chufangao/CTO huggingface dataset:
Clinical trial NCT03223298: Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles
Official title: Comparison of Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles in the Management of Myofascial Pain Disorder: A Randomized Clinical Trial
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 75.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-31
Primary completion date: 2020-03-13
Completion date: 2020-03-13
Plan to share individual participant data: NO
Clinical trial NCT03579758: Chemotherapy Before & After Surgery in Patients With Resectable Gallbladder Cancer
Official title: Perioperative Chemotherapy Prior To and After Reoperation for Incidental Gallbladder Cancer - An International, Randomized Phase III Trial
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: This trial will open as an NCTN trial.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-03
Primary completion date: 2020-06-01
Completion date: 2020-06-01
Plan to share individual participant data: NO
Clinical trial NCT03052010: The Partners Scale-Up Project
Official title: Delivery of Integrated PrEP and ART for Couples in Kenya
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 4898.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-02-06
Primary completion date: 2020-12-15
Completion date: 2021-04-30
Plan to share individual participant data: YES
IPD sharing description: Data from the Partners Scale-Up Project will be available at end of the Project by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu)
Clinical trial NCT04199585: Safety and Tolerability of Lu AF95245 in Healthy Young Men
Official title: Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AF95245 and Open-label Crossover Study to Investigate Intra-subject Variability, Effect of Food on Lu AF95245, and Metabolic Profile of [14C]-Lu AF95245 in Healthy Young Men
Sponsor: H. Lundbeck A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: new safety data from another study
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-10
Primary completion date: 2020-02-16
Completion date: 2020-02-19
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05209152: AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia
Official title: A Phase 1 Study of AMG 176 as Monotherapy and in Combination With Azacitidine in Higher-Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 7.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-11-14
Primary completion date: 2023-12-19
Completion date: 2023-12-19
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 NCT03732469: Rectal Acetaminophen Use During Oocyte Retrievals to Reduce Post-Operative Opioid Utilization
Official title: Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients
Sponsor: University of South Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Significant change in our clinic structure prevented continued recruitment of patients to the study
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-01
Primary completion date: 2020-12-31
Completion date: 2021-03-01
Plan to share individual participant data: NO
Clinical trial NCT02608125: A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma
Official title: A Phase I Open-Label, Multicenter, Dose-Escalation Study of PRN1371, a FGFR 1-4 Kinase Inhibitor, in Adult Patients With Advanced Solid Tumors, Followed by an Expansion Cohort in Patients With Metastatic Urothelial Carcinoma With FGFR 1, 2, 3, or 4 Genetic Alterations
Sponsor: Principia Biopharma, a Sanofi Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: focus portfolio on immune-mediated diseases
Enrollment: 45.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-10-28
Primary completion date: 2020-06-23
Completion date: 2020-06-23
Clinical trial NCT02923986: Clinical Trial of BP1001 (Liposomal Grb2 Antisense Oligonucleotide) in Combination With Dasatinib in Patients With Ph + CML Who Have Failed TKI, Ph+ AML, Ph+ MDS
Official title: A Phase Ib/IIa Single-arm, Open-label Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Dasatinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML) Including Chronic Phase Patients Who Have Failed Initial Tyrosine Kinase Inhibitor (TKI) Therapy, Accelerated or Blast Phase, Ph+ Acute Myeloid Leukemia (AML) or High-risk Ph+ Myelodysplastic Syndrome (MDS)
Sponsor: Bio-Path Holdings, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: No enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-01
Primary completion date: 2020-05-27
Completion date: 2020-05-27
Plan to share individual participant data: NO
Clinical trial NCT04899349: Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant
Official title: EPIK-B4: A Phase II, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR During Treatment With Alpelisib (BYL719) in Combination With Fulvestrant in Participants With HR+, HER2-, Advanced Breast Cancer With a PIK3CA Mutation Following Progression on/After Endocrine-based Therapy
Acronym: EPIK-B4
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was early terminated due to slow recruitment and emerging data showing that prophylactic use of metformin may prevent or reduce the incidence of all-grades alpelisib-related hyperglycemia. The decision was not driven by safety concerns
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-06
Primary completion date: 2023-05-10
Completion date: 2023-05-10
Baseline population: The trial was early terminated and no participants were randomized to the Alpelisib+Fulvestrant+Metformin XR arm.
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 NCT02360371: A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans
Official title: A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 100.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-04-30
Primary completion date: 2020-05-31
Completion date: 2021-05-31
Clinical trial NCT03927911: Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Official title: A Multicenter, Prospective, Active Controlled, Real World, Phase 4 Study of EXPAREL in Multimodal Regimens Compared With Standard of Care for Postsurgical Pain Management in Subjects Undergoing Lumbar Posterior Spine Surgeries (FUSION)
Acronym: FUSION
Sponsor: Pacira Pharmaceuticals, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Due to protocol feasibility given the rapid evolution of medical practice for spinal procedure. Data from approximately 65 FUSION study subjects will be analyzed with the intent to create either a future study or registry for this patient population.
Enrollment: 65.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-31
Primary completion date: 2020-08-04
Completion date: 2020-08-04
Baseline population: Trial was terminated, not all arms had participants enrolled.
Clinical trial NCT03996473: Study to Test the Safety and How Radium-223 Dichloride an Alpha Particle-emitting Radioactive Agent Works in Combination With Pembrolizumab an Immune Checkpoint Inhibitor in Patients With Stage IV Non-small Cell Lung Cancer With Bone Metastases
Official title: An Open-label, Multicenter, Phase 1/2 Study of Radium-223 Dichloride in Combination With Pembrolizumab in Participants With Stage IV Non-small Cell Lung Cancer
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: LPLV reached on 30Jan2023. Study was closed early for feasibility reasons related to enrollment of first line IO naïve patients. Safety data is consistent with the known safety profile of both drugs and no new safety issues have been observed
Enrollment: 8.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-03-06
Primary completion date: 2021-04-14
Completion date: 2023-01-30
Baseline population: Safety analysis set (SAF): includes all participants who received at least 1 administration of study treatment.
Limitations and caveats: The study was terminated early during the Phase 1 part of the study. This decision was based on strategic considerations also acknowledging the recruitment challenges for the first-line population. Due to the early termination, tumor responses were only listed, none of the efficacy outcome measures were actually analyzed.
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 NCT05502081: Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients
Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of Antibodies Combination (Casirivimab and Imdevimab) Versus Standard Antiviral Therapy (Remdesivir and Favipravir) as Antiviral Agent Against Corona Virus 2 Infection in Hospitalized COVID-19 Patients
Sponsor: Mansoura University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 265.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-09-02
Primary completion date: 2022-12-28
Completion date: 2022-12-28
Limitations and caveats: 1. applicable only on hospitalized COVID-19 patients (not include outpatients),~2. non-randomization of antiviral drugs among included patients,~3. non-blinding of interventions to investigators
Plan to share individual participant data: YES
IPD sharing description: After the end and publication of the study
IPD time frame: After the end and publication of the study
IPD access criteria: all will be accessiable
Clinical trial NCT03858634: A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
Official title: KPL-716-C202: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Pilot Study to Investigate the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Diseases Characterized by Chronic Pruritus
Sponsor: Kiniksa Pharmaceuticals International, plc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 58.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-29
Primary completion date: 2020-04-01
Completion date: 2020-06-08
Baseline population: The baseline characteristics data are presented by combined cohorts for public reporting purposes because the low numbers of participants in the individual disease-specific cohorts may cause re-identification concerns if presented separately.
Plan to share individual participant data: NO
Clinical trial NCT04134728: Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors
Official title: A 24-week, Phase 3, Multicentre, Randomised, Double-blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Sarilumab, in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological DMARDs and/or Janus Kinase Inhibitors
Acronym: contRAst 3
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 550.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-10-31
Primary completion date: 2021-09-15
Completion date: 2022-02-01
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, key secondary endpoints and safety data 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 NCT02552212: Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS
Official title: Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-Ray Evidence of Ankylosing Spondylitis (AS) and Objective Signs of Inflammation
Acronym: C-AXSPAND
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 317.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-09-30
Primary completion date: 2018-05-31
Completion date: 2020-05-31
Baseline population: Baseline Characteristics refer to the Randomized Set witch consisted of all subjects randomized into the study.
Clinical trial NCT03004976: Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke
Official title: Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke - CoBIS 2
Acronym: CoBIS 2
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 79.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-14
Primary completion date: 2020-07-17
Completion date: 2021-03-27
Plan to share individual participant data: NO
Clinical trial NCT04326790: The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
Official title: The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
Acronym: GRECCO-19
Sponsor: National and Kapodistrian University of Athens (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow enrollment as a result of the rapid flattening of the curve of COVID-19 cases in Greece
Enrollment: 105.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-03
Primary completion date: 2020-04-27
Completion date: 2020-04-27
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04601324: Allergic Rhinitis Combination Pharmacotherapy Efficacy Study
Official title: Randomized Controlled Trial Evaluating Combination Rupatadine and Fluticasone Propionate Compared to Azelastine Hydrochloride and Fluticasone Propionate in Treating Allergic Rhinitis
Sponsor: St. Paul's Sinus Centre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: PI did not pursue this study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-15
Primary completion date: 2021-06-01
Completion date: 2021-07-01
Clinical trial NCT02691026: A Study of Pembrolizumab in Patients With Malignant Peripheral Nerve Sheath Tumor (MPNST), Not Eligible for Curative Surgery
Official title: A Phase II Study of Pembrolizumab in Patients With Malignant Peripheral Nerve Sheath Tumor (MPNST), Not Eligible for Curative Surgery
Sponsor: Oslo University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow enrollment as a result of low incidence of MPNST and the COVID-19 pandemic.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-06-30
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT03984812: Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK3732394 in Healthy Participants
Sponsor: ViiV Healthcare (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated early (following completion of SAD Cohort 3; 80 mg) based on PK/PD modelling which demonstrated the medicine's intended target profile was not achievable.
Enrollment: 24.0 (ACTUAL)
Number of arms: 9.0
Start date: 2019-06-17
Primary completion date: 2020-03-23
Completion date: 2020-03-23
Baseline population: Only data for Part 1 is presented as study was terminated during Part 1; Part 2 was not initiated.
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 NCT04435314: Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19
Official title: Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg Three Times a Day for Post Exposure Prophylaxis of COVID-19 in Subjects From Vulnerable Communities
Sponsor: Azidus Brasil (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor's strategic decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-30
Primary completion date: 2020-08-31
Completion date: 2020-08-31
Plan to share individual participant data: NO
IPD sharing description: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
Clinical trial NCT02271893: Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management
Official title: Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management
Acronym: CHEMODEX
Sponsor: University Hospital, Clermont-Ferrand (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recruitment difficulties
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-11-25
Primary completion date: 2017-10-26
Completion date: 2022-04-21
Clinical trial NCT02933255: PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer
Official title: Phase I/II Study of PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-18
Primary completion date: 2023-06-20
Completion date: 2023-12-01
Plan to share individual participant data: YES
IPD sharing description: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
IPD time frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
IPD access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.