chufangao/CTO huggingface dataset:
Clinical trial NCT03536884: A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Acronym: BE RADIANT
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 743.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-06-13
Primary completion date: 2019-09-12
Completion date: 2023-08-09
Baseline population: Baseline Characteristics refer to the Randomized Set (RS) which consisted of all randomized study participants.
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 NCT03896724: Safety, Immunogenicity and Efficacy of R21 Matrix-M in 5-17 Month Old Children in Nanoro, Burkina Faso
Official title: A Phase Ib/IIb Randomised Controlled Trial of the Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine, R21 Adjuvanted With Matrix-M (R21/MM), in 5-17 Month Old Children in Nanoro, Burkina Faso
Sponsor: University of Oxford (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 450.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-07
Primary completion date: 2023-07-07
Completion date: 2023-07-07
Plan to share individual participant data: YES
IPD sharing description: Study information will be made available through an open repository. The information to be made available will be anonymized so that there is no link to participants and will include data on safety, immune responses and any other data generated from samples obtained in this study.
IPD time frame: Within 12 months of manuscripts related to the trial being published.
IPD access criteria: A link to the data respository will be given below
Clinical trial NCT04625699: Study of Durvalumab + Tremelimumab in NSCLC Patients After Adjuvant Treatment
Official title: A Feasibility Study of Durvalumab + Tremelimumab in Resected Non Small Cell Lung Cancer (NSCLC) Patients With Detectable Circulating Tumor DNA After Adjuvant Treatment
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Contract was never finalized.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-31
Primary completion date: 2023-07-31
Completion date: 2023-12-31
Plan to share individual participant data: NO
Clinical trial NCT02698111: Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma
Official title: Donafenib Monotherapy for Previously Treated Metastatic Nasopharyngeal Carcinoma：an Open-label,Phase 1 Study.
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Corporate policy adjustments
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-02-08
Primary completion date: 2021-10-20
Completion date: 2021-10-20
Plan to share individual participant data: NO
Clinical trial NCT03555968: Effects of THC and Alcohol on Driving Performance
Official title: Determining the Combined Effects of THC and Alcohol on Driving Performance
Sponsor: Lakehead University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Logistical issues
Enrollment: 0.0 (ACTUAL)
Number of arms: 9.0
Start date: 2021-07-31
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT03300427: The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients
Official title: Controlled Trial on the Short-term Effects of Sacubitril/Valsartan Therapy on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Patients With NYHA II-III Heart Failure and Reduced Systolic Function Using 11C-acetate Positron Emission Tomography and Echocardiography
Acronym: TurkuPET
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 55.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-05
Primary completion date: 2022-03-23
Completion date: 2022-03-23
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 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 NCT03181789: Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA, in Healthy, HIV-Uninfected Adult Participants
Acronym: HVTN119
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 56.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-10-18
Primary completion date: 2019-10-25
Completion date: 2020-04-29
Clinical trial NCT02614261: Evaluation of Galcanezumab in the Prevention of Chronic Migraine
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN Study
Acronym: REGAIN
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1117.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-11-30
Primary completion date: 2017-03-16
Completion date: 2021-07-14
Baseline population: All randomized participants.
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 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 NCT04311294: Development of a Selective ALDH2 Inhibitor to Treat AUD
Official title: Development of a Selective ALDH2 Inhibitor for the Treatment of Alcohol Use Disorder
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Project was not funded.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-04-30
Primary completion date: 2022-01-31
Completion date: 2022-03-31
Plan to share individual participant data: NO
IPD sharing description: All data collected in this project will be shared (after appropriate de-identification) with the scientific community in a timely manner, in accordance with NIH Policy. Specifically, the dataset will be made available to the scientific community upon request and a data application will be required. These procedures are consistent with the recent NIAAA announcement: NOT-AA-18-010
Clinical trial NCT04042051: Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
Official title: Phase Ib Clinical Trial of Copanlisib in Combination With Trastuzumab Emtansine (T-DM1) in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer Panthera
Acronym: Panthera
Sponsor: Cancer Trials Ireland (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Accrual rate to date was too low to finish the trial in a reasonable timeframe
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-12
Primary completion date: 2020-11-02
Completion date: 2020-11-02
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04514510: Fixed Dose Flavonoid Isoquercetin on Thrombo-Inflammatory Biomarkers in Subjects With Stable Sickle Cell Disease
Official title: A Study to Evaluate the Effects of Fixed Dose Flavonoid Isoquercetin on Thrombo-Inflammatory Biomarkers in Subjects With Stable Sickle Cell Disease
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 46.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-02
Primary completion date: 2022-06-13
Completion date: 2022-07-07
Clinical trial NCT01639339: Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab Plus Standard of Care Versus Placebo Plus Standard of Care in Adult Subjects With Active Lupus Nephritis
Acronym: BLISS-LN
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 448.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-07-12
Primary completion date: 2019-07-25
Completion date: 2020-03-12
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 NCT02565914: A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation
Official title: A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Sponsor: Vertex Pharmaceuticals Incorporated (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1131.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-08-31
Primary completion date: 2019-05-31
Completion date: 2022-12-05
Baseline population: Baseline data is based on the parent study baseline, which is defined as the most recent non-missing measurements collected before the first dose of the study drug in the treatment period of parent studies. Baseline data is presented for all participants who signed informed consent and enrolled, or dosed, in Part A, Part B, or Part C, respectively in this study.
Clinical trial NCT04535453: A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive
Sponsor: Janssen Vaccines & Prevention B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 635.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-08-28
Primary completion date: 2022-03-09
Completion date: 2022-03-09
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 NCT04981678: The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder
Official title: A Prospective, Randomized Trial of the Effect of Buprenorphine Continuation Versus Dose Reduction on Pain Control and Post-Operative Opioid Use
Sponsor: MaineHealth (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: This study was halted prior to accumulating the full number of participants due to difficulty in recruiting study subjects.
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-01
Primary completion date: 2023-09-15
Completion date: 2023-10-16
Plan to share individual participant data: NO
Clinical trial NCT02534935: Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
Official title: A PHASE 2, RANDOMIZED, CONTROLLED, OBSERVER-BLINDED STUDY CONDUCTED TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A NEISSERIA MENINGITIDIS SEROGROUP B BIVALENT RECOMBINANT LIPOPROTEIN 2086 VACCINE (BIVALENT RLP2086) WHEN ADMINISTERED TO HEALTHY TODDLERS AGED 12 TO <18 MONTHS OR 18 TO <24 MONTHS, AND THE SAFETY AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT RLP2086
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 396.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-08-31
Primary completion date: 2017-08-21
Completion date: 2020-03-17
Baseline population: Safety population included all participants who received at least 1 dose of the investigational product (rLP2086, HAV vaccine or saline) and had safety data available.
Limitations and caveats: The immunogenicity data at 36 and 48 months after vaccination 3 was not collected due to change in planned analysis as per latest protocol amendment, according to which blood draw of participants at 36 and 48 months after Vaccination 3 was removed.
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 NCT03303235: Intravenous Versus Intramuscular Administration of Methylergonovine for Uterine Contraction in Cesarean Sections
Official title: How's the Tone? Intravenous Versus Intramuscular Administration of Methylergonovine for Uterine Contraction in Cesarean Sections
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Collaborators left the institution.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-31
Primary completion date: 2020-10-31
Completion date: 2020-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04123444: Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure
Official title: Efficacy and Safety of 72-hour Infusion of Prostacyclin (1 Nanogram(ng)/Kilo(kg)/Minute(Min)) in Patients With Septic Shock Induced Endotheliopathy - a Multicentre Randomized, Placebo-controlled, Blinded, Investigator-initiated Trial
Acronym: COMBAT-SHINE
Sponsor: Rigshospitalet, Denmark (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 279.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-30
Primary completion date: 2022-06-28
Completion date: 2022-06-28
Plan to share individual participant data: NO
Clinical trial NCT03888066: Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)
Acronym: DIAMOND
Sponsor: Vifor Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1195.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-24
Primary completion date: 2021-09-02
Completion date: 2021-09-02
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 can be requested 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 the study sponsor and researchers must sign a data sharing agreement.
Clinical trial NCT06610279: A Study of TAK-951 in Healthy Adults
Official title: A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, 3-Part Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-951 in Healthy Subjects
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated based on the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data of this study.
Enrollment: 48.0 (ACTUAL)
Number of arms: 9.0
Start date: 2022-01-07
Primary completion date: 2023-09-21
Completion date: 2023-09-21
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT04563936: Efficacy and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX®
Official title: A Multicenter, Randomized, Open-Label Phase Ⅲ Trial to Compare Efficacy and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in Patients With Prostate Cancer
Sponsor: Luye Pharma Group Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 290.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-06
Primary completion date: 2021-03-09
Completion date: 2021-03-09
Plan to share individual participant data: NO
Clinical trial NCT04307940: Study to Collect Information on How Well the Study Drug Naproxen Sodium Tablets Works Compared to Hydrocodone/Acetaminophen Tablets in Order to Relieve Pain in Participants Experiencing Moderate to Severe Pain After Having Their Wisdom Teeth Removed
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Hydrocodone/Acetaminophen Tablets in Postsurgical Dental Pain
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 221.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-03-12
Primary completion date: 2020-10-02
Completion date: 2020-10-05
Baseline population: Safety Population: included all subjects who were randomized and received at least one dose of study drug
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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Clinical trial NCT03003195: The P10s-PADRE Basket Trial: Vaccination of Metastatic Cancer Patients
Official title: A Combined Phase I/II Study of a Carbohydrate Mimotope-Based Vaccine with MONTANIDE™ ISA 51 VG STERILE for Metastatic Cancer
Sponsor: University of Arkansas (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of Funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-01
Primary completion date: 2021-03-01
Completion date: 2021-03-01
Plan to share individual participant data: NO