chufangao/CTO huggingface dataset:
Clinical trial NCT04707352: Impact on Atrial Remodeling of Dapaglifozin in Patients With Heart Failure .
Official title: Impact on Atrial Remodeling of Dapaglifozin in Patients With Heart Failure .
Acronym: MODA
Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 162.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-08
Primary completion date: 2023-03-26
Completion date: 2023-03-26
Clinical trial NCT02255656: Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409
Official title: A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)
Acronym: TOPAZ
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 1062.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-01-07
Primary completion date: 2020-07-15
Completion date: 2020-07-15
Baseline population: Analysis was performed on all enrolled participants.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT05012436: A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects
Official title: A Study to Evaluate the Pharmacokinetics and Safety Following a Single Oral Dose of YHD1119 in Subjects With Renal Impairment and Healthy Subjects
Sponsor: Yuhan Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-24
Primary completion date: 2022-05-10
Completion date: 2022-05-10
Plan to share individual participant data: NO
Clinical trial NCT01977638: Phase 1 Trial of CXD101 in Patients With Advanced Cancer
Official title: Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CXD101 Given Orally (Twice Daily Dosing for 5 Consecutive Days in a 21-day Period) in Patients With Advanced Malignancies Expressing the Biomarker HR23B
Sponsor: Oxford University Hospitals NHS Trust (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 51.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-02-14
Primary completion date: 2019-10-08
Completion date: 2022-10-14
Plan to share individual participant data: NO
Clinical trial NCT04571515: Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
Official title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
Sponsor: Viatris Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 114.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-09-29
Primary completion date: 2020-12-15
Completion date: 2020-12-22
Baseline population: Safety Analysis Set
Clinical trial NCT04483687: Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy
Acronym: SEALION1-IR
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Development program terminated
Enrollment: 0.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-12-31
Primary completion date: 2023-01-31
Completion date: 2024-09-30
Plan to share individual participant data: NO
Clinical trial NCT04641975: A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
Official title: A Phase 3, Double-blind, Randomized, Multicenter, Parallel Group, Placebo-controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Subjects From 5 to < 18 Years of Age With Overactive Bladder
Acronym: Dolphin
Sponsor: Astellas Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Termination due to operational futility
Enrollment: 26.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-03-15
Primary completion date: 2023-07-07
Completion date: 2023-07-24
Baseline population: Safety Analysis Set (SAF) included all participants who received at least one dose of study drug.
Plan to share individual participant data: NO
IPD sharing description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.
Clinical trial NCT02544880: PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC
Official title: PDE5 Inhibition Via Tadalafil (Cialis®) to Enhance Anti-Tumor MUC1 Vaccine Efficacy in Patients With Resectable, and Recurrent or Second Primary Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase I/II Clinical Trial
Sponsor: University of Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 5.0
Start date: 2016-04-25
Primary completion date: 2019-06-02
Completion date: 2021-06-08
Plan to share individual participant data: NO
Clinical trial NCT04008043: Pilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain
Official title: The Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain After Periodontal Surgery Among Patients at the Henry M. Goldman School of Dental Medicine Pilot Study
Sponsor: Boston University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Inadequate resources to start the study at this site.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-29
Primary completion date: 2021-05-31
Completion date: 2021-05-31
Plan to share individual participant data: NO
Clinical trial NCT02721979: Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance
Official title: A Phase 2 Study of Apalutamide in Active Surveillance Patients
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated due to slow accrual
Enrollment: 24.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-02
Primary completion date: 2020-02-12
Completion date: 2021-11-30
Baseline population: There are 24 participants who signed the consent form, and only 23 progressed into the treatment phase. One patient was a screen fail.
Limitations and caveats: We acknowledge that the small sample size of this study is one of its primary limitations, which was further challenged by its premature termination.
Clinical trial NCT05829187: Momordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency
Official title: Effectiveness of Momordica Charantia Extract Compared to the Standard Antimalarial Drug Combination Dihydroartemisinin Piperaquine-primaquine in Patients With Uncomplicated Falciparum Malaria, in Sumba Barat Daya District of Indonesia
Acronym: MCHUPF
Sponsor: Pancasila University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-01
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Clinical trial NCT04025632: Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated based on the primary efficacy endpoint analysis after the first data lock.
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-07
Primary completion date: 2021-03-04
Completion date: 2021-06-14
Baseline population: Intent-to-Treat (ITT) Population included all randomized participants.
Limitations and caveats: The study was terminated based on the primary efficacy endpoint analysis after the first data lock.
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 NCT02581943: Effect of Pembrolizumab With or Without Carboplatin and Paclitaxel on Immune Response in Patients With Recurrent or Stage IIIB-IV Non-small Cell Lung Cancer
Official title: Immune Response in Patients With Recurrent or Metastatic Non-small Cell Lung Cancer and Performance Status of 2 Treated With a Combination of Pembrolizumab and Low Dose Weekly Carboplatin/Paclitaxel
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 43.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-17
Primary completion date: 2022-11-19
Completion date: 2022-12-28
Clinical trial NCT05567523: Safety Study of Dexmedetomidine in Elderly Under General Anesthesia
Official title: Effects of Dexmedetomidine at Different Doses on Hemodynamics and Recovery Quality in Elderly Patients Undergoing Hip Replacement Surgery Under General Anesthesia
Sponsor: Zhenjiang First People's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 200.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-01
Primary completion date: 2022-02-28
Completion date: 2022-03-30
Plan to share individual participant data: YES
IPD sharing description: all collected IPD, all IPD that underlie results in a publication
IPD time frame: Data are available after publication and up to one year after publication.
IPD access criteria: Send an email to dolinet@163.com
Clinical trial NCT04561219: Nitazoxanide Therapy for Patients With COVID-19 Pneumonia
Official title: Nitazoxanide for Moderate to Severe COVID-19 Pneumonia: a Multicenter, Randomized, Placebo-controlled, Double-Blind Clinical Trial
Sponsor: Universidade Federal do Rio de Janeiro (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 500.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-19
Primary completion date: 2020-10-02
Completion date: 2020-10-02
Plan to share individual participant data: YES
IPD sharing description: The investigators plan on sharing all IPD that underlie results in a publication for editorial board, with cautious of not sharing confidential data.
IPD time frame: Available as soon as the editorial board of the journal accepting the manuscript requires.
IPD access criteria: Editorial board of the Journal accepting the manuscript.
Clinical trial NCT05152563: A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis
Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of Subcutaneous AK002 in Subjects With Moderate to Severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis
Acronym: ENIGMA-SC
Sponsor: Allakos Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Company decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-12-31
Primary completion date: 2022-01-20
Completion date: 2022-01-20
Plan to share individual participant data: NO
Clinical trial NCT02341625: A Study of BMS-986148 in Patients With Select Advanced Solid Tumors
Official title: A Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study terminated for business reasons not related to safety.
Enrollment: 126.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-06-19
Primary completion date: 2019-02-25
Completion date: 2020-05-07
Clinical trial NCT04181255: Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy
Official title: The Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy Following Deep Hypothermic Circulatory Arrest During Cardiac Surgery
Sponsor: University of Michigan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Investigator Retirement
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-25
Primary completion date: 2020-06-12
Completion date: 2020-06-12
Plan to share individual participant data: NO
Clinical trial NCT04149275: Cabozantinib Plus Nivolumab and Ipilimumab in Women With Recurrent Gynecologic Carcinosarcoma
Official title: A Phase II Single Arm Study of Cabozantinib Plus Nivolumab and Ipilimumab in Women With Recurrent Gynecologic Carcinosarcoma
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Funding withdrawn by sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-28
Primary completion date: 2021-02-28
Completion date: 2021-02-28
Plan to share individual participant data: NO
IPD sharing description: To Be Determined
Clinical trial NCT01378273: Preterm Erythropoietin Neuroprotection Trial (PENUT Trial)
Official title: Preterm Erythropoietin Neuroprotection Trial (PENUT Trial)
Acronym: PENUT
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 941.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-12-31
Primary completion date: 2019-02-28
Completion date: 2020-02-28
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data will be made available through the NINDS Data Archive: https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Clinical-Research/Archived-Clinical-Research-Datasets. The data will be de-identified and a limited access data set will be available after December 2020 through a request form on that page. Data dictionaries, in addition to study protocol, the statistical analysis plan, and the informed consent form will be included. The data will be made available upon publication of all PENUT Trial related manuscripts to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
IPD time frame: December 2020
IPD access criteria: The data will be made available upon publication of all PENUT Trial related manuscripts to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
Clinical trial NCT05996445: A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors
Official title: A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®662 in Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors
Sponsor: Xencor, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The Sponsor made a business decision to end the study.
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-07-28
Primary completion date: 2024-05-21
Completion date: 2024-05-21
Clinical trial NCT04563559: PREFERENTIAL Study
Official title: Patient PReference, Efficacy, and SaFety of an Intracanalicular DExamenthasone InseRt comparEd to Topical PrednisoloNe in PatienTs UndergoIng SequentiAl PhacoemuLsification With Intraocular Lens Surgery OR Combined Phacoemulsification With IOL and a Minimally Invasive Glaucoma Surgery (MIGS)
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: PI decided not to open study
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-30
Primary completion date: 2021-11-30
Completion date: 2021-11-30
Plan to share individual participant data: NO
Clinical trial NCT02620761: Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants
Official title: Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants
Acronym: Fenaki
Sponsor: Medical College of Wisconsin (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Inability to recruit patients
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-06
Primary completion date: 2020-01-31
Completion date: 2020-01-31
Baseline population: No analysis performed as only a single patient was enrolled
Clinical trial NCT05123599: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
Official title: A Phase 1b, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Treatment With JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, HBeAg-negative Participants With Chronic Hepatitis B Virus Infection
Acronym: OSPREY
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-06
Primary completion date: 2023-07-31
Completion date: 2024-06-26
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT04297917: First in Human Study of ChAdOx1-HBV
Official title: A Phase 1 Monotherapy Study to Evaluate the Safety, Tolerability & Immunogenicity of Vaccination With Candidate Chimpanzee Adenovirus-vectored HepB Virus Vaccine ChAdOx1 HBV in Healthy Participants & Participants With Chronic HepB Infection
Sponsor: Barinthus Biotherapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 47.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-02-10
Primary completion date: 2022-05-26
Completion date: 2022-05-26
Clinical trial NCT02258815: CH14.18 1021 Antibody and IL2 After Haplo SCT in Children With Relapsed Neuroblastoma
Official title: Phase II Feasability Study Using ch14.18/CHO Antibody and Subcutaneous Interleukin 2 After Haploidentical Stem Cell Transplantation in Children With Relapsed Neuroblastoma
Sponsor: University Children's Hospital Tuebingen (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 35.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2010-08-31
Primary completion date: 2018-11-30
Completion date: 2022-12-31
Clinical trial NCT04410874: Imvamune Vaccine for the Treatment of Non-melanoma Skin Cancer
Official title: MVA-BN Imvamune Smallpox Vaccine Virus for Treatment of Basal Cell Carcinoma, Squamous Cell Carcinomas
Acronym: MUSIC-01
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Inability to recruit patients/lack of funding
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-16
Primary completion date: 2023-05-23
Completion date: 2023-05-23
Plan to share individual participant data: NO
Clinical trial NCT03773302: Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
Official title: A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial
Sponsor: QED Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The sponsor has decided to close the study due to the discontinuation of infigratinib development in oncology within the sponsor's territory. The discontinuation of the study was not due to safety issues.
Enrollment: 48.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-27
Primary completion date: 2023-03-02
Completion date: 2023-03-02
Plan to share individual participant data: NO