chufangao/CTO huggingface dataset:
Clinical trial NCT03721172: Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy
Official title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Mild to Moderate Plaque Psoriasis
Acronym: ADVANCE
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 595.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-03-11
Primary completion date: 2020-03-06
Completion date: 2020-07-24
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT04954326: A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Official title: A Multicentre, Phase II Randomized Study, Open-label, With 2-arm Parallel Group, Comparing the Pharmacokinetics of the Liquid and the Lyophilized Formulations of Pegaspargase (S95014) in Treatment of Paediatric Patients With Newly-Diagnosed Acute Lymphoblastic Leukemia (ALL)
Acronym: ALL
Sponsor: Servier (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 89.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-07
Primary completion date: 2022-05-20
Completion date: 2022-05-20
Baseline population: One patient in the S95014 liquid (LIQ) group was prematurely withdrawn from the study on the day of randomization due to a major deviation/protocol violation (patient with B-cell Burkitt Acute Lymphoblastic Leukemia) and did not receive the study treatment. Another patient who was randomized in the lyophilizate (LYO) group but received the LIQ formulation in error, was analyzed according to the treatment actually received, LIQ, and counted here under LIQ.
Plan to share individual participant data: YES
IPD sharing description: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Clinical trial NCT04655157: Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma
Official title: A Multi-Center Phase I/II Open Label Study to Evaluate Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimumab. (QUAD 01: Quadruple Therapy in Melanoma)
Acronym: QUAD01
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study terminated due to slow enrollment
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-28
Primary completion date: 2022-08-03
Completion date: 2022-09-20
Plan to share individual participant data: NO
Clinical trial NCT02980276: A Randomized Placebo Controlled Trial of the Effectiveness of Metformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects
Official title: A Randomised Placebo Controlled Trial of the Effectiveness of Early MEtformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects (EMERGE)
Acronym: EMERGE
Sponsor: National University of Ireland, Galway, Ireland (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 535.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-06
Primary completion date: 2023-01-12
Completion date: 2023-04-13
Plan to share individual participant data: NO
Clinical trial NCT03834519: Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)
Official title: A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)
Acronym: KEYLYNK-010
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 793.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-02
Primary completion date: 2022-03-14
Completion date: 2024-01-27
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04363840: The LEAD COVID-19 Trial: Low-risk, Early Aspirin and Vitamin D to Reduce COVID-19 Hospitalizations
Official title: The LEAD COVID-19 Trial: Low-risk, Early Aspirin and Vitamin D to Reduce COVID-19 Hospitalizations
Acronym: LEAD COVID-19
Sponsor: Louisiana State University Health Sciences Center in New Orleans (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-05-31
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Clinical trial NCT03205891: Study of Brentuximab Vedotin Plus TAK228 for Relapsed/Refractory Classical Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma and Other CD30+Peripheral T-Cell Lymphomas
Official title: An Open Label Phase I Study of Brentuximab Vedotin Plus TAK228 for Patients With Relapsed/Refractory Classical Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma and Other CD30+Peripheral T-Cell Lymphomas
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Change in treatment priorities for these disease types as well as staffing concerns.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-31
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Clinical trial NCT03238963: A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.
Official title: A Randomized, Double-masked, Placebo-controlled Exploratory Study to Evaluate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Orally Administered BI 1467335 for 12 Weeks With a 12 Week Follow up Period in Patients With Non-proliferative Diabetic Retinopathy Without Center-involved Diabetic Macular Edema (ROBIN Study)
Acronym: ROBIN
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 79.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-19
Primary completion date: 2020-05-14
Completion date: 2020-05-14
Baseline population: Treated set (TS): the TS consists of all patients who were treated with at least one dose of trial drug (BI 1467335 or placebo).
Clinical trial NCT04931511: Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder
Official title: Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder: a Randomized Double Blind Study
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Since the COVID-19 pendemic, the regular follow-up of participant became very hard. The participant were not willing to go back to the hospital for repeat measurement. So we stop the study and plan to redesign the protocol.
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-01
Primary completion date: 2022-09-01
Completion date: 2022-09-01
Plan to share individual participant data: YES
IPD sharing description: I'd like to share the IPD with the other researchers after the paper is published.
IPD time frame: I'd like to share the IPD with the other researchers after the paper is published.
Clinical trial NCT03400943: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
Official title: A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to a change in the development program, the study was closed prematurely.
Enrollment: 93.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-01-17
Primary completion date: 2019-06-09
Completion date: 2022-04-06
Baseline population: SAF consisted of all randomized participants in FAS who took at least 1 dose of study drug. The discrepancy of group B1 and B2 between subject dispostion and baseline characteristics was caused by mistakes in the administration of study drug.~Three participants who were assigned to B1, erroneously received vilaprisan treatment instead of placebo in Treatment Period (TP) 1. Two participants who were assigned to B1, erroneously received placebo instead of vilaprisan in TP2.
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Clinical trial NCT04883138: Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients
Official title: A Phase 1 Single Ascending Dose Study of a Recombinant Hyperimmune Polyclonal Antibody Against SARS CoV-2 (GIGA-2050) in Patients Hospitalized With COVID-19
Sponsor: GigaGen, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study stopped for commercial reasons.
Enrollment: 3.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-05-24
Primary completion date: 2022-01-11
Completion date: 2022-01-11
Plan to share individual participant data: NO
IPD sharing description: No current plan to share IPD due to evaluation of potential DLTs.
Clinical trial NCT03119766: Clinical Trial of Efficacy and Safety of Kolofort in Functional Dyspepsia Patients
Official title: Multicenter Double-blind Placebo-controlled Randomized Clinical Trial of Efficacy and Safety of Kolofort in the Treatment of Patients With Functional Dyspepsia
Sponsor: Materia Medica Holding (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 370.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-28
Primary completion date: 2020-01-11
Completion date: 2020-01-11
Baseline population: The study will enroll the subjects of either gender aged 18-45 years old with verified diagnosis of functional dyspepsia according to Rome-IV criteria, intensity of dyspeptic symptoms ≥ 6 according to GIS and negative H. pylori test.
Clinical trial NCT04596995: A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Official title: An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Acronym: myOpportunITy3
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Strategic Business Decision; Not a safety decision
Enrollment: 43.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-06
Primary completion date: 2022-12-21
Completion date: 2022-12-21
Baseline population: Baseline Characteristics refer to Enrolled Set which consisted of all study participants who signed the informed consent form (ICF).
Plan to share individual participant data: YES
IPD sharing description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD time frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Clinical trial NCT03365752: Chloroprocaine Spinal for Outpatient Knee Surgery
Official title: A Comparison Study to Facilitate Earlier Discharge: Spinal Versus General Anesthesia for Outpatient Knee Surgeries, a Randomized Controlled Study
Sponsor: Hospital for Special Surgery, New York (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study halted due to COVID-19 pandemic and terminated early per request of principal investigator as Chloroprocaine use in spinal procedures has become incorporated as standard of care at HSS.
Enrollment: 39.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-06-24
Primary completion date: 2021-02-04
Completion date: 2021-02-04
Limitations and caveats: This project was terminated early, as enrollment was negatively impacted to due to the COVID-19 pandemic and because clinical practice has shifted to include the use of chloroprocaine in spinal procedures as standard of care at the Hospital for Special Surgery.
Plan to share individual participant data: NO
Clinical trial NCT02612311: Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
Official title: Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 (Umbralisib) Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
Acronym: UNITY-CLL
Sponsor: TG Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Strategic/Business decision
Enrollment: 603.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-11-19
Primary completion date: 2023-02-22
Completion date: 2023-02-22
Baseline population: The Intent-to-Treat (ITT) population included all randomized participants, regardless of administration of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202).
Limitations and caveats: Due to sponsor's business decision, the clinical trial was terminated by the sponsor prematurely. As such, the study results are reflective of the data captured to the time of study termination and with limited data verification.
Plan to share individual participant data: NO
Clinical trial NCT04362813: Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia
Official title: Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Canakinumab on Cytokine Release Syndrome in Patients With COVID-19-induced Pneumonia (CAN-COVID)
Acronym: CAN-COVID
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 454.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-30
Primary completion date: 2020-09-16
Completion date: 2020-12-22
Baseline population: While patient flow and baseline measure tables show 454 participants enrolled, only 451 randomized. 3 were mis-randomized i.e. assigned a randomization number in error and not treated.
Plan to share individual participant data: UNDECIDED
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Clinical trial NCT03890198: A Phase 1 Study of LCAR-C182A Cells in the Treatment of Advanced Gastric Cancer and Pancreatic Ductal Adenocarcinoma
Official title: A Phase 1, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of LCAR-C182A, an Anti-Claudin18.2 CAR-T Cell Therapy in Patients With Advanced Gastric Cancer and Pancreatic Ductal Adenocarcinoma
Sponsor: First Affiliated Hospital Xi'an Jiaotong University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: the Preliminary data, progress of this study and the adjustment of the pipeline and strategy .
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-22
Primary completion date: 2020-03-06
Completion date: 2020-03-06
Clinical trial NCT04598477: A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
Official title: An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Pemphigus
Acronym: ADDRESS+
Sponsor: argenx (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Based on the lack of observed efficacy in the primary study ARGX-113-1904, the sponsor decided to discontinue the open-label extension study.
Enrollment: 183.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-15
Primary completion date: 2024-03-25
Completion date: 2024-03-25
Clinical trial NCT05317442: Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
Official title: Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
Sponsor: Taipei Medical University WanFang Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Study halted prematurely and will not resume.
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-04-06
Primary completion date: 2024-04-19
Completion date: 2024-04-19
Plan to share individual participant data: NO
IPD sharing description: IIT study
Clinical trial NCT02854670: A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia
Acronym: CAPSIVU
Sponsor: Centre Hospitalier Universitaire de Besancon (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Recruitment difficulties
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-01-20
Primary completion date: 2021-02-03
Completion date: 2021-02-03
Plan to share individual participant data: NO
Clinical trial NCT02420795: Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official title: Phase I/II Study of Oral ONC201 in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Per PI Request
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-11-03
Primary completion date: 2020-11-16
Completion date: 2020-11-16
Baseline population: Patients enrolled on Arm A until Arm B approved in 2/9/2016 IRB amendment