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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
Enrollment goals not met
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment goals unable to be reached.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment has been terminated due to a slow rate of enrollment.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment into acute phase therapy ended August 1st, 2008. Randomized continuation phase trial is slated to end in June 2009 and follow-up to end in June 2011."
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
Enrollment into study was slower than expected.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment is paused due to COVID-19. This is not a suspension of IRB approval.
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment is pending further analysis of the stability of exendin-(9-39) at higherÊ concentrations.
[ "Interim_Analysis" ]
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
Enrollment is suspended due to COVID-19.
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment is temporarily paused due to COVID-19 and is expected to reopen in the future. This
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment is temporarily paused due to COVID-19 and is expected to reopen in the future. ThisÊ is not a suspension of IRB approval.
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment is temporarily paused due to COVID-19; interactions/interventions with current
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment not initiated for study.
[ "Insufficient_Enrollment", "Invalid_Reason" ]
false
false
false
false
false
false
true
false
true
false
false
false
false
false
false
false
false
Enrollment of patients has halted prematurely and will not resume. No future patients will be enrolled or treated.
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
Enrollment on Hold (COVID-19)
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment on hold due to COVID-19 pandemic.
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment rate was too slow.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment slower than expected
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment stopped prior to Phase 1b, change in strategic focus
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment stopped until further notice due to COVID-19 restrictions
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment suspended based upon interim analysis; subjects allowed to stay on study until disease progression.
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Enrollment suspended due to COVID-19 pandemic
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment suspended due to COVID-19, pre-screening continues for future enrollment
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment suspended due to COVID-19, prescreening continues for future enrollment
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment suspended due to low drug exposure.
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Enrollment suspended due to protocol amendment
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Enrollment suspended during the COVID-19 pandemic
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment target not reached
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment temporarily suspended to prepare grant; need IRB reapproval
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Enrollment temporarily suspended, while protocol is being revised"
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Enrollment too difficult
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment was completed with insufficient sample size for publishable results
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Enrollment was difficult
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment was much slower than anticipated, leading to a decision to terminate the studyÊ early for enrollment futility.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment was slow and we decided to refocus our efforts on other studies
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment was slower than anticipated.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment was stopped based on the Data Monitoring Committee's recommendation.
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Enrollment was too low.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment was too slow
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment was too slow and principal investigator moved to another country
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Enrollment.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Ethics Committee approval denied
[ "Ethical_Reason" ]
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
Ethics approval denied
[ "Ethical_Reason" ]
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
Evaluation of surgical technique
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Evident advantages of one treatment (seton) over the other (Tissucol Glue)
[ "Endpoint_Met" ]
false
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
Evolution of patient's care allows no more recruitment
[ "Insufficient_Enrollment", "Study_Design" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
true
false
false
Evotec has indicated that this study was discontinued due to a clinical hold issued by the FDA
[ "Regulatory" ]
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
Excess toxicity
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
Executive committee determined to close study after interim analysis.
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Exhausted personel after a long recruiting period
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Existing vessel analysis software could not be applied to breast MRI data.
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Expected mortality rates in placebo and treatment groups lower than predicted
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Experience gained from this study is sufficient to design and facilitate the follow-on study
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
Experience gained from this study is sufficient to design and facilitate the follow-on study.
[ "Success" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
Experimental arm (induction + low dose tacrolimus) not effective.
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Experimental results were unsatisfatory compared with control.
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Expiration of current lot of MEDI-507, ongoing discussion about future source of MEDI-507"
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Expired IRB approval
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Expired for lack of continuing review
[ "Regulatory" ]
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
Exploratory study proactively terminated by Roche after slow enrollment due to concerns regarding the CV safety profile of TZDs in patients with symptomatic CHF
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Extreme toxicity in Phase I, study did not proceed to Phase II
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
F Funding Expiration
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
FDA Clinical Hold
[ "Regulatory" ]
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
FDA Clinical Hold as of 12/21/07 due to safety concerns
[ "Safety_Sideeffects", "Regulatory" ]
false
false
false
false
false
false
false
false
false
false
false
false
true
true
false
false
false
FDA Hold May 2007
[ "Business_Administrative", "Regulatory" ]
false
true
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
FDA agreed to early termination of the study due to difficulties enrolling patients.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
FDA concerns regarding Avandamet
[ "Safety_Sideeffects", "Regulatory" ]
false
false
false
false
false
false
false
false
false
false
false
false
true
true
false
false
false
FDA drug recall on July 30, 2010
[ "Study_Design", "Regulatory" ]
false
false
false
false
false
false
false
false
false
false
false
false
true
false
true
false
false
FDA has placed all trials involving Pacritinib on Full Clinical Hold
[ "Regulatory" ]
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
Facet no longer has ownership of ularitide.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Fail of applying funding
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Failed primary endpoint
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Failed to enroll patients
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Failure of an inroducer sheath used in the technique specified by the study. posing a risk. No adverse outcome has occurred in a study patient.
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
Failure rate was 100% in one arm of the study (the intervention)
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Failure to Recruit in a Timely manner
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Failure to demonstrate a tolerable dose that had potential for efficacy.
[ "Study_Design", "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
true
false
false
Failure to include
[ "No_Context" ]
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
Failure to recruit
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Failure to recruit due to polypharmacy
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Failure to recruit enough patients
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Failure to recruit patients with membranous lupus nephritis not previously treated with azathioprine .
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Failure to recruit sufficient participants
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Failure to recruit sufficient participants.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Failure to secure adequate funding
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Feasibility and low enrollment
[ "Study_Design", "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
true
false
false
Feasibility concerns due to changes in standard of care
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Feasibility issues, only 1 patient recruited."
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Felt not to show benefit over control per DMC and confirmed via futility analysis
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Few subjects recruited, sponsor withdrew support."
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Field Safety Notice related to potential ventricular oversensing associated to the PhD featureÊ on Paradym ICDs
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
Final study report has been completed and submitted
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
Financial Constraints
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Financial and administrative matters did not allow collaboration among centers.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Financial concerns with device manufacturer.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Financial constraints
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Financial difficulties
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Financing and re-organization
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
First subject over five years after the transplant. The second subject is not in compliance Ê with follow ups. We do not plan to enroll more subjects.
[ "Study_Design", "Insufficient_Data" ]
false
false
false
false
false
true
false
false
false
false
false
false
false
false
true
false
false
First two patients enrolled after trial reopened, developed grade III-IV acute GVHD and Ê subsequently passed away.
[ "Safety_Sideeffects", "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
true
false
false
false
FlowMedica was purchased by AngioDynamics. Study will be re-started by AngioDynamics.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false