text
stringlengths 4
164
| label_descriptions
sequence | Another_Study
bool 2
classes | Business_Administrative
bool 2
classes | Covid19
bool 2
classes | Endpoint_Met
bool 2
classes | Ethical_Reason
bool 2
classes | Insufficient_Data
bool 2
classes | Insufficient_Enrollment
bool 2
classes | Interim_Analysis
bool 2
classes | Invalid_Reason
bool 2
classes | Logistics_Resources
bool 2
classes | Negative
bool 2
classes | No_Context
bool 2
classes | Regulatory
bool 2
classes | Safety_Sideeffects
bool 2
classes | Study_Design
bool 2
classes | Study_Staff_Moved
bool 2
classes | Success
bool 2
classes |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Unable to recruit participants. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unable to recruit patients | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unable to recruit subjects | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unable to recruit subjects in the Turkey site. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unable to recruit subjects into the trial. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unable to recruit sufficient numbers of patients. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unable to recruit target enrollment numbers | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unable to renegotiate an expired contract w/sponsor providing study med | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Unable to secure supply of the study medication | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Unable to successfully recruit subjects to this study. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unacceptable Neurotoxicity (2 cases) | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Unacceptable incidence of wound dehiscence in the PDS group | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Unavailability of clarithromycin 250 mg in the market | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Unavailability of investigational product | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Unavailability of study article | [
"No_Context"
] | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false |
Unavailable study resources | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
Under additional IRB Review | [
"Regulatory"
] | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false |
Undergoing interim analysis | [
"Interim_Analysis"
] | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false |
Unexpected adverse event | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Unexpected difficult recruitment. Study drug expired | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unexpected safety events. | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Unexpected side-effects: reversible and mild to moderate neurological impairment | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Unexpected withdrawal of funding | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Unexpectedely high rates of treatment-failure | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Unfavourable Pharmakokinetics | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Unforeseen difficulty identifying and enrolling eligible subjects | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unfortunately we had unforeseen difficulty recruiting to this study. Therefore we have decided to halt the study and not publish the results. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unfortunately, other Phase III clinical Study (GEM+S-1 vs GEM vs S-1) have been started in Japan." | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
UniQure, has decided not to renew the Marketing Authorization of Glybera in the EU. ThisÊ decision is not related to any safety, efficacy or quality issue | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Unknown | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
Unplanned interim analysis by DSMB indicated possible reduced response rate with the addition of Ca/Mg in pooled population. Further analysis pending. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Unrelated serious adverse events involving one of the proposed medications | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Unsatisfactory enrollment | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unsatisfactory filter deployment in several cases | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Unsuccessful recruitment | [
"Insufficient_Enrollment",
"Study_Design"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | true | false | false |
Unsufficient recruitment | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unsufficient referrals for recruitment | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Unusual high frequency of elevated liver function tests. | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Urgent shift among clinical sites toward efforts to combat COVID-19 pandemic;impacted | [
"Covid19"
] | false | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Varience of supply chain from that required by protocol | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Ventricular rate during AF in CRT-patients much lower than expected | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Very difficult to recruit patients/slow recruitment(2 patients in nearly 2 years). | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Very low rate of recruitment anticipated futility of pursuing the study | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Very low recruitment | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Very low recruitment rate | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Very poor enrollment | [
"Insufficient_Enrollment",
"Insufficient_Data"
] | false | false | false | false | false | true | true | false | false | false | false | false | false | false | false | false | false |
Very poor recruitment in the Part 4 of the study | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Very poor recruitment of patients to the study | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Very slow enrollment.Study entry criteria not in line w/local standards of care | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Voluntarily closed and terminated by the PI due to lack of feasibility | [
"Logistics_Resources",
"Study_Design"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | true | false | false |
Voluntarily terminated based on preliminary non-clinical findings. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Voluntary halt of further dosing due to an FDA Clinical Hold issued in relation to Dynavax study DV2-HBV-10 | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Voluntary suspension due to substantial study updates and COVID-19 | [
"Covid19"
] | false | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Waiting for FDA approval of IND | [
"Regulatory"
] | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false |
Was not able to recruit enough patients | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Was unable to accrue any patients | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
We are awaiting publication of the Erythropoietin in Acute Ischemic Stroke Study(NCT00604630). | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
We believe regional anesth better for TKR,90% patients got epidural. Last year we started spinal morphine one shot, and found it very promissing." | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
We can't obtained the test drug (Vadenafil) from Bayer. They decided not to carry out this trail in Taiwan. Therefore this trail has never been started. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
We closed the study to further enrollment based on the lack of perceived need for domperidone in this population. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
We could not get funding for study. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
We could not receive the support from the national medical insurance owing to the changedÊ policy of the government for clincal trials. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
We decided that the study would not substantially add to existing contributions in the literature | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
We decided to enroll patients via e-mail rather than via telephone and are waiting for the hospital registration system to be updated with patients' e-mail. | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
We determined that the results would not be worth reporting. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
We did not achieve a tolerogenic profile. Subjects withdrew from protocol and enrolled inÊ other islet transplant trials. | [
"Study_Design",
"Insufficient_Enrollment",
"Another_Study"
] | true | false | false | false | false | false | true | false | false | false | false | false | false | false | true | false | false |
We did not see any effect of Palifermin on benign or malignant tumor growth | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
We didn't use this tech in patient. | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
We didnt recieved the medicine | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
We encounter technical problems to continue with the study. (Notably difficulty in teaching the patients to use the dressing set involved in the study.) | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
We failed to recruit patients | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
We found out that there is another study on the same issue | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
We had got enough data, therefore we stopped the study and published the data." | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
We had to suspend our clinical trials due to the pandemic of COVID-19. | [
"Covid19"
] | false | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
We have decided to cancel this study. | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
We have recruited 16 subjects for the pilot study. The recruitment will resume once the amendments are approved for increasing sample size to 30 subjects. | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
We need to make significant adjustments to proposed drug and its delivery method | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
We strongly feel that the ability to recruit the required number of patients is very low andÊ thus decided to stop the study. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
We were unable to enroll a sufficient number of patients due to manpower. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
We were unable to procure the supplement for this study. | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
We were unable to receive IVIG free from phamaceutical company. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
We were unable to recruit sufficient patients within the confines of our budget | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
We wish to wait until there is more data available using this substance. | [
"Insufficient_Data"
] | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false | false |
When 9 subjects of targeted 12 subjects had been studied, no changes in plasma potassium were detected and it was deemed futile to continue with enrolment." | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
When used appear DNE3 toxic properties. The DSMB determined that due to higher than expected Ê risk and safety concerns the study should be closed. | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
While the GBT440 IPF results noted an improvement in oxygen saturation, they did not translateÊ into a clinically meaningful benefit. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Will study new T-cell construct for the same indication | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Withdrawal of drug supply. | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Withdrawal of marketing autorization of efalizumab by the EMEA. | [
"Regulatory"
] | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false |
Withdrawal of pharmaceutical company support for the investigational drug | [
"Business_Administrative",
"Logistics_Resources"
] | false | true | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Withdrawal of pharmaceutical support from Novartis | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Withdrawn (No Participants Enrolled) | [
"Study_Design",
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | true | false | false |
Withdrawn - due to lack of accrual | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Withdrawn as NCI rescinded approval for parent study NSABP-B-45 | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Withdrawn as company has shut down and filed for bankruptcy | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Withdrawn as early analysis indicated stereotactic radiosurgery not as beneficial post-op as pre-op | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Withdrawn as study has been abandoned | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
Withdrawn as study never opened | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
Withdrawn as the clinical development of ATN-224 was terminated by the drug company who was providing ATN-224 for the study | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Withdrawn as the sponsor has stopped the drug for NSCLC population | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |