chufangao/CTO huggingface dataset:
Clinical trial NCT04875039: Dexametasone Versus Dexametasone Plus Dexmedetomidine in Nerve Blocks
Official title: A Randomized Comparison Between Perineural Dexamethasone and Perineural Mixture of Dexamethasone-Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Block
Sponsor: University of Chile (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-31
Primary completion date: 2022-03-01
Completion date: 2022-03-01
Plan to share individual participant data: NO
Clinical trial NCT04665921: A Study of SGN-STNV in Advanced Solid Tumors
Official title: A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
Sponsor: Seagen Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study closed due to portfolio prioritization
Enrollment: 111.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-18
Primary completion date: 2024-03-01
Completion date: 2024-03-01
Clinical trial NCT03144583: Pilot Study on the Infusion of ARI-0001 Cells in Patients With CD19+ Leukemia or Lymphoma Refractory to Therapy
Official title: Pilot Study on the Infusion of Differentiated Autologous T-cells From Peripheral Blood, Expanded and Transduced With a Lentivirus to Express a Chimeric Antigen Receptor With Anti-CD19 Specificity Conjugated With the Co-stimulatory Regions 4-1BB and CD3z in Patients With CD19+ Leukemia or Lymphoma Refractory to Therapy
Acronym: CART19-BE-01
Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-06-15
Primary completion date: 2022-09-13
Completion date: 2022-09-13
Plan to share individual participant data: NO
Clinical trial NCT02607956: Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 657.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-11-11
Primary completion date: 2017-05-12
Completion date: 2021-07-05
Baseline population: Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of the study drug.
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.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
IPD time frame: 18 months after study completion
IPD access criteria: A secured external environment with username, password, and RSA code.
Clinical trial NCT03762122: Rogaratinib in Patients With Advanced Pretreated Squamous-cell Non-small Cell Lung Cancer (SQCLC)
Official title: Fibroblast Growth Factor Receptor (FGFR) Inhibitor Rogaratinib in Patients With Advanced Pretreated Squamous-cell Non-small Cell Lung Cancer (SQCLC) Overexpressing FGFR mRNA. A Multicenter, Single Arm Phase II Trial
Sponsor: Swiss Group for Clinical Cancer Research (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to financial restructure of SAKK
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-25
Primary completion date: 2021-08-13
Completion date: 2021-08-24
Clinical trial NCT04220489: Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery
Official title: Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery: A Randomized, Double-blind, Placebo-controlled Trial
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study stopped due to unexpected issues surrounding the 2020 COVID-19 pandemic
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-17
Primary completion date: 2022-11-19
Completion date: 2022-11-19
Baseline population: Only one subject was enrolled into this trial and they were in the ketamine group
Plan to share individual participant data: NO
IPD sharing description: There is no current plan to share individual participant data. In the future, the investigators may decide to share data with other investigators both within and outside of this institution. If that were to occur, we would de-identify all of the information prior to sharing any data in this way.
Clinical trial NCT04191577: Study of CVN424 in Parkinson's Disease Patients With Motor Fluctuations
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor Fluctuations
Sponsor: Cerevance (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 136.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-02
Primary completion date: 2021-11-06
Completion date: 2021-12-13
Baseline population: Safety Analysis Set comprised of all participants who were enrolled and received at least 1 dose of study drug, classified according to the treatment they actually received.
Plan to share individual participant data: NO
Clinical trial NCT03158688: Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma.
Official title: A Randomized, Open-label, Phase 3 Study Comparing Carfilzomib, Dexamethasone, and Daratumumab to Carfilzomib and Dexamethasone for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
Acronym: CANDOR
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 466.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-13
Primary completion date: 2019-07-14
Completion date: 2022-04-15
Baseline population: Intent to Treat population
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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
Clinical trial NCT04265274: Vinorelbine, Cisplatin, Disulfiram and Copper in CTC_EMT Positive Refractory Metastatic Breast Cancer.
Official title: Phase II Study of Vinorelbine, Cisplatin, Disulfiram and Copper in CTC_EMT Positive Refractory Metastatic Breast Cancer.
Sponsor: National Cancer Institute, Slovakia (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Poor acrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-01
Primary completion date: 2022-01-01
Completion date: 2023-01-01
Plan to share individual participant data: NO
Clinical trial NCT03720470: Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
Official title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 AND DUPILUMAB IN COMPARISON WITH PLACEBO IN ADULT SUBJECTS ON BACKGROUND TOPICAL THERAPY, WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Acronym: JADE Compare
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 838.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-10-29
Primary completion date: 2019-12-27
Completion date: 2020-03-06
Baseline population: Safety analysis set included all randomized participants who received at least 1 dose of study medication.
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 NCT04635696: Ethyl Chloride for NPWT
Official title: Evaluating the Efficacy of Ethyl Chloride on Patients' Reported Pain With Negative Pressure Wound Therapy
Sponsor: ProMedica Health System (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 100.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-07
Primary completion date: 2020-12-10
Completion date: 2020-12-10
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04360187: Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis
Official title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CRISABOROLE OINTMENT, 2% IN CHINESE AND JAPANESE PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 391.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-27
Primary completion date: 2021-09-08
Completion date: 2021-09-08
Baseline population: Safety Analysis Set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
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 NCT01849250: Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors
Official title: A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients With a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 65.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-05-31
Primary completion date: 2016-01-11
Completion date: 2020-04-22
Clinical trial NCT03541369: Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Official title: A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia.
Acronym: 20170528
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Premature discontinuation of study, a strategic decision.
Enrollment: 64.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-14
Primary completion date: 2023-02-21
Completion date: 2023-02-21
Limitations and caveats: Due to the early termination of the study, the dose expansion cohort was not opened, and the secondary endpoint for duration of response which was pre-specified for the dose expansion cohort was not collected.
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 NCT03891420: A Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effects of Galidesivir in Yellow Fever or COVID-19
Official title: A Phase 1b Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Pharmacokinetics, and Anti-viral Effects of Galidesivir Administered Via Intravenous Infusion to Subjects With Yellow Fever or COVID-19
Sponsor: BioCryst Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision to no longer pursue indications studied in this trial
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-09
Primary completion date: 2021-01-31
Completion date: 2021-04-30
Plan to share individual participant data: NO
Clinical trial NCT04684381: Pharmacokinetics and Safety of Endari (L-glutamine) in Sickle Cell Disease Patients
Official title: A Phase 4, Open-Label, Single-Center Study to Assess Pharmacokinetic Characteristics and Safety of Endari in Patients With Sickle Cell Disease
Sponsor: Emmaus Medical, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-04
Primary completion date: 2021-06-30
Completion date: 2021-06-30
Plan to share individual participant data: NO
Clinical trial NCT03161483: A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus
Official title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 289.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-08-31
Primary completion date: 2021-08-03
Completion date: 2021-08-03
Plan to share individual participant data: NO
Clinical trial NCT03329690: DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]
Official title: A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor: Daiichi Sankyo (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 233.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-11-02
Primary completion date: 2019-11-08
Completion date: 2020-12-11
Baseline population: Baseline and demographic characteristics were assessed in the Full Analysis Set.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Clinical trial NCT04356690: Etoposide in Patients With COVID-19 Infection
Official title: A Phase II Single-Center, Randomized, Open-Label, Safety and Efficacy Study of Etoposide in Patients With COVID-19 Infection
Sponsor: Boston Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual, change in COVID prevalence, availability of effective vaccine
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-08
Primary completion date: 2022-07-01
Completion date: 2022-07-01
Limitations and caveats: The study was halted prematurely due to slow accrual, change in COVID prevalence, and the availability of an effective vaccine.
Plan to share individual participant data: NO
Clinical trial NCT03878914: Steroid Sensitive Nephrotic Syndrome in Children
Official title: A Multinational Prospective Study on the Duration of Steroid Therapy in Steroid Sensitive Nephrotic Syndrome
Sponsor: Wayne State University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study was terminated at all but one site because of the pandemic
Enrollment: 34.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-06
Primary completion date: 2021-10-31
Completion date: 2021-10-31
Plan to share individual participant data: NO
IPD sharing description: Depending on available resources, we may share data without any patient identifier with the study site investigators as well as others who might be interested.
Clinical trial NCT03633227: Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
Official title: A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment
Sponsor: Intercept Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Due to Ocaliva (obeticholic acid) US labeling update, the sponsor decided to terminate the study.
Enrollment: 22.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-22
Primary completion date: 2021-07-09
Completion date: 2021-07-09
Baseline population: The Intent-to-treat (ITT) population included all randomized participants who received any amount of investigational product (OCA or placebo).
Clinical trial NCT03941834: Trial for Treatment Refractory Trigeminal Neuralgia
Official title: BHV3000-202: Phase 2: A Double-Blind, Placebo Controlled, Crossover Trial of BHV-3000 (Rimegepant) for Treatment Refractory Trigeminal Neuralgia
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
Enrollment: 65.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-25
Primary completion date: 2023-05-11
Completion date: 2023-05-11
Baseline population: Participants who received at least 1 dose of double-blind study drug in DBT phase and OLE phase. Participants in DBT and OLE phases are not exclusive. Eligible participants from DBT phase entered OLE phase after completing treatment in DBT phase.
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 NCT04649203: Cytoflavin in the Treatment of Patients With Diabetic Polyneuropathy
Official title: Multicenter, Double-blind, Placebo-controlled Randomized Clinical Trial of Efficacy and Safety of the Drug Cytoflavin®, Administered Intravenously Followed by Oral Intake, in Patients With Diabetic Polyneuropathy
Acronym: CYLINDER
Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 216.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-25
Primary completion date: 2021-03-29
Completion date: 2021-06-06