chufangao/CTO huggingface dataset:
Clinical trial NCT04251156: Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity
Official title: Effect and Safety of Semaglutide 2.4 mg Once-weekly on Weight Management in Subjects With Overweight or Obesity
Acronym: STEP 7
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 375.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-08
Primary completion date: 2022-08-23
Completion date: 2022-09-18
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT02623439: A Study of Haploidentical Bone Marrow Transplant for Patients With Hematologic Malignancies
Official title: A Phase 2 Study of Nonmyeloablative Conditioning With Transplantation of Partially Human Leukocyte Antigen (HLA)-Mismatched Bone Marrow and Post-transplant Cyclophosphamide for Patients With Hematologic Malignancies
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: On hold for toxicitiy
Enrollment: 20.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2012-07-31
Primary completion date: 2022-07-31
Completion date: 2022-07-31
Clinical trial NCT04063904: Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
Official title: Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
Sponsor: Gynuity Health Projects (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Difficulties with recruitment, COVID 19 pandemic
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-16
Primary completion date: 2020-04-03
Completion date: 2021-04-03
Clinical trial NCT03548415: Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Official title: A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 766720 (IONIS-GHR-LRx, an Antisense Inhibitor of the Growth Hormone Receptor) Administered Once Every 28 Days for 16 Weeks in Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (SRL)
Sponsor: Ionis Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 43.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-09-13
Primary completion date: 2021-02-18
Completion date: 2021-04-02
Baseline population: The Safety Set included all participants who were randomized and received at least one dose of Study Drug.
Limitations and caveats: While no longer powered to assess the primary endpoint (% IGF- lowering at Day 141) in accordance with the protocol, the study did permit placebo-controlled evaluation of safety and efficacy.
Plan to share individual participant data: NO
Clinical trial NCT03439514: A Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation
Official title: A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation (REALM-DCM)
Acronym: REALM-DCM
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The Sponsor terminated the study due to futility. The decision to stop the study was not based on safety concerns.
Enrollment: 77.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-17
Primary completion date: 2022-10-13
Completion date: 2022-10-13
Baseline population: The full analysis set (FAS) consisted of all randomized participants.
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 NCT03676725: Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD
Official title: Assessing the Frequency of Lidocaine Ineffectiveness in the General Population vs. Males With ADHD, and Females With ADHD, With or Without PMS
Sponsor: PhenoSolve, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 90.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-14
Primary completion date: 2020-03-01
Completion date: 2020-03-01
Plan to share individual participant data: YES
IPD sharing description: We plan to submit for publication descriptions of what was accomplished, and the evaluations as described in the study, including the incidence of lidocaine ineffectiveness in those with ADHD and in the general population.
IPD time frame: 9-12 months
IPD access criteria: Researchers
Clinical trial NCT04359680: Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection
Official title: A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection
Sponsor: Romark Laboratories L.C. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1407.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-13
Primary completion date: 2021-04-07
Completion date: 2021-04-07
Baseline population: Safety population consists of all subjects receiving at least one dose of study medication.
Clinical trial NCT03358706: A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis
Official title: A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis.
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: unavailability of probe substrates
Enrollment: 57.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2018-02-02
Primary completion date: 2024-10-01
Completion date: 2024-10-01
Clinical trial NCT03338959: Pembrolizumab and Radiation Therapy in Treating Patients With Intermediate or High-Grade Soft Tissue Sarcoma
Official title: A Pilot Study of Pembrolizumab and Neoadjuvant Radiation for Large, High-Risk Soft Tissue Sarcomas
Sponsor: Fred Hutchinson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 27.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-28
Primary completion date: 2023-06-08
Completion date: 2023-08-04
Plan to share individual participant data: NO
Clinical trial NCT03847090: Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
Official title: Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)
Acronym: URIROX-2
Sponsor: Allena Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Interim Analysis -
Enrollment: 92.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-26
Primary completion date: 2022-05-19
Completion date: 2022-05-19
Plan to share individual participant data: NO
Clinical trial NCT03197935: A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer
Official title: A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer
Acronym: IMpassion031
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 333.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-24
Primary completion date: 2020-04-03
Completion date: 2022-09-28
Limitations and caveats: This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of EFS, DFS and OS. The analyses of these secondary endpoints are descriptive in nature.
Clinical trial NCT03868566: An Open-Label Study to Assess the Hepatic Protection Effect of SNP-612, in Patients With NAFLD
Official title: An Open-Label Study to Assess the Hepatic Protection Effect of a Food Supplement Product, SNP-612, in Patients With Non-alcoholic Fatty Liver Disease
Sponsor: Sinew Pharma Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: recruitment difficulties due to Covid-19
Enrollment: 90.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-04
Primary completion date: 2021-09-22
Completion date: 2021-10-19
Plan to share individual participant data: NO
Clinical trial NCT04218565: Golimumab for the Treatment of Refractory Behcet's Uveitis
Official title: Efficacy and Safety of Golimumab in the Treatment of Refractory Uveitis in Patients With Behcet's Disease
Sponsor: Peking Union Medical College Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: only one patient enrolled
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-15
Primary completion date: 2022-12-15
Completion date: 2022-12-15
Plan to share individual participant data: NO
Clinical trial NCT05053737: Radiotherapy in Combination With Atezolizumab Prior to Surgical Resection for HPV Unrelated HNSCC
Official title: Phase I/II Trial of Radiotherapy in Combination With Atezolizumab Prior to Surgical Resection for HPV-unrelated Squamous Cell Carcinoma of the Head and Neck (HNSCC)
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: Interim Analysis
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-02
Primary completion date: 2023-11-24
Completion date: 2024-11-30
Plan to share individual participant data: NO
Clinical trial NCT03978156: Dronabinol for Pain and Inflammation in Adults Living With Sickle Cell Disease
Official title: Dronabinol for Pain and Inflammation in Adults Living With Sickle Cell Disease
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Covid-19. Relocation of trainee/investigator. Covid-19.
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-26
Primary completion date: 2021-01-01
Completion date: 2021-01-01
Clinical trial NCT03461861: Network-Level Mechanisms for Preclinical Alzheimer's Disease Development
Official title: Network-Level Mechanisms for Preclinical Alzheimer's Disease Development
Sponsor: Medical College of Wisconsin (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-11
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Baseline population: One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis
Limitations and caveats: 26 total patients were enrolled in the project, and 25 total patients were included in analysis. One enrolled subject did not have detectable LEV in their blood sample and was discarded in analysis.
Plan to share individual participant data: NO
Clinical trial NCT05198362: Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome
Official title: A Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi-center, 16-week Dose Finding, Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Prader-Willi Syndrome
Acronym: PWS
Sponsor: Saniona (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Due to financial considerations Sponsor is unable to complete the trial and assess the planned objectives/endpoints. No subjects have been randomized to treatment in the clinical trial and the decision therefore has no safety concern for patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-12-28
Primary completion date: 2022-12-09
Completion date: 2022-12-09
Plan to share individual participant data: YES
IPD sharing description: The Sponsor will consider requests from qualified researchers for access to TM006 study materials
IPD time frame: Following completion of Tesomet clinical development
Clinical trial NCT04367935: Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome
Official title: Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome: A Pilot Study
Sponsor: Ain Shams University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 43.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-01
Primary completion date: 2022-04-25
Completion date: 2022-04-25
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04027946: LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase II Study of LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated due to slow accrual.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-11
Primary completion date: 2020-06-17
Completion date: 2023-12-22
Baseline population: Although 3 participants were screen failures, data collected for all (6) participants enrolled is shown here.
Plan to share individual participant data: YES
IPD sharing description: 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 Plan (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.
Clinical trial NCT03156621: Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Homozygous Familial Hypercholesterolemia
Acronym: ODYSSEY HoFH
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 69.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-03
Primary completion date: 2019-09-27
Completion date: 2020-02-13
Clinical trial NCT03389750: A Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists.
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists in Physically Dependent Opioid Users With Moderate-to-Severe Opioid Use Disorder
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-03-15
Primary completion date: 2022-06-15
Completion date: 2023-06-28
Baseline population: Baseline demographics include all participants who were randomized/enrolled.
Plan to share individual participant data: NO
Clinical trial NCT03019588: Efficacy and Safety Study of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-line Therapy With Platinum and Fluoropyrimidine (MK-3475-063/KEYNOTE-063)
Official title: A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Business Reasons
Enrollment: 94.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-02-16
Primary completion date: 2021-06-29
Completion date: 2021-06-29
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04091438: A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
Official title: A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Crossover Study of a Single Intravenous Infusion Dose of TAK-925 in Patients With Idiopathic Hypersomnia
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 28.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-26
Primary completion date: 2020-11-19
Completion date: 2020-11-23
Baseline population: The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT03508453: IC14 for Treatment of Amyotrophic Lateral Sclerosis
Official title: A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study of IC14 for Treatment of Patients With Rapidly Progressive Motor Neuron Disease
Sponsor: Implicit Bioscience (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study will not be conducted due to lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-15
Primary completion date: 2021-05-15
Completion date: 2021-12-15
Plan to share individual participant data: NO
Clinical trial NCT02545127: Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Trial Exploring the Efficacy and Safety of Intra-nasal Administration of Merotocin in Increasing Milk Production in Maternal Subjects With Preterm Delivery and Inadequate Milk Production
Acronym: MERMAID
Sponsor: Ferring Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The trial was prematurely terminated. Termination was not because of safety concerns but due to slow recruitment.
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-28
Primary completion date: 2022-11-11
Completion date: 2022-11-11
Plan to share individual participant data: NO
Clinical trial NCT04679818: Postoperative Consequences of Intraoperative NOL Titration
Official title: Postoperative Consequences of Intraoperative NOL Titration
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 72.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-30
Primary completion date: 2022-12-30
Completion date: 2023-01-10
Clinical trial NCT04333654: Hydroxychloroquine in Outpatient Adults With COVID-19
Official title: A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Rate of enrollment too slow to allow completion in a reasonable timeframe
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-12
Primary completion date: 2020-05-26
Completion date: 2020-05-26
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 NCT05007509: Safety and Immunogenicity Study of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers (COVID-19)
Official title: A Phase I/IIa Study to Evaluate Safety and Immunogenicity of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers
Sponsor: Laboratorios Hipra, S.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-16
Primary completion date: 2021-09-30
Completion date: 2022-09-30
Plan to share individual participant data: UNDECIDED
IPD sharing description: To be decided
Clinical trial NCT04560309: Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF
Official title: Role of Glutamine as Myocardial Protector in Elective On-Pump Coronary Artery Bypass Graft Surgery With Low Ejection Fraction
Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-01
Primary completion date: 2021-10-30
Completion date: 2021-11-23
Limitations and caveats: This study has some limitations. Limitations includes the sampling time of right atrial appendage tissue which was only at 5 minutes after CPB. Right atrial appendage tissue was used for apoptotic index assessment using TUNEL staining. Right atrial appendage tissue could not be sampled at 6 hours after CPB because sternal closure was performed prior to 6 hours.
Plan to share individual participant data: YES
IPD sharing description: Individual deidentified participant data reported in this study will be made available on request after publication and ending 36 months following article publication. Researchers needs to state their aims of analyses and provide a methodologically sound proposal. Proposals should be directed to the corresponding author.
IPD time frame: Data will be made available after publication until 36 months following article publication
IPD access criteria: Researchers needs to state their aims of analyses and provide a methodologically sound proposal. Proposals should be directed to the corresponding author.