chufangao/CTO huggingface dataset:
Clinical trial NCT05020249: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-27
Primary completion date: 2022-09-05
Completion date: 2022-09-06
Baseline population: Baseline Characteristics refer to the Randomized Set which consisted of all randomized study participants.
Limitations and caveats: This study protocol was not submitted to FDA, and was not conducted under a US IND or IDE.
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 NCT05399368: An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis
Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 as Monotherapy in Adults With Moderate-to-Severe Atopic Dermatitis
Sponsor: RAPT Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study on clinical hold by FDA
Enrollment: 229.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-06-07
Primary completion date: 2024-05-24
Completion date: 2024-05-24
Plan to share individual participant data: NO
Clinical trial NCT05219578: RTX-224 Monotherapy in Patients With Solid Tumors
Official title: A Phase 1/2 Study of RTX-224 for the Treatment of Patients With Advanced Solid Tumors
Sponsor: Rubius Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The Sponsor terminated study after dosing 2 dose groups (7 pts) and closed trial on 11/30/22. RTX-224 was well-tolerated with no DLTs, no related deaths, SAEs or Gr. 3/4 AEs and cleared rapidly (w/in 10 min).
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-12
Primary completion date: 2022-11-30
Completion date: 2022-11-30
Plan to share individual participant data: NO
Clinical trial NCT02550652: A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 126.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-11-13
Primary completion date: 2019-01-15
Completion date: 2023-08-02
Plan to share individual participant data: NO
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT04480164: Evaluation of the Safety and Efficacy of N-desmethylclobazam in Patients With Peripheral Neuropathic Pain
Official title: A Randomized Double-blind Ascending-dose Placebo-controlled Study of N-desmethylclobazam in Patients With Peripheral Neuropathic Pain
Acronym: NDMC-201
Sponsor: University Hospital, Geneva (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: low recruitment rate and end of study finding
Enrollment: 76.0 (ESTIMATED)
Number of arms: 4.0
Start date: 2020-06-24
Primary completion date: 2022-09-01
Completion date: 2023-05-31
Plan to share individual participant data: NO
Clinical trial NCT02678312: Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure
Official title: Multicenter, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 393.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-11-03
Primary completion date: 2022-01-03
Completion date: 2022-01-03
Baseline population: Full Analysis Set included all randomized participants who received study drug, with the exception of \[2 patients in Part 2\] who had not received any study drug, but had been inadvertently randomized into the study (mis-randomized).
Plan to share individual participant data: YES
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 based on 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 NCT04129086: Ketamine for Acute Pain Management After Trauma
Official title: Ketamine for Acute Pain After Trauma: KAPT Trial
Acronym: KAPT
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 305.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-01
Primary completion date: 2022-03-30
Completion date: 2022-09-30
Plan to share individual participant data: NO
Clinical trial NCT02584777: A Phase II Non-Controlled, Open-Label, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Pacritinib in Myelofibrosis
Official title: A Phase II, Prospective, Non-Controlled, Open-Label, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Pacritinib in Asian Subjects With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post- Essential Thrombocythemia Myelofibrosis
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-11-30
Primary completion date: 2017-09-30
Completion date: 2020-08-31
Clinical trial NCT01952847: Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis
Official title: Randomized, Double Blinded Placebo-Controlled Study of Glutamine in Patients With Oral Mucositis on an mTOR Inhibitor-based Regimen or Esophagitis on a Regimen Receiving Radiation to the Esophagus
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Per PI
Enrollment: 77.0 (ACTUAL)
Number of arms: 4.0
Start date: 2014-07-10
Primary completion date: 2021-03-03
Completion date: 2021-03-03
Baseline population: Data were unavailable for 1 participant who withdrew consent after randomization but before treatment start in mTOR Inhibitor Patient Group-Placebo
Clinical trial NCT03024996: A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy
Official title: A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy
Acronym: IMmotion010
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The sponsor decided to terminate this study before the protocol-defined end-of-study, as permitted per protocol.
Enrollment: 778.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-03
Primary completion date: 2022-05-03
Completion date: 2022-12-08
Clinical trial NCT03722498: Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE
Official title: Randomized Phase Ⅱ Study of Second-line Treatment Comparing Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-fluorouracil and Leucovorin With Sorafenib in Hepatocellular Carcinoma Refractory to Transarterial Chemoembolization
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No patients join
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-01
Primary completion date: 2021-03-22
Completion date: 2021-03-22
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04333732: CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION
Official title: An International, Multi-site, Bayesian Platform Adaptive, Randomized, Placebo-controlled Trial Assessing the Effectiveness of Candidate Agents in Mitigating COVID-19 Disease in Adults
Acronym: CROWN CORONA
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 3411.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-04
Primary completion date: 2021-08-10
Completion date: 2021-12-03
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie the results reported in the main publication may be shared, after de-identification.
IPD time frame: From 3 months after the last patient last visit onward.
IPD access criteria: Investigators whose proposed use of the data has been approved by a review committee identified for this purpose.
Clinical trial NCT04042077: Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
Official title: A Randomized, Observer-blinded, Active-controlled, Phase Illb Study to Compare IV / Oral Delafloxacin Fixed-dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections
Acronym: DRESS
Sponsor: Menarini Group (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: COVID-19 seriously affected the study execution as required by the protocol
Enrollment: 268.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-25
Primary completion date: 2020-10-07
Completion date: 2020-10-28
Baseline population: ITT analysis population used as reference
Clinical trial NCT05092750: Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer
Official title: Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: 0 accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-15
Primary completion date: 2023-08-29
Completion date: 2023-08-29
Clinical trial NCT03616821: Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official title: A 54-Week, Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in)
Acronym: Expedition
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.
Enrollment: 242.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-08-07
Primary completion date: 2023-10-23
Completion date: 2023-10-23
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.
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 de-identified 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 NCT04487444: Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection
Official title: A Pilot Trial of Thymalfasin (Ta1) to Treat COVID-19 Infection in Patients With Lymphocytopenia
Acronym: Ta1
Sponsor: Rhode Island Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated due to slow enrollment and the transfer of the PI to another institution.
Enrollment: 56.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-10
Primary completion date: 2023-02-03
Completion date: 2023-02-03
Plan to share individual participant data: NO
Clinical trial NCT04109313: An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU
Official title: An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in CLOU064A2201
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 229.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-24
Primary completion date: 2022-09-09
Completion date: 2022-09-09
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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 NCT02520245: Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-08-31
Primary completion date: 2023-11-30
Completion date: 2023-11-30
Clinical trial NCT05155982: A Clinical Trial of COVAC-1, a COVID-19 Vaccine, in Generally Healthy Adults
Official title: A Randomized, Observer-Blind, Dose-Escalation, Placebo-Controlled Phase 1 Clinical Trial of COVAC-1 in Generally Healthy Adults
Sponsor: University of Saskatchewan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Decided not to move forward with the study design.
Enrollment: 0.0 (ACTUAL)
Number of arms: 8.0
Start date: 2022-06-30
Primary completion date: 2023-06-30
Completion date: 2023-10-31
Plan to share individual participant data: NO
Clinical trial NCT03610048: A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)
Official title: A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder
Sponsor: Alkermes, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 175.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-09
Primary completion date: 2020-05-01
Completion date: 2020-05-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT06074094: Probiotic Supplementation IN NAFLD Patients
Official title: Effect of Probiotic Supplementation on Non-alcoholic Fatty Liver Disease in Patients Attending Family Medicine Clinic in Ain Shams University Hospitals
Sponsor: Ain Shams University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-12
Primary completion date: 2022-12-31
Completion date: 2023-03-01
Plan to share individual participant data: UNDECIDED
IPD sharing description: when appropriate.
Clinical trial NCT05195749: A Prospective, Phase II Study to Evaluate Safety of 101-PGC-005 ('005) for Moderate to Severe COVID-19 Disease Along With Standard of Care
Official title: A Prospective, Phase II Study to Evaluate Safety of 101-PGC-005 ('005) for Moderate to Severe COVID-19 Disease Along With Standard of Care
Sponsor: 101 Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low Enrollment
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-13
Primary completion date: 2023-02-14
Completion date: 2023-02-14
Plan to share individual participant data: NO
Clinical trial NCT04313088: Investigation of Eluxadoline for Diabetic Diarrhea
Official title: Double Blind, Placebo Controlled, Cross Over Study to Investigate the Effectiveness and Safety of Eluxadoline in the Treatment of Diabetic Diarrhea
Sponsor: Temple University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: This study did not enroll any subjects
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-01
Primary completion date: 2023-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT03347422: A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion
Acronym: Cadenza
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 42.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-17
Primary completion date: 2021-12-03
Completion date: 2021-12-03
Baseline population: Analysis was performed on full analysis set (FAS) which included all randomized participants who received at least 1 dose (including partial dose) of study drug (BIVV009 or placebo).
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 NCT03763760: High-Dose Steroid for Hip Arthroplasty Patients Expected to Have Postoperative Pain
Official title: High-Dose Steroids in High Pain Responders Undergoing Total Hip-arthroplasty: A Randomized Double Blinded Controlled Trial
Sponsor: Copenhagen University Hospital, Hvidovre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 160.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-29
Primary completion date: 2021-01-01
Completion date: 2021-01-01
Plan to share individual participant data: NO
Clinical trial NCT03672175: A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder
Official title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 581.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-19
Primary completion date: 2019-09-24
Completion date: 2020-03-17
Baseline population: Safety Set included all participants who were administered IP.
Plan to share individual participant data: YES
IPD sharing description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Clinical trial NCT03095404: Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery
Official title: Optimum Dosage of Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery
Sponsor: McMaster University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: No funding available.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-30
Primary completion date: 2021-12-31
Completion date: 2022-02-28
Plan to share individual participant data: UNDECIDED