chufangao/CTO huggingface dataset:
Clinical trial NCT04311567: Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease
Official title: Effects of Tofacitinib vs Methotrexate on Clinical and Molecular Disease Activity Markers in Joints and Lungs in Early Rheumatoid Arthritis (PULMORA) - A Randomized, Controlled, Open-label, Assessor-blinded, Phase IV Trial
Acronym: PULMORA
Sponsor: Vastra Gotaland Region (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Low recruitment due to the pandemic and high screening failure rate in particular because of low prevalence of interstitial abnormalities at diagnosis in Sweden.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-07
Primary completion date: 2023-11-30
Completion date: 2024-03-26
Clinical trial NCT04578886: The Effect of Guanfacine on Delirium in Critically Ill Patients
Official title: The Effect of Guanfacine on Delirium in Critically Ill Patients
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 100.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-23
Primary completion date: 2023-02-20
Completion date: 2023-04-01
Baseline population: Patients admitted to surgical intensive care units at the University of Alabama at Birmingham Hospital.
Limitations and caveats: This study is limited by the nature of being a single center design with a small sample size. The study population is in the critically ill surgical patient and this acuity and demographic may limit the external validity.
Plan to share individual participant data: NO
Clinical trial NCT02678455: Safety and Immunogenicity of the Dengue Virus Vaccine TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh
Official title: Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Immunogenicity of the Recombinant Live Attenuated Tetravalent Dengue Virus Vaccine Admixture TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 192.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2016-03-31
Primary completion date: 2017-08-10
Completion date: 2020-02-05
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03173859: Efficacy of Rotations Between Abiraterone Acetate and Apalutamide in mCRPC Patients
Official title: A Randomized Phase II Study to Investigate the Efficacy of Rotations Between Abiraterone Acetate and Apalutamide Versus Sequential Administration in Chemo-naïve Metastatic Castration Resistant Prostate Cancer Patients
Acronym: AERA
Sponsor: University of Athens (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Delayed initiation
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-31
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT03478982: Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern
Official title: A Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam (STAP-001) in Subjects With Epilepsy With a Predictable Seizure Pattern
Acronym: StATES
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 156.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-03-16
Primary completion date: 2019-12-22
Completion date: 2020-01-04
Baseline population: Baseline Characteristics refers to Intent-to-treat (ITT) population. ITT population included all participants who had a seizure event and received study drug during the Treatment Period.
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 NCT04959266: A Study to Assess the Effects of Itraconazole, Rifampicin, and Omeprazole on Pharmacokinetics of Adavosertib
Official title: A Phase I, Open-label, Non-randomised Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor), Rifampicin (a CYP3A4 Inducer), and Omeprazole (a Proton Pump Inhibitor) on the Pharmacokinetics of a Single Oral Dose of Adavosertib in Patients With Advanced Solid Tumours
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study terminated because the clinical development programme for Adavosertib has been discontinued
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-06-28
Primary completion date: 2022-06-01
Completion date: 2022-06-01
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the~Disclosure Statements at:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Clinical trial NCT04746495: Effect of Eplerenone on Novel Biomarkers of Mineralocorticoid Receptor Activation (ENOVA)
Official title: Effect of Eplerenone on Novel Biomarkers of Mineralocorticoid Receptor Activation (ENOVA)
Acronym: ENOVA
Sponsor: University of Michigan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Issues relate to COVID-19 and staffing challenges, as well as very tight finances.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-02-28
Primary completion date: 2023-07-01
Completion date: 2023-12-01
Plan to share individual participant data: YES
IPD sharing description: We will de-identify participant information and will share it with a trusted repository, such as National Institutes of Health (NIH) Figshare or The Inter-university Consortium for Political and Social Research (ICPSR).~We will de-identify and share data obtained from analyzing urinary mRNA biomarkers and measuring the systolic and diastolic blood pressure following consumption of a high-sodium and low-sodium diet. Additionally, specific lab values that support the validity and quality of the study treatment will be shared in a trusted repository.
IPD time frame: De-identified data will be deposited into a repository within 1 year of the conclusion of the study.
IPD access criteria: No additional access restrictions will be placed on the de-identified data, beyond those required by the repository to access or download the data.
Clinical trial NCT02829723: A Study of BLZ945 Single Agent or BLZ945 in Combination With PDR001 in Advanced Solid Tumors
Official title: A Phase I/II, Open-label, Multi-center Study of the Safety and Efficacy of BLZ945 as Single Agent and in Combination With PDR001 in Adults Patients With Advanced Solid Tumors
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Enrollment: 192.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-21
Primary completion date: 2022-12-01
Completion date: 2022-12-01
Baseline population: Full Analysis Set
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 NCT04983589: A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily
Official title: A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of BID Dosing of AGN-190584 in Subjects With Presbyopia
Acronym: Virgo
Sponsor: Allergan (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 230.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-02
Primary completion date: 2022-02-11
Completion date: 2022-02-11
Baseline population: Intent-to-treat (ITT) Population included all randomized participants.
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, analyses plans, 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: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT03737617: Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis
Official title: Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis- A Proof of Concept Study
Sponsor: University of Edinburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Cant obtain IMP
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-05
Primary completion date: 2024-08-01
Completion date: 2024-12-01
Plan to share individual participant data: NO
IPD sharing description: No plan to share IPD- will present overall data
Clinical trial NCT02747797: Lucitanib (E3810) in Patients With Advanced Cancer and FGFR, VEGFR, or PDGFR Pathway Aberrations
Official title: Histology-Independent Study of the Multikinase Inhibitor Lucitanib (E3810) in Patients With Advanced Cancer and Fibroblast Growth Factor Receptor (FGFR), Vascular Endothelial Growth Factor Receptors (VEGFR), or Platelet Derived Growth Factor Receptor (PDGFR) Pathway Aberrations
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Drug Supply No Longer Available
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-04-30
Primary completion date: 2021-04-30
Completion date: 2022-04-30
Clinical trial NCT04439071: A Study to Evaluate Efficacy and Safety of PTC299 (Emvododstat) in Hospitalized Participants With Coronavirus (COVID-19)
Official title: Evaluation of the Efficacy and Safety of PTC299 in Hospitalized Subjects With COVID-19 (FITE19)
Acronym: FITE19
Sponsor: PTC Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 189.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-09
Primary completion date: 2022-07-20
Completion date: 2022-07-20
Baseline population: Safety population included all randomized participants who received at least 1 dose of study drug.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03455556: Anetumab Ravtansine and Atezolizumab in Treating Participants With Advanced Non-small Cell Lung Cancer
Official title: Phase I/II Study of the Human Anti-Mesothelin Antibody Drug Conjugate Anetumab Ravtansine (AR), Combined With the PD-L1 Inhibitor Atezolizumab in Non-Small Cell Lung Cancer
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: slow accrual
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-10
Primary completion date: 2019-09-11
Completion date: 2020-01-07
Baseline population: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Clinical trial NCT04166383: VB-111 in Combination With Nivolumab in People With Metastatic Colorectal Cancer (mCRC)
Official title: Phase II Trial of VB-111 in Combination With Nivolumab in Patients With Metastatic Colorectal Cancer (mCRC).
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-08-09
Primary completion date: 2022-04-12
Completion date: 2022-12-31
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.
IPD time frame: Clinical data available during the study and indefinitely.
IPD access criteria: Clinical data will be made available via subscription to the Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
Clinical trial NCT05387668: Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Japanese and Caucasian Subjects
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Japanese and Caucasian Subjects
Sponsor: BeiGene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Sponsor determined the data was no longer needed.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-17
Primary completion date: 2022-10-17
Completion date: 2022-10-17
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05296525: Evaluation of Safety and Efficacy of Allo GDA-201 NK Cells in Patients With Relapsed/Refractory B Cell NHL
Official title: A Phase I/II Multicenter Study Evaluating the Safety and Efficacy of Allogeneic GDA-201 Natural Killer Cells in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma
Sponsor: Gamida Cell ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study terminated by Sponsor.
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-07-05
Primary completion date: 2024-04-22
Completion date: 2024-04-22
Clinical trial NCT03237325: DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
Official title: A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck
Sponsor: Soligenix (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 266.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-04
Primary completion date: 2020-06-24
Completion date: 2021-06-24
Baseline population: The baseline analysis population was defined as all participants that were treated with at least one dose of treatment (SGX942 or Placebo)
Plan to share individual participant data: NO
Clinical trial NCT03660657: Ozone Therapy in Refractory Ischemic Heart Disease.
Official title: Effectiveness and Cost-effectiveness of Ozone Therapy in Patients With Ischemic Heart Disease Refractory to Medical and Surgical Treatment: Randomized, Triple-blind Clinical Trial
Acronym: O3Cardio
Sponsor: Dr. Negrin University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Very low recruitment. During COVID-19 pandemic these are patients of high risk.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-26
Primary completion date: 2020-11-30
Completion date: 2020-11-30
Plan to share individual participant data: NO
Clinical trial NCT02646748: Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors
Official title: A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Pembrolizumab + INCB Combinations in Advanced Solid Tumors
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 159.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-25
Primary completion date: 2019-11-07
Completion date: 2020-11-20
Clinical trial NCT03484520: A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Official title: Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 48.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-23
Primary completion date: 2022-12-01
Completion date: 2022-12-01
Plan to share individual participant data: NO
Clinical trial NCT04190433: Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial
Official title: AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment (ATACAR) Trial
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Administratively closed due to low/no accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-01
Primary completion date: 2023-04-18
Completion date: 2023-04-18
Clinical trial NCT02918500: Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery
Official title: Effect of Pre-operative Nicotine Replacement Therapy on Peri-operative Complications and Long-term Abstinence: A Pilot Placebo-controlled Trial in Patients Undergoing Coronary Artery Bypass Surgery (CABG)
Sponsor: Ottawa Heart Institute Research Corporation (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Due to recruitment challenges.
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-23
Primary completion date: 2020-07-31
Completion date: 2020-07-31
Limitations and caveats: Study was terminated early due to recruitment challenges; only 4 participants were recruited. The data for these 4 participants will not be analyzed.
Plan to share individual participant data: NO
Clinical trial NCT04337827: Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder
Official title: Phase II Study of Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder (PTLD)
Sponsor: Case Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-09-02
Primary completion date: 2022-06-27
Completion date: 2022-12-19
Limitations and caveats: Early termination leading to small numbers of subjects, unable to perform analysis of data.
Plan to share individual participant data: NO
IPD sharing description: There are no plans to share individual patient data in order to protect the confidentiality of the subjects who enroll on this study
Clinical trial NCT03593109: A Single-center Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-L10D Cell Formulations Targeting CD19 and CD22 in Patients With CD19- and/or CD22-Positive Relapsed/Refractory B-cell Lymphoma
Official title: A Single-center Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-L10D Cell Formulations Targeting CD19 and CD22 in Patients With CD19- and/or CD22-Positive Relapsed/Refractory B-cell Lymphoma
Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Suitable patients were not recruited
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-30
Primary completion date: 2021-05-01
Completion date: 2021-05-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05067946: Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines
Official title: A Phase 2/3, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GX-19N, A DNA Vaccine, in Healthy Individuals Who Have Received One of the COVID-19 Vaccines
Sponsor: Genexine, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Change of development strategy in consideration of the global COVID-19 situation
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-31
Primary completion date: 2022-10-31
Completion date: 2023-10-31