chufangao/CTO huggingface dataset:
Clinical trial NCT04700280: A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sjögren's Syndrome (pSS)
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Primary Sjögren's Syndrome
Acronym: GLIDER
Sponsor: Galapagos NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated based on Sponsor decision
Enrollment: 31.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-28
Primary completion date: 2021-10-28
Completion date: 2021-12-27
Baseline population: The safety analysis set included all randomized participants who received at least one dose of study drug.
Limitations and caveats: There were limitations in the dataset, given the small number of participants completing the treatment period due to early termination of the study.
Plan to share individual participant data: NO
Clinical trial NCT02661464: Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
Official title: A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
Sponsor: Janssen Vaccines & Prevention B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to the pandemic with only one participant in follow up, as the impact on the safety was determined to be negligible, the study was terminated early.
Enrollment: 677.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-05-31
Primary completion date: 2021-12-13
Completion date: 2021-12-13
Baseline population: Full analysis set (FAS) included all participants who were enrolled in this study and had at least one post-baseline visit, regardless of the occurrence of protocol deviations.
Limitations and caveats: As none of the participants met Cohort 2 eligibility criteria pre-specified in the protocol, therefore no participants were enrolled in Cohort 2. So the results were only presented for Cohorts 1 and 3.
Clinical trial NCT03732638: Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults
Official title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 1590.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-14
Primary completion date: 2019-12-10
Completion date: 2021-02-02
Baseline population: Participants who received at least one dose of study drug.
Clinical trial NCT02382523: Acthar on Proteinuria in IgA Nephropathy Patients
Official title: Impact of Acthar on Proteinuria and Disease Progression in IgA Nephropathy Patients With Nephrotic Range Proteinuria
Sponsor: Baylor College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: There were no subjects enrolled locally on this study since it opened. Local IRB closure has been requested.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-02-28
Primary completion date: 2019-01-31
Completion date: 2020-01-31
Clinical trial NCT05093608: SELINEXOR in Combination w/Bevacizumab and Atezolizumab in Newly Diagnosed Advanced Hepatocellular Carcinoma
Official title: An Investigator-initiated Phase I Study of SELINEXOR in Combination With Bevacizumab and Atezolizumab in Newly Diagnosed Advanced Hepatocellular Carcinoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Loss of funding
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-03
Primary completion date: 2022-10-12
Completion date: 2022-10-12
Clinical trial NCT03993457: Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression
Official title: Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression
Acronym: PRECISE-D
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: terminated during COVID due to inability to see participants in person.
Enrollment: 18.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-07-23
Primary completion date: 2022-03-25
Completion date: 2022-03-25
Plan to share individual participant data: NO
Clinical trial NCT04114097: The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover
Official title: The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover
Sponsor: University Hospital, Gentofte, Copenhagen (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-22
Primary completion date: 2021-03-15
Completion date: 2021-03-15
Clinical trial NCT03819218: A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream in Adolescent Subjects
Official title: A Multicentre, Open-label, Single-group Maximal Use Trial, Evaluating the Safety and Pharmacokinetic Profile of the Active Ingredients and Their Metabolites After Application of MC2-01 Cream in Adolescents With Extensive Psoriasis Vulgaris
Sponsor: MC2 Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of recruitment
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-27
Primary completion date: 2020-12-11
Completion date: 2020-12-11
Clinical trial NCT03118570: A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804
Official title: A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804)
Acronym: Asteroid
Sponsor: Ultragenyx Pharmaceutical Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 112.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-09-11
Primary completion date: 2019-10-01
Completion date: 2020-11-12
Baseline population: The 19 participants who transitioned from the Placebo arm to the Setrusumab 20 mg/kg Open-Label arm are NOT double-counted for this analysis.
Plan to share individual participant data: NO
Clinical trial NCT04232813: Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
Official title: Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
Sponsor: Instituto Palacios (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 120.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-09
Primary completion date: 2020-06-30
Completion date: 2020-11-30
Plan to share individual participant data: NO
Clinical trial NCT03330834: CAR-T Cell Immunotherapy for Advanced Lung Cancer
Official title: Safety and Toxicity of CAR-T Cell Immunotherapy in Patients With Advanced Lung Cancer After Standard Treatment Failure: A Single-Arm and Single-Center Phase I Clinical Study
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Serious adverse events
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-20
Primary completion date: 2020-04-14
Completion date: 2020-04-14
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03353454: A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)
Official title: Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat (SHP625) in the Treatment of Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)
Sponsor: Mirum Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: The study was withdrawn due to change of ownership of the study drug maralixibat. Future studies of maralixibat will be posted by Mirum Pharmaceuticals.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-25
Primary completion date: 2020-06-15
Completion date: 2020-06-15
Plan to share individual participant data: NO
Clinical trial NCT04201145: Pembrolizumab + Defactinib In Pleural Mesothelioma
Official title: Phase IA-IB Open-label, Non-randomized, Neoadjuvant Treatment With Combination Pembrolizumab and Defactinib for Patients With Surgically Resectable Malignant Pleural Mesothelioma
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Funding complications coupled with competing scientific objectives
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-09-30
Primary completion date: 2021-12-31
Completion date: 2022-12-31
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD time frame: Data can be shared no earlier than 1 year following the date of publication
IPD access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
Clinical trial NCT01771471: A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo
Official title: A Phase II, Randomized, Double Blind, Placebo Controlled Study Evaluating the Treatment of Degenerative Lumbar Discs With Allogeneic Cultured Chondrocytes
Sponsor: ISTO Technologies, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Change in clinical strategy
Enrollment: 44.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-11-30
Primary completion date: 2020-09-30
Completion date: 2020-09-30
Clinical trial NCT04320290: HCV + to HCV - Kidney Transplant
Official title: Hepatitis C Viral Kidneys Used for Non-Viremic Recipients
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: New Related Protocol to be submitted
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-21
Primary completion date: 2020-06-16
Completion date: 2020-06-16
Plan to share individual participant data: YES
IPD sharing description: Anticipate to share coded data with collaborators
IPD time frame: Ancicipate data would be available to share by 6 months are the final patient visit.
IPD access criteria: Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.
Clinical trial NCT04136145: Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects
Official title: An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the PK and Safety of Belimumab 200 mg Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Participants
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-28
Primary completion date: 2020-01-14
Completion date: 2020-01-14
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT04695704: Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19:
Official title: Double-blind Randomized Clinical Trial, Placebo-controlled to Assess the Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19: E-SPERANZA COVID-19 PROJECT
Acronym: E-SPERANZA
Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The incidence of respiratory Long COVID has decreased in the new waves, thus made impossible to achieve the required study sample.
Enrollment: 86.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-11
Primary completion date: 2023-07-24
Completion date: 2023-08-28
Plan to share individual participant data: NO
Clinical trial NCT04639843: Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma
Official title: A Phase 1 Study of Doxorubicin, CC-486 (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Safety issues with PI3 kinase inhibitors
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-03
Primary completion date: 2022-11-03
Completion date: 2022-11-03
Plan to share individual participant data: YES
IPD sharing description: .All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@All collected IPD will be shared with collaborators under the terms of collaborative agreements.
IPD time frame: Clinical data will be available during the study and indefinitely.
IPD access criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
Clinical trial NCT03130439: Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer
Official title: A Phase 2 Study of Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 27.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-05-26
Primary completion date: 2021-08-18
Completion date: 2022-01-30
Plan to share individual participant data: NO
Clinical trial NCT03820726: A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Official title: An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 435.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-16
Primary completion date: 2022-08-30
Completion date: 2022-08-30
Baseline population: Treated Set (TS): This set included all patients who were dispensed trial medication (nintedanib) and were documented to have taken at least 1 dose of open-label trial medication (nintedanib).
Plan to share individual participant data: YES
IPD sharing description: Once the criteria in section 'time frame frame' are fulfilled , researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT03852160: A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression
Official title: A Randomized, Double-Blind, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly-dosed Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression
Sponsor: Janssen-Cilag International NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: New design was developed to better fit company strategy, a new study has replaced 5413541TRD3011 study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-01
Primary completion date: 2021-07-25
Completion date: 2021-07-25
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT05042934: Lurbinectedin With or Without Irinotecan in Treating Patients With Relapsed or High Risk Metastatic Ewing Sarcoma
Official title: Phase 1B/2 Study of Lurbinectedin With or Without Irinotecan for Patients With Relapsed or High Risk Chemotherapy-Naive Ewing Sarcoma
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: PI stated trial no longer fits the framework \& portfolio of work that is prioritized by the department. PI will not have the anticipated accrual in PI view to complete the study. Given that, PI request this protocol be closed prior to its activation.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-15
Primary completion date: 2022-08-30
Completion date: 2022-08-30
Clinical trial NCT00943722: A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
Official title: A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 3074.0 (ACTUAL)
Number of arms: 5.0
Start date: 2009-08-27
Primary completion date: 2011-04-30
Completion date: 2021-04-22
Baseline population: Per protocol, baseline characteristics were analyzed in all participants randomized in the base study.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04255862: A Study to Evaluate the Bioequivalence of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants
Official title: An Open-Label, Single-Center, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study recruitment terminated due to operational difficulties executing the study under the COVID-19 pandemic.
Enrollment: 71.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-02-12
Primary completion date: 2021-04-26
Completion date: 2021-04-26
Plan to share individual participant data: NO
IPD sharing description: Data from Phase 1 trials in Healthy Volunteers is outside of UCB's data sharing policy and is unavailable for sharing.
Clinical trial NCT04466410: Safety and Efficacy of XT-150 for Treatment of Neuropathic Pain
Official title: A Double Blind, Placebo Controlled, Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Neuropathic Pain
Sponsor: Xalud Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Failure to enroll a sufficient number of patients.
Enrollment: 5.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-04-14
Primary completion date: 2022-09-27
Completion date: 2022-09-27
Plan to share individual participant data: NO
Clinical trial NCT03394924: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
Official title: A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)
Sponsor: Enanta Pharmaceuticals, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 68.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-12-27
Primary completion date: 2019-12-19
Completion date: 2020-01-16
Plan to share individual participant data: NO
Clinical trial NCT04546802: HepATocellular Cancer Hcv Therapy Study
Official title: Open Label Trial to Study the Efficacy and Safety of MK-5172 and MK-8742 +/- Ribavirin (RBV) in the Treatment of Hepatitis C G1 and 4, in Patients Eligible for Liver Transplant (HCC) or Curative Therapy or Clinically Stable Disease Post Local Resection, Embolization or Ablative Therapy
Acronym: HATCHeT
Sponsor: Bayside Health (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Recruitment will be too difficult due to available PBS funded treatment and recent Australian clinical guidelines will conflict with the premise of the study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-30
Primary completion date: 2021-06-30
Completion date: 2023-06-30
Plan to share individual participant data: NO