chufangao/CTO huggingface dataset:
Clinical trial NCT04501094: A Phase II Study of Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Naive and Refractory Subjects With Urothelial Carcinoma
Official title: A Phase II Study of Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Naive and Refractory Subjects With Urothelial Carcinoma
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Because of the low accrual and the safety concerns we closed the study.
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-26
Primary completion date: 2021-01-19
Completion date: 2021-10-13
Plan to share individual participant data: YES
IPD sharing description: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
IPD time frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active
IPD access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).~Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
Clinical trial NCT03886220: A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Official title: A Phase 4 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 82.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-12
Primary completion date: 2021-03-31
Completion date: 2021-04-28
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing, please refer to the link below.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT04086342: CHI-902 for Treatment of Social Anxiety Disorder
Official title: CHI-902 for Treatment of Social Anxiety Disorder - A Phase IIb Randomized Double-Blind Placebo-Controlled Clinical Trial
Sponsor: Canopy Growth Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Changes in pipeline
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-24
Primary completion date: 2021-01-26
Completion date: 2021-01-26
Plan to share individual participant data: NO
Clinical trial NCT04047303: CNS Penetration, PK and PD of Preoperative CC-90010 in Progressive/Recurrent Diffuse Astrocytoma, Anaplastic Astrocytoma and Glioblastoma
Official title: A Phase 1, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics and Central Nervous System (CNS) Penetration of CC-90010 in Preoperative Subjects With Progressive or Recurrent Who Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma and Recurrent Glioblastoma Scheduled for Resection
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business objectives have changed.
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-02
Primary completion date: 2024-06-03
Completion date: 2024-06-03
Plan to share individual participant data: YES
IPD sharing description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD time frame: See Plan Description
IPD access criteria: See Plan Description
Clinical trial NCT03243838: Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer
Official title: Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer (LANCET): A Multicenter, Single-arm, Phase II Trial
Acronym: LANCET
Sponsor: Guangdong Provincial People's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 31.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-01
Primary completion date: 2021-10-13
Completion date: 2021-12-31
Clinical trial NCT01265849: Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity
Official title: Phase III Study of LI [Multikine®] Plus SOC (Surgery + Radiotherapy or Surgery + Concurrent Radiochemotherapy) in Subjects With Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate vs. SOC Only
Acronym: IT-MATTERS
Sponsor: CEL-SCI Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 928.0 (ACTUAL)
Number of arms: 3.0
Start date: 2010-12-31
Primary completion date: 2020-05-15
Completion date: 2020-12-04
Baseline population: Five randomized subjects were excluded due to the Crimean war (4 cases could not be followed) and one USA case where the Principal Investigator did not sign the full CRF, which left 923 ITT subjects in the study.
Plan to share individual participant data: NO
IPD sharing description: There is no plan
Clinical trial NCT04809220: A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes
Official title: A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Two Doses of Dulaglutide in Combination With a Single Oral Antihyperglycemic Medication or as Monotherapy in Japanese Patients With Type 2 Diabetes Mellitus (AWARD-JPN: Assessment of Weekly Administration of LY2189265 in Diabetes - JAPAN)
Acronym: AWARD-JPN
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 591.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-13
Primary completion date: 2022-10-01
Completion date: 2023-04-26
Baseline population: All randomly assigned participants, excluding the GCP compliance investigative site, who were exposed to at least 1 dose of study intervention.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT04875338: Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial
Official title: Platelet-rich Plasma, Glucocorticoid, Saline Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial
Sponsor: Istanbul University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-01-01
Primary completion date: 2023-01-01
Completion date: 2023-01-01
Plan to share individual participant data: NO
Clinical trial NCT02203513: A Phase II Single Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) in BRCA1/2 Mutation Associated Breast or Ovarian Cancer, Triple Negative Breast Cancer, High Grade Serous Ovarian Cancer, and Metastatic Castrate-Resistant Prostate Cancer
Official title: A Phase II Single Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) In BRCA1/2 Mutation Associated Breast or Ovarian Cancer, Triple Negative Breast Cancer, and High Grade Serous Ovarian Cancer
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Eli Lilly prematurely terminated the study.
Enrollment: 111.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-01-20
Primary completion date: 2021-08-27
Completion date: 2021-08-27
Baseline population: Cohorts 5 \& 6 are combined because they are for platinum resistant BRCA wild type high grade serous ovarian cancer (HGSOC) participants, literally the same population. Only difference between the two cohorts is cohort 5 is a research biopsy cohort \& cohort 6 had no safely biopsiable disease. Given that Eli Lilly prematurely terminated the study we could not enroll enough number of participants for both cohorts. Thus, it is appropriate and scientifically relevant to report the data in one group.
Plan to share individual participant data: YES
IPD sharing description: For All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.~In addition, all large-scale genomic sequencing data will be shared with subscribers to database of Genotypes and Phenotypes (dbGaP).
IPD time frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol genomic data sharing plan (GDS) for as long as database is active.
IPD access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).~Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
Clinical trial NCT02947880: Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology
Official title: Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology : Multicenter and Double Blind-study With Randomized Parallel Group, Against Placebo.
Acronym: BUMAUTEP
Sponsor: University Hospital, Limoges (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: the recently feasibility study shows that the number of patients is insufficient in the centers
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-12-31
Primary completion date: 2019-12-31
Completion date: 2020-06-30
Clinical trial NCT04369794: COVID-19: BCG As Therapeutic Vaccine, Transmission Limitation, and Immunoglobulin Enhancement
Official title: COVID-19: BCG As Therapeutic Vaccine, Transmission Limitation, and Immunoglobulin Enhancement
Acronym: BATTLE
Sponsor: University of Campinas, Brazil (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 400.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-01
Primary completion date: 2022-06-04
Completion date: 2023-08-02
Plan to share individual participant data: NO
Clinical trial NCT02912104: A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Failure
Official title: A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Failure
Acronym: POF
Sponsor: International Peace Maternity and Child Health Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-20
Primary completion date: 2022-01-05
Completion date: 2023-01-05
Plan to share individual participant data: YES
IPD sharing description: The public can require the data and protocol from clinicaltrials.gov posted by investigator
IPD time frame: 2 years
IPD access criteria: public
Clinical trial NCT03852524: Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention
Official title: Double-Blind, Randomized Trial of Peri-operative Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention After Adult Spinal Arthrodesis
Sponsor: Ohio State University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 82.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-21
Primary completion date: 2021-04-04
Completion date: 2021-05-12
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04410445: Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
Official title: A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)
Acronym: PIVOT-12
Sponsor: Nektar Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: (Sponsor decision)
Enrollment: 765.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-27
Primary completion date: 2022-09-22
Completion date: 2022-09-22
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05413369: iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
Official title: A Randomized, 24 Weeks, Active-controlled, Open-label, 2-arm Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to IDegAsp in Chinese Type 2 Diabetes Mellitus Participants Insufficiently Controlled With Oral Antidiabetic Drug(s)
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 582.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-07
Primary completion date: 2023-10-20
Completion date: 2023-10-20
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT02367794: A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]
Official title: A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1021.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-06-11
Primary completion date: 2018-10-03
Completion date: 2021-02-17
Clinical trial NCT04905212: A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
Official title: A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) With an Optional Open Label Extension in Subjects With IgA Nephropathy
Sponsor: RemeGen Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Decision that continuing with the study would not generate useful data
Enrollment: 15.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-11-04
Primary completion date: 2023-11-09
Completion date: 2023-11-09
Plan to share individual participant data: NO
Clinical trial NCT02677688: Autologous EBV-specific Cytotoxic T Cells for the Treatment of Systemic Lupus Erythematosus (SLE)
Official title: Restauration of EBV Control in SLE Phase 1-2 Trial Evaluating Adoptive Transfer of Autologous EBV- Specific Cytotoxic T Lymphocytes in SLE Treatment
Acronym: LUPUS CTL EBV
Sponsor: Nantes University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: completed inclusions
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-01-31
Primary completion date: 2021-07-01
Completion date: 2021-07-01
Plan to share individual participant data: NO
Clinical trial NCT02291055: A Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (HPV)+ Head & Neck Cancer
Official title: Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combination In Previously Treated Locally Advanced or Metastatic Cervical or HPV+ Head & Neck Cancer
Sponsor: Advaxis, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Enrollment: 75.0 (ACTUAL)
Number of arms: 5.0
Start date: 2015-04-30
Primary completion date: 2019-07-09
Completion date: 2020-11-20
Baseline population: All Treated Population included participants who received at least 1 dose of study drug.
Limitations and caveats: Based on a discussion with the FDA, a 1-year duration of the Listeria monocytogenes surveillance period was considered sufficient (instead of protocol specified 3-years period) to monitor and characterize any potential risk associated with delayed listeremia, and therefore, the study was terminated early.
Plan to share individual participant data: NO
Clinical trial NCT05228834: Voxelotor Neurocognitive Function Study
Official title: A Phase 3b, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Treatment Effect of Voxelotor on Neurocognitive Function in Pediatric Participants 8 to < 18 Years of Age With Sickle Cell Disease
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Data will not inform further development of Voxelotor
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-24
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Baseline population: Only one participant was enrolled. Hence, data cannot be reported due to risk of re-identification of participant.
Limitations and caveats: The study was terminated due to slow enrollment and resource reprioritization at L-GBT. Based on the low enrolment data was not reported due to risk of re-identification of participant.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04870112: A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
Official title: A Phase 1/2a, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Subcutaneous Durvalumab in Patients With Non-Small Cell and Small Cell Lung Cancer - SCope-D1
Acronym: SCope-D1
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 was not initiated
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-28
Primary completion date: 2023-08-30
Completion date: 2023-08-30
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT03331666: Impact of LDL-cholesterol Lowering on Platelet Activation
Official title: Impact of LDL-cholesterol Lowering on Platelet Activation
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Terminated Prematurely due to COVID-19
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-16
Primary completion date: 2020-02-04
Completion date: 2020-02-04
Baseline population: Patients who have a clinical diagnosis of familial hypercholesterolemia and are referred for treatment with PCSK9 inhibitor, with LDL cholesterol levels ≥70 mg/dl on baseline treatment with statins and/or ezetimibe or intolerant to statin and/or ezetimibe.
Plan to share individual participant data: NO
Clinical trial NCT04365985: Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19
Official title: Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19
Acronym: SINK COVID-19
Sponsor: William Beaumont Hospitals (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Because of the decrease in COVID cases, enrollment is extremely low. Given the current study design, it is not possible to gather data necessary to answer the question about whether study treatment reduces mortality
Enrollment: 70.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-04-29
Primary completion date: 2021-04-01
Completion date: 2021-04-01
Plan to share individual participant data: NO