy" ], "offsets": [ [ 660, 678 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T20", "type": "Observation", "text": [ "frequency of apathy" ], "offsets": [ [ 582, 601 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T21", "type": "Scope", "text": [ "'Frequently' or 'Often'" ], "offsets": [ [ 628, 651 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T22", "type": "Value", "text": [ "Moderate" ], "offsets": [ [ 706, 714 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T23", "type": "Value", "text": [ "Marked" ], "offsets": [ [ 720, 726 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T24", "type": "Scope", "text": [ "'Moderate' or 'Marked'" ], "offsets": [ [ 705, 727 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T25", "type": "Scope", "text": [ "frequency of apathy as assessed by the NPI is 'Frequently' or 'Often' AND the severity of apathy as assessed by the NPI is 'Moderate' or 'Marked'" ], "offsets": [ [ 582, 727 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T26", "type": "Observation", "text": [ "frequency of apathy" ], "offsets": [ [ 478, 497 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T27", "type": "Drug", "text": [ "medication for apathy" ], "offsets": [ [ 731, 752 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T28", "type": "Condition", "text": [ "apathy" ], "offsets": [ [ 746, 752 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T34", "type": "Drug", "text": [ "AD medications" ], "offsets": [ [ 1330, 1344 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T35", "type": "Temporal", "text": [ "within the month preceding randomization" ], "offsets": [ [ 1345, 1385 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T36", "type": "Reference_point", "text": [ "randomization" ], "offsets": [ [ 1372, 1385 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T37", "type": "Observation", "text": [ "change to AD medications" ], "offsets": [ [ 1320, 1344 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T38", "type": "Negation", "text": [ "No" ], "offsets": [ [ 1317, 1319 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T39", "type": "Drug", "text": [ "selective serotonin reuptake inhibitor antidepressants(SSRIs)" ], "offsets": [ [ 1473, 1534 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T40", "type": "Qualifier", "text": [ "stable doses" ], "offsets": [ [ 1457, 1469 ] ], "normalized": [] }, { "id": "NCT01117181_inc_T41", "type": "Procedure", "text": [ "Treatment" ], "offsets": [ [ 1442, 1451 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01117181_inc_R1", "type": "AND", "arg1_id": "NCT01117181_inc_T1", "arg2_id": "NCT01117181_inc_T2", "normalized": [] }, { "id": "NCT01117181_inc_R2", "type": "Has_scope", "arg1_id": "NCT01117181_inc_T2", "arg2_id": "NCT01117181_inc_T5", "normalized": [] }, { "id": "NCT01117181_inc_R3", "type": "Has_value", "arg1_id": "NCT01117181_inc_T8", "arg2_id": "NCT01117181_inc_T9", "normalized": [] }, { "id": "NCT01117181_inc_R4", "type": "Has_value", "arg1_id": "NCT01117181_inc_T6", "arg2_id": "NCT01117181_inc_T7", "normalized": [] }, { "id": "NCT01117181_inc_R5", "type": "Has_value", "arg1_id": "NCT01117181_inc_T13", "arg2_id": "NCT01117181_inc_T14", "normalized": [] }, { "id": "NCT01117181_inc_R6", "type": "AND", "arg1_id": "NCT01117181_inc_T20", "arg2_id": "NCT01117181_inc_T15", "normalized": [] }, { "id": "NCT01117181_inc_R7", "type": "Has_scope", "arg1_id": "NCT01117181_inc_T18", "arg2_id": "NCT01117181_inc_T24", "normalized": [] }, { "id": "NCT01117181_inc_R8", "type": "Has_scope", "arg1_id": "NCT01117181_inc_T15", "arg2_id": "NCT01117181_inc_T21", "normalized": [] }, { "id": "NCT01117181_inc_R9", "type": "AND", "arg1_id": "NCT01117181_inc_T19", "arg2_id": "NCT01117181_inc_T18", "normalized": [] }, { "id": "NCT01117181_inc_R10", "type": "AND", "arg1_id": "NCT01117181_inc_T26", "arg2_id": "NCT01117181_inc_T13", "normalized": [] }, { "id": "NCT01117181_inc_R11", "type": "AND", "arg1_id": "NCT01117181_inc_T27", "arg2_id": "NCT01117181_inc_T28", "normalized": [] }, { "id": "NCT01117181_inc_R12", "type": "Has_index", "arg1_id": "NCT01117181_inc_T35", "arg2_id": "NCT01117181_inc_T36", "normalized": [] }, { "id": "NCT01117181_inc_R13", "type": "Has_negation", "arg1_id": "NCT01117181_inc_T37", "arg2_id": "NCT01117181_inc_T38", "normalized": [] }, { "id": "NCT01117181_inc_R14", "type": "AND", "arg1_id": "NCT01117181_inc_T37", "arg2_id": "NCT01117181_inc_T34", "normalized": [] }, { "id": "NCT01117181_inc_R15", "type": "Has_temporal", "arg1_id": "NCT01117181_inc_T37", "arg2_id": "NCT01117181_inc_T35", "normalized": [] }, { "id": "NCT01117181_inc_R16", "type": "AND", "arg1_id": "NCT01117181_inc_T41", "arg2_id": "NCT01117181_inc_T39", "normalized": [] }, { "id": "NCT01117181_inc_R17", "type": "Has_qualifier", "arg1_id": "NCT01117181_inc_T39", "arg2_id": "NCT01117181_inc_T40", "normalized": [] } ]

[ { "id": "NCT01118871_exc_text", "type": "exclusion", "text": [ "current alcohol abuse or drug dependence \npregnancy \nactive opportunistic infection or significant co-morbidities \ncurrent prohibited concomitant medication \na likelihood of diminished response to any of the study treatment arms, in the opinion of the investigator, based on HIV genotypic resistance testing \n \n" ], "offsets": [ [ 0, 320 ] ] } ]

[ { "id": "NCT01118871_exc_T1", "type": "Condition", "text": [ "alcohol abuse" ], "offsets": [ [ 8, 21 ] ], "normalized": [] }, { "id": "NCT01118871_exc_T2", "type": "Condition", "text": [ "drug dependence" ], "offsets": [ [ 25, 40 ] ], "normalized": [] }, { "id": "NCT01118871_exc_T3", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT01118871_exc_T4", "type": "Scope", "text": [ "alcohol abuse or drug dependence" ], "offsets": [ [ 8, 40 ] ], "normalized": [] }, { "id": "NCT01118871_exc_T5", "type": "Condition", "text": [ "pregnancy" ], "offsets": [ [ 42, 51 ] ], "normalized": [] }, { "id": "NCT01118871_exc_T6", "type": "Condition", "text": [ "opportunistic infection" ], "offsets": [ [ 60, 83 ] ], "normalized": [] }, { "id": "NCT01118871_exc_T7", "type": "Condition", "text": [ "co-morbidities" ], "offsets": [ [ 99, 113 ] ], "normalized": [] }, { "id": "NCT01118871_exc_T8", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 87, 98 ] ], "normalized": [] }, { "id": "NCT01118871_exc_T10", "type": "Drug", "text": [ "medication" ], "offsets": [ [ 146, 156 ] ], "normalized": [] }, { "id": "NCT01118871_exc_T11", "type": "Temporal", "text": [ "concomitant" ], "offsets": [ [ 134, 145 ] ], "normalized": [] }, { "id": "NCT01118871_exc_T12", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 115, 122 ] ], "normalized": [] }, { "id": "NCT01118871_exc_T13", "type": "Qualifier", "text": [ "prohibited" ], "offsets": [ [ 123, 133 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01118871_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01118871_exc_T4", "arg2_id": "NCT01118871_exc_T3", "normalized": [] }, { "id": "NCT01118871_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01118871_exc_T10", "arg2_id": "NCT01118871_exc_T11", "normalized": [] }, { "id": "NCT01118871_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01118871_exc_T10", "arg2_id": "NCT01118871_exc_T12", "normalized": [] }, { "id": "NCT01118871_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01118871_exc_T10", "arg2_id": "NCT01118871_exc_T13", "normalized": [] } ]

[ { "id": "NCT01118871_inc_text", "type": "inclusion", "text": [ "HIV-1 infected males or females \nover 18 years of age \nsigned informed consent \ncurrently receiving a stable antiretroviral regimen comprising of: \ntwo or more licensed NRTIs \none licensed NNRTI or boosted protease inhibitor \nno previous protease inhibitor resistance documented on HIV-1 genotypic resistance testing \nfailure of current antiretroviral regimen due to: \ntoxicity, intolerance or virological failure if receiving an NNRTI containing regimen at screening \ntoxicity or intolerance if receiving a boosted-protease inhibitor regimen at screening (with plasma HIV RNA < 400 copies/mL at screening) \nwilling to modify antiretroviral therapy, in accordance with the randomisation assignment \nno previous exposure to etravirine \nsubjects in good health upon medical history, physical exam, and laboratory testing in the opinion of the investigator \nhave no serologic evidence of active HBV infection evidenced by negative hepatitis B surface antigen \nfemale subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening through completion of the study: \nbarrier contraceptives (condom, diaphragm with spermicide) \nIUD or Depo PLUS a barrier contraceptive \nfemale subjects of childbearing potential must have a negative pregnancy test. \n" ], "offsets": [ [ 0, 1372 ] ] } ]

[ { "id": "NCT01118871_inc_T1", "type": "Condition", "text": [ "HIV-1 infected" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T2", "type": "Person", "text": [ "males" ], "offsets": [ [ 15, 20 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T3", "type": "Person", "text": [ "females" ], "offsets": [ [ 24, 31 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T4", "type": "Value", "text": [ "over 18 years" ], "offsets": [ [ 33, 46 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T5", "type": "Person", "text": [ "age" ], "offsets": [ [ 50, 53 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T7", "type": "Procedure", "text": [ "antiretroviral regimen" ], "offsets": [ [ 109, 131 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T8", "type": "Multiplier", "text": [ "two or more" ], "offsets": [ [ 148, 159 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T9", "type": "Drug", "text": [ "NRTI" ], "offsets": [ [ 169, 173 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T10", "type": "Qualifier", "text": [ "licensed" ], "offsets": [ [ 160, 168 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T11", "type": "Multiplier", "text": [ "one" ], "offsets": [ [ 176, 179 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T12", "type": "Qualifier", "text": [ "licensed" ], "offsets": [ [ 180, 188 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T13", "type": "Drug", "text": [ "NNRTI" ], "offsets": [ [ 189, 194 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T14", "type": "Drug", "text": [ "boosted protease inhibitor" ], "offsets": [ [ 198, 224 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T15", "type": "Scope", "text": [ "NNRTI or boosted protease inhibitor" ], "offsets": [ [ 189, 224 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T16", "type": "Drug", "text": [ "protease inhibitor" ], "offsets": [ [ 238, 256 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T17", "type": "Condition", "text": [ "protease inhibitor resistance" ], "offsets": [ [ 238, 267 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T18", "type": "Procedure", "text": [ "HIV-1 genotypic resistance testing" ], "offsets": [ [ 282, 316 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T19", "type": "Condition", "text": [ "HIV-1" ], "offsets": [ [ 282, 287 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T20", "type": "Condition", "text": [ "HIV-1 genotypic resistance" ], "offsets": [ [ 282, 308 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T21", "type": "Procedure", "text": [ "antiretroviral regimen" ], "offsets": [ [ 337, 359 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T22", "type": "Condition", "text": [ "failure of current antiretroviral regimen" ], "offsets": [ [ 318, 359 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T23", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 329, 336 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T24", "type": "Condition", "text": [ "toxicity" ], "offsets": [ [ 369, 377 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T25", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 379, 390 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T26", "type": "Condition", "text": [ "virological failure" ], "offsets": [ [ 394, 413 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T27", "type": "Drug", "text": [ "NNRTI" ], "offsets": [ [ 430, 435 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T28", "type": "Procedure", "text": [ "NNRTI containing regimen" ], "offsets": [ [ 430, 454 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T29", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 455, 467 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T30", "type": "Scope", "text": [ "NNRTI containing regimen at screening" ], "offsets": [ [ 430, 467 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T31", "type": "Scope", "text": [ "toxicity, intolerance or virological failure" ], "offsets": [ [ 369, 413 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T32", "type": "Condition", "text": [ "toxicity" ], "offsets": [ [ 469, 477 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T33", "type": "Condition", "text": [ "intolerance" ], "offsets": [ [ 481, 492 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T34", "type": "Procedure", "text": [ "boosted-protease inhibitor regimen" ], "offsets": [ [ 508, 542 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T35", "type": "Drug", "text": [ "protease inhibitor" ], "offsets": [ [ 516, 534 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T36", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 543, 555 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T37", "type": "Measurement", "text": [ "plasma HIV RNA" ], "offsets": [ [ 562, 576 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T38", "type": "Value", "text": [ "< 400 copies/mL" ], "offsets": [ [ 577, 592 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T39", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 593, 605 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T40", "type": "Scope", "text": [ "boosted-protease inhibitor regimen at screening (with plasma HIV RNA < 400 copies/mL at screening)" ], "offsets": [ [ 508, 606 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T41", "type": "Scope", "text": [ "toxicity or intolerance" ], "offsets": [ [ 469, 492 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T42", "type": "Procedure", "text": [ "antiretroviral therapy" ], "offsets": [ [ 626, 648 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T43", "type": "Observation", "text": [ "willing" ], "offsets": [ [ 608, 615 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T44", "type": "Drug", "text": [ "etravirine" ], "offsets": [ [ 723, 733 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T45", "type": "Negation", "text": [ "no" ], "offsets": [ [ 699, 701 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T46", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 702, 710 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T47", "type": "Condition", "text": [ "good health" ], "offsets": [ [ 747, 758 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T48", "type": "Observation", "text": [ "medical history" ], "offsets": [ [ 764, 779 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T49", "type": "Procedure", "text": [ "physical exam" ], "offsets": [ [ 781, 794 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T50", "type": "Procedure", "text": [ "laboratory testing" ], "offsets": [ [ 800, 818 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T51", "type": "Scope", "text": [ "medical history, physical exam, and laboratory testing" ], "offsets": [ [ 764, 818 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T52", "type": "Condition", "text": [ "serologic evidence of active HBV infection" ], "offsets": [ [ 863, 905 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T53", "type": "Condition", "text": [ "HBV infection" ], "offsets": [ [ 892, 905 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T54", "type": "Measurement", "text": [ "hepatitis B surface antigen" ], "offsets": [ [ 928, 955 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T55", "type": "Value", "text": [ "negative" ], "offsets": [ [ 919, 927 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T56", "type": "Person", "text": [ "female" ], "offsets": [ [ 957, 963 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T57", "type": "Condition", "text": [ "heterosexually active" ], "offsets": [ [ 981, 1002 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T58", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 1010, 1032 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T59", "type": "Condition", "text": [ "surgically sterile" ], "offsets": [ [ 1044, 1062 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T60", "type": "Procedure", "text": [ "surgically" ], "offsets": [ [ 1044, 1054 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T61", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1040, 1043 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T62", "type": "Temporal", "text": [ "at least two years" ], "offsets": [ [ 1066, 1084 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T63", "type": "Condition", "text": [ "post menopausal" ], "offsets": [ [ 1085, 1100 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T64", "type": "Scope", "text": [ "not surgically sterile or at least two years post menopausal" ], "offsets": [ [ 1040, 1100 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T65", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 1116, 1129 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T68", "type": "Device", "text": [ "barrier contraceptives" ], "offsets": [ [ 1190, 1212 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T69", "type": "Device", "text": [ "condom" ], "offsets": [ [ 1214, 1220 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T70", "type": "Device", "text": [ "diaphragm" ], "offsets": [ [ 1222, 1231 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T71", "type": "Qualifier", "text": [ "with spermicide" ], "offsets": [ [ 1232, 1247 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T72", "type": "Scope", "text": [ "condom, diaphragm with spermicide" ], "offsets": [ [ 1214, 1247 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T73", "type": "Device", "text": [ "IUD" ], "offsets": [ [ 1250, 1253 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T74", "type": "Device", "text": [ "Depo" ], "offsets": [ [ 1257, 1261 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T75", "type": "Device", "text": [ "barrier contraceptive" ], "offsets": [ [ 1269, 1290 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T76", "type": "Measurement", "text": [ "pregnancy test" ], "offsets": [ [ 1355, 1369 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T77", "type": "Value", "text": [ "negative" ], "offsets": [ [ 1346, 1354 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T78", "type": "Condition", "text": [ "childbearing potential" ], "offsets": [ [ 1311, 1333 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T79", "type": "Person", "text": [ "female" ], "offsets": [ [ 1292, 1298 ] ], "normalized": [] }, { "id": "NCT01118871_inc_T80", "type": "Scope", "text": [ "female subjects of childbearing potential" ], "offsets": [ [ 1292, 1333 ] ], "normalized": [] } ]

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[ { "id": "NCT01118871_inc_R1", "type": "Has_value", "arg1_id": "NCT01118871_inc_T5", "arg2_id": "NCT01118871_inc_T4", "normalized": [] }, { "id": "NCT01118871_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01118871_inc_T9", "arg2_id": "NCT01118871_inc_T10", "normalized": [] }, { "id": "NCT01118871_inc_R3", "type": "Has_multiplier", "arg1_id": "NCT01118871_inc_T9", "arg2_id": "NCT01118871_inc_T8", "normalized": [] }, { "id": "NCT01118871_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT01118871_inc_T15", "arg2_id": "NCT01118871_inc_T12", "normalized": [] }, { "id": "NCT01118871_inc_R5", "type": "Has_multiplier", "arg1_id": "NCT01118871_inc_T15", "arg2_id": "NCT01118871_inc_T11", "normalized": [] }, { "id": "NCT01118871_inc_R6", "type": "AND", "arg1_id": "NCT01118871_inc_T17", "arg2_id": "NCT01118871_inc_T16", "normalized": [] }, { "id": "NCT01118871_inc_R7", "type": "AND", "arg1_id": "NCT01118871_inc_T20", "arg2_id": "NCT01118871_inc_T19", "normalized": [] }, { "id": "NCT01118871_inc_R8", "type": "AND", "arg1_id": "NCT01118871_inc_T18", "arg2_id": "NCT01118871_inc_T20", "normalized": [] }, { "id": "NCT01118871_inc_R9", "type": "AND", "arg1_id": "NCT01118871_inc_T17", "arg2_id": "NCT01118871_inc_T20", "normalized": [] }, { "id": "NCT01118871_inc_R10", "type": "Has_temporal", "arg1_id": "NCT01118871_inc_T21", "arg2_id": "NCT01118871_inc_T23", "normalized": [] }, { "id": "NCT01118871_inc_R11", "type": "AND", "arg1_id": "NCT01118871_inc_T22", "arg2_id": "NCT01118871_inc_T21", "normalized": [] }, { "id": "NCT01118871_inc_R12", "type": "AND", "arg1_id": "NCT01118871_inc_T28", "arg2_id": "NCT01118871_inc_T27", "normalized": [] }, { "id": "NCT01118871_inc_R13", "type": "Has_scope", "arg1_id": "NCT01118871_inc_T30", "arg2_id": "NCT01118871_inc_T31", "normalized": [] }, { "id": "NCT01118871_inc_R14", "type": "AND", "arg1_id": "NCT01118871_inc_T34", "arg2_id": "NCT01118871_inc_T35", "normalized": [] }, { "id": "NCT01118871_inc_R15", "type": "Has_value", "arg1_id": "NCT01118871_inc_T37", "arg2_id": "NCT01118871_inc_T38", "normalized": [] }, { "id": "NCT01118871_inc_R16", "type": "Has_temporal", "arg1_id": "NCT01118871_inc_T37", "arg2_id": "NCT01118871_inc_T39", "normalized": [] }, { "id": "NCT01118871_inc_R17", "type": "Has_temporal", "arg1_id": "NCT01118871_inc_T34", "arg2_id": "NCT01118871_inc_T36", "normalized": [] }, { "id": "NCT01118871_inc_R18", "type": "Has_scope", "arg1_id": "NCT01118871_inc_T40", "arg2_id": "NCT01118871_inc_T41", "normalized": [] }, { "id": "NCT01118871_inc_R20", "type": "Has_temporal", "arg1_id": "NCT01118871_inc_T44", "arg2_id": "NCT01118871_inc_T46", "normalized": [] }, { "id": "NCT01118871_inc_R21", "type": "Has_negation", "arg1_id": "NCT01118871_inc_T44", "arg2_id": "NCT01118871_inc_T45", "normalized": [] }, { "id": "NCT01118871_inc_R22", "type": "Has_scope", "arg1_id": "NCT01118871_inc_T47", "arg2_id": "NCT01118871_inc_T51", "normalized": [] }, { "id": "NCT01118871_inc_R23", "type": "Has_value", "arg1_id": "NCT01118871_inc_T54", "arg2_id": "NCT01118871_inc_T55", "normalized": [] }, { "id": "NCT01118871_inc_R24", "type": "AND", "arg1_id": "NCT01118871_inc_T52", "arg2_id": "NCT01118871_inc_T53", "normalized": [] }, { "id": "NCT01118871_inc_R25", "type": "AND", "arg1_id": "NCT01118871_inc_T52", "arg2_id": "NCT01118871_inc_T54", "normalized": [] }, { "id": "NCT01118871_inc_R26", "type": "AND", "arg1_id": "NCT01118871_inc_T59", "arg2_id": "NCT01118871_inc_T60", "normalized": [] }, { "id": "NCT01118871_inc_R27", "type": "Has_negation", "arg1_id": "NCT01118871_inc_T59", "arg2_id": "NCT01118871_inc_T61", "normalized": [] }, { "id": "NCT01118871_inc_R28", "type": "Has_temporal", "arg1_id": "NCT01118871_inc_T63", "arg2_id": "NCT01118871_inc_T62", "normalized": [] }, { "id": "NCT01118871_inc_R29", "type": "Has_negation", "arg1_id": "NCT01118871_inc_T63", "arg2_id": "NCT01118871_inc_T61", "normalized": [] }, { "id": "NCT01118871_inc_R30", "type": "Subsumes", "arg1_id": "NCT01118871_inc_T58", "arg2_id": "NCT01118871_inc_T64", "normalized": [] }, { "id": "NCT01118871_inc_R31", "type": "Has_qualifier", "arg1_id": "NCT01118871_inc_T70", "arg2_id": "NCT01118871_inc_T71", "normalized": [] }, { "id": "NCT01118871_inc_R32", "type": "Subsumes", "arg1_id": "NCT01118871_inc_T68", "arg2_id": "NCT01118871_inc_T72", "normalized": [] }, { "id": "NCT01118871_inc_R33", "type": "Has_value", "arg1_id": "NCT01118871_inc_T76", "arg2_id": "NCT01118871_inc_T77", "normalized": [] }, { "id": "NCT01118871_inc_R34", "type": "AND", "arg1_id": "NCT01118871_inc_T80", "arg2_id": "NCT01118871_inc_T76", "normalized": [] } ]

[ { "id": "NCT01175044_exc_text", "type": "exclusion", "text": [ "Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).\nAge = 17.\nAllergy to povidone iodine.\nAny condition requiring antibiotics 14 days prior to arriving for surgery.\nPatients with chronic immunosuppression (such as HIV/AIDS).\nUnable to adhere to follow up schedule and treatment.\nPatients scheduled to undergo revision total knee arthroplasty for infectious reasons.\n" ], "offsets": [ [ 0, 447 ] ] } ]

[ { "id": "NCT01175044_exc_T2", "type": "Person", "text": [ "Age" ], "offsets": [ [ 133, 136 ] ], "normalized": [] }, { "id": "NCT01175044_exc_T3", "type": "Value", "text": [ "= 17" ], "offsets": [ [ 137, 141 ] ], "normalized": [] }, { "id": "NCT01175044_exc_T4", "type": "Condition", "text": [ "Allergy" ], "offsets": [ [ 143, 150 ] ], "normalized": [] }, { "id": "NCT01175044_exc_T5", "type": "Drug", "text": [ "povidone iodine" ], "offsets": [ [ 154, 169 ] ], "normalized": [] }, { "id": "NCT01175044_exc_T6", "type": "Procedure", "text": [ "antibiotics" ], "offsets": [ [ 195, 206 ] ], "normalized": [] }, { "id": "NCT01175044_exc_T7", "type": "Temporal", "text": [ "14 days prior to arriving for surgery" ], "offsets": [ [ 207, 244 ] ], "normalized": [] }, { "id": "NCT01175044_exc_T8", "type": "Reference_point", "text": [ "arriving for surgery" ], "offsets": [ [ 224, 244 ] ], "normalized": [] }, { "id": "NCT01175044_exc_T9", "type": "Procedure", "text": [ "surgery" ], "offsets": [ [ 237, 244 ] ], "normalized": [] }, { "id": "NCT01175044_exc_T10", "type": "Condition", "text": [ "immunosuppression" ], "offsets": [ [ 268, 285 ] ], "normalized": [] }, { "id": "NCT01175044_exc_T11", "type": "Qualifier", "text": [ "chronic" ], "offsets": [ [ 260, 267 ] ], "normalized": [] }, { "id": "NCT01175044_exc_T12", "type": "Condition", "text": [ "HIV/AIDS" ], "offsets": [ [ 295, 303 ] ], "normalized": [] }, { "id": "NCT01175044_exc_T14", "type": "Procedure", "text": [ "revision total knee arthroplasty" ], "offsets": [ [ 390, 422 ] ], "normalized": [] }, { "id": "NCT01175044_exc_T15", "type": "Condition", "text": [ "infectious reasons" ], "offsets": [ [ 427, 445 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT01175044_exc_R1", "type": "Has_value", "arg1_id": "NCT01175044_exc_T2", "arg2_id": "NCT01175044_exc_T3", "normalized": [] }, { "id": "NCT01175044_exc_R2", "type": "AND", "arg1_id": "NCT01175044_exc_T4", "arg2_id": "NCT01175044_exc_T5", "normalized": [] }, { "id": "NCT01175044_exc_R4", "type": "Has_index", "arg1_id": "NCT01175044_exc_T7", "arg2_id": "NCT01175044_exc_T8", "normalized": [] }, { "id": "NCT01175044_exc_R5", "type": "Has_temporal", "arg1_id": "NCT01175044_exc_T6", "arg2_id": "NCT01175044_exc_T7", "normalized": [] }, { "id": "NCT01175044_exc_R6", "type": "Has_qualifier", "arg1_id": "NCT01175044_exc_T10", "arg2_id": "NCT01175044_exc_T11", "normalized": [] }, { "id": "NCT01175044_exc_R7", "type": "Subsumes", "arg1_id": "NCT01175044_exc_T10", "arg2_id": "NCT01175044_exc_T12", "normalized": [] }, { "id": "NCT01175044_exc_R8", "type": "AND", "arg1_id": "NCT01175044_exc_T14", "arg2_id": "NCT01175044_exc_T15", "normalized": [] } ]

[ { "id": "NCT01175044_inc_text", "type": "inclusion", "text": [ "Scheduled to undergo revision total knee arthroplasty\n" ], "offsets": [ [ 0, 54 ] ] } ]

[ { "id": "NCT01175044_inc_T1", "type": "Procedure", "text": [ "revision total knee arthroplasty" ], "offsets": [ [ 21, 53 ] ], "normalized": [] } ]

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[ { "id": "NCT01177891_exc_text", "type": "exclusion", "text": [ "Blood donation of more than 450ml in the previous three months. \nSubject with an abnormal karyotype in favor of Turner syndrome or having a premutation of the FMR1 gene or a syndromic form \nSubject exclusion period in another study without direct individual benefit \nSubject refusing to sign the consent form \n \n" ], "offsets": [ [ 0, 321 ] ] } ]

[ { "id": "NCT01177891_exc_T1", "type": "Procedure", "text": [ "Blood donation" ], "offsets": [ [ 0, 14 ] ], "normalized": [] }, { "id": "NCT01177891_exc_T2", "type": "Qualifier", "text": [ "of more than 450ml" ], "offsets": [ [ 15, 33 ] ], "normalized": [] }, { "id": "NCT01177891_exc_T3", "type": "Value", "text": [ "more than 450ml" ], "offsets": [ [ 18, 33 ] ], "normalized": [] }, { "id": "NCT01177891_exc_T4", "type": "Temporal", "text": [ "in the previous three months" ], "offsets": [ [ 34, 62 ] ], "normalized": [] }, { "id": "NCT01177891_exc_T5", "type": "Condition", "text": [ "abnormal karyotype" ], "offsets": [ [ 81, 99 ] ], "normalized": [] }, { "id": "NCT01177891_exc_T6", "type": "Condition", "text": [ "Turner syndrome" ], "offsets": [ [ 112, 127 ] ], "normalized": [] }, { "id": "NCT01177891_exc_T7", "type": "Condition", "text": [ "premutation of the FMR1 gene" ], "offsets": [ [ 140, 168 ] ], "normalized": [] }, { "id": "NCT01177891_exc_T8", "type": "Condition", "text": [ "syndromic form" ], "offsets": [ [ 174, 188 ] ], "normalized": [] } ]

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[ { "id": "NCT01177891_exc_R1", "type": "Has_value", "arg1_id": "NCT01177891_exc_T2", "arg2_id": "NCT01177891_exc_T3", "normalized": [] }, { "id": "NCT01177891_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01177891_exc_T1", "arg2_id": "NCT01177891_exc_T2", "normalized": [] }, { "id": "NCT01177891_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01177891_exc_T1", "arg2_id": "NCT01177891_exc_T4", "normalized": [] }, { "id": "NCT01177891_exc_R4", "type": "Subsumes", "arg1_id": "NCT01177891_exc_T5", "arg2_id": "NCT01177891_exc_T6", "normalized": [] } ]

[ { "id": "NCT01177891_inc_text", "type": "inclusion", "text": [ "Patients of familial cases of POF : \nFemale subjects between 16 and 40 years or women older than 40 years with a cessation of ovarian function before the age of 40 years with increased levels of FSH \nPrimary or secondary amenorrhea for more than three months with LH and FSH> 30mUI/ml \nNo cases of fragile X syndrome in the family or blepharophimosis syndrome \nAt least two cases in the family \nOrigin Caucasian \nPatient signing the consent form for at least the blood sample \nPatient with Social Security \nPopulation Index related topics : \nThe presence of cycles until the age of 40 years with proven fertility, at least one child \nAmenorrhea and FSH> 30mUI/ml according to the criteria of the index subject \nMen of the family of index case \nPopulation control : \nWomen of Caucasian origin \nWomen who had regular cycles until at least age 40 and at least one child \nLack of land autoimmune (no history of thyroid disease or diabetes type 1) \nWoman signing the consent form for at least the blood sample \n" ], "offsets": [ [ 0, 1006 ] ] } ]

[ { "id": "NCT01177891_inc_T2", "type": "Person", "text": [ "Female" ], "offsets": [ [ 37, 43 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T3", "type": "Value", "text": [ "between 16 and 40 years" ], "offsets": [ [ 53, 76 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T4", "type": "Value", "text": [ "older than 40 years" ], "offsets": [ [ 86, 105 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T5", "type": "Person", "text": [ "years" ], "offsets": [ [ 71, 76 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T6", "type": "Person", "text": [ "women" ], "offsets": [ [ 80, 85 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T7", "type": "Reference_point", "text": [ "older" ], "offsets": [ [ 86, 91 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T8", "type": "Condition", "text": [ "cessation of ovarian function" ], "offsets": [ [ 113, 142 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T9", "type": "Value", "text": [ "before the age of 40 years" ], "offsets": [ [ 143, 169 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T10", "type": "Person", "text": [ "age" ], "offsets": [ [ 154, 157 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T11", "type": "Value", "text": [ "increased" ], "offsets": [ [ 175, 184 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T12", "type": "Measurement", "text": [ "levels of FSH" ], "offsets": [ [ 185, 198 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T13", "type": "Condition", "text": [ "amenorrhea" ], "offsets": [ [ 221, 231 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T14", "type": "Qualifier", "text": [ "secondary" ], "offsets": [ [ 211, 220 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T15", "type": "Qualifier", "text": [ "Primary" ], "offsets": [ [ 200, 207 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T16", "type": "Scope", "text": [ "Primary or secondary" ], "offsets": [ [ 200, 220 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T17", "type": "Temporal", "text": [ "for more than three months" ], "offsets": [ [ 232, 258 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T18", "type": "Measurement", "text": [ "LH" ], "offsets": [ [ 264, 266 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T19", "type": "Measurement", "text": [ "FSH" ], "offsets": [ [ 271, 274 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T20", "type": "Value", "text": [ "> 30mUI/ml" ], "offsets": [ [ 274, 284 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T21", "type": "Scope", "text": [ "LH and FSH" ], "offsets": [ [ 264, 274 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T22", "type": "Condition", "text": [ "fragile X syndrome" ], "offsets": [ [ 298, 316 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T23", "type": "Observation", "text": [ "in the family" ], "offsets": [ [ 317, 330 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T24", "type": "Condition", "text": [ "blepharophimosis syndrome" ], "offsets": [ [ 334, 359 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T25", "type": "Negation", "text": [ "No" ], "offsets": [ [ 286, 288 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T26", "type": "Scope", "text": [ "fragile X syndrome in the family or blepharophimosis syndrome" ], "offsets": [ [ 298, 359 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T27", "type": "Multiplier", "text": [ "At least two" ], "offsets": [ [ 361, 373 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T30", "type": "Condition", "text": [ "Caucasian" ], "offsets": [ [ 402, 411 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T34", "type": "Condition", "text": [ "presence of cycles" ], "offsets": [ [ 546, 564 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T35", "type": "Value", "text": [ "until the age of 40 years" ], "offsets": [ [ 565, 590 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T36", "type": "Person", "text": [ "age" ], "offsets": [ [ 575, 578 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T38", "type": "Condition", "text": [ "Amenorrhea" ], "offsets": [ [ 634, 644 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T39", "type": "Measurement", "text": [ "FSH" ], "offsets": [ [ 649, 652 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T40", "type": "Value", "text": [ "> 30mUI/ml" ], "offsets": [ [ 652, 662 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T42", "type": "Condition", "text": [ "Caucasian origin" ], "offsets": [ [ 775, 791 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T43", "type": "Person", "text": [ "Women" ], "offsets": [ [ 766, 771 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T44", "type": "Person", "text": [ "Women" ], "offsets": [ [ 793, 798 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T45", "type": "Condition", "text": [ "regular cycles" ], "offsets": [ [ 807, 821 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T48", "type": "Value", "text": [ "until at least age 40" ], "offsets": [ [ 822, 843 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T49", "type": "Person", "text": [ "age" ], "offsets": [ [ 837, 840 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T50", "type": "Condition", "text": [ "who had regular cycles until at least age 40" ], "offsets": [ [ 799, 843 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T51", "type": "Condition", "text": [ "autoimmune" ], "offsets": [ [ 881, 891 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T52", "type": "Condition", "text": [ "thyroid disease" ], "offsets": [ [ 907, 922 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T53", "type": "Condition", "text": [ "diabetes type 1" ], "offsets": [ [ 926, 941 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T54", "type": "Negation", "text": [ "no" ], "offsets": [ [ 893, 895 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T55", "type": "Observation", "text": [ "history" ], "offsets": [ [ 896, 903 ] ], "normalized": [] }, { "id": "NCT01177891_inc_T56", "type": "Scope", "text": [ "thyroid disease or diabetes type 1" ], "offsets": [ [ 907, 941 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01177891_inc_R1", "type": "Has_value", "arg1_id": "NCT01177891_inc_T5", "arg2_id": "NCT01177891_inc_T3", "normalized": [] }, { "id": "NCT01177891_inc_R2", "type": "Has_index", "arg1_id": "NCT01177891_inc_T4", "arg2_id": "NCT01177891_inc_T7", "normalized": [] }, { "id": "NCT01177891_inc_R3", "type": "AND", "arg1_id": "NCT01177891_inc_T2", "arg2_id": "NCT01177891_inc_T5", "normalized": [] }, { "id": "NCT01177891_inc_R4", "type": "Has_value", "arg1_id": "NCT01177891_inc_T6", "arg2_id": "NCT01177891_inc_T4", "normalized": [] }, { "id": "NCT01177891_inc_R5", "type": "Has_value", "arg1_id": "NCT01177891_inc_T10", "arg2_id": "NCT01177891_inc_T9", "normalized": [] }, { "id": "NCT01177891_inc_R6", "type": "Has_value", "arg1_id": "NCT01177891_inc_T12", "arg2_id": "NCT01177891_inc_T11", "normalized": [] }, { "id": "NCT01177891_inc_R7", "type": "Has_scope", "arg1_id": "NCT01177891_inc_T13", "arg2_id": "NCT01177891_inc_T16", "normalized": [] }, { "id": "NCT01177891_inc_R8", "type": "Has_value", "arg1_id": "NCT01177891_inc_T21", "arg2_id": "NCT01177891_inc_T20", "normalized": [] }, { "id": "NCT01177891_inc_R9", "type": "Has_temporal", "arg1_id": "NCT01177891_inc_T16", "arg2_id": "NCT01177891_inc_T17", "normalized": [] }, { "id": "NCT01177891_inc_R10", "type": "AND", "arg1_id": "NCT01177891_inc_T8", "arg2_id": "NCT01177891_inc_T10", "normalized": [] }, { "id": "NCT01177891_inc_R11", "type": "AND", "arg1_id": "NCT01177891_inc_T6", "arg2_id": "NCT01177891_inc_T8", "normalized": [] }, { "id": "NCT01177891_inc_R12", "type": "AND", "arg1_id": "NCT01177891_inc_T8", "arg2_id": "NCT01177891_inc_T12", "normalized": [] }, { "id": "NCT01177891_inc_R14", "type": "Has_negation", "arg1_id": "NCT01177891_inc_T26", "arg2_id": "NCT01177891_inc_T25", "normalized": [] }, { "id": "NCT01177891_inc_R15", "type": "Has_value", "arg1_id": "NCT01177891_inc_T36", "arg2_id": "NCT01177891_inc_T35", "normalized": [] }, { "id": "NCT01177891_inc_R16", "type": "AND", "arg1_id": "NCT01177891_inc_T34", "arg2_id": "NCT01177891_inc_T36", "normalized": [] }, { "id": "NCT01177891_inc_R17", "type": "Has_value", "arg1_id": "NCT01177891_inc_T39", "arg2_id": "NCT01177891_inc_T40", "normalized": [] }, { "id": "NCT01177891_inc_R18", "type": "AND", "arg1_id": "NCT01177891_inc_T50", "arg2_id": "NCT01177891_inc_T45", "normalized": [] }, { "id": "NCT01177891_inc_R19", "type": "AND", "arg1_id": "NCT01177891_inc_T45", "arg2_id": "NCT01177891_inc_T49", "normalized": [] }, { "id": "NCT01177891_inc_R20", "type": "Has_value", "arg1_id": "NCT01177891_inc_T49", "arg2_id": "NCT01177891_inc_T48", "normalized": [] }, { "id": "NCT01177891_inc_R21", "type": "Has_temporal", "arg1_id": "NCT01177891_inc_T56", "arg2_id": "NCT01177891_inc_T55", "normalized": [] }, { "id": "NCT01177891_inc_R22", "type": "Has_negation", "arg1_id": "NCT01177891_inc_T56", "arg2_id": "NCT01177891_inc_T54", "normalized": [] }, { "id": "NCT01177891_inc_R23", "type": "Subsumes", "arg1_id": "NCT01177891_inc_T51", "arg2_id": "NCT01177891_inc_T56", "normalized": [] } ]

[ { "id": "NCT01184638_exc_text", "type": "exclusion", "text": [ "With the history of cognitive disorders\nWith chronic neurological disorders\nCannot communicate with investigators\nCannot stand general anesthesia\n" ], "offsets": [ [ 0, 146 ] ] } ]

[ { "id": "NCT01184638_exc_T1", "type": "Condition", "text": [ "cognitive disorders" ], "offsets": [ [ 20, 39 ] ], "normalized": [] }, { "id": "NCT01184638_exc_T3", "type": "Condition", "text": [ "chronic neurological disorders" ], "offsets": [ [ 45, 75 ] ], "normalized": [] }, { "id": "NCT01184638_exc_T4", "type": "Observation", "text": [ "Cannot communicate" ], "offsets": [ [ 76, 94 ] ], "normalized": [] }, { "id": "NCT01184638_exc_T2", "type": "Observation", "text": [ "Cannot stand" ], "offsets": [ [ 114, 126 ] ], "normalized": [] }, { "id": "NCT01184638_exc_T5", "type": "Procedure", "text": [ "general anesthesia" ], "offsets": [ [ 127, 145 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01184638_exc_R1", "type": "AND", "arg1_id": "NCT01184638_exc_T2", "arg2_id": "NCT01184638_exc_T5", "normalized": [] } ]

[ { "id": "NCT01184638_inc_text", "type": "inclusion", "text": [ "Patients with informed consents\nWithout basal disorders of neurology and psychiatrics\n" ], "offsets": [ [ 0, 86 ] ] } ]

[ { "id": "NCT01184638_inc_T2", "type": "Condition", "text": [ "basal disorders of neurology" ], "offsets": [ [ 40, 68 ] ], "normalized": [] }, { "id": "NCT01184638_inc_T3", "type": "Condition", "text": [ "asal disorders of", "sychiatrics" ], "offsets": [ [ 41, 58 ], [ 74, 85 ] ], "normalized": [] }, { "id": "NCT01184638_inc_T4", "type": "Negation", "text": [ "Without" ], "offsets": [ [ 32, 39 ] ], "normalized": [] }, { "id": "NCT01184638_inc_T5", "type": "Scope", "text": [ "basal disorders of neurology and psychiatrics" ], "offsets": [ [ 40, 85 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01184638_inc_R1", "type": "Has_negation", "arg1_id": "NCT01184638_inc_T5", "arg2_id": "NCT01184638_inc_T4", "normalized": [] } ]

[ { "id": "NCT01205334_exc_text", "type": "exclusion", "text": [ "Severe intercurrent infection \nKnown HIV positivity \nPregnant or lactating \nHistory of hypersensitivity reactions to murine protein-containing products. \n \n" ], "offsets": [ [ 0, 165 ] ] } ]

[ { "id": "NCT01205334_exc_T1", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 20, 29 ] ], "normalized": [] }, { "id": "NCT01205334_exc_T2", "type": "Temporal", "text": [ "intercurrent" ], "offsets": [ [ 7, 19 ] ], "normalized": [] }, { "id": "NCT01205334_exc_T3", "type": "Qualifier", "text": [ "Severe" ], "offsets": [ [ 0, 6 ] ], "normalized": [] }, { "id": "NCT01205334_exc_T4", "type": "Condition", "text": [ "HIV positivity" ], "offsets": [ [ 37, 51 ] ], "normalized": [] }, { "id": "NCT01205334_exc_T5", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 53, 61 ] ], "normalized": [] }, { "id": "NCT01205334_exc_T6", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 65, 74 ] ], "normalized": [] }, { "id": "NCT01205334_exc_T7", "type": "Condition", "text": [ "hypersensitivity reactions" ], "offsets": [ [ 87, 113 ] ], "normalized": [] }, { "id": "NCT01205334_exc_T8", "type": "Drug", "text": [ "murine protein-containing products" ], "offsets": [ [ 117, 151 ] ], "normalized": [] }, { "id": "NCT01205334_exc_T9", "type": "Drug", "text": [ "murine" ], "offsets": [ [ 117, 123 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01205334_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01205334_exc_T1", "arg2_id": "NCT01205334_exc_T3", "normalized": [] }, { "id": "NCT01205334_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01205334_exc_T1", "arg2_id": "NCT01205334_exc_T2", "normalized": [] }, { "id": "NCT01205334_exc_R3", "type": "AND", "arg1_id": "NCT01205334_exc_T7", "arg2_id": "NCT01205334_exc_T8", "normalized": [] }, { "id": "NCT01205334_exc_R4", "type": "AND", "arg1_id": "NCT01205334_exc_T8", "arg2_id": "NCT01205334_exc_T9", "normalized": [] } ]

[ { "id": "NCT01205334_inc_text", "type": "inclusion", "text": [ "Histopathological verification of glioblastoma multiforme (GBM: WHO grade IV) in remission (Group A) or with active disease (Group B). \nCMV-positive GBM \nCMV seropositive \nLife expectancy 6 weeks or greater \nKarnofsky/Lansky score 50 or greater \nPatient or parent/guardian capable of providing informed consent \nBilirubin less than 1.5x upper limit of normal, AST less than 3x upper limit of normal, serum creatinine less than 1.5x normal and Hgb 8.0 g/dL or greater \nPulse oximetry of 90% or greater on room air \nSexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. The male partner should use a condom. \nPatients should have been off other investigational antineoplastic therapy for one month prior to entry in this study. \nInformed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. \n" ], "offsets": [ [ 0, 937 ] ] } ]

[ { "id": "NCT01205334_inc_T1", "type": "Condition", "text": [ "glioblastoma multiforme" ], "offsets": [ [ 34, 57 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T2", "type": "Procedure", "text": [ "Histopathological" ], "offsets": [ [ 0, 17 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T3", "type": "Observation", "text": [ "Histopathological verification" ], "offsets": [ [ 0, 30 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T4", "type": "Measurement", "text": [ "WHO" ], "offsets": [ [ 64, 67 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T5", "type": "Value", "text": [ "grade IV" ], "offsets": [ [ 68, 76 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T6", "type": "Qualifier", "text": [ "in remission" ], "offsets": [ [ 78, 90 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T7", "type": "Qualifier", "text": [ "Group A" ], "offsets": [ [ 92, 99 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T8", "type": "Qualifier", "text": [ "Group B" ], "offsets": [ [ 125, 132 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T9", "type": "Temporal", "text": [ "active" ], "offsets": [ [ 109, 115 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T10", "type": "Qualifier", "text": [ "with active disease" ], "offsets": [ [ 104, 123 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T11", "type": "Scope", "text": [ "in remission (Group A) or with active disease (Group B)" ], "offsets": [ [ 78, 133 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T12", "type": "Qualifier", "text": [ "CMV-positive" ], "offsets": [ [ 136, 148 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T13", "type": "Condition", "text": [ "GBM" ], "offsets": [ [ 149, 152 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T14", "type": "Condition", "text": [ "GBM" ], "offsets": [ [ 59, 62 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T15", "type": "Condition", "text": [ "CMV" ], "offsets": [ [ 136, 139 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T16", "type": "Condition", "text": [ "CMV seropositive" ], "offsets": [ [ 154, 170 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T17", "type": "Observation", "text": [ "Life expectancy" ], "offsets": [ [ 172, 187 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T18", "type": "Value", "text": [ "6 weeks or greater" ], "offsets": [ [ 188, 206 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T19", "type": "Measurement", "text": [ "Karnofsky/Lansky" ], "offsets": [ [ 208, 224 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T20", "type": "Value", "text": [ "score 50 or greater" ], "offsets": [ [ 225, 244 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T22", "type": "Measurement", "text": [ "Bilirubin" ], "offsets": [ [ 312, 321 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T23", "type": "Value", "text": [ "less than 1.5x upper limit of normal" ], "offsets": [ [ 322, 358 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T24", "type": "Measurement", "text": [ "AST" ], "offsets": [ [ 360, 363 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T25", "type": "Value", "text": [ "less than 3x upper limit of normal" ], "offsets": [ [ 364, 398 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T26", "type": "Measurement", "text": [ "Pulse oximetry" ], "offsets": [ [ 468, 482 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T27", "type": "Value", "text": [ "90% or greater" ], "offsets": [ [ 486, 500 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T28", "type": "Qualifier", "text": [ "on room air" ], "offsets": [ [ 501, 512 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T31", "type": "Procedure", "text": [ "antineoplastic therapy" ], "offsets": [ [ 742, 764 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T32", "type": "Negation", "text": [ "been off" ], "offsets": [ [ 711, 719 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T33", "type": "Temporal", "text": [ "for one month prior to entry in this study" ], "offsets": [ [ 765, 807 ] ], "normalized": [] }, { "id": "NCT01205334_inc_T34", "type": "Reference_point", "text": [ "entry in this study" ], "offsets": [ [ 788, 807 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01205334_inc_R1", "type": "AND", "arg1_id": "NCT01205334_inc_T3", "arg2_id": "NCT01205334_inc_T2", "normalized": [] }, { "id": "NCT01205334_inc_R2", "type": "AND", "arg1_id": "NCT01205334_inc_T3", "arg2_id": "NCT01205334_inc_T1", "normalized": [] }, { "id": "NCT01205334_inc_R3", "type": "Has_value", "arg1_id": "NCT01205334_inc_T4", "arg2_id": "NCT01205334_inc_T5", "normalized": [] }, { "id": "NCT01205334_inc_R4", "type": "AND", "arg1_id": "NCT01205334_inc_T1", "arg2_id": "NCT01205334_inc_T4", "normalized": [] }, { "id": "NCT01205334_inc_R5", "type": "Has_qualifier", "arg1_id": "NCT01205334_inc_T7", "arg2_id": "NCT01205334_inc_T6", "normalized": [] }, { "id": "NCT01205334_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT01205334_inc_T8", "arg2_id": "NCT01205334_inc_T10", "normalized": [] }, { "id": "NCT01205334_inc_R7", "type": "Has_scope", "arg1_id": "NCT01205334_inc_T1", "arg2_id": "NCT01205334_inc_T11", "normalized": [] }, { "id": "NCT01205334_inc_R8", "type": "Subsumes", "arg1_id": "NCT01205334_inc_T1", "arg2_id": "NCT01205334_inc_T14", "normalized": [] }, { "id": "NCT01205334_inc_R9", "type": "Has_qualifier", "arg1_id": "NCT01205334_inc_T13", "arg2_id": "NCT01205334_inc_T12", "normalized": [] }, { "id": "NCT01205334_inc_R10", "type": "AND", "arg1_id": "NCT01205334_inc_T12", "arg2_id": "NCT01205334_inc_T15", "normalized": [] }, { "id": "NCT01205334_inc_R11", "type": "Has_value", "arg1_id": "NCT01205334_inc_T17", "arg2_id": "NCT01205334_inc_T18", "normalized": [] }, { "id": "NCT01205334_inc_R12", "type": "Has_value", "arg1_id": "NCT01205334_inc_T19", "arg2_id": "NCT01205334_inc_T20", "normalized": [] }, { "id": "NCT01205334_inc_R13", "type": "Has_value", "arg1_id": "NCT01205334_inc_T22", "arg2_id": "NCT01205334_inc_T23", "normalized": [] }, { "id": "NCT01205334_inc_R14", "type": "Has_value", "arg1_id": "NCT01205334_inc_T24", "arg2_id": "NCT01205334_inc_T25", "normalized": [] }, { "id": "NCT01205334_inc_R15", "type": "Has_value", "arg1_id": "NCT01205334_inc_T26", "arg2_id": "NCT01205334_inc_T27", "normalized": [] }, { "id": "NCT01205334_inc_R16", "type": "Has_qualifier", "arg1_id": "NCT01205334_inc_T26", "arg2_id": "NCT01205334_inc_T28", "normalized": [] }, { "id": "NCT01205334_inc_R17", "type": "Has_negation", "arg1_id": "NCT01205334_inc_T31", "arg2_id": "NCT01205334_inc_T32", "normalized": [] }, { "id": "NCT01205334_inc_R18", "type": "Has_index", "arg1_id": "NCT01205334_inc_T33", "arg2_id": "NCT01205334_inc_T34", "normalized": [] }, { "id": "NCT01205334_inc_R19", "type": "Has_temporal", "arg1_id": "NCT01205334_inc_T31", "arg2_id": "NCT01205334_inc_T33", "normalized": [] } ]

[ { "id": "NCT01214096_exc_text", "type": "exclusion", "text": [ "1. Atrial fibrillation; \n2. Subject underwent cardiac pacemaker treatment; \n3. Subject underwent metal graft treatment; \n4. Claustrophobia; \n5. Acute myocardial infarction, cardiac ischemia indicated by 6-minute walk test, hypertrophic cardiomyopathy, constrictive pericarditis, significant valve disease or congenital heart disease, severe pulmonary hypertension; \n6. Ischemic heart failure without the revascularization or undergone the revascularization within last 6 months; \n7. Subject underwent cardiac surgery or cerebrovascular events within the previous six months; \n8. Subjects who plan to have cardiac transplantation; \n9. Severe hepatic and renal insufficiency (serum creatinine>2.0 mg /dl, AST or ALT is five times higher than the upper limit of normal range); \n10. Subject needs mechanical ventilation; \n11. Systolic blood pressure < 90mmHg, or > 160mmHg; \n12. Chronic heart failure complicated with acute hemodynamic disturbance or acute decompensation within last 1 month; \n13. Mobitz Type II or III° atrial ventricular block，severe ventricular arrhythmia (polymorphic and frequent premature ventricular beats, frequent non-sustained ventricular tachycardia); \n14. Serum potassium<3.2mmol/L, or>5.5mmol/L; \n15. Female subject is pregnant or plan to become pregnant \n16. Childbearing-aged female subject who is unmarried or dose not bear child; \n17. Subject with life expectancy less than 6 months as assessed by investigators; \n18. Subject participated in any other clinical trial within the previous three months; \n19. Subject with previous history of tumor, or current tumor patient, or subject with pre-cancerous disease manifested by pathological examination (such as ductal carcinoma in situ or cervical epithelial dysplasia) \n20. Examinations (physical examination, X-ray examination, type-B ultrasonic detection or other methods) reveal that the subject has malignant mass, gland hyperplasia or adenoma with endocrine activity, or impact on heart, or endocrine function (such as pheochromocytoma, thyroid enlargement); \n21. The Investigator deemed for whatever reason that the subject is not likely to complete the study or comply with the study procedures (due to administration or any other reason). \n \n" ], "offsets": [ [ 0, 2237 ] ] } ]

[ { "id": "NCT01214096_exc_T1", "type": "Condition", "text": [ "Atrial fibrillation" ], "offsets": [ [ 3, 22 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T2", "type": "Procedure", "text": [ "cardiac pacemaker treatment" ], "offsets": [ [ 46, 73 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T3", "type": "Device", "text": [ "cardiac pacemaker" ], "offsets": [ [ 46, 63 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T4", "type": "Procedure", "text": [ "metal graft treatment" ], "offsets": [ [ 97, 118 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T5", "type": "Device", "text": [ "metal graft" ], "offsets": [ [ 97, 108 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T6", "type": "Condition", "text": [ "Claustrophobia" ], "offsets": [ [ 124, 138 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T7", "type": "Condition", "text": [ "Acute myocardial infarction" ], "offsets": [ [ 144, 171 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T8", "type": "Condition", "text": [ "cardiac ischemia" ], "offsets": [ [ 173, 189 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T9", "type": "Procedure", "text": [ "6-minute walk test" ], "offsets": [ [ 203, 221 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T10", "type": "Condition", "text": [ "hypertrophic cardiomyopathy" ], "offsets": [ [ 223, 250 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T11", "type": "Condition", "text": [ "constrictive pericarditis" ], "offsets": [ [ 252, 277 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T12", "type": "Condition", "text": [ "valve disease" ], "offsets": [ [ 291, 304 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T13", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 279, 290 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T14", "type": "Condition", "text": [ "congenital heart disease" ], "offsets": [ [ 308, 332 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T15", "type": "Condition", "text": [ "severe pulmonary hypertension" ], "offsets": [ [ 334, 363 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T16", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 334, 340 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T17", "type": "Qualifier", "text": [ "congenital" ], "offsets": [ [ 308, 318 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T18", "type": "Scope", "text": [ "6-minute walk test, hypertrophic cardiomyopathy, constrictive pericarditis, significant valve disease or congenital heart disease, severe pulmonary hypertension" ], "offsets": [ [ 203, 363 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T19", "type": "Scope", "text": [ "Acute myocardial infarction, cardiac ischemia" ], "offsets": [ [ 144, 189 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T20", "type": "Condition", "text": [ "Ischemic heart failure" ], "offsets": [ [ 369, 391 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T21", "type": "Procedure", "text": [ "revascularization" ], "offsets": [ [ 404, 421 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T22", "type": "Negation", "text": [ "without" ], "offsets": [ [ 392, 399 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T23", "type": "Procedure", "text": [ "revascularization" ], "offsets": [ [ 439, 456 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T24", "type": "Temporal", "text": [ "within last 6 months" ], "offsets": [ [ 457, 477 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T25", "type": "Scope", "text": [ "without the revascularization or undergone the revascularization within last 6 months" ], "offsets": [ [ 392, 477 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T26", "type": "Procedure", "text": [ "cardiac surgery" ], "offsets": [ [ 501, 516 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T27", "type": "Condition", "text": [ "cerebrovascular events" ], "offsets": [ [ 520, 542 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T28", "type": "Temporal", "text": [ "within the previous six months" ], "offsets": [ [ 543, 573 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T29", "type": "Scope", "text": [ "cardiac surgery or cerebrovascular events" ], "offsets": [ [ 501, 542 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T30", "type": "Procedure", "text": [ "cardiac transplantation" ], "offsets": [ [ 605, 628 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T31", "type": "Observation", "text": [ "plan" ], "offsets": [ [ 592, 596 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T32", "type": "Condition", "text": [ "renal insufficiency" ], "offsets": [ [ 653, 672 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T33", "type": "Condition", "text": [ "hepatic", "insufficiency" ], "offsets": [ [ 641, 648 ], [ 659, 672 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T34", "type": "Measurement", "text": [ "serum creatinine" ], "offsets": [ [ 674, 690 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T35", "type": "Value", "text": [ ">2.0 mg /dl" ], "offsets": [ [ 690, 701 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T36", "type": "Measurement", "text": [ "AST" ], "offsets": [ [ 703, 706 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T37", "type": "Measurement", "text": [ "ALT" ], "offsets": [ [ 710, 713 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T38", "type": "Value", "text": [ "five times higher than the upper limit of normal range" ], "offsets": [ [ 717, 771 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T39", "type": "Scope", "text": [ "AST or ALT" ], "offsets": [ [ 703, 713 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T40", "type": "Scope", "text": [ "hepatic and renal insufficiency" ], "offsets": [ [ 641, 672 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T41", "type": "Procedure", "text": [ "mechanical ventilation" ], "offsets": [ [ 793, 815 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T42", "type": "Measurement", "text": [ "blood pressure" ], "offsets": [ [ 831, 845 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T43", "type": "Value", "text": [ "< 90mmHg" ], "offsets": [ [ 846, 854 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T44", "type": "Value", "text": [ "> 160mmHg" ], "offsets": [ [ 859, 868 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T45", "type": "Scope", "text": [ "< 90mmHg, or > 160mmHg" ], "offsets": [ [ 846, 868 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T46", "type": "Condition", "text": [ "Chronic heart failure" ], "offsets": [ [ 875, 896 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T47", "type": "Condition", "text": [ "acute hemodynamic disturbance" ], "offsets": [ [ 914, 943 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T48", "type": "Condition", "text": [ "acute decompensation" ], "offsets": [ [ 947, 967 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T49", "type": "Temporal", "text": [ "within last 1 month" ], "offsets": [ [ 968, 987 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T50", "type": "Scope", "text": [ "acute hemodynamic disturbance or acute decompensation" ], "offsets": [ [ 914, 967 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T51", "type": "Measurement", "text": [ "Mobitz" ], "offsets": [ [ 994, 1000 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T52", "type": "Value", "text": [ "Type II or III" ], "offsets": [ [ 1001, 1015 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T53", "type": "Condition", "text": [ "atrial ventricular block" ], "offsets": [ [ 1017, 1041 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T54", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 1042, 1048 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T55", "type": "Condition", "text": [ "ventricular arrhythmia" ], "offsets": [ [ 1049, 1071 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T56", "type": "Observation", "text": [ "premature ventricular beats" ], "offsets": [ [ 1098, 1125 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T57", "type": "Condition", "text": [ "ventricular tachycardia" ], "offsets": [ [ 1150, 1173 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T58", "type": "Qualifier", "text": [ "non-sustained" ], "offsets": [ [ 1136, 1149 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T59", "type": "Multiplier", "text": [ "frequent" ], "offsets": [ [ 1127, 1135 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T60", "type": "Measurement", "text": [ "Serum potassium" ], "offsets": [ [ 1181, 1196 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T61", "type": "Value", "text": [ "<3.2mmol/L" ], "offsets": [ [ 1196, 1206 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T62", "type": "Value", "text": [ ">5.5mmol/L" ], "offsets": [ [ 1210, 1220 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T63", "type": "Scope", "text": [ "<3.2mmol/L, or>5.5mmol/L" ], "offsets": [ [ 1196, 1220 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T64", "type": "Multiplier", "text": [ "frequent" ], "offsets": [ [ 1089, 1097 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T65", "type": "Qualifier", "text": [ "polymorphic" ], "offsets": [ [ 1073, 1084 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T66", "type": "Scope", "text": [ "polymorphic and frequent premature ventricular beats, frequent non-sustained ventricular tachycardia" ], "offsets": [ [ 1073, 1173 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T67", "type": "Person", "text": [ "Female" ], "offsets": [ [ 1227, 1233 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T68", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 1245, 1253 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T69", "type": "Observation", "text": [ "plan" ], "offsets": [ [ 1257, 1261 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T70", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 1272, 1280 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T71", "type": "Person", "text": [ "female" ], "offsets": [ [ 1304, 1310 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T72", "type": "Observation", "text": [ "unmarried" ], "offsets": [ [ 1326, 1335 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T73", "type": "Observation", "text": [ "bear child" ], "offsets": [ [ 1348, 1358 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T74", "type": "Negation", "text": [ "not" ], "offsets": [ [ 1344, 1347 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T75", "type": "Value", "text": [ "less than 6 months" ], "offsets": [ [ 1394, 1412 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T76", "type": "Observation", "text": [ "life expectancy" ], "offsets": [ [ 1378, 1393 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T78", "type": "Condition", "text": [ "tumor" ], "offsets": [ [ 1569, 1574 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T79", "type": "Observation", "text": [ "previous history" ], "offsets": [ [ 1549, 1565 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T80", "type": "Condition", "text": [ "tumor" ], "offsets": [ [ 1587, 1592 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T81", "type": "Temporal", "text": [ "current" ], "offsets": [ [ 1579, 1586 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T82", "type": "Condition", "text": [ "pre-cancerous disease" ], "offsets": [ [ 1618, 1639 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T83", "type": "Procedure", "text": [ "pathological examination" ], "offsets": [ [ 1654, 1678 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T84", "type": "Condition", "text": [ "ductal carcinoma in situ" ], "offsets": [ [ 1688, 1712 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T85", "type": "Condition", "text": [ "cervical epithelial dysplasia" ], "offsets": [ [ 1716, 1745 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T86", "type": "Scope", "text": [ "ductal carcinoma in situ or cervical epithelial dysplasia" ], "offsets": [ [ 1688, 1745 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T87", "type": "Procedure", "text": [ "physical examination" ], "offsets": [ [ 1766, 1786 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T88", "type": "Procedure", "text": [ "X-ray examination" ], "offsets": [ [ 1788, 1805 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T89", "type": "Procedure", "text": [ "type-B ultrasonic detection" ], "offsets": [ [ 1807, 1834 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T90", "type": "Procedure", "text": [ "other methods" ], "offsets": [ [ 1838, 1851 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T91", "type": "Scope", "text": [ "physical examination, X-ray examination, type-B ultrasonic detection or other methods" ], "offsets": [ [ 1766, 1851 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T92", "type": "Procedure", "text": [ "Examinations" ], "offsets": [ [ 1752, 1764 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T94", "type": "Condition", "text": [ "malignant mass" ], "offsets": [ [ 1881, 1895 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T95", "type": "Condition", "text": [ "gland hyperplasia" ], "offsets": [ [ 1897, 1914 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T96", "type": "Condition", "text": [ "adenoma" ], "offsets": [ [ 1918, 1925 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T97", "type": "Condition", "text": [ "endocrine activity" ], "offsets": [ [ 1931, 1949 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T98", "type": "Qualifier", "text": [ "with endocrine activity" ], "offsets": [ [ 1926, 1949 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T99", "type": "Condition", "text": [ "pheochromocytoma" ], "offsets": [ [ 2002, 2018 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T100", "type": "Condition", "text": [ "thyroid enlargement" ], "offsets": [ [ 2020, 2039 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T101", "type": "Condition", "text": [ "impact on", "endocrine function" ], "offsets": [ [ 1954, 1963 ], [ 1974, 1992 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T102", "type": "Condition", "text": [ "impact on heart" ], "offsets": [ [ 1954, 1969 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T103", "type": "Scope", "text": [ "impact on heart, or endocrine function" ], "offsets": [ [ 1954, 1992 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T104", "type": "Scope", "text": [ "pheochromocytoma, thyroid enlargement" ], "offsets": [ [ 2002, 2039 ] ], "normalized": [] }, { "id": "NCT01214096_exc_T105", "type": "Scope", "text": [ "malignant mass, gland hyperplasia or adenoma with endocrine activity, or impact on heart, or endocrine function (such as pheochromocytoma, thyroid enlargement)" ], "offsets": [ [ 1881, 2040 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01214096_exc_R1", "type": "AND", "arg1_id": "NCT01214096_exc_T2", "arg2_id": "NCT01214096_exc_T3", "normalized": [] }, { "id": "NCT01214096_exc_R2", "type": "AND", "arg1_id": "NCT01214096_exc_T4", "arg2_id": "NCT01214096_exc_T5", "normalized": [] }, { "id": "NCT01214096_exc_R3", "type": "Has_qualifier", "arg1_id": "NCT01214096_exc_T12", "arg2_id": "NCT01214096_exc_T13", "normalized": [] }, { "id": "NCT01214096_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01214096_exc_T15", "arg2_id": "NCT01214096_exc_T16", "normalized": [] }, { "id": "NCT01214096_exc_R5", "type": "Has_qualifier", "arg1_id": "NCT01214096_exc_T14", "arg2_id": "NCT01214096_exc_T17", "normalized": [] }, { "id": "NCT01214096_exc_R6", "type": "Subsumes", "arg1_id": "NCT01214096_exc_T19", "arg2_id": "NCT01214096_exc_T18", "normalized": [] }, { "id": "NCT01214096_exc_R7", "type": "Has_negation", "arg1_id": "NCT01214096_exc_T21", "arg2_id": "NCT01214096_exc_T22", "normalized": [] }, { "id": "NCT01214096_exc_R8", "type": "Has_temporal", "arg1_id": "NCT01214096_exc_T23", "arg2_id": "NCT01214096_exc_T24", "normalized": [] }, { "id": "NCT01214096_exc_R9", "type": "Subsumes", "arg1_id": "NCT01214096_exc_T20", "arg2_id": "NCT01214096_exc_T25", "normalized": [] }, { "id": "NCT01214096_exc_R10", "type": "Has_temporal", "arg1_id": "NCT01214096_exc_T29", "arg2_id": "NCT01214096_exc_T28", "normalized": [] }, { "id": "NCT01214096_exc_R11", "type": "Has_mood", "arg1_id": "NCT01214096_exc_T30", "arg2_id": "NCT01214096_exc_T31", "normalized": [] }, { "id": "NCT01214096_exc_R12", "type": "Has_value", "arg1_id": "NCT01214096_exc_T34", "arg2_id": "NCT01214096_exc_T35", "normalized": [] }, { "id": "NCT01214096_exc_R13", "type": "Has_value", "arg1_id": "NCT01214096_exc_T39", "arg2_id": "NCT01214096_exc_T38", "normalized": [] }, { "id": "NCT01214096_exc_R14", "type": "Has_scope", "arg1_id": "NCT01214096_exc_T46", "arg2_id": "NCT01214096_exc_T50", "normalized": [] }, { "id": "NCT01214096_exc_R15", "type": "Has_temporal", "arg1_id": "NCT01214096_exc_T46", "arg2_id": "NCT01214096_exc_T49", "normalized": [] }, { "id": "NCT01214096_exc_R16", "type": "Has_value", "arg1_id": "NCT01214096_exc_T51", "arg2_id": "NCT01214096_exc_T52", "normalized": [] }, { "id": "NCT01214096_exc_R17", "type": "AND", "arg1_id": "NCT01214096_exc_T53", "arg2_id": "NCT01214096_exc_T51", "normalized": [] }, { "id": "NCT01214096_exc_R18", "type": "Has_qualifier", "arg1_id": "NCT01214096_exc_T55", "arg2_id": "NCT01214096_exc_T54", "normalized": [] }, { "id": "NCT01214096_exc_R19", "type": "Has_scope", "arg1_id": "NCT01214096_exc_T60", "arg2_id": "NCT01214096_exc_T63", "normalized": [] }, { "id": "NCT01214096_exc_R21", "type": "Has_qualifier", "arg1_id": "NCT01214096_exc_T57", "arg2_id": "NCT01214096_exc_T58", "normalized": [] }, { "id": "NCT01214096_exc_R20", "type": "Has_multiplier", "arg1_id": "NCT01214096_exc_T57", "arg2_id": "NCT01214096_exc_T59", "normalized": [] }, { "id": "NCT01214096_exc_R22", "type": "Has_multiplier", "arg1_id": "NCT01214096_exc_T56", "arg2_id": "NCT01214096_exc_T64", "normalized": [] }, { "id": "NCT01214096_exc_R23", "type": "Has_qualifier", "arg1_id": "NCT01214096_exc_T56", "arg2_id": "NCT01214096_exc_T65", "normalized": [] }, { "id": "NCT01214096_exc_R24", "type": "Subsumes", "arg1_id": "NCT01214096_exc_T55", "arg2_id": "NCT01214096_exc_T66", "normalized": [] }, { "id": "NCT01214096_exc_R25", "type": "Has_mood", "arg1_id": "NCT01214096_exc_T70", "arg2_id": "NCT01214096_exc_T69", "normalized": [] }, { "id": "NCT01214096_exc_R26", "type": "Has_negation", "arg1_id": "NCT01214096_exc_T73", "arg2_id": "NCT01214096_exc_T74", "normalized": [] }, { "id": "NCT01214096_exc_R27", "type": "Has_value", "arg1_id": "NCT01214096_exc_T76", "arg2_id": "NCT01214096_exc_T75", "normalized": [] }, { "id": "NCT01214096_exc_R28", "type": "Has_temporal", "arg1_id": "NCT01214096_exc_T78", "arg2_id": "NCT01214096_exc_T79", "normalized": [] }, { "id": "NCT01214096_exc_R29", "type": "Has_temporal", "arg1_id": "NCT01214096_exc_T80", "arg2_id": "NCT01214096_exc_T81", "normalized": [] }, { "id": "NCT01214096_exc_R30", "type": "AND", "arg1_id": "NCT01214096_exc_T82", "arg2_id": "NCT01214096_exc_T83", "normalized": [] }, { "id": "NCT01214096_exc_R31", "type": "Subsumes", "arg1_id": "NCT01214096_exc_T82", "arg2_id": "NCT01214096_exc_T86", "normalized": [] }, { "id": "NCT01214096_exc_R32", "type": "Subsumes", "arg1_id": "NCT01214096_exc_T92", "arg2_id": "NCT01214096_exc_T91", "normalized": [] }, { "id": "NCT01214096_exc_R33", "type": "AND", "arg1_id": "NCT01214096_exc_T98", "arg2_id": "NCT01214096_exc_T97", "normalized": [] }, { "id": "NCT01214096_exc_R34", "type": "Has_qualifier", "arg1_id": "NCT01214096_exc_T96", "arg2_id": "NCT01214096_exc_T98", "normalized": [] }, { "id": "NCT01214096_exc_R35", "type": "Subsumes", "arg1_id": "NCT01214096_exc_T103", "arg2_id": "NCT01214096_exc_T104", "normalized": [] }, { "id": "NCT01214096_exc_R36", "type": "Has_scope", "arg1_id": "NCT01214096_exc_T92", "arg2_id": "NCT01214096_exc_T105", "normalized": [] } ]

[ { "id": "NCT01214096_inc_text", "type": "inclusion", "text": [ "1. Age: 18-75 years old, no limitation in gender; \n2. Left ventricular ejection fraction (LVEF) ≤ 40% (ECHO); \n3. Patients with chronic heart failure (NYHA class II or III); \n4. In the past one month, the clinical condition (including history, clinical symptoms and signs) was relatively stable; \n5. Patients on standard treatment of chronic heart failure at the target dose or maximum tolerance dose for over 1 month ,or unchanged dose in last 1 month; \n6. Understand and sign the informed consent form; \n" ], "offsets": [ [ 0, 506 ] ] } ]

[ { "id": "NCT01214096_inc_T1", "type": "Value", "text": [ "18-75 years" ], "offsets": [ [ 8, 19 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T2", "type": "Person", "text": [ "Age" ], "offsets": [ [ 3, 6 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T3", "type": "Measurement", "text": [ "Left ventricular ejection fraction (LVEF)" ], "offsets": [ [ 54, 95 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T4", "type": "Value", "text": [ "≤ 40%" ], "offsets": [ [ 96, 101 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T5", "type": "Procedure", "text": [ "ECHO" ], "offsets": [ [ 103, 107 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T6", "type": "Condition", "text": [ "chronic heart failure" ], "offsets": [ [ 128, 149 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T7", "type": "Measurement", "text": [ "NYHA" ], "offsets": [ [ 151, 155 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T8", "type": "Value", "text": [ "class II or III" ], "offsets": [ [ 156, 171 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T9", "type": "Temporal", "text": [ "In the past one month" ], "offsets": [ [ 178, 199 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T10", "type": "Observation", "text": [ "history" ], "offsets": [ [ 235, 242 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T11", "type": "Condition", "text": [ "clinical symptoms" ], "offsets": [ [ 244, 261 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T12", "type": "Condition", "text": [ "clinical", "signs" ], "offsets": [ [ 244, 252 ], [ 266, 271 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T13", "type": "Qualifier", "text": [ "relatively stable" ], "offsets": [ [ 277, 294 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T14", "type": "Scope", "text": [ "history, clinical symptoms and signs" ], "offsets": [ [ 235, 271 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T15", "type": "Condition", "text": [ "chronic heart failure" ], "offsets": [ [ 334, 355 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T16", "type": "Procedure", "text": [ "treatment of chronic heart failure" ], "offsets": [ [ 321, 355 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T17", "type": "Observation", "text": [ "maximum tolerance dose" ], "offsets": [ [ 378, 400 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T18", "type": "Observation", "text": [ "target dose" ], "offsets": [ [ 363, 374 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T19", "type": "Temporal", "text": [ "for over 1 month" ], "offsets": [ [ 401, 417 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T20", "type": "Temporal", "text": [ "in last 1 month" ], "offsets": [ [ 437, 452 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T21", "type": "Observation", "text": [ "unchanged dose" ], "offsets": [ [ 422, 436 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T22", "type": "Scope", "text": [ "target dose or maximum tolerance dose" ], "offsets": [ [ 363, 400 ] ], "normalized": [] }, { "id": "NCT01214096_inc_T23", "type": "Scope", "text": [ "target dose or maximum tolerance dose for over 1 month ,or unchanged dose in last 1 month" ], "offsets": [ [ 363, 452 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01214096_inc_R1", "type": "Has_value", "arg1_id": "NCT01214096_inc_T2", "arg2_id": "NCT01214096_inc_T1", "normalized": [] }, { "id": "NCT01214096_inc_R2", "type": "Has_value", "arg1_id": "NCT01214096_inc_T3", "arg2_id": "NCT01214096_inc_T4", "normalized": [] }, { "id": "NCT01214096_inc_R3", "type": "AND", "arg1_id": "NCT01214096_inc_T3", "arg2_id": "NCT01214096_inc_T5", "normalized": [] }, { "id": "NCT01214096_inc_R4", "type": "Has_value", "arg1_id": "NCT01214096_inc_T7", "arg2_id": "NCT01214096_inc_T8", "normalized": [] }, { "id": "NCT01214096_inc_R5", "type": "AND", "arg1_id": "NCT01214096_inc_T6", "arg2_id": "NCT01214096_inc_T7", "normalized": [] }, { "id": "NCT01214096_inc_R6", "type": "Has_qualifier", "arg1_id": "NCT01214096_inc_T14", "arg2_id": "NCT01214096_inc_T13", "normalized": [] }, { "id": "NCT01214096_inc_R7", "type": "Has_temporal", "arg1_id": "NCT01214096_inc_T14", "arg2_id": "NCT01214096_inc_T9", "normalized": [] }, { "id": "NCT01214096_inc_R8", "type": "AND", "arg1_id": "NCT01214096_inc_T16", "arg2_id": "NCT01214096_inc_T15", "normalized": [] }, { "id": "NCT01214096_inc_R9", "type": "Has_temporal", "arg1_id": "NCT01214096_inc_T22", "arg2_id": "NCT01214096_inc_T19", "normalized": [] }, { "id": "NCT01214096_inc_R10", "type": "Has_scope", "arg1_id": "NCT01214096_inc_T16", "arg2_id": "NCT01214096_inc_T23", "normalized": [] } ]

[ { "id": "NCT01217671_exc_text", "type": "exclusion", "text": [ "FEV1 >= 80% or FEV1 < 20% of predicted value post-bronchodilator. \nFEV1/SVC>=70% \nHistory of lung transplant. \nAny lung surgery within the past two years. \nOn any thoracic surgery waiting list. \nEnd of last exacerbation less than 6 weeks prior to screening/re-screening visit. \nClinically significant intercurrent illnesses (except for respiratory or liver disease secondary to AAT deficiency), including: cardiac, hepatic, renal, endocrine, neurological, hematological, neoplastic, immunological, skeletal or other) that in the opinion of the investigator, could interfere with the safety, compliance or other aspects of this study. Patients with well-controlled, chronic diseases could possibly be included after consultation with the treating physician and the sponsor. \nActive smoking during the last 12 months from screening date. \nPregnancy or lactation. \nWoman of child-bearing potential not taking adequate contraception deemed reliable by the investigator. \nPresence of psychiatric/ mental disorder or any other medical disorder which might impair the patient's ability to give informed consent or to comply with the requirements of the study protocol. \nEvidence of ongoing viral infection with HCV, HBV and/or HIV. \nEvidence of alcohol abuse or history of alcohol abuse or illegal and/or legally prescribed drugs. \nIgA Deficiency \nHistory of life threatening allergy, anaphylactic reaction, or systemic response to human plasma derived products. \nParticipation in another clinical trial within 30 days prior to baseline visit. \nInability to attend scheduled clinic visits and/or comply with the study protocol. \nAny other factor that, in the opinion of the investigator, would prevent the patient from complying with the requirements of the protocol. \n \n" ], "offsets": [ [ 0, 1773 ] ] } ]

[ { "id": "NCT01217671_exc_T1", "type": "Measurement", "text": [ "FEV1" ], "offsets": [ [ 0, 4 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T2", "type": "Value", "text": [ ">= 80%" ], "offsets": [ [ 5, 11 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T3", "type": "Measurement", "text": [ "FEV1" ], "offsets": [ [ 15, 19 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T4", "type": "Value", "text": [ "< 20% of predicted value" ], "offsets": [ [ 20, 44 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T5", "type": "Qualifier", "text": [ "post-bronchodilator" ], "offsets": [ [ 45, 64 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T6", "type": "Temporal", "text": [ "post-bronchodilator" ], "offsets": [ [ 45, 64 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T7", "type": "Drug", "text": [ "bronchodilator" ], "offsets": [ [ 50, 64 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T8", "type": "Reference_point", "text": [ "bronchodilator" ], "offsets": [ [ 50, 64 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T9", "type": "Measurement", "text": [ "FEV1/SVC" ], "offsets": [ [ 67, 75 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T10", "type": "Value", "text": [ ">=70%" ], "offsets": [ [ 75, 80 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T11", "type": "Procedure", "text": [ "lung transplant" ], "offsets": [ [ 93, 108 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T12", "type": "Observation", "text": [ "History" ], "offsets": [ [ 82, 89 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T13", "type": "Procedure", "text": [ "lung surgery" ], "offsets": [ [ 115, 127 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T14", "type": "Temporal", "text": [ "within the past two years" ], "offsets": [ [ 128, 153 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T15", "type": "Procedure", "text": [ "thoracic surgery" ], "offsets": [ [ 163, 179 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T16", "type": "Observation", "text": [ "thoracic surgery waiting list" ], "offsets": [ [ 163, 192 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T17", "type": "Condition", "text": [ "exacerbation" ], "offsets": [ [ 207, 219 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T18", "type": "Temporal", "text": [ "less than 6 weeks prior to screening/re-screening visit" ], "offsets": [ [ 220, 275 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T19", "type": "Reference_point", "text": [ "screening/re-screening visit" ], "offsets": [ [ 247, 275 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T20", "type": "Condition", "text": [ "intercurrent illnesses" ], "offsets": [ [ 301, 323 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T21", "type": "Qualifier", "text": [ "Clinically significant" ], "offsets": [ [ 278, 300 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T24", "type": "Negation", "text": [ "except for" ], "offsets": [ [ 325, 335 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T25", "type": "Condition", "text": [ "respiratory", "disease" ], "offsets": [ [ 336, 347 ], [ 357, 364 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T26", "type": "Condition", "text": [ "liver disease" ], "offsets": [ [ 351, 364 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T27", "type": "Qualifier", "text": [ "secondary to AAT deficiency" ], "offsets": [ [ 365, 392 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T28", "type": "Condition", "text": [ "AAT deficiency" ], "offsets": [ [ 378, 392 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T29", "type": "Scope", "text": [ "respiratory or liver disease" ], "offsets": [ [ 336, 364 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T30", "type": "Condition", "text": [ "cardiac" ], "offsets": [ [ 406, 413 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T31", "type": "Condition", "text": [ "hepatic" ], "offsets": [ [ 415, 422 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T32", "type": "Condition", "text": [ "renal" ], "offsets": [ [ 424, 429 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T33", "type": "Condition", "text": [ "endocrine" ], "offsets": [ [ 431, 440 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T34", "type": "Condition", "text": [ "neurological" ], "offsets": [ [ 442, 454 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T35", "type": "Condition", "text": [ "hematological" ], "offsets": [ [ 456, 469 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T36", "type": "Condition", "text": [ "neoplastic" ], "offsets": [ [ 471, 481 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T37", "type": "Condition", "text": [ "immunological" ], "offsets": [ [ 483, 496 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T38", "type": "Condition", "text": [ "skeletal" ], "offsets": [ [ 498, 506 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T39", "type": "Condition", "text": [ "other" ], "offsets": [ [ 510, 515 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T41", "type": "Scope", "text": [ "cardiac, hepatic, renal, endocrine, neurological, hematological, neoplastic, immunological, skeletal or other" ], "offsets": [ [ 406, 515 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T44", "type": "Condition", "text": [ "Active smoking" ], "offsets": [ [ 774, 788 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T45", "type": "Temporal", "text": [ "Active" ], "offsets": [ [ 774, 780 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T46", "type": "Temporal", "text": [ "during the last 12 months from screening date" ], "offsets": [ [ 789, 834 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T47", "type": "Reference_point", "text": [ "screening date" ], "offsets": [ [ 820, 834 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T48", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 837, 846 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T49", "type": "Condition", "text": [ "lactation" ], "offsets": [ [ 850, 859 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T50", "type": "Person", "text": [ "Woman" ], "offsets": [ [ 862, 867 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T51", "type": "Condition", "text": [ "child-bearing potential" ], "offsets": [ [ 871, 894 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T52", "type": "Procedure", "text": [ "contraception" ], "offsets": [ [ 915, 928 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T53", "type": "Qualifier", "text": [ "adequate" ], "offsets": [ [ 906, 914 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T56", "type": "Negation", "text": [ "not" ], "offsets": [ [ 895, 898 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T57", "type": "Scope", "text": [ "Woman of child-bearing potentia" ], "offsets": [ [ 862, 893 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T58", "type": "Qualifier", "text": [ "deemed reliable by the investigator" ], "offsets": [ [ 929, 964 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T60", "type": "Condition", "text": [ "psychiatric", "disorder" ], "offsets": [ [ 979, 990 ], [ 999, 1007 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T61", "type": "Condition", "text": [ "mental disorder" ], "offsets": [ [ 992, 1007 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T62", "type": "Condition", "text": [ "other medical disorder" ], "offsets": [ [ 1015, 1037 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T64", "type": "Observation", "text": [ "impair the patient's ability to give informed consent" ], "offsets": [ [ 1050, 1103 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T66", "type": "Scope", "text": [ "psychiatric/ mental disorder or any other medical disorder" ], "offsets": [ [ 979, 1037 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T67", "type": "Condition", "text": [ "viral infection" ], "offsets": [ [ 1183, 1198 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T68", "type": "Condition", "text": [ "HCV" ], "offsets": [ [ 1204, 1207 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T69", "type": "Condition", "text": [ "HBV" ], "offsets": [ [ 1209, 1212 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T70", "type": "Condition", "text": [ "HIV" ], "offsets": [ [ 1220, 1223 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T71", "type": "Scope", "text": [ "HCV, HBV and/or HIV" ], "offsets": [ [ 1204, 1223 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T72", "type": "Temporal", "text": [ "ongoing" ], "offsets": [ [ 1175, 1182 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T73", "type": "Condition", "text": [ "alcohol abuse" ], "offsets": [ [ 1238, 1251 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T74", "type": "Condition", "text": [ "alcohol abuse" ], "offsets": [ [ 1266, 1279 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T75", "type": "Observation", "text": [ "history" ], "offsets": [ [ 1255, 1262 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T76", "type": "Condition", "text": [ "abuse", "illegal", "drugs" ], "offsets": [ [ 1274, 1279 ], [ 1283, 1290 ], [ 1317, 1322 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T77", "type": "Condition", "text": [ "abuse", "legally prescribed drugs" ], "offsets": [ [ 1274, 1279 ], [ 1298, 1322 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T78", "type": "Scope", "text": [ "alcohol abuse or illegal and/or legally prescribed drugs" ], "offsets": [ [ 1266, 1322 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T79", "type": "Condition", "text": [ "IgA Deficiency" ], "offsets": [ [ 1325, 1339 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T80", "type": "Condition", "text": [ "life threatening allergy" ], "offsets": [ [ 1352, 1376 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T81", "type": "Qualifier", "text": [ "life threatening" ], "offsets": [ [ 1352, 1368 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T82", "type": "Condition", "text": [ "anaphylactic reaction" ], "offsets": [ [ 1378, 1399 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T83", "type": "Condition", "text": [ "systemic response to human plasma derived products" ], "offsets": [ [ 1404, 1454 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T84", "type": "Qualifier", "text": [ "human plasma derived" ], "offsets": [ [ 1425, 1445 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T85", "type": "Drug", "text": [ "products" ], "offsets": [ [ 1446, 1454 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T86", "type": "Observation", "text": [ "History" ], "offsets": [ [ 1341, 1348 ] ], "normalized": [] }, { "id": "NCT01217671_exc_T87", "type": "Scope", "text": [ "life threatening allergy, anaphylactic reaction, or systemic response to human plasma derived products" ], "offsets": [ [ 1352, 1454 ] ], "normalized": [] } ]

[]

[]

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[ { "id": "NCT01217671_inc_text", "type": "inclusion", "text": [ "Diagnosis of emphysema confirmed by CT scan. If a report of past CT scan is not available at site documenting then a CT scan is to be performed at screening \nMale or female patients at least 18 years of age. \nAble and willing to sign an informed consent. \nPatient with record of congenital AAT deficiency of phenotype PiZZ (homozygote) or other rare phenotypes related to AAT deficiency and with AAT serum level ≤ 11 micromole. For patients receiving IV AAT augmentation therapy the serum AAT level threshold does not apply. \nFEV1/SVC <70% of predicted value post bronchodilator (SVC is slow VC) and FEV1 < 80% of predicted value post-bronchodilator \nHistory of at least two moderate or severe exacerbations that required change in treatment (antibiotics, systemic steroids, hospitalization) in the last 18 months prior to date of screening , with at least one of these occurring within the last 12 months prior to screening. \nAbility to comply with completion of electronic diary. \nAbility to self-administer inhaled AAT. \nNo significant abnormalities in serum hematology, serum chemistry and serum inflammatory / immunogenic markers according to the Principal Investigator's judgment, taking into considerations the potential effects of the AAT deficiency. \nNo significant abnormalities in urinalysis according to the Principal Investigator's judgment, taking into considerations the potential effects of the AAT deficiency. \nNo significant abnormalities in ECG per investigator judgment. \nNegative for HBsAg and for antibodies to HCV, HIV-1. \nAAT deficient patients who are either naïve (not receiving IV augmentation therapy) or AAT deficient patients (receiving IV augmentation therapy), if they have been stable on regular therapy for at least 3 months prior to the screening visit and are willing to continue the same regime throughout this trial. Note that only sites in Germany can recruit patients who are currently being treated with IV AAT.Patients who stopped IV augmentation treatment 6 months prior to screening date and will not re-start this treatment for the course of the study will be considered Naïve. \nNon-pregnant, non-lactating female patients, whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investigator, or who are at least 2 years post-menopausal or surgically sterilized. \n" ], "offsets": [ [ 0, 2360 ] ] } ]

[ { "id": "NCT01217671_inc_T1", "type": "Condition", "text": [ "emphysema" ], "offsets": [ [ 13, 22 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T2", "type": "Procedure", "text": [ "CT scan" ], "offsets": [ [ 36, 43 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T3", "type": "Procedure", "text": [ "CT scan" ], "offsets": [ [ 65, 72 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T4", "type": "Temporal", "text": [ "past" ], "offsets": [ [ 60, 64 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T6", "type": "Negation", "text": [ "not available" ], "offsets": [ [ 76, 89 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T7", "type": "Observation", "text": [ "report of past CT scan" ], "offsets": [ [ 50, 72 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T8", "type": "Procedure", "text": [ "CT scan" ], "offsets": [ [ 117, 124 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T9", "type": "Scope", "text": [ "report of past CT scan is not available" ], "offsets": [ [ 50, 89 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T5", "type": "Scope", "text": [ "report of past CT scan is not available at site documenting then a CT scan is to be performed at screening" ], "offsets": [ [ 50, 156 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T10", "type": "Temporal", "text": [ "at screening" ], "offsets": [ [ 144, 156 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T11", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 147, 156 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T12", "type": "Person", "text": [ "Male" ], "offsets": [ [ 158, 162 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T13", "type": "Person", "text": [ "female" ], "offsets": [ [ 166, 172 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T14", "type": "Value", "text": [ "at least 18 years" ], "offsets": [ [ 182, 199 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T15", "type": "Person", "text": [ "age" ], "offsets": [ [ 203, 206 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T17", "type": "Condition", "text": [ "congenital AAT deficiency of phenotype PiZZ (homozygote)" ], "offsets": [ [ 279, 335 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T18", "type": "Condition", "text": [ "rare phenotypes related to AAT deficiency" ], "offsets": [ [ 345, 386 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T19", "type": "Measurement", "text": [ "AAT serum level" ], "offsets": [ [ 396, 411 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T20", "type": "Value", "text": [ "≤ 11 micromole" ], "offsets": [ [ 412, 426 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T21", "type": "Procedure", "text": [ "IV AAT augmentation therapy" ], "offsets": [ [ 451, 478 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T23", "type": "Measurement", "text": [ "FEV1/SVC" ], "offsets": [ [ 526, 534 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T24", "type": "Value", "text": [ "<70% of predicted value" ], "offsets": [ [ 535, 558 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T25", "type": "Qualifier", "text": [ "post bronchodilator" ], "offsets": [ [ 559, 578 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T26", "type": "Temporal", "text": [ "post bronchodilator" ], "offsets": [ [ 559, 578 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T27", "type": "Drug", "text": [ "bronchodilator" ], "offsets": [ [ 564, 578 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T28", "type": "Measurement", "text": [ "FEV1" ], "offsets": [ [ 600, 604 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T29", "type": "Value", "text": [ "< 80% of predicted value" ], "offsets": [ [ 605, 629 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T30", "type": "Qualifier", "text": [ "post-bronchodilator" ], "offsets": [ [ 630, 649 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T31", "type": "Temporal", "text": [ "post-bronchodilator" ], "offsets": [ [ 630, 649 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T32", "type": "Drug", "text": [ "bronchodilator" ], "offsets": [ [ 635, 649 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T33", "type": "Reference_point", "text": [ "bronchodilator" ], "offsets": [ [ 564, 578 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T34", "type": "Reference_point", "text": [ "bronchodilator" ], "offsets": [ [ 635, 649 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T35", "type": "Multiplier", "text": [ "at least two" ], "offsets": [ [ 662, 674 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T36", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 675, 683 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T37", "type": "Qualifier", "text": [ "severe" ], "offsets": [ [ 687, 693 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T38", "type": "Condition", "text": [ "exacerbations" ], "offsets": [ [ 694, 707 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T39", "type": "Scope", "text": [ "moderate or severe" ], "offsets": [ [ 675, 693 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T40", "type": "Observation", "text": [ "change in treatment" ], "offsets": [ [ 722, 741 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T41", "type": "Qualifier", "text": [ "required change in treatment" ], "offsets": [ [ 713, 741 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T42", "type": "Drug", "text": [ "antibiotics" ], "offsets": [ [ 743, 754 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T43", "type": "Drug", "text": [ "systemic steroids" ], "offsets": [ [ 756, 773 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T44", "type": "Procedure", "text": [ "hospitalization" ], "offsets": [ [ 775, 790 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T45", "type": "Qualifier", "text": [ "systemic" ], "offsets": [ [ 756, 764 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T46", "type": "Temporal", "text": [ "in the last 18 months prior to date of screening" ], "offsets": [ [ 792, 840 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T47", "type": "Reference_point", "text": [ "date of screening" ], "offsets": [ [ 823, 840 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T48", "type": "Multiplier", "text": [ "at least one" ], "offsets": [ [ 848, 860 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T49", "type": "Temporal", "text": [ "within the last 12 months prior to screening" ], "offsets": [ [ 880, 924 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T50", "type": "Reference_point", "text": [ "screening" ], "offsets": [ [ 915, 924 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T51", "type": "Scope", "text": [ "antibiotics, systemic steroids, hospitalization" ], "offsets": [ [ 743, 790 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T52", "type": "Procedure", "text": [ "treatment" ], "offsets": [ [ 732, 741 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T53", "type": "Observation", "text": [ "self-administer inhaled AAT" ], "offsets": [ [ 994, 1021 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T54", "type": "Observation", "text": [ "comply with completion of electronic diary" ], "offsets": [ [ 938, 980 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T61", "type": "Procedure", "text": [ "ECG" ], "offsets": [ [ 1460, 1463 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T62", "type": "Condition", "text": [ "abnormalities in ECG" ], "offsets": [ [ 1443, 1463 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T63", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 1431, 1442 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T64", "type": "Negation", "text": [ "No" ], "offsets": [ [ 1428, 1430 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T66", "type": "Measurement", "text": [ "HBsAg" ], "offsets": [ [ 1505, 1510 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T67", "type": "Value", "text": [ "Negative" ], "offsets": [ [ 1492, 1500 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T68", "type": "Measurement", "text": [ "antibodies to HCV" ], "offsets": [ [ 1519, 1536 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T69", "type": "Measurement", "text": [ "HIV-1" ], "offsets": [ [ 1538, 1543 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T70", "type": "Condition", "text": [ "AAT deficient" ], "offsets": [ [ 1546, 1559 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T71", "type": "Condition", "text": [ "naïve" ], "offsets": [ [ 1584, 1589 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T72", "type": "Procedure", "text": [ "IV augmentation therapy" ], "offsets": [ [ 1605, 1628 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T73", "type": "Negation", "text": [ "not receiving" ], "offsets": [ [ 1591, 1604 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T75", "type": "Procedure", "text": [ "IV augmentation therapy" ], "offsets": [ [ 1667, 1690 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T74", "type": "Procedure", "text": [ "therapy" ], "offsets": [ [ 1729, 1736 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T76", "type": "Temporal", "text": [ "for at least 3 months prior to the screening" ], "offsets": [ [ 1737, 1781 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T77", "type": "Reference_point", "text": [ "the screening" ], "offsets": [ [ 1768, 1781 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T78", "type": "Observation", "text": [ "willing to continue" ], "offsets": [ [ 1796, 1815 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T79", "type": "Temporal", "text": [ "throughout this trial" ], "offsets": [ [ 1832, 1853 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T80", "type": "Reference_point", "text": [ "this trial" ], "offsets": [ [ 1843, 1853 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T81", "type": "Qualifier", "text": [ "stable" ], "offsets": [ [ 1711, 1717 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T82", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 2128, 2136 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T83", "type": "Negation", "text": [ "Non" ], "offsets": [ [ 2124, 2127 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T84", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 2142, 2151 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T85", "type": "Negation", "text": [ "non" ], "offsets": [ [ 2138, 2141 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T86", "type": "Person", "text": [ "female" ], "offsets": [ [ 2152, 2158 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T87", "type": "Measurement", "text": [ "pregnancy test" ], "offsets": [ [ 2185, 2199 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T88", "type": "Value", "text": [ "negative" ], "offsets": [ [ 2203, 2211 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T89", "type": "Device", "text": [ "contraceptive methods" ], "offsets": [ [ 2230, 2251 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T91", "type": "Temporal", "text": [ "at least 2 years" ], "offsets": [ [ 2300, 2316 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T92", "type": "Condition", "text": [ "post-menopausal" ], "offsets": [ [ 2317, 2332 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T93", "type": "Condition", "text": [ "surgically sterilized" ], "offsets": [ [ 2336, 2357 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T94", "type": "Procedure", "text": [ "surgically" ], "offsets": [ [ 2336, 2346 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T95", "type": "Qualifier", "text": [ "deemed reliable by the investigator" ], "offsets": [ [ 2252, 2287 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T96", "type": "Scope", "text": [ "post-menopausal or surgically sterilized" ], "offsets": [ [ 2317, 2357 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T97", "type": "Scope", "text": [ "Non-pregnant, non-lactating female" ], "offsets": [ [ 2124, 2158 ] ], "normalized": [] }, { "id": "NCT01217671_inc_T98", "type": "Scope", "text": [ "pregnancy test is negative and who are using contraceptive methods deemed reliable by the investigator, or who are at least 2 years post-menopausal or surgically sterilized" ], "offsets": [ [ 2185, 2357 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01217671_inc_R1", "type": "AND", "arg1_id": "NCT01217671_inc_T1", "arg2_id": "NCT01217671_inc_T2", "normalized": [] }, { "id": "NCT01217671_inc_R2", "type": "Has_temporal", "arg1_id": "NCT01217671_inc_T3", "arg2_id": "NCT01217671_inc_T4", "normalized": [] }, { "id": "NCT01217671_inc_R5", "type": "AND", "arg1_id": "NCT01217671_inc_T7", "arg2_id": "NCT01217671_inc_T3", "normalized": [] }, { "id": "NCT01217671_inc_R3", "type": "Has_negation", "arg1_id": "NCT01217671_inc_T3", "arg2_id": "NCT01217671_inc_T6", "normalized": [] }, { "id": "NCT01217671_inc_R4", "type": "AND", "arg1_id": "NCT01217671_inc_T9", "arg2_id": "NCT01217671_inc_T8", "normalized": [] }, { "id": "NCT01217671_inc_R6", "type": "Has_temporal", "arg1_id": "NCT01217671_inc_T8", "arg2_id": "NCT01217671_inc_T10", "normalized": [] }, { "id": "NCT01217671_inc_R7", "type": "Subsumes", "arg1_id": "NCT01217671_inc_T2", "arg2_id": "NCT01217671_inc_T5", "normalized": [] }, { "id": "NCT01217671_inc_R8", "type": "Has_value", "arg1_id": "NCT01217671_inc_T15", "arg2_id": "NCT01217671_inc_T14", "normalized": [] }, { "id": "NCT01217671_inc_R9", "type": "Has_value", "arg1_id": "NCT01217671_inc_T19", "arg2_id": "NCT01217671_inc_T20", "normalized": [] }, { "id": "NCT01217671_inc_R10", "type": "Has_value", "arg1_id": "NCT01217671_inc_T23", "arg2_id": "NCT01217671_inc_T24", "normalized": [] }, { "id": "NCT01217671_inc_R11", "type": "Has_qualifier", "arg1_id": "NCT01217671_inc_T23", "arg2_id": "NCT01217671_inc_T25", "normalized": [] }, { "id": "NCT01217671_inc_R12", "type": "Has_temporal", "arg1_id": "NCT01217671_inc_T25", "arg2_id": "NCT01217671_inc_T26", "normalized": [] }, { "id": "NCT01217671_inc_R13", "type": "Has_index", "arg1_id": "NCT01217671_inc_T26", "arg2_id": "NCT01217671_inc_T33", "normalized": [] }, { "id": "NCT01217671_inc_R14", "type": "AND", "arg1_id": "NCT01217671_inc_T33", "arg2_id": "NCT01217671_inc_T27", "normalized": [] }, { "id": "NCT01217671_inc_R15", "type": "AND", "arg1_id": "NCT01217671_inc_T34", "arg2_id": "NCT01217671_inc_T32", "normalized": [] }, { "id": "NCT01217671_inc_R16", "type": "Has_index", "arg1_id": "NCT01217671_inc_T31", "arg2_id": "NCT01217671_inc_T34", "normalized": [] }, { "id": "NCT01217671_inc_R17", "type": "Has_temporal", "arg1_id": "NCT01217671_inc_T30", "arg2_id": "NCT01217671_inc_T31", "normalized": [] }, { "id": "NCT01217671_inc_R19", "type": "Has_value", "arg1_id": "NCT01217671_inc_T28", "arg2_id": "NCT01217671_inc_T29", "normalized": [] }, { "id": "NCT01217671_inc_R18", "type": "Has_qualifier", "arg1_id": "NCT01217671_inc_T28", "arg2_id": "NCT01217671_inc_T30", "normalized": [] }, { "id": "NCT01217671_inc_R20", "type": "Has_scope", "arg1_id": "NCT01217671_inc_T38", "arg2_id": "NCT01217671_inc_T39", "normalized": [] }, { "id": "NCT01217671_inc_R22", "type": "Has_multiplier", "arg1_id": "NCT01217671_inc_T38", "arg2_id": "NCT01217671_inc_T35", "normalized": [] }, { "id": "NCT01217671_inc_R23", "type": "Has_qualifier", "arg1_id": "NCT01217671_inc_T43", "arg2_id": "NCT01217671_inc_T45", "normalized": [] }, { "id": "NCT01217671_inc_R24", "type": "Has_index", "arg1_id": "NCT01217671_inc_T46", "arg2_id": "NCT01217671_inc_T47", "normalized": [] }, { "id": "NCT01217671_inc_R25", "type": "Has_index", "arg1_id": "NCT01217671_inc_T49", "arg2_id": "NCT01217671_inc_T50", "normalized": [] }, { "id": "NCT01217671_inc_R26", "type": "Has_temporal", "arg1_id": "NCT01217671_inc_T48", "arg2_id": "NCT01217671_inc_T49", "normalized": [] }, { "id": "NCT01217671_inc_R27", "type": "AND", "arg1_id": "NCT01217671_inc_T40", "arg2_id": "NCT01217671_inc_T52", "normalized": [] }, { "id": "NCT01217671_inc_R28", "type": "Subsumes", "arg1_id": "NCT01217671_inc_T52", "arg2_id": "NCT01217671_inc_T51", "normalized": [] }, { "id": "NCT01217671_inc_R29", "type": "Has_qualifier", "arg1_id": "NCT01217671_inc_T38", "arg2_id": "NCT01217671_inc_T41", "normalized": [] }, { "id": "NCT01217671_inc_R30", "type": "Has_temporal", "arg1_id": "NCT01217671_inc_T40", "arg2_id": "NCT01217671_inc_T46", "normalized": [] }, { "id": "NCT01217671_inc_R31", "type": "Has_multiplier", "arg1_id": "NCT01217671_inc_T41", "arg2_id": "NCT01217671_inc_T48", "normalized": [] }, { "id": "NCT01217671_inc_R33", "type": "Has_qualifier", "arg1_id": "NCT01217671_inc_T62", "arg2_id": "NCT01217671_inc_T63", "normalized": [] }, { "id": "NCT01217671_inc_R32", "type": "Has_negation", "arg1_id": "NCT01217671_inc_T62", "arg2_id": "NCT01217671_inc_T64", "normalized": [] }, { "id": "NCT01217671_inc_R34", "type": "AND", "arg1_id": "NCT01217671_inc_T61", "arg2_id": "NCT01217671_inc_T62", "normalized": [] }, { "id": "NCT01217671_inc_R35", "type": "Has_value", "arg1_id": "NCT01217671_inc_T66", "arg2_id": "NCT01217671_inc_T67", "normalized": [] }, { "id": "NCT01217671_inc_R36", "type": "Has_value", "arg1_id": "NCT01217671_inc_T68", "arg2_id": "NCT01217671_inc_T67", "normalized": [] }, { "id": "NCT01217671_inc_R37", "type": "Has_value", "arg1_id": "NCT01217671_inc_T69", "arg2_id": "NCT01217671_inc_T67", "normalized": [] }, { "id": "NCT01217671_inc_R38", "type": "Has_negation", "arg1_id": "NCT01217671_inc_T72", "arg2_id": "NCT01217671_inc_T73", "normalized": [] }, { "id": "NCT01217671_inc_R39", "type": "Subsumes", "arg1_id": "NCT01217671_inc_T71", "arg2_id": "NCT01217671_inc_T72", "normalized": [] }, { "id": "NCT01217671_inc_R40", "type": "AND", "arg1_id": "NCT01217671_inc_T70", "arg2_id": "NCT01217671_inc_T71", "normalized": [] }, { "id": "NCT01217671_inc_R41", "type": "Has_index", "arg1_id": "NCT01217671_inc_T76", "arg2_id": "NCT01217671_inc_T77", "normalized": [] }, { "id": "NCT01217671_inc_R42", "type": "Has_index", "arg1_id": "NCT01217671_inc_T79", "arg2_id": "NCT01217671_inc_T80", "normalized": [] }, { "id": "NCT01217671_inc_R43", "type": "Has_temporal", "arg1_id": "NCT01217671_inc_T78", "arg2_id": "NCT01217671_inc_T79", "normalized": [] }, { "id": "NCT01217671_inc_R44", "type": "Has_temporal", "arg1_id": "NCT01217671_inc_T74", "arg2_id": "NCT01217671_inc_T76", "normalized": [] }, { "id": "NCT01217671_inc_R45", "type": "Has_qualifier", "arg1_id": "NCT01217671_inc_T74", "arg2_id": "NCT01217671_inc_T81", "normalized": [] }, { "id": "NCT01217671_inc_R46", "type": "Has_value", "arg1_id": "NCT01217671_inc_T87", "arg2_id": "NCT01217671_inc_T88", "normalized": [] }, { "id": "NCT01217671_inc_R47", "type": "Has_negation", "arg1_id": "NCT01217671_inc_T82", "arg2_id": "NCT01217671_inc_T83", "normalized": [] }, { "id": "NCT01217671_inc_R48", "type": "Has_negation", "arg1_id": "NCT01217671_inc_T84", "arg2_id": "NCT01217671_inc_T85", "normalized": [] }, { "id": "NCT01217671_inc_R49", "type": "AND", "arg1_id": "NCT01217671_inc_T93", "arg2_id": "NCT01217671_inc_T94", "normalized": [] }, { "id": "NCT01217671_inc_R50", "type": "Has_qualifier", "arg1_id": "NCT01217671_inc_T89", "arg2_id": "NCT01217671_inc_T95", "normalized": [] }, { "id": "NCT01217671_inc_R52", "type": "Has_temporal", "arg1_id": "NCT01217671_inc_T96", "arg2_id": "NCT01217671_inc_T91", "normalized": [] }, { "id": "NCT01217671_inc_R53", "type": "Has_scope", "arg1_id": "NCT01217671_inc_T97", "arg2_id": "NCT01217671_inc_T98", "normalized": [] } ]

[ { "id": "NCT01218737_exc_text", "type": "exclusion", "text": [ "Surgery and/or previous ocular pathology (presence of scar/change in the cornea, glaucoma, retinopathies, etc.). \nPatient has diabetes or is immunodepressed. \nAny systemic infection during the study. \nSigns and/or symptoms of ocular inflammation/infection (bacterial, viral, fungal, caused by Chlamydia, by Mycobacterium, Acanthamoeba or of allergic etiology). \nHave used any systemic or topical antibiotics for ocular infection in the previous 14 days. \nPatient has known hypersensitivity to any of the components of the formulations used in the study. \n \n" ], "offsets": [ [ 0, 566 ] ] } ]

[ { "id": "NCT01218737_exc_T1", "type": "Procedure", "text": [ "Surgery" ], "offsets": [ [ 0, 7 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T2", "type": "Condition", "text": [ "ocular pathology" ], "offsets": [ [ 24, 40 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T3", "type": "Temporal", "text": [ "previous" ], "offsets": [ [ 15, 23 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T4", "type": "Condition", "text": [ "scar" ], "offsets": [ [ 54, 58 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T5", "type": "Observation", "text": [ "change in the cornea" ], "offsets": [ [ 59, 79 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T6", "type": "Condition", "text": [ "glaucoma" ], "offsets": [ [ 81, 89 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T7", "type": "Condition", "text": [ "retinopathies" ], "offsets": [ [ 91, 104 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T8", "type": "Scope", "text": [ "scar/change in the cornea, glaucoma, retinopathies" ], "offsets": [ [ 54, 104 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T9", "type": "Condition", "text": [ "diabetes" ], "offsets": [ [ 126, 134 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T10", "type": "Condition", "text": [ "immunodepressed" ], "offsets": [ [ 141, 156 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T11", "type": "Condition", "text": [ "infection" ], "offsets": [ [ 172, 181 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T12", "type": "Qualifier", "text": [ "systemic" ], "offsets": [ [ 163, 171 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T13", "type": "Temporal", "text": [ "during the study" ], "offsets": [ [ 182, 198 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T14", "type": "Reference_point", "text": [ "the study" ], "offsets": [ [ 189, 198 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T15", "type": "Condition", "text": [ "ocular inflammation" ], "offsets": [ [ 226, 245 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T16", "type": "Condition", "text": [ "ocular", "infection" ], "offsets": [ [ 226, 232 ], [ 246, 255 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T17", "type": "Qualifier", "text": [ "bacterial", "etiology" ], "offsets": [ [ 257, 266 ], [ 350, 358 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T18", "type": "Qualifier", "text": [ "viral", "etiology" ], "offsets": [ [ 268, 273 ], [ 350, 358 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T19", "type": "Qualifier", "text": [ "fungal", "etiology" ], "offsets": [ [ 275, 281 ], [ 350, 358 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T20", "type": "Observation", "text": [ "Chlamydia" ], "offsets": [ [ 293, 302 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T21", "type": "Observation", "text": [ "Mycobacterium" ], "offsets": [ [ 307, 320 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T22", "type": "Observation", "text": [ "Acanthamoeba" ], "offsets": [ [ 322, 334 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T23", "type": "Condition", "text": [ "allergic etiology" ], "offsets": [ [ 341, 358 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T24", "type": "Qualifier", "text": [ "caused by Chlamydia" ], "offsets": [ [ 283, 302 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T25", "type": "Qualifier", "text": [ "caused", "by Mycobacterium" ], "offsets": [ [ 283, 289 ], [ 304, 320 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T26", "type": "Qualifier", "text": [ "caused by", "Acanthamoeba" ], "offsets": [ [ 283, 292 ], [ 322, 334 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T27", "type": "Scope", "text": [ "bacterial, viral, fungal, caused by Chlamydia, by Mycobacterium, Acanthamoeba or of allergic etiology" ], "offsets": [ [ 257, 358 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T28", "type": "Scope", "text": [ "ocular inflammation/infection" ], "offsets": [ [ 226, 255 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T29", "type": "Drug", "text": [ "topical antibiotics" ], "offsets": [ [ 388, 407 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T30", "type": "Qualifier", "text": [ "topical" ], "offsets": [ [ 388, 395 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T31", "type": "Drug", "text": [ "systemic", "antibiotics" ], "offsets": [ [ 376, 384 ], [ 396, 407 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T32", "type": "Qualifier", "text": [ "systemic" ], "offsets": [ [ 376, 384 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T33", "type": "Condition", "text": [ "ocular infection" ], "offsets": [ [ 412, 428 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T34", "type": "Temporal", "text": [ "in the previous 14 days" ], "offsets": [ [ 429, 452 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T35", "type": "Scope", "text": [ "systemic or topical antibiotics" ], "offsets": [ [ 376, 407 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T36", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 473, 489 ] ], "normalized": [] }, { "id": "NCT01218737_exc_T37", "type": "Qualifier", "text": [ "components of the formulations" ], "offsets": [ [ 504, 534 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01218737_exc_R1", "type": "Has_temporal", "arg1_id": "NCT01218737_exc_T2", "arg2_id": "NCT01218737_exc_T3", "normalized": [] }, { "id": "NCT01218737_exc_R2", "type": "Subsumes", "arg1_id": "NCT01218737_exc_T2", "arg2_id": "NCT01218737_exc_T8", "normalized": [] }, { "id": "NCT01218737_exc_R3", "type": "Subsumes", "arg1_id": "NCT01218737_exc_T28", "arg2_id": "NCT01218737_exc_T27", "normalized": [] }, { "id": "NCT01218737_exc_R4", "type": "Has_qualifier", "arg1_id": "NCT01218737_exc_T29", "arg2_id": "NCT01218737_exc_T30", "normalized": [] }, { "id": "NCT01218737_exc_R5", "type": "AND", "arg1_id": "NCT01218737_exc_T35", "arg2_id": "NCT01218737_exc_T33", "normalized": [] }, { "id": "NCT01218737_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01218737_exc_T35", "arg2_id": "NCT01218737_exc_T34", "normalized": [] }, { "id": "NCT01218737_exc_R7", "type": "Has_qualifier", "arg1_id": "NCT01218737_exc_T36", "arg2_id": "NCT01218737_exc_T37", "normalized": [] }, { "id": "NCT01218737_exc_R8", "type": "Has_temporal", "arg1_id": "NCT01218737_exc_T11", "arg2_id": "NCT01218737_exc_T13", "normalized": [] }, { "id": "NCT01218737_exc_R9", "type": "Has_index", "arg1_id": "NCT01218737_exc_T13", "arg2_id": "NCT01218737_exc_T14", "normalized": [] }, { "id": "NCT01218737_exc_R10", "type": "Has_qualifier", "arg1_id": "NCT01218737_exc_T11", "arg2_id": "NCT01218737_exc_T12", "normalized": [] } ]

[ { "id": "NCT01218737_inc_text", "type": "inclusion", "text": [ "Patient is indicated to have an ocular refractive surgery performed (myopia, astigmatism, hypermetropy) by the Lasik method. \nPatient presents a normal eye fundus. \nPatient has intraocular pressure (IOP) ≤ 20 mmHg. \n" ], "offsets": [ [ 0, 216 ] ] } ]

[ { "id": "NCT01218737_inc_T1", "type": "Procedure", "text": [ "ocular refractive surgery" ], "offsets": [ [ 32, 57 ] ], "normalized": [] }, { "id": "NCT01218737_inc_T2", "type": "Condition", "text": [ "indicated to have an ocular refractive surgery performed" ], "offsets": [ [ 11, 67 ] ], "normalized": [] }, { "id": "NCT01218737_inc_T3", "type": "Condition", "text": [ "myopia" ], "offsets": [ [ 69, 75 ] ], "normalized": [] }, { "id": "NCT01218737_inc_T4", "type": "Condition", "text": [ "astigmatism" ], "offsets": [ [ 77, 88 ] ], "normalized": [] }, { "id": "NCT01218737_inc_T5", "type": "Condition", "text": [ "hypermetropy" ], "offsets": [ [ 90, 102 ] ], "normalized": [] }, { "id": "NCT01218737_inc_T6", "type": "Qualifier", "text": [ "Lasik method" ], "offsets": [ [ 111, 123 ] ], "normalized": [] }, { "id": "NCT01218737_inc_T7", "type": "Scope", "text": [ "myopia, astigmatism, hypermetropy" ], "offsets": [ [ 69, 102 ] ], "normalized": [] }, { "id": "NCT01218737_inc_T8", "type": "Condition", "text": [ "normal eye fundus" ], "offsets": [ [ 145, 162 ] ], "normalized": [] }, { "id": "NCT01218737_inc_T9", "type": "Measurement", "text": [ "eye fundus" ], "offsets": [ [ 152, 162 ] ], "normalized": [] }, { "id": "NCT01218737_inc_T10", "type": "Value", "text": [ "normal" ], "offsets": [ [ 145, 151 ] ], "normalized": [] }, { "id": "NCT01218737_inc_T11", "type": "Measurement", "text": [ "intraocular pressure (IOP)" ], "offsets": [ [ 177, 203 ] ], "normalized": [] }, { "id": "NCT01218737_inc_T12", "type": "Value", "text": [ "≤ 20 mmHg" ], "offsets": [ [ 204, 213 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01218737_inc_R1", "type": "AND", "arg1_id": "NCT01218737_inc_T2", "arg2_id": "NCT01218737_inc_T1", "normalized": [] }, { "id": "NCT01218737_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01218737_inc_T1", "arg2_id": "NCT01218737_inc_T6", "normalized": [] }, { "id": "NCT01218737_inc_R3", "type": "Subsumes", "arg1_id": "NCT01218737_inc_T2", "arg2_id": "NCT01218737_inc_T7", "normalized": [] }, { "id": "NCT01218737_inc_R4", "type": "Has_value", "arg1_id": "NCT01218737_inc_T9", "arg2_id": "NCT01218737_inc_T10", "normalized": [] }, { "id": "NCT01218737_inc_R5", "type": "AND", "arg1_id": "NCT01218737_inc_T8", "arg2_id": "NCT01218737_inc_T9", "normalized": [] }, { "id": "NCT01218737_inc_R6", "type": "Has_value", "arg1_id": "NCT01218737_inc_T11", "arg2_id": "NCT01218737_inc_T12", "normalized": [] } ]

[ { "id": "NCT01228279_exc_text", "type": "exclusion", "text": [ "Diabetes Mellitus\nAcute coronary syndrome in the past 6 months\nCardiac arrhythmias (2nd and 3rd degree heart block or premature ventricular complexes in Lown classes 4 or 5)\nSymptoms suggestive of obstructive or central sleep apnea (with a score of > 10 on Epworth sleepiness scale)\nPatients taking Clonidine\nBody mass index (BMI) > 34\nPatients unable to give consent\nPregnant women\nPatients with leg injury involving nerve damage\nPatients taking anticoagulant medication\nPatients with significant bleeding disorder or liver disorder\nHemoglobin <1.05 g/dl at the time of initiation of therapy\npatients with unilateral or bilateral nephrectomy\nPlanned kidney transplant in the next 4 months\nLife expectancy under 6 months\nOliguria (urine output less than 400 ml per day)\n" ], "offsets": [ [ 0, 770 ] ] } ]

[ { "id": "NCT01228279_exc_T1", "type": "Condition", "text": [ "Diabetes Mellitus" ], "offsets": [ [ 0, 17 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T2", "type": "Condition", "text": [ "Acute coronary syndrome" ], "offsets": [ [ 18, 41 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T3", "type": "Temporal", "text": [ "in the past 6 months" ], "offsets": [ [ 42, 62 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T4", "type": "Condition", "text": [ "Cardiac arrhythmia" ], "offsets": [ [ 63, 81 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T5", "type": "Condition", "text": [ "3rd degree heart block" ], "offsets": [ [ 92, 114 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T6", "type": "Condition", "text": [ "d a", "gree heart block o" ], "offsets": [ [ 86, 89 ], [ 98, 116 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T7", "type": "Condition", "text": [ "premature ventricular complexes" ], "offsets": [ [ 118, 149 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T8", "type": "Qualifier", "text": [ "Lown classes 4" ], "offsets": [ [ 153, 167 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T9", "type": "Qualifier", "text": [ "wn classes 4", "" ], "offsets": [ [ 155, 167 ], [ 173, 173 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T10", "type": "Scope", "text": [ "Lown classes 4 or 5" ], "offsets": [ [ 153, 172 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T11", "type": "Scope", "text": [ "(2nd and 3rd degree heart block or premature ventricular complexes in Lown classes 4 or 5)" ], "offsets": [ [ 83, 173 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T12", "type": "Condition", "text": [ "tructive or", "ep apnea (w" ], "offsets": [ [ 200, 211 ], [ 223, 234 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T13", "type": "Condition", "text": [ "central sleep apnea" ], "offsets": [ [ 212, 231 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T14", "type": "Measurement", "text": [ "Epworth sleepiness scale" ], "offsets": [ [ 257, 281 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T15", "type": "Value", "text": [ "score of > 10" ], "offsets": [ [ 240, 253 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T17", "type": "Scope", "text": [ "obstructive or central sleep apnea" ], "offsets": [ [ 197, 231 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T16", "type": "Drug", "text": [ "Clonidine" ], "offsets": [ [ 299, 308 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T18", "type": "Measurement", "text": [ "Body mass index" ], "offsets": [ [ 309, 324 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T19", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 326, 329 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T20", "type": "Value", "text": [ "> 34" ], "offsets": [ [ 331, 335 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T23", "type": "Condition", "text": [ "leg injury" ], "offsets": [ [ 397, 407 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T24", "type": "Condition", "text": [ "nerve damage" ], "offsets": [ [ 418, 430 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T25", "type": "Drug", "text": [ "anticoagulant" ], "offsets": [ [ 447, 460 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T26", "type": "Condition", "text": [ "bleeding disorder" ], "offsets": [ [ 498, 515 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T27", "type": "Condition", "text": [ "liver disorder" ], "offsets": [ [ 519, 533 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T28", "type": "Qualifier", "text": [ "significant" ], "offsets": [ [ 486, 497 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T29", "type": "Measurement", "text": [ "Hemoglobin" ], "offsets": [ [ 534, 544 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T30", "type": "Value", "text": [ "<1.05 g/dl" ], "offsets": [ [ 545, 555 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T31", "type": "Temporal", "text": [ "at the time of initiation of therapy" ], "offsets": [ [ 556, 592 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T32", "type": "Reference_point", "text": [ "initiation of therapy" ], "offsets": [ [ 571, 592 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T33", "type": "Procedure", "text": [ "nephrectomy" ], "offsets": [ [ 631, 642 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T34", "type": "Qualifier", "text": [ "bilateral" ], "offsets": [ [ 621, 630 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T35", "type": "Qualifier", "text": [ "unilateral" ], "offsets": [ [ 607, 617 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T36", "type": "Scope", "text": [ "unilateral or bilateral" ], "offsets": [ [ 607, 630 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T37", "type": "Condition", "text": [ "kidney transplant" ], "offsets": [ [ 651, 668 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T38", "type": "Qualifier", "text": [ "Planned" ], "offsets": [ [ 643, 650 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T39", "type": "Temporal", "text": [ "in the next 4 months" ], "offsets": [ [ 669, 689 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T40", "type": "Observation", "text": [ "Life expectancy" ], "offsets": [ [ 690, 705 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T41", "type": "Value", "text": [ "under 6 months" ], "offsets": [ [ 706, 720 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T42", "type": "Condition", "text": [ "Oliguria" ], "offsets": [ [ 721, 729 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T43", "type": "Measurement", "text": [ "urine output" ], "offsets": [ [ 731, 743 ] ], "normalized": [] }, { "id": "NCT01228279_exc_T44", "type": "Value", "text": [ "less than 400 ml per day" ], "offsets": [ [ 744, 768 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01228279_exc_R1", "type": "Has_scope", "arg1_id": "NCT01228279_exc_T7", "arg2_id": "NCT01228279_exc_T10", "normalized": [] }, { "id": "NCT01228279_exc_R2", "type": "Subsumes", "arg1_id": "NCT01228279_exc_T4", "arg2_id": "NCT01228279_exc_T11", "normalized": [] }, { "id": "NCT01228279_exc_R3", "type": "Has_value", "arg1_id": "NCT01228279_exc_T14", "arg2_id": "NCT01228279_exc_T15", "normalized": [] }, { "id": "NCT01228279_exc_R5", "type": "AND", "arg1_id": "NCT01228279_exc_T17", "arg2_id": "NCT01228279_exc_T14", "normalized": [] }, { "id": "NCT01228279_exc_R4", "type": "Subsumes", "arg1_id": "NCT01228279_exc_T18", "arg2_id": "NCT01228279_exc_T19", "normalized": [] }, { "id": "NCT01228279_exc_R6", "type": "Has_value", "arg1_id": "NCT01228279_exc_T18", "arg2_id": "NCT01228279_exc_T20", "normalized": [] }, { "id": "NCT01228279_exc_R7", "type": "AND", "arg1_id": "NCT01228279_exc_T23", "arg2_id": "NCT01228279_exc_T24", "normalized": [] }, { "id": "NCT01228279_exc_R8", "type": "Has_qualifier", "arg1_id": "NCT01228279_exc_T26", "arg2_id": "NCT01228279_exc_T28", "normalized": [] }, { "id": "NCT01228279_exc_R9", "type": "Has_index", "arg1_id": "NCT01228279_exc_T31", "arg2_id": "NCT01228279_exc_T32", "normalized": [] }, { "id": "NCT01228279_exc_R10", "type": "Has_value", "arg1_id": "NCT01228279_exc_T29", "arg2_id": "NCT01228279_exc_T30", "normalized": [] }, { "id": "NCT01228279_exc_R11", "type": "Has_temporal", "arg1_id": "NCT01228279_exc_T29", "arg2_id": "NCT01228279_exc_T31", "normalized": [] }, { "id": "NCT01228279_exc_R12", "type": "Has_scope", "arg1_id": "NCT01228279_exc_T33", "arg2_id": "NCT01228279_exc_T36", "normalized": [] }, { "id": "NCT01228279_exc_R13", "type": "Has_qualifier", "arg1_id": "NCT01228279_exc_T37", "arg2_id": "NCT01228279_exc_T38", "normalized": [] }, { "id": "NCT01228279_exc_R14", "type": "Has_temporal", "arg1_id": "NCT01228279_exc_T37", "arg2_id": "NCT01228279_exc_T39", "normalized": [] }, { "id": "NCT01228279_exc_R15", "type": "Has_value", "arg1_id": "NCT01228279_exc_T40", "arg2_id": "NCT01228279_exc_T41", "normalized": [] }, { "id": "NCT01228279_exc_R16", "type": "Has_value", "arg1_id": "NCT01228279_exc_T43", "arg2_id": "NCT01228279_exc_T44", "normalized": [] }, { "id": "NCT01228279_exc_R17", "type": "AND", "arg1_id": "NCT01228279_exc_T42", "arg2_id": "NCT01228279_exc_T43", "normalized": [] } ]

[ { "id": "NCT01228279_inc_text", "type": "inclusion", "text": [ "Adult (age 18 years and older)\nPatients with end-stage renal disease(ESRD)/chronic kidney disease(CKD)stage 5\n" ], "offsets": [ [ 0, 110 ] ] } ]

[ { "id": "NCT01228279_inc_T1", "type": "Person", "text": [ "Adult" ], "offsets": [ [ 0, 5 ] ], "normalized": [] }, { "id": "NCT01228279_inc_T2", "type": "Person", "text": [ "age" ], "offsets": [ [ 7, 10 ] ], "normalized": [] }, { "id": "NCT01228279_inc_T3", "type": "Value", "text": [ "18 years and older" ], "offsets": [ [ 11, 29 ] ], "normalized": [] }, { "id": "NCT01228279_inc_T4", "type": "Condition", "text": [ "end-stage renal disease" ], "offsets": [ [ 45, 68 ] ], "normalized": [] }, { "id": "NCT01228279_inc_T5", "type": "Condition", "text": [ "ESRD" ], "offsets": [ [ 69, 73 ] ], "normalized": [] }, { "id": "NCT01228279_inc_T6", "type": "Condition", "text": [ "chronic kidney disease" ], "offsets": [ [ 75, 97 ] ], "normalized": [] }, { "id": "NCT01228279_inc_T7", "type": "Condition", "text": [ "CKD" ], "offsets": [ [ 98, 101 ] ], "normalized": [] }, { "id": "NCT01228279_inc_T8", "type": "Qualifier", "text": [ "stage 5" ], "offsets": [ [ 102, 109 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01228279_inc_R1", "type": "Has_value", "arg1_id": "NCT01228279_inc_T2", "arg2_id": "NCT01228279_inc_T3", "normalized": [] }, { "id": "NCT01228279_inc_R2", "type": "Subsumes", "arg1_id": "NCT01228279_inc_T4", "arg2_id": "NCT01228279_inc_T5", "normalized": [] }, { "id": "NCT01228279_inc_R3", "type": "Subsumes", "arg1_id": "NCT01228279_inc_T6", "arg2_id": "NCT01228279_inc_T7", "normalized": [] }, { "id": "NCT01228279_inc_R4", "type": "Has_qualifier", "arg1_id": "NCT01228279_inc_T6", "arg2_id": "NCT01228279_inc_T8", "normalized": [] }, { "id": "NCT01228279_inc_R5", "type": "Subsumes", "arg1_id": "NCT01228279_inc_T4", "arg2_id": "NCT01228279_inc_T6", "normalized": [] } ]

[ { "id": "NCT01236417_exc_text", "type": "exclusion", "text": [ "Inability to comply with study requirements. \nMetastatic breast cancer. \nPatients with orthopedic or neuromuscular disorders that preclude participation in exercise. \nRheumatoid arthritis. \nHistory of MI, angina or congestive heart failure. \nPregnant or lactating females. \nPatients that are high risk for moderate exercise based on ACSM risk classification. \nPatients who exceed minimal physical activity recommendations from the US Surgeon General's Report: Accumulation of 30 minutes or more of moderate physical activity on most days of the week. \nMorbidly obese with BMI ≥ 40 \n \n" ], "offsets": [ [ 0, 593 ] ] } ]

[ { "id": "NCT01236417_exc_T2", "type": "Condition", "text": [ "breast cancer" ], "offsets": [ [ 57, 70 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T3", "type": "Qualifier", "text": [ "Metastatic" ], "offsets": [ [ 46, 56 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T4", "type": "Condition", "text": [ "neuromuscular disorders" ], "offsets": [ [ 101, 124 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T5", "type": "Condition", "text": [ "disorders", "orthopedic" ], "offsets": [ [ 115, 124 ], [ 87, 97 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T6", "type": "Condition", "text": [ "Rheumatoid arthritis" ], "offsets": [ [ 167, 187 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T7", "type": "Condition", "text": [ "MI" ], "offsets": [ [ 201, 203 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T8", "type": "Condition", "text": [ "angina" ], "offsets": [ [ 205, 211 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T9", "type": "Condition", "text": [ "congestive heart failure" ], "offsets": [ [ 215, 239 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T10", "type": "Observation", "text": [ "History" ], "offsets": [ [ 190, 197 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T11", "type": "Scope", "text": [ "MI, angina or congestive heart failure" ], "offsets": [ [ 201, 239 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T12", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 242, 250 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T13", "type": "Condition", "text": [ "lactating" ], "offsets": [ [ 254, 263 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T14", "type": "Person", "text": [ "females" ], "offsets": [ [ 264, 271 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T16", "type": "Measurement", "text": [ "risk for moderate exercise" ], "offsets": [ [ 297, 323 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T17", "type": "Value", "text": [ "high" ], "offsets": [ [ 292, 296 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T18", "type": "Measurement", "text": [ "ACSM risk classification" ], "offsets": [ [ 333, 357 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T19", "type": "Observation", "text": [ "exceed minimal physical activity recommendations" ], "offsets": [ [ 373, 421 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T21", "type": "Condition", "text": [ "Morbidly obese" ], "offsets": [ [ 552, 566 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T22", "type": "Measurement", "text": [ "BMI" ], "offsets": [ [ 572, 575 ] ], "normalized": [] }, { "id": "NCT01236417_exc_T23", "type": "Value", "text": [ "≥ 40" ], "offsets": [ [ 576, 580 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01236417_exc_R1", "type": "Has_qualifier", "arg1_id": "NCT01236417_exc_T2", "arg2_id": "NCT01236417_exc_T3", "normalized": [] }, { "id": "NCT01236417_exc_R2", "type": "Has_temporal", "arg1_id": "NCT01236417_exc_T11", "arg2_id": "NCT01236417_exc_T10", "normalized": [] }, { "id": "NCT01236417_exc_R3", "type": "Subsumes", "arg1_id": "NCT01236417_exc_T16", "arg2_id": "NCT01236417_exc_T18", "normalized": [] }, { "id": "NCT01236417_exc_R4", "type": "Has_value", "arg1_id": "NCT01236417_exc_T16", "arg2_id": "NCT01236417_exc_T17", "normalized": [] }, { "id": "NCT01236417_exc_R5", "type": "Has_value", "arg1_id": "NCT01236417_exc_T22", "arg2_id": "NCT01236417_exc_T23", "normalized": [] }, { "id": "NCT01236417_exc_R6", "type": "Subsumes", "arg1_id": "NCT01236417_exc_T21", "arg2_id": "NCT01236417_exc_T22", "normalized": [] } ]

[ { "id": "NCT01236417_inc_text", "type": "inclusion", "text": [ "Post menopausal women with a history of estrogen positive breast cancer who are receiving aromatase inhibitors for at least one month. \nPatients must complain of mild to moderate arthralgia. \nAbility to understand and sign informed consent. \nPatients meet criteria for low to moderate risk for moderate exercise based oon the ACSM guidelines. \n" ], "offsets": [ [ 0, 344 ] ] } ]

[ { "id": "NCT01236417_inc_T1", "type": "Condition", "text": [ "Post menopausal" ], "offsets": [ [ 0, 15 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T2", "type": "Person", "text": [ "women" ], "offsets": [ [ 16, 21 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T3", "type": "Observation", "text": [ "history" ], "offsets": [ [ 29, 36 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T4", "type": "Qualifier", "text": [ "estrogen positive" ], "offsets": [ [ 40, 57 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T5", "type": "Condition", "text": [ "breast cancer" ], "offsets": [ [ 58, 71 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T6", "type": "Drug", "text": [ "aromatase inhibitors" ], "offsets": [ [ 90, 110 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T7", "type": "Temporal", "text": [ "for at least one month" ], "offsets": [ [ 111, 133 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T8", "type": "Condition", "text": [ "arthralgia" ], "offsets": [ [ 179, 189 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T9", "type": "Qualifier", "text": [ "moderate" ], "offsets": [ [ 170, 178 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T10", "type": "Qualifier", "text": [ "mild" ], "offsets": [ [ 162, 166 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T11", "type": "Scope", "text": [ "mild to moderate" ], "offsets": [ [ 162, 178 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T13", "type": "Value", "text": [ "low" ], "offsets": [ [ 269, 272 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T14", "type": "Value", "text": [ "moderate" ], "offsets": [ [ 276, 284 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T15", "type": "Measurement", "text": [ "risk for moderate exercise" ], "offsets": [ [ 285, 311 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T16", "type": "Scope", "text": [ "low to moderate" ], "offsets": [ [ 269, 284 ] ], "normalized": [] }, { "id": "NCT01236417_inc_T17", "type": "Measurement", "text": [ "ACSM guidelines" ], "offsets": [ [ 326, 341 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01236417_inc_R1", "type": "Has_temporal", "arg1_id": "NCT01236417_inc_T6", "arg2_id": "NCT01236417_inc_T7", "normalized": [] }, { "id": "NCT01236417_inc_R2", "type": "Has_qualifier", "arg1_id": "NCT01236417_inc_T5", "arg2_id": "NCT01236417_inc_T4", "normalized": [] }, { "id": "NCT01236417_inc_R3", "type": "Has_temporal", "arg1_id": "NCT01236417_inc_T5", "arg2_id": "NCT01236417_inc_T3", "normalized": [] }, { "id": "NCT01236417_inc_R4", "type": "Has_scope", "arg1_id": "NCT01236417_inc_T8", "arg2_id": "NCT01236417_inc_T11", "normalized": [] }, { "id": "NCT01236417_inc_R5", "type": "Has_scope", "arg1_id": "NCT01236417_inc_T15", "arg2_id": "NCT01236417_inc_T16", "normalized": [] }, { "id": "NCT01236417_inc_R6", "type": "Subsumes", "arg1_id": "NCT01236417_inc_T15", "arg2_id": "NCT01236417_inc_T17", "normalized": [] } ]

[ { "id": "NCT01261832_exc_text", "type": "exclusion", "text": [ "The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Cilostazol\nUncontrolled hypertension\nHistory of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or refuses blood transfusions.\nBaseline hemogram with Hb<10g/dL or PLT count<100,000/μL\nPatients already taking warfarin, cilostazol or any other type of anti-platelet agents except aspirin and clopidogrel\nGastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.\nPregnancy\n" ], "offsets": [ [ 0, 584 ] ] } ]

[ { "id": "NCT01261832_exc_T1", "type": "Condition", "text": [ "hypersensitivity" ], "offsets": [ [ 24, 40 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T2", "type": "Condition", "text": [ "contraindication" ], "offsets": [ [ 44, 60 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T4", "type": "Drug", "text": [ "Heparin" ], "offsets": [ [ 98, 105 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T3", "type": "Drug", "text": [ "Aspirin" ], "offsets": [ [ 107, 114 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T5", "type": "Drug", "text": [ "Clopidogrel" ], "offsets": [ [ 116, 127 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T6", "type": "Drug", "text": [ "Cilostazol" ], "offsets": [ [ 129, 139 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T7", "type": "Scope", "text": [ "hypersensitivity or contraindication" ], "offsets": [ [ 24, 60 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T8", "type": "Scope", "text": [ "Heparin, Aspirin, Clopidogrel, Cilostazol" ], "offsets": [ [ 98, 139 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T9", "type": "Qualifier", "text": [ "Uncontrolled" ], "offsets": [ [ 140, 152 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T10", "type": "Condition", "text": [ "hypertension" ], "offsets": [ [ 153, 165 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T11", "type": "Condition", "text": [ "bleeding diathesis" ], "offsets": [ [ 177, 195 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T12", "type": "Observation", "text": [ "History" ], "offsets": [ [ 166, 173 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T13", "type": "Condition", "text": [ "coagulopathy" ], "offsets": [ [ 205, 217 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T14", "type": "Condition", "text": [ "heparin-induced thrombocytopenia" ], "offsets": [ [ 229, 261 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T15", "type": "Observation", "text": [ "refuses blood transfusions" ], "offsets": [ [ 267, 293 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T16", "type": "Procedure", "text": [ "blood transfusions" ], "offsets": [ [ 275, 293 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T17", "type": "Procedure", "text": [ "hemogram" ], "offsets": [ [ 304, 312 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T18", "type": "Temporal", "text": [ "Baseline" ], "offsets": [ [ 295, 303 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T19", "type": "Measurement", "text": [ "Hb" ], "offsets": [ [ 318, 320 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T20", "type": "Value", "text": [ "<10g/dL" ], "offsets": [ [ 320, 327 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T21", "type": "Measurement", "text": [ "PLT count" ], "offsets": [ [ 331, 340 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T22", "type": "Value", "text": [ "<100,000/μL" ], "offsets": [ [ 340, 351 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T23", "type": "Scope", "text": [ "Hb<10g/dL or PLT count<100,000/μL" ], "offsets": [ [ 318, 351 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T24", "type": "Drug", "text": [ "warfarin" ], "offsets": [ [ 376, 384 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T25", "type": "Drug", "text": [ "cilostazol" ], "offsets": [ [ 386, 396 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T26", "type": "Drug", "text": [ "anti-platelet agents" ], "offsets": [ [ 418, 438 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T27", "type": "Drug", "text": [ "aspirin" ], "offsets": [ [ 446, 453 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T28", "type": "Drug", "text": [ "clopidogrel" ], "offsets": [ [ 458, 469 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T29", "type": "Negation", "text": [ "except" ], "offsets": [ [ 439, 445 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T30", "type": "Scope", "text": [ "aspirin and clopidogrel" ], "offsets": [ [ 446, 469 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T31", "type": "Condition", "text": [ "genitourinary bleeding" ], "offsets": [ [ 490, 512 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T32", "type": "Condition", "text": [ "ointestinal or g", "ing with" ], "offsets": [ [ 475, 491 ], [ 509, 517 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T33", "type": "Temporal", "text": [ "within the prior 3 months" ], "offsets": [ [ 513, 538 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T34", "type": "Scope", "text": [ "Gastrointestinal or genitourinary bleeding" ], "offsets": [ [ 470, 512 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T35", "type": "Procedure", "text": [ "major surgery" ], "offsets": [ [ 543, 556 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T36", "type": "Temporal", "text": [ "within 2 months" ], "offsets": [ [ 557, 572 ] ], "normalized": [] }, { "id": "NCT01261832_exc_T37", "type": "Condition", "text": [ "Pregnancy" ], "offsets": [ [ 574, 583 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01261832_exc_R1", "type": "Has_scope", "arg1_id": "NCT01261832_exc_T7", "arg2_id": "NCT01261832_exc_T8", "normalized": [] }, { "id": "NCT01261832_exc_R2", "type": "Has_qualifier", "arg1_id": "NCT01261832_exc_T10", "arg2_id": "NCT01261832_exc_T9", "normalized": [] }, { "id": "NCT01261832_exc_R3", "type": "Has_temporal", "arg1_id": "NCT01261832_exc_T11", "arg2_id": "NCT01261832_exc_T12", "normalized": [] }, { "id": "NCT01261832_exc_R4", "type": "Subsumes", "arg1_id": "NCT01261832_exc_T13", "arg2_id": "NCT01261832_exc_T14", "normalized": [] }, { "id": "NCT01261832_exc_R6", "type": "Has_temporal", "arg1_id": "NCT01261832_exc_T17", "arg2_id": "NCT01261832_exc_T18", "normalized": [] }, { "id": "NCT01261832_exc_R7", "type": "Has_value", "arg1_id": "NCT01261832_exc_T19", "arg2_id": "NCT01261832_exc_T20", "normalized": [] }, { "id": "NCT01261832_exc_R8", "type": "Has_value", "arg1_id": "NCT01261832_exc_T21", "arg2_id": "NCT01261832_exc_T22", "normalized": [] }, { "id": "NCT01261832_exc_R9", "type": "Has_scope", "arg1_id": "NCT01261832_exc_T17", "arg2_id": "NCT01261832_exc_T23", "normalized": [] }, { "id": "NCT01261832_exc_R10", "type": "Has_negation", "arg1_id": "NCT01261832_exc_T30", "arg2_id": "NCT01261832_exc_T29", "normalized": [] }, { "id": "NCT01261832_exc_R11", "type": "Has_scope", "arg1_id": "NCT01261832_exc_T26", "arg2_id": "NCT01261832_exc_T30", "normalized": [] }, { "id": "NCT01261832_exc_R12", "type": "Has_temporal", "arg1_id": "NCT01261832_exc_T34", "arg2_id": "NCT01261832_exc_T33", "normalized": [] }, { "id": "NCT01261832_exc_R13", "type": "Has_temporal", "arg1_id": "NCT01261832_exc_T35", "arg2_id": "NCT01261832_exc_T36", "normalized": [] } ]

[ { "id": "NCT01261832_inc_text", "type": "inclusion", "text": [ "Acute Myocardial Infarction Undergoing Primary percutaneous coronary intervention.\n" ], "offsets": [ [ 0, 83 ] ] } ]

[ { "id": "NCT01261832_inc_T1", "type": "Condition", "text": [ "Acute Myocardial Infarction" ], "offsets": [ [ 0, 27 ] ], "normalized": [] }, { "id": "NCT01261832_inc_T2", "type": "Procedure", "text": [ "Primary percutaneous coronary intervention" ], "offsets": [ [ 39, 81 ] ], "normalized": [] } ]

[]

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[ { "id": "NCT01312012_exc_text", "type": "exclusion", "text": [ "major systemic disease\nPregnant woman with infection of human immunodeficiency virus or hepatitis C virus\nPregnant woman is receiving any drug with antiviral activity or any form of drug therapy for hepatitis B virus\nPregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus\nPregnant woman whose amniocentesis reveals any genetic abnormality\n" ], "offsets": [ [ 0, 374 ] ] } ]

[ { "id": "NCT01312012_exc_T1", "type": "Condition", "text": [ "major systemic disease" ], "offsets": [ [ 0, 22 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T2", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 23, 31 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T3", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 106, 114 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T4", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 217, 225 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T5", "type": "Condition", "text": [ "Pregnant" ], "offsets": [ [ 307, 315 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T6", "type": "Person", "text": [ "woman" ], "offsets": [ [ 32, 37 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T7", "type": "Person", "text": [ "woman" ], "offsets": [ [ 115, 120 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T8", "type": "Person", "text": [ "woman" ], "offsets": [ [ 226, 231 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T9", "type": "Person", "text": [ "woman" ], "offsets": [ [ 316, 321 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T10", "type": "Condition", "text": [ "human immunodeficiency virus" ], "offsets": [ [ 56, 84 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T11", "type": "Condition", "text": [ "hepatitis C virus" ], "offsets": [ [ 88, 105 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T12", "type": "Drug", "text": [ "drug with antiviral activity" ], "offsets": [ [ 138, 166 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T13", "type": "Procedure", "text": [ "drug therapy" ], "offsets": [ [ 182, 194 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T14", "type": "Condition", "text": [ "hepatitis B virus" ], "offsets": [ [ 199, 216 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T15", "type": "Procedure", "text": [ "ultrasonographic examination" ], "offsets": [ [ 238, 266 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T16", "type": "Value", "text": [ "congenital anomaly of the fetus" ], "offsets": [ [ 275, 306 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T17", "type": "Procedure", "text": [ "amniocentesis" ], "offsets": [ [ 328, 341 ] ], "normalized": [] }, { "id": "NCT01312012_exc_T18", "type": "Value", "text": [ "genetic abnormality" ], "offsets": [ [ 354, 373 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01312012_exc_R1", "type": "AND", "arg1_id": "NCT01312012_exc_T13", "arg2_id": "NCT01312012_exc_T14", "normalized": [] }, { "id": "NCT01312012_exc_R2", "type": "Has_value", "arg1_id": "NCT01312012_exc_T15", "arg2_id": "NCT01312012_exc_T16", "normalized": [] }, { "id": "NCT01312012_exc_R3", "type": "Has_value", "arg1_id": "NCT01312012_exc_T17", "arg2_id": "NCT01312012_exc_T18", "normalized": [] } ]

[ { "id": "NCT01312012_inc_text", "type": "inclusion", "text": [ "pregnant women in 30 to 32 weeks of gestation, with positive HBsAg and HBeAg,serum viral load above 8log10 copies per mL\n" ], "offsets": [ [ 0, 121 ] ] } ]

[ { "id": "NCT01312012_inc_T1", "type": "Condition", "text": [ "pregnant" ], "offsets": [ [ 0, 8 ] ], "normalized": [] }, { "id": "NCT01312012_inc_T2", "type": "Person", "text": [ "women" ], "offsets": [ [ 9, 14 ] ], "normalized": [] }, { "id": "NCT01312012_inc_T3", "type": "Value", "text": [ "30 to 32 weeks" ], "offsets": [ [ 18, 32 ] ], "normalized": [] }, { "id": "NCT01312012_inc_T4", "type": "Measurement", "text": [ "gestation" ], "offsets": [ [ 36, 45 ] ], "normalized": [] }, { "id": "NCT01312012_inc_T5", "type": "Measurement", "text": [ "HBsAg" ], "offsets": [ [ 61, 66 ] ], "normalized": [] }, { "id": "NCT01312012_inc_T6", "type": "Measurement", "text": [ "HBeAg" ], "offsets": [ [ 71, 76 ] ], "normalized": [] }, { "id": "NCT01312012_inc_T7", "type": "Value", "text": [ "positive" ], "offsets": [ [ 52, 60 ] ], "normalized": [] }, { "id": "NCT01312012_inc_T8", "type": "Scope", "text": [ "HBsAg and HBeAg" ], "offsets": [ [ 61, 76 ] ], "normalized": [] }, { "id": "NCT01312012_inc_T9", "type": "Measurement", "text": [ "serum viral load" ], "offsets": [ [ 77, 93 ] ], "normalized": [] }, { "id": "NCT01312012_inc_T10", "type": "Value", "text": [ "above 8log10 copies per mL" ], "offsets": [ [ 94, 120 ] ], "normalized": [] } ]

[]

[]

[ { "id": "NCT01312012_inc_R1", "type": "Has_value", "arg1_id": "NCT01312012_inc_T4", "arg2_id": "NCT01312012_inc_T3", "normalized": [] }, { "id": "NCT01312012_inc_R2", "type": "Has_value", "arg1_id": "NCT01312012_inc_T8", "arg2_id": "NCT01312012_inc_T7", "normalized": [] }, { "id": "NCT01312012_inc_R3", "type": "Has_value", "arg1_id": "NCT01312012_inc_T9", "arg2_id": "NCT01312012_inc_T10", "normalized": [] } ]