chufangao/CTO huggingface dataset:
Clinical trial NCT03620149: Reduced Dose-density of Denosumab for Unresectable GCTB
Official title: Reduced Dose-density of Denosumab for Maintenance Therapy of Unresectable Giant Cell Tumor of Bone: a Multicenter Phase II Study REDUCE
Acronym: REDUCE
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Poor accrual
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-26
Primary completion date: 2020-07-30
Completion date: 2020-07-30
Plan to share individual participant data: YES
IPD sharing description: All publications must comply with the terms specified in the EORTC Policy 009 Release of Results and Publication Policy.
Clinical trial NCT04639024: ADCT-301 in Patients With R/R AML, MDS, or MDS/MPN
Official title: An Open-label Pilot Study to Evaluate the Safety and Efficacy of ADCT-301 in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Myeloproliferative Neoplasms.
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: ADCT is reallocating all resources to the phase III program.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-07
Primary completion date: 2022-11-03
Completion date: 2022-11-03
Plan to share individual participant data: NO
Clinical trial NCT04608331: Dexmedetomidine Supplemented Analgesia in Patients at High-risk of Obstructive Sleep Apnea
Official title: Impact of Dexmedetomidine Supplemented Analgesia on Sleep Quality in Patients at High-risk of Obstructive Sleep Apnea After Major Surgery: A Randomized, Double-blind, and Placebo-controlled Pilot Study
Sponsor: Peking University First Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 152.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-29
Primary completion date: 2022-08-17
Completion date: 2022-09-20
Plan to share individual participant data: NO
Clinical trial NCT04633772: Use of Angiotensin-(1-7) in COVID-19
Official title: Randomized Clinical Trial Phase I/II for the Use of Angiotensin-(1-7) in the Treatment of Severe Infection by Sars-CoV-2
Sponsor: Erasme University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 112.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-05
Primary completion date: 2021-11-01
Completion date: 2021-11-01
Plan to share individual participant data: NO
Clinical trial NCT03349775: Cardiometabolic Disease and Pulmonary Hypertension
Official title: Cardiometabolic Disease and Pulmonary Hypertension
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: After discussion with the Data Safety Monitoring Board and NIH, the randomized clinical trial involving metformin vs. placebo is terminated due to slow enrollment in the setting of the COVID-19 pandemic.
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-27
Primary completion date: 2020-12-22
Completion date: 2020-12-22
Baseline population: Baseline population includes participants who completed the assigned arm (metformin or placebo) and were included in analysis.
Limitations and caveats: After discussion with the Data Safety Monitoring Board and NIH, the randomized clinical trial involving metformin vs. placebo was terminated due to slow enrollment in the setting of the COVID-19 pandemic, resulting in small numbers of subjects analyzed.
Plan to share individual participant data: NO
Clinical trial NCT01720524: A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
Official title: A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN) OR HYPOXIC RESPIRATORY FAILURE AND AT RISK FOR PPHN, WITH A LONG TERM FOLLOW-UP INVESTIGATION OF DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS AFTER COMPLETION OF STUDY TREATMENT
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 59.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-08-05
Primary completion date: 2018-10-17
Completion date: 2020-09-28
Baseline population: Safety population included all participants treated with study treatment.
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 NCT04091737: CSL200 Gene Therapy in Adults With Severe Sickle Cell Disease
Official title: A Phase 1 Pilot Study to Evaluate the Safety and Feasibility of Gene Therapy With CSL200 (Autologous Enriched CD34+ Cell Fraction That Contains CD34+ Cells Transduced With Lentiviral Vector Encoding Human γ-GlobinG16D and Short-Hairpin RNA734) in Adult Subjects With Severe Sickle Cell Disease
Sponsor: CSL Behring (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Unanticipated delays, not for safety reasons
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-02
Primary completion date: 2021-05-05
Completion date: 2021-05-05
Plan to share individual participant data: YES
IPD sharing description: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
IPD time frame: IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
IPD access criteria: Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
Clinical trial NCT02144077: Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy
Official title: A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) in Comparison to Metvix® in the Treatment of Non-aggressive Basal Cell Carcinoma (BCC) With Photodynamic Therapy (PDT)
Sponsor: Biofrontera Bioscience GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 281.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-01-28
Primary completion date: 2015-11-17
Completion date: 2020-09-09
Clinical trial NCT03725267: Melatonin for Renal Protection in Patients Receiving Polymyxin B
Official title: Melatonin for Renal Protection in Patients Receiving Polymyxin B:a Randomized Clinical Trial
Sponsor: Hospital de Clinicas de Porto Alegre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to COVID 19 pandemic social isolation measures, we had to stop recruting hospitalized patients.
Enrollment: 88.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-01
Primary completion date: 2021-06-15
Completion date: 2021-07-01
Plan to share individual participant data: UNDECIDED
IPD sharing description: We will provide individual participant data if required by direct contact with our PI.
Clinical trial NCT04387461: Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
Official title: A Phase 2, Single Arm Study of CG0070 Combined With Pembrolizumab in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
Acronym: CORE-001
Sponsor: CG Oncology, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 35.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-08
Primary completion date: 2023-03-07
Completion date: 2024-05-28
Plan to share individual participant data: NO
Clinical trial NCT03150420: A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients
Official title: A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Trial
Acronym: CALISTA
Sponsor: Hope Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Inability to accrue subjects that met the exclusion criterion Any prior (within the past 30 days) or current Sodium Thiosulfate treatment.
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-24
Primary completion date: 2020-04-15
Completion date: 2020-04-15
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03044249: A Study of MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression
Official title: Tolerability, Pharmacokinetics, and Efficacy of MP-101 in the Treatment of Patients With Dementia-Related Psychosis and/or Agitation and Aggression
Sponsor: Mediti Pharma Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Statistical futility; totality of evidence suggests study unlikely to meet endpoint
Enrollment: 81.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-04
Primary completion date: 2020-01-30
Completion date: 2020-01-30
Baseline population: All randomized participants who received at least one dose of study drug.
Limitations and caveats: Statistical futility; totality of evidence suggests study unlikely to meet endpoint.
Plan to share individual participant data: NO
Clinical trial NCT02991651: Study of IRX4204 With Erlotinib in Previously Treated Advanced NSCLC
Official title: A Phase I Study of IRX4204 in Combination With Erlotinib in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer
Sponsor: Io Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: Limited IRX4204 Study Drug Supply
Enrollment: 12.0 (ESTIMATED)
Number of arms: 3.0
Start date: 2016-05-31
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT03857139: Opioids and Smoking Cessation
Official title: The Impact of Opioid Misuse on Tobacco Smoking Cessation
Sponsor: University of Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Grant funding not obtained
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-31
Primary completion date: 2022-01-31
Completion date: 2023-01-31
Plan to share individual participant data: NO
Clinical trial NCT04292223: Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis
Official title: A 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis
Sponsor: ACADIA Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 29.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-10
Primary completion date: 2022-04-26
Completion date: 2022-04-26
Plan to share individual participant data: NO
Clinical trial NCT03926728: Safety and Immunogenicity of a Chlamydia Vaccine CTH522
Official title: A Phase I, Double-blind, Parallel, Randomised and Placebo-controlled Trial Investigating the Safety and Immunogenicity of a Chlamydia Vaccine, CTH522, in Healthy Adults
Acronym: CHLM-02
Sponsor: Statens Serum Institut (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 65.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-02-17
Primary completion date: 2022-02-22
Completion date: 2022-02-22
Limitations and caveats: Screening and recruitment activities had to be paused during the trial due to the Covid-19 pandemic.
Plan to share individual participant data: NO
Clinical trial NCT04221061: 18F-FluorThanatrace (PET/CT) in Glioblastoma
Official title: A Pilot Study Evaluating in Vivo PARP-1 Expression with18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Glioblastoma
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Companion treatment trial closed early with negative results. No imaging study participants completed the full study imaging planned due to logistical difficulties.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-20
Primary completion date: 2024-06-10
Completion date: 2024-06-10
Clinical trial NCT03944512: Pravastatin to Prevent Preeclampsia
Official title: A Randomized Controlled Trial of Pravastatin to Prevent Preeclampsia in High Risk Women
Acronym: Pravastatin
Sponsor: The George Washington University Biostatistics Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: participants are no longer being examined or receiving intervention
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-17
Primary completion date: 2021-06-06
Completion date: 2024-06-20
Plan to share individual participant data: YES
IPD sharing description: The dataset will be shared per NIH policy after the completion and publication of the main analyses. The limited access data set will be submitted to NICHD (Data and Specimen Hub - DASH) and NHLBI (Biologic Specimen and Data Repository Information Coordinating Center - BioLINCC).
Clinical trial NCT03694834: Window of Opportunity Pilot Study of Pembrolizumab in Obesity-driven Endometrial Cancer
Official title: Window of Opportunity Pilot Study of Pembrolizumab in Obesity-driven Endometrial Cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-29
Primary completion date: 2023-10-23
Completion date: 2023-10-23
Plan to share individual participant data: NO
Clinical trial NCT04001803: Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US)
Official title: A Qualitative Hybrid III Implementation Study to Identify and Evaluate Strategies for Successful Implementation of the Cabotegravir + Rilpivirine Long-acting Injectable Regimen in the US
Sponsor: ViiV Healthcare (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 115.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-08
Primary completion date: 2020-10-05
Completion date: 2022-03-18
Baseline population: Baseline characteristics were reported for Safety Population(comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA).Study staff participants only provided input through completion of surveys,semi-structured interviews,facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Demographics for study staff participants were not collected because it was not required per study design
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/
IPD time frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Clinical trial NCT01449461: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral Anaplastic Lymphoma Kinase (ALK)/Epidermal Growth Factor Receptor (EGFR) Inhibitor Brigatinib (AP26113)
Official title: A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral ALK/EGFR Inhibitor AP26113
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 137.0 (ACTUAL)
Number of arms: 6.0
Start date: 2011-09-20
Primary completion date: 2015-11-16
Completion date: 2020-02-18
Baseline population: Safety population included all enrolled participants who received at least one dose of 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 NCT03228940: Safety and Effect of Oral RVX000222 in Subjects With Fabry Disease
Official title: An Open-Label Study to Assess the Safety and Effect on Key Biomarkers of Oral RVX000222 in Subjects With Fabry Disease
Sponsor: Resverlogix Corp (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Changed development priorities
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-11-22
Primary completion date: 2022-11-22
Completion date: 2022-11-22
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02499120: Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
Official title: A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 2 STUDY OF PALBOCICLIB PLUS CETUXIMAB VERSUS CETUXIMAB FOR THE TREATMENT OF HUMAN PAPILLOMAVIRUS-NEGATIVE, CETUXIMAB-NAÏVE PATIENTS WITH RECURRENT/METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK AFTER FAILURE OF ONE PRIOR PLATINUM-CONTAINING CHEMOTHERAPY REGIMEN
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 125.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-09-10
Primary completion date: 2018-07-19
Completion date: 2022-09-07
Baseline population: Baseline analysis population included all participants who were randomized.
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 NCT02591030: Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours
Official title: Randomised Phase II/III Study, Assessing the Safety and Efficacy of Modified Folfirinox Versus Gemcis in Locally Advanced, Unresectable and/or Metastatic Bile Duct Tumours
Acronym: AMEBICA
Sponsor: Centre Hospitalier Universitaire de Saint Etienne (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 191.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-12-15
Primary completion date: 2018-06-27
Completion date: 2020-01-16
Plan to share individual participant data: NO
Clinical trial NCT04442178: InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection ( ILIAD-7-US-I )
Official title: A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection. US Infectious Cohort
Acronym: ILIAD-7-US-I
Sponsor: Revimmune (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: POOR ACCRUAL
Enrollment: 26.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-15
Primary completion date: 2022-03-30
Completion date: 2022-03-30
Plan to share individual participant data: NO
IPD sharing description: Publication
Clinical trial NCT04798027: Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older
Official title: Immunogenicity and Safety of the First-in-Human SARS-CoV-2 mRNA Vaccine Formulation in Healthy Adults 18 Years of Age and Older
Acronym: VAW00001
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor's decision not to pursue further development of this product given the wide availability of authorized/approved mRNA COVID-19 vaccines
Enrollment: 182.0 (ACTUAL)
Number of arms: 9.0
Start date: 2021-03-12
Primary completion date: 2022-06-27
Completion date: 2022-06-27
Baseline population: Analysis was performed on all enrolled participants according to the intervention to which they were randomized. Data for baseline characteristics was planned to be collected and analyzed for combined population (Full Enrollment Cohort + Sentinel Cohort) in which the same dose-level groups in Sentinel Cohort and Full Enrollment Cohort were pooled for the analysis. Since Sentinel Cohort: SARS-CoV-2 Vaccine Medium Dose group received 2 injections; they were presented under Cohort 2 for analysis.
Limitations and caveats: Due to early termination of this study by the Sponsor prior to full enrollment, the corresponding testing was not conducted, and few planned efficacy outcome measures data were not collected and analysis was not performed.
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 NCT02450773: Prevention of Severe Postpartum Hypertension
Official title: Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-08-31
Primary completion date: 2022-05-31
Completion date: 2022-05-31