chufangao/CTO huggingface dataset:
Clinical trial NCT04057014: Immediate Versus Delayed Treatment of Odontogenic Infections
Official title: A Prospective Study of Immediate Versus Delayed Treatment of Odontogenic Infections
Sponsor: Boston Children's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: No funding available for the activity
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-10-31
Primary completion date: 2020-10-02
Completion date: 2020-10-02
Plan to share individual participant data: NO
IPD sharing description: There is no plan to share participant data.
Clinical trial NCT04565717: A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 3-Part Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-HSD in Healthy Adult Subjects and Multiple Dose ALN-HSD in Adult Patients With Nonalcoholic Steatohepatitis (NASH)
Sponsor: Alnylam Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study ALN-HSD-001 was terminated due to business reasons and changes in the development strategy of the product. No safety issues were found.
Enrollment: 6.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-10-09
Primary completion date: 2023-01-06
Completion date: 2023-12-21
Plan to share individual participant data: NO
Clinical trial NCT02689024: Delirium in Elderly Patients With Trauma of the Hip
Official title: A Multicenter Randomized Controlled Trial in Elderly Patients With Hip Fractures Comparing Continuous Fascia Iliaca Compartment Block to Systemic Opioids and Its Effect on Delirium Occurrence
Acronym: DEPTHip
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: recruitment too slow; intervention was standard care in patients who were not included; acute care pathways changed due to policy regarding hip fracture patients
Enrollment: 239.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-05-31
Primary completion date: 2023-07-19
Completion date: 2023-07-19
Plan to share individual participant data: YES
IPD sharing description: After an embargo period data can be shared, depending on research question, objectives, statistics and methodology.
Clinical trial NCT03973918: Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG
Official title: A Phase II Study of Binimetinib in Combination With Encorafenib in Adults With Recurrent BRAF V600-Mutated High-Grade Astrocytoma or Other Primary Brain Tumor
Acronym: BRAF
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer
Enrollment: 5.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-07-29
Primary completion date: 2022-04-30
Completion date: 2023-10-01
Baseline population: No patient were enrolled on the Surgical arm. this study was terminated early by a mandate from NCI to shut down the ABTC Consortium due to wanting a different strategy for Brain Tumor Research. As such,
Limitations and caveats: Due to early termination, results are given per cohort per patient, as the data is meaningless otherwise due to small numbers.~The NCI/CTEP mandated the closure of ABTC Consortium and hence why this study was terminated early
Plan to share individual participant data: NO
Clinical trial NCT01606098: The Role of Surgery of the Primary Tumour in Patients With Synchronous Unresectable Metastases of Colorectal Cancer
Official title: The Role of Surgery of the Primary Tumour With Few or Absent Symptoms in Patients With Synchronous Unresectable Metastases of Colorectal Cancer, a Randomized Phase III Study. A Study of the Dutch Colorectal Cancer Group (DCCG)
Acronym: CAIRO4
Sponsor: Dutch Colorectal Cancer Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 206.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-07-31
Primary completion date: 2022-06-30
Completion date: 2022-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03787251: A Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Cancer Treated With Apatinib
Official title: Randomized, Open, Positive Drug Control, Multicenter Clinical Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Squamous Cell Carcinoma With Chemotherapy in Patients Treated With Apatinib Mesylate
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: In China, apatinib has been approved as an indication drug for esophageal squamous cell carcinoma, which makes it very difficult for our clinical trial to enroll patients. We regret that we failed to implement the design as planned.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-01
Primary completion date: 2020-12-31
Completion date: 2021-12-31
Clinical trial NCT03654326: A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)
Official title: A Phase 2a, Proof of Concept, Randomized, Double-Blind, Placebo-Controlled Clinical Trial, to Evaluate the Efficacy and Safety of MK-7264 in Women With Moderate to Severe Endometriosis-Related Pain
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 187.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-11
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04853927: Proxalutamide Treatment for COVID-19 Patients in Intensive Care Unit
Official title: Proxalutamide Treatment for COVID-19 Patients in Intensive Care Unit
Sponsor: Applied Biology, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor to focus on hospitalised patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-08
Primary completion date: 2021-10-30
Completion date: 2021-12-31
Clinical trial NCT05376839: A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment
Official title: A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Multiple Doses of Cedirogant (ABBV-157) in Subjects With Mild, Moderate and Severe Hepatic Impairment
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 6.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-07-06
Primary completion date: 2022-11-08
Completion date: 2022-11-08
Plan to share individual participant data: NO
Clinical trial NCT03739606: Flotetuzumab in Treating Patients With Recurrent or Refractory CD123 Positive Blood Cancer
Official title: A Phase 2 Study to Evaluate the Anti-Tumor Activity of Single Agent Flotetuzumab in Advanced CD123-Positive Hematological Malignancies
Sponsor: City of Hope Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: RSS recommendation
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-20
Primary completion date: 2020-10-20
Completion date: 2020-10-20
Clinical trial NCT02959411: Tolvaptan for Advanced or Refractory Heart Failure
Official title: Tolvaptan for the Management of Acute Decompensated Heart Failure in Patients With Advanced or Refractory Heart Failure
Sponsor: University of Calgary (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Low accrual rate
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-31
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Plan to share individual participant data: NO
Clinical trial NCT03300479: Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®)
Official title: Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®) for Blood Pressure Reduction in Patients With Primary Intracerebral Hemorrhage: A Randomized Controlled Trial
Acronym: Clevidipine
Sponsor: University of Zurich (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: No patient enrolled. No study conduct due to lack of human resources.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-15
Primary completion date: 2021-05-14
Completion date: 2021-05-14
Plan to share individual participant data: NO
Clinical trial NCT03611985: Phase I/IIa Study of Pharmacokinetics and Safety of Epidiferphane™ and Taxanes in Breast Cancer Patients
Official title: Study of Pharmacokinetics and Safety of Epidiferphane™ and Taxanes in Breast Cancer Patients
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: institutional conflict of interest
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-31
Primary completion date: 2023-03-31
Completion date: 2023-03-31
Clinical trial NCT04493359: Switch of Renin-Angiotensin System Inhibitors in Patients With Covid-19
Official title: Switch or Maintenance of Renin-Angiotensin System Inhibitors in Patients With Covid-19: A Randomized Proof of Concept Trial
Acronym: SWITCH-COVID
Sponsor: University of Sao Paulo (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Dificulteis in enrolling patients
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-25
Primary completion date: 2021-09-28
Completion date: 2021-09-28
Plan to share individual participant data: UNDECIDED
IPD sharing description: Data may be requested for collaboration projects
Clinical trial NCT03875729: Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
Official title: Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
Acronym: PROTECT
Sponsor: Provention Bio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 328.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-05
Primary completion date: 2023-05-01
Completion date: 2023-05-01
Baseline population: Intent-to-treat population
Limitations and caveats: Enrollment into the study was temporarily suspended due to COronaVIrus Disease of 2019 (COVID-19) pandemic restrictions. Participants who were unable to receive the second 12-day treatment course at 6 months due to COVID-19 pandemic restrictions were given the second course at approximately 12 months (modified dosing schedule).
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 levels 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.
IPD time frame: After drug approval
IPD access criteria: Qualified researchers
Clinical trial NCT04749797: Cranial Blocks for Postoperative Anesthesia
Official title: Randomized Study Of Cranial Blocks For Postoperative Anesthesia To Reduce Pain And Postoperative Opioid Usage
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: PI left institution
Enrollment: 11.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-09-02
Primary completion date: 2021-07-20
Completion date: 2021-07-20
Limitations and caveats: Study concluded before reaching subject n goal due to slow enrollment related to COVID-19 pandemic and PI leaving institution. Sample size not significant enough to accurately analyze data.
Plan to share individual participant data: UNDECIDED
IPD sharing description: No plan at this time to share data with other researchers.
Clinical trial NCT02743806: Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease
Official title: Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Early Completed - Alternative Source of Drug Available
Enrollment: 331.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-01
Primary completion date: 2023-01-03
Completion date: 2023-01-03
Baseline population: Full Analysis Set (FAS) consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
Plan to share individual participant data: YES
IPD sharing description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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 NCT04618393: A Study of EMB-02 in Participants With Advanced Solid Tumors
Official title: A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients With Advanced Solid Tumors
Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Company's resource optimization and product's development change
Enrollment: 47.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-11
Primary completion date: 2023-07-12
Completion date: 2024-03-21
Plan to share individual participant data: NO
Clinical trial NCT05612633: A Study of Zelavespib (PU-H71) in Subjects With AP-MPN or BP-MPN
Official title: A Phase 2 Open-label Study of Zelavespib (PU-H71) in Subjects With Accelerated Phase Myeloproliferative Neoplasm (AP MPN) or Blast Phase Myeloproliferative Neoplasm
Acronym: AP-MPN
Sponsor: Samus Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Samus Therapeutics Closure
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-06-15
Primary completion date: 2023-12-15
Completion date: 2024-02-23
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03836885: Apremilast - Oral Lichen Planus Trial
Official title: The APOLP Trial: A Single-Center, Randomized, 16 Weeks, Explanatory, Parallel-Group, Superiority, Blinded, Placebo-Controlled, Clinical Trial of Apremilast Use in Oral Lichen Planus
Acronym: APOLP
Sponsor: Sunnybrook Health Sciences Centre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was terminated due to delay in enrollment.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-21
Primary completion date: 2020-04-22
Completion date: 2020-04-22
Plan to share individual participant data: NO
Clinical trial NCT02684032: A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer
Official title: PHASE 1B STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND CLINICAL ACTIVITY OF GEDATOLISIB IN COMBINATION WITH PALBOCICLIB AND EITHER LETROZOLE OR FULVESTRANT IN WOMEN WITH METASTATIC OR LOCALLY ADVANCED/RECURRENT BREAST CANCER (MBC)
Sponsor: Celcuity Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 141.0 (ACTUAL)
Number of arms: 6.0
Start date: 2016-06-14
Primary completion date: 2022-01-19
Completion date: 2022-01-19
Plan to share individual participant data: NO
IPD sharing description: Celcuity 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.
Clinical trial NCT02065869: Safety Study of Gene Modified Donor T-cells Following TCRαβ+ Depleted Stem Cell Transplant
Official title: Phase I/II Study of CaspaCIDe T Cells (BPX-501; Rivogenlecleucel) From an HLA Partially Matched Family Donor After Negative Selection of TCRαβ+ T Cells in Paediatric Patients Affected by Haematological Disorders
Sponsor: Bellicum Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 187.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-04-30
Primary completion date: 2020-06-30
Completion date: 2021-09-07
Baseline population: All enrolled patients iwho received HSCT (HSCT safety population)
Plan to share individual participant data: NO
Clinical trial NCT04108858: Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer
Official title: Phase Ib/II Trial of Copanlisib in Combination With Trastuzumab and Pertuzumab After Induction Treatment of HER2 Positive (HER2+) Metastatic Breast Cancer (MBC) With PIK3CA Mutation or PTEN Mutation
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Inadequate accrual rate
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-20
Primary completion date: 2022-04-29
Completion date: 2022-04-29
Baseline population: This clinical trial did not attract participants who met the eligibility criteria, resulting in poor accrual.
Plan to share individual participant data: YES
IPD sharing description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Clinical trial NCT03711279: A Study of SHR-1210 Plus Apatinib in Patients With Soft Tissue Sarcoma
Official title: A Multicenter, Randomized, Open, Phase 2 Trial of SHR-1210 Plus Apatinib Versus Doxorubicin (ADM) Plus Ifosfamide (IFO) in Patients With Soft Tissue Sarcoma
Sponsor: Jiangsu HengRui Medicine Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor R \& D Strategy Adjustment
Enrollment: 99.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-22
Primary completion date: 2021-06-21
Completion date: 2021-06-21
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02818894: Spinal Anesthesia in Total Hip Arthroplasty
Official title: Comparison of Lidocaine Versus Bupivacaine Spinal Anesthesia in Total Hip Arthroplasty: A Randomized, Double-Blind, Prospective Study
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: This study was terminated due to pressing matters related to the COVID-19 pandemic - staff shortages and changes of personnel, data gaps due to the pandemic, participants not being able to continue follow-up visits, and ongoing enrollment issues.
Enrollment: 135.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-09-27
Primary completion date: 2020-03-05
Completion date: 2020-03-05
Limitations and caveats: The study was terminated due to extended suspension of the study related to personnel issues and pandemic-related issues. Missing data due to lost study records limited the number of available data points.
Plan to share individual participant data: NO
Clinical trial NCT04604652: Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
Official title: A Phase 2 Open Label, Proof of Concept Study of HTD1801 (BUDCA) in Adult Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to Standard Therapy - PRONTO-PBC
Acronym: PRONTO-PBC
Sponsor: HighTide Biopharma Pty Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-05-27
Primary completion date: 2022-05-31
Completion date: 2022-05-31
Limitations and caveats: This was a small, open-label, proof of concept study with no control group where subjects discontinued UDCA at Baseline. Limitations of the study include potentially being underpowered for the primary endpoint and the safety included adverse events from the 4-week follow-up period after treatment discontinuation. Additional placebo-controlled studies are needed to further evaluate the benefit of HTD1801 in PBC.
Plan to share individual participant data: NO
Clinical trial NCT04176952: PRIMUS002: Looking at 2 Neo-adjuvant Treatment Regimens for Resectable and Borderline Resectable Pancreatic Cancer
Official title: PRIMUS002: An Umbrella Phase II Study Examining Two Neo-adjuvant Regimens (FOLFOX-A and AG) in Resectable and Borderline Resectable Pancreatic Ductal AdenoCarcinoma (PDAC), Focusing on Biomarker and Liquid Biopsy Development
Acronym: PRIMUS002
Sponsor: University of Glasgow (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to funding being withdrawn
Enrollment: 31.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-05
Primary completion date: 2021-08-19
Completion date: 2021-08-19
Plan to share individual participant data: YES
IPD sharing description: Clinical data will be made available on request once clinical study report has been written and primary publication accepted by peer reviewed journal
IPD time frame: Once clinical study report has been written and primary publication accepted by peer reviewed journal
IPD access criteria: On request to trial management group