chufangao/CTO huggingface dataset:
Clinical trial NCT03430843: A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Official title: A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma
Sponsor: BeiGene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 512.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-26
Primary completion date: 2020-12-01
Completion date: 2022-12-28
Limitations and caveats: The impact on treatment was considered very limited due to the small number of patients remaining on treatment, the short COVID-19 restriction period (in Asia), and limited restrictions for healthcare visits (in Europe/North America).
Plan to share individual participant data: YES
Clinical trial NCT05700630: Ph1 Study of FT538 Alone and With Vorinostat for Persistent Low-Level HIV Viremia
Official title: MT2022-06: Phase I Study of FT538 Monotherapy and in Combination With Vorinostat for the Treatment of Persistent Low-Level HIV Viremia
Sponsor: Masonic Cancer Center, University of Minnesota (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Abandoned
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-07-15
Primary completion date: 2024-07-26
Completion date: 2024-08-21
Plan to share individual participant data: NO
IPD sharing description: Research related samples will be managed using established protocols in the Schacker Laboratory.
Clinical trial NCT03116347: Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
Official title: Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects With Primary Immunodeficiency Diseases
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 42.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-05-30
Primary completion date: 2021-01-15
Completion date: 2021-01-15
Baseline population: Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia.
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 NCT03315182: Gene Transfer Clinical Trial for Mucopolysaccharidosis (MPS) IIIB
Official title: Phase I/II Gene Transfer Clinical Trial of rAAV9.CMV.hNAGLU for Mucopolysaccharidosis (MPS) IIIB
Acronym: MPSIIIB
Sponsor: Abeona Therapeutics, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Abeona has decided to discontinue development activities for Product ABO-101 due to a lack of drug supply and for business reasons unrelated to the product safety profile and/or signs of efficacy
Enrollment: 11.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-10-16
Primary completion date: 2022-04-07
Completion date: 2022-04-07
Plan to share individual participant data: NO
IPD sharing description: There is no plan to share data
Clinical trial NCT03231722: First Line mFOLFOXIRI + PANITUMUMAB vs mFOLFOX + PANITUMUMAB IN RAS AND BRAF WT METASTATIC COLORECTAL CANCER PATIENTS
Official title: The TRIPLETE Study RANDOMIZED PHASE III STUDY OF TRIPLET mFOLFOXIRI PLUS PANITUMUMAB Versus mFOLFOX6 PLUS PANITUMUMAB AS INITIAL THERAPY FOR UNRESECTABLE RAS AND BRAF WILDTYPE METASTATIC COLORECTAL CANCER PATIENTS
Acronym: TRIPLETE
Sponsor: Gruppo Oncologico del Nord-Ovest (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 435.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-13
Primary completion date: 2022-06-15
Completion date: 2022-06-24
Plan to share individual participant data: NO
Clinical trial NCT04951492: Olaparib for the Treatment of Castration Resistant Prostate Adenocarcinoma
Official title: Olaparib in Prostate Cancer Patients With Evidence of Homologous Recombination Deficiency as Assessed Using an Integrated Genomic Signature
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Withdrawal of funding
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-11-09
Primary completion date: 2023-10-15
Completion date: 2023-10-15
Plan to share individual participant data: NO
Clinical trial NCT03219164: Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
Official title: Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/Colonization
Acronym: ALPINE 2
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study was terminated early by sponsor due to the challenges and risks introduced by Coronavirus disease 2019 (COVID-19) pandemic.
Enrollment: 149.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-28
Primary completion date: 2020-05-27
Completion date: 2021-09-23
Baseline population: Safety Analysis Set included participants who were randomized and received at least one dose of study drug.
Limitations and caveats: The study was terminated early due to Coronavirus disease 2019 (COVID-19) pandemic. At the time of study termination, all evaluable participants completed the initial eradication period and provided data for the primary analysis.
Plan to share individual participant data: YES
IPD sharing description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
IPD time frame: 18 months after study completion
IPD access criteria: A secured external environment with username, password, and RSA code.
Clinical trial NCT04437953: Avatrombopag for Thrombocytopenia in People With Cancer
Official title: Clinical Trial of Avatrombopag for Thrombocytopenia in Cancer, A Phase II Single Arm Study
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-27
Primary completion date: 2020-12-03
Completion date: 2020-12-03
Plan to share individual participant data: YES
IPD sharing description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Clinical trial NCT05195528: A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)
Official title: A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg Compared to Placebo for Relief of Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD) After 4 Weeks and to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg for Relief of Heartburn in Subjects With NERD After 6 Months
Sponsor: Phathom Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 776.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-01-17
Primary completion date: 2022-11-21
Completion date: 2023-05-17
Baseline population: Data is presented for the Placebo-controlled treatment Period, ITT population.
Plan to share individual participant data: NO
Clinical trial NCT04270019: Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration
Official title: The Use of Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration: A Randomized Controlled Trial
Sponsor: Nova Scotia Health Authority (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: lack of staff, REB closed the file due to expired renewal
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-26
Primary completion date: 2023-09-15
Completion date: 2023-09-15
Plan to share individual participant data: NO
Clinical trial NCT04094077: Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Brain Metastases
Official title: A Phase II Study Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Oligo Brain Metastases.
Acronym: NANOSTEREO
Sponsor: Centre Leon Berard (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study stopped after a negative result delivred by the CPP for a substancial modification of the protocol
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-17
Primary completion date: 2021-02-24
Completion date: 2021-02-24
Clinical trial NCT04163718: TGR-1202 (Umbralisib) in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL)
Official title: A Phase 2 Study to Assess the Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Parameters of Umbralisib in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL)
Sponsor: H. Lee Moffitt Cancer Center and Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Drug no longer available
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-12
Primary completion date: 2022-10-19
Completion date: 2022-10-19
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04373460: Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
Official title: Comparison of the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune) Plasma Among Outpatients With Symptomatic COVID-19
Acronym: CSSC-004
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 1225.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-03
Primary completion date: 2022-01-14
Completion date: 2022-12-14
Baseline population: Includes participants who were randomized and received transfusion
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual participant data (IPD) collected in this study, including data dictionaries, will be made available to other researchers after the end of the study.
IPD time frame: After publication of initial study manuscript
IPD access criteria: Public
Clinical trial NCT04485429: Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia
Official title: Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study
Sponsor: D'Or Institute for Research and Education (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: It was not possible to perform the study due to the availability and logistics of porcine heparin
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-07-20
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT04403685: Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 With Inflammatory Markers
Official title: Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 and Increased Inflammatory Markers: a Phase III Randomized Clinical Trial (COVID-19 Coalition Brazil VI) (TOCIBRAS)
Acronym: TOCIBRAS
Sponsor: Beneficência Portuguesa de São Paulo (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Safety
Enrollment: 129.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-08
Primary completion date: 2020-07-08
Completion date: 2020-07-21
Plan to share individual participant data: NO
Clinical trial NCT03345550: OPTIMA-TBI Pilot Study
Official title: Pilot Study of Omega-3 Polyunsaturated Fatty Acid Treatment in Mild Acute TBI (OPTIMA-TBI Pilot)
Acronym: OPTIMA
Sponsor: University of Michigan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual of patients, lack of financial resources
Enrollment: 44.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-12
Primary completion date: 2021-07-27
Completion date: 2021-07-27
Clinical trial NCT03823378: A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib
Official title: A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial With ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599)
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study M16-763 was terminated early as the benefit of each treatment arm from the feeder study (Study M16-063) did not provide appreciable evidence of differentiated clinical effect to warrant further long-term continuation.
Enrollment: 97.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-05-13
Primary completion date: 2020-09-09
Completion date: 2020-09-09
Baseline population: Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT04059198: Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic Treatment Naive Subjects Infected With Hepatitis B Virus
Official title: A Phase 2, Exploratory Study Evaluating the Safety and Antiviral Efficacy of Inarigivir Soproxil in Non-cirrhotic Treatment-Naive Subjects Infected With Chronic Hepatitis B Virus
Sponsor: F-star Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Evidence of liver injury in a separate Inarigavir study
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-10-10
Primary completion date: 2020-04-02
Completion date: 2020-04-02
Clinical trial NCT04227756: Comparative Acute Effects of LSD, Psilocybin and Mescaline
Official title: Comparative Acute Effects of LSD, Psilocybin and Mescaline in a Random-Order Placebo-Controlled Cross-Over Study in Healthy Subjects
Acronym: LPM
Sponsor: University Hospital, Basel, Switzerland (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-05-19
Primary completion date: 2022-09-02
Completion date: 2022-09-02
Plan to share individual participant data: NO
Clinical trial NCT03093402: JBT-101 in Systemic Lupus Erythematosus (SLE)
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 109.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-12-21
Primary completion date: 2021-07-28
Completion date: 2021-07-28
Baseline population: The modified-intent-to-treat population includes all randomized participants who received at least one dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: The plan is to share data in ImmPort \[https://immport.niaid.nih.gov/ \], a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts, upon completion of the study.
IPD time frame: After completion of the study.
IPD access criteria: Data is available to the public once Individual Participant-Level data is posted to ImmPort.
Clinical trial NCT02285179: Clinical Trial to Evaluate the Safety and Effectiveness of GDC-0032 When Given Alongside Tamoxifen
Official title: Phase I/Prospective Randomized Phase II Trial Of the Safety and Efficacy of Tamoxifen in Combination With GDC-0032 Compared With Tamoxifen alONe.
Acronym: Poseidon
Sponsor: The Netherlands Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 189.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-11-30
Primary completion date: 2022-05-01
Completion date: 2022-05-01
Clinical trial NCT03739840: A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy
Acronym: DUET
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure
Enrollment: 232.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-03-06
Primary completion date: 2020-09-28
Completion date: 2020-09-28
Baseline population: Baseline Characteristics refer to the Randomized Set (RS) consisted of all participants randomized into the study.
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 NCT04811573: A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food
Official title: Bioequivalence of Three Different Tablet Formulations of 30 mg of Apremilast (EU-sourced Otezla® vs. US-sourced Otezla® vs. Japan-sourced Otezla®) Administered in Healthy Male and Female Subjects in the Fasted State as Well as (for EU-sourced Otezla® vs. US-sourced Otezla®) in the Fed State (an Open-label, Randomised, Single-dose, Five-period, Ten-sequence Crossover Study)
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: due to company decision
Enrollment: 20.0 (ACTUAL)
Number of arms: 10.0
Start date: 2021-03-31
Primary completion date: 2021-08-18
Completion date: 2021-08-18
Baseline population: Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
Limitations and caveats: This trial was prematurely discontinued due to sponsor decision. The planned recruitment amount was not reached. The planned statistical analyses of the pharmacokinetic parameters were not performed.
Plan to share individual participant data: NO
IPD sharing description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing