chufangao/CTO huggingface dataset:
Clinical trial NCT04842721: Effect of Hypertonic Saturated Saline Mouth Rinse on Covid-19 Virus in Vivo.
Official title: Effect of Prolonged Mouth Rinse With Hypertonic Saturated Saline Solution on the Naso-Pharyngeal Viral Load of Covid-19 Virus in Vivo.
Sponsor: Batroussy, Rafik (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Not yet meeting Health Canada's requirements for Clinical Trials
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-31
Primary completion date: 2021-10-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT04427774: A Study of Surufatinib Plus Sintilimab in Patients With Advanced Solid Tumor
Official title: A Phase Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Surufatinib Plus Sintilimab in Patients With Advanced Solid Tumor
Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Policy change, not for security reasons
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-29
Primary completion date: 2021-02-08
Completion date: 2021-04-27
Clinical trial NCT02384122: Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias
Official title: A Multicenter, Randomized, Open-label Clinical Trial Assessing the Efficacy of Octreotide in Decreasing Blood and Iron Requirements in Patients With Refractory Anemia Due to Angiodysplasias
Acronym: OCEAN
Sponsor: Radboud University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 62.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-09-30
Primary completion date: 2022-07-31
Completion date: 2023-05-31
Plan to share individual participant data: YES
IPD sharing description: Deidentified individual participant data and a data dictionary defining each field in the set will be available, upon reasonable request to Lia Goltstein and subjected to an appropriate data sharing agreement.
IPD access criteria: Data sharing agreement
Clinical trial NCT03496298: Effect of Efpeglenatide on Cardiovascular Outcomes
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk
Acronym: AMPLITUDE-O
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision to cancel TRIAL, not related to safety concern
Enrollment: 4076.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-04-27
Primary completion date: 2020-12-10
Completion date: 2020-12-10
Baseline population: Analysis was performed on Intent-to-treat (ITT) population that included all randomized participants irrespective of compliance with the study protocol and procedures and were analyzed in the treatment group to which they were randomized.
Limitations and caveats: The study was terminated early by the Sponsor but not due to any safety concerns.
Plan to share individual participant data: NO
IPD sharing description: No plan to share individual participant data (IPD) by Sanofi: product rights transferred to Hanmi pharmaceutical.
Clinical trial NCT04252612: Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study
Official title: Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study
Sponsor: H. Lee Moffitt Cancer Center and Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Poor accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-01-30
Primary completion date: 2023-06-26
Completion date: 2023-06-26
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03345836: A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 624.0 (ACTUAL)
Number of arms: 6.0
Start date: 2017-11-29
Primary completion date: 2021-08-11
Completion date: 2021-08-11
Baseline population: Intent-to-Treat (ITT) Population for the 12-week DB Induction Period (Part 1) i.e., ITT1 included all randomized participants who received at least one dose of DB study drug during Part 1. ITT Population for the 12-week OL Induction Period (Part 2) i.e., ITT2 included all participants who received at least one dose of study drug in Part 2.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing, please refer to the link below.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT05082688: Age Differences in Influenza and Herpes Zoster Vaccine Responses (INFLUENZA-SHINGRIX)
Official title: Exploratory Study Into Age-related Immunological Differences Related to Immunogenicity in Influenza Vaccination and Herpes Zoster Vaccination
Sponsor: Radboud University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 148.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-09-20
Primary completion date: 2023-05-17
Completion date: 2023-05-17
Clinical trial NCT04571944: Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)
Official title: A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of MK-4305 (Suvorexant) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 207.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-22
Primary completion date: 2022-12-23
Completion date: 2022-12-23
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04245722: FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies
Official title: A Phase I, Open-Label, Multicenter Study of FT596 as a Monotherapy and in Combination With Rituximab or Obinutuzumab in Subjects With Relapsed/Refractory B-cell Lymphoma and Chronic Lymphocytic Leukemia
Sponsor: Fate Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated by the Sponsor.
Enrollment: 98.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-03-19
Primary completion date: 2023-09-27
Completion date: 2023-09-27
Plan to share individual participant data: NO
Clinical trial NCT05124210: Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19
Official title: An Open-label, Non-comparator, Multicenter Study to Describe the Pharmacokinetics (PK), Pharmacodynamics (PD; Viral Load) and Safety Following a Single Intravenous or Intramuscular Dose of Sotrovimab in Pediatric Participants With Mild to Moderate COVID-19 at High Risk of Disease Progression
Acronym: COMET-PACE
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Decrease in in-vitro neutralization of study drug against circulating SARS-CoV-2 variants
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-16
Primary completion date: 2023-06-14
Completion date: 2023-06-14
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
Clinical trial NCT04073134: The CHORAL Flow Study
Official title: Cholesterol Reduction With Evolocumab and Coronary MicrovascuLar Function and Coronary Flow: The CHORAL Flow Study
Acronym: CHORAL
Sponsor: Imperial College London (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Funding withdrawn
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-11
Primary completion date: 2022-03-27
Completion date: 2022-05-27
Plan to share individual participant data: NO
Clinical trial NCT03989232: A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
Official title: Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects With Type 2 Diabetes
Acronym: SUSTAIN FORTE
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 961.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-19
Primary completion date: 2020-09-18
Completion date: 2020-11-09
Baseline population: The full analysis set (FAS) included all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT02432846: Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)
Official title: An Open-label, Randomized, Controlled, Multicenter, Phase II Study Evaluating Safety and Efficacy of Intratumorally Administered Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy, Compared to Sunitinib Post-nephrectomy in Metastatic Renal Cell Carcinoma Patients
Acronym: MERECA
Sponsor: Mendus (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 88.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-04-30
Primary completion date: 2021-01-31
Completion date: 2021-01-31
Baseline population: The 6 groups are not mutually exclusive. The patients are presented both separately by risk stratum and treatment (4 groups) and by treatment group overall (2 groups) where high-risk and intermediate-risk strata are combined. This split of baseline characteristics provides transparency for efficacy outcomes that are analysed by these 6 groups.
Limitations and caveats: Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
Plan to share individual participant data: NO
Clinical trial NCT02036502: A Study of Pembrolizumab (MK-3475) in Combination With Standard of Care Treatments in Participants With Multiple Myeloma (MK-3475-023/KEYNOTE-023)
Official title: A Phase I Multi-Cohort Trial of Pembrolizumab (MK-3475) in Combination With Backbone Treatments for Subjects With Multiple Myeloma
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business Reasons
Enrollment: 77.0 (ACTUAL)
Number of arms: 8.0
Start date: 2014-02-14
Primary completion date: 2020-03-19
Completion date: 2020-03-19
Baseline population: The analysis population consisted of all randomized participants
Limitations and caveats: Enrollment of participants into this study was stopped after the FDA implemented a clinical hold after determining the risks of pembrolizumab + pomalidomide or lenalidomide outweighed any potential benefit for participants with multiple myeloma.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03954106: A Safety and Efficacy Study of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity
Official title: Prospective, Multicenter, Open-Label, Single Arm, Phase 2 Study to Evaluate the Safety and Efficacy of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma Receiving Axicabtagene Ciloleucel (Yescarta®)
Sponsor: Jazz Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Primary endpoint would unlikely to be met based on the unplanned interim assessment on the first 20 efficacy evaluable patients.
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-04
Primary completion date: 2020-09-18
Completion date: 2020-09-30
Baseline population: Baseline demographics were assessed in the Safety Analysis Set (N=25) which was comprised of the Part 1: Defibrotide 2.5 mg/kg (n=4) and the combined Part 1: Defibrotide 6.25 mg/kg and Phase 2: RP2D 6.25 mg/kg (n=21). The baseline demographics are reported in this format as per the Statistical Analysis Plan.
Clinical trial NCT02956486: A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease
Official title: A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease
Acronym: MissionAD1
Sponsor: Eisai Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to an unfavorable risk-benefit ratio including no evidence of potential efficacy, and the adverse event profile of E2609 being worse than placebo.
Enrollment: 2212.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-10-20
Primary completion date: 2020-01-15
Completion date: 2020-01-15
Baseline population: The SAS was the group of participants who received at least 1 dose of study drug in the core phase and had at least 1 post-dose safety assessment.
Limitations and caveats: This study was terminated early due to an unfavorable risk-benefit ratio including no evidence of potential efficacy and the adverse event profile in participants with drug treatment was worse than that in participants who received placebo. The small sample size at the 24 month time point of the core phase limits the interpretability of the data.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03977727: FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump
Official title: An Exploratory, Single-center, Randomized, Open Label, Active-control, Cross-over Trial Comparing the Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart (Fiasp®) Compared to NovoLog® Used in the Medtronic 670G Closed Loop System in Adults With Type 1 Diabetes
Sponsor: Texas Diabetes & Endocrinology, P.A. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-11
Primary completion date: 2020-03-09
Completion date: 2020-04-20
Clinical trial NCT03117049: Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
Official title: A Multicenter, Randomized, Double-Blind Trial in Subjects With Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
Sponsor: Ono Pharmaceutical Co. Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 550.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-13
Primary completion date: 2020-02-10
Completion date: 2023-12-04
Plan to share individual participant data: NO
Clinical trial NCT04593940: Immune Modulators for Treating COVID-19
Official title: Randomized Master Protocol for Immune Modulators for Treating COVID-19
Acronym: ACTIV-1 IM
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1971.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-10-15
Primary completion date: 2022-01-30
Completion date: 2022-03-05
Plan to share individual participant data: NO
Clinical trial NCT04128956: Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With PTS
Official title: Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With Post-thrombotic Syndrome a Multi-center, International, Randomized, Open Label, Controlled Trial
Acronym: ARIVA
Sponsor: University of Zurich (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recommendation by DSMB
Enrollment: 172.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-11
Primary completion date: 2024-02-21
Completion date: 2024-02-21
Plan to share individual participant data: NO
Clinical trial NCT03674242: Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone for the Treatment of TNBC (TRYbeCA-2)
Official title: A Randomized Phase 2/3 Study of Eryaspase in Combination With Gemcitabine and Carboplatin Chemotherapy Versus Chemotherapy Alone for the Treatment of Patients With Metastatic or Locally Recurrent Triple-Negative Breast Cancer
Sponsor: ERYtech Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: sponsor decision
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-13
Primary completion date: 2022-03-31
Completion date: 2022-03-31
Clinical trial NCT01602302: Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis
Official title: Ultrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid Arthritis
Acronym: RA-BioStop
Sponsor: Medical University of Graz (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: low recruitment
Enrollment: 40.0 (ACTUAL)
Number of arms: 1.0
Start date: 2012-06-30
Primary completion date: 2020-11-19
Completion date: 2020-11-19
Clinical trial NCT04510493: Canakinumab in Patients With COVID-19 and Type 2 Diabetes
Official title: Canakinumab in Patients With COVID-19 and Type 2 Diabetes - CanCovDia Trial
Acronym: CanCovDia
Sponsor: University Hospital, Basel, Switzerland (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 116.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-23
Primary completion date: 2021-08-17
Completion date: 2021-08-17
Clinical trial NCT04025307: Phase I Trial of bacTRL-IL-12 in Adult Subjects With Advanced, Treatment-refractory Solid Tumours
Official title: A Multi-centre, Open-label, Phase I Trial of bacTRL-IL-12 in Adult Subjects With Advanced, Treatment-refractory Solid Tumours
Sponsor: Iqvia Pty Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-05
Primary completion date: 2020-12-29
Completion date: 2020-12-29
Plan to share individual participant data: NO
Clinical trial NCT04469114: Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Trial of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia
Sponsor: Hospital Israelita Albert Einstein (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 289.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-16
Primary completion date: 2021-01-09
Completion date: 2021-01-09
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04777708: BO-112 and Pembrolizumab for the Treatment of PD-1/PD-L1 Refractory Liver Cancer
Official title: Pilot Feasibility Study of Intratumoral BO-112 in Combination With Pembrolizumab for Advanced Hepatocellular Carcinoma
Sponsor: Jonsson Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Withdrawn by sponsor
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-13
Primary completion date: 2023-03-13
Completion date: 2023-03-13
Clinical trial NCT01986348: Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas
Official title: A Phase 2 Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Patients With Recurrent Gliomas
Acronym: KING
Sponsor: Karyopharm Therapeutics Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated due to Sponsor decision (all except 1 patient were off-treatment and 2 patients were in survival follow-up)
Enrollment: 76.0 (ACTUAL)
Number of arms: 4.0
Start date: 2014-03-03
Primary completion date: 2020-01-23
Completion date: 2020-01-23
Baseline population: Safety population consisted of all participants who had received any amount of study treatment.
Limitations and caveats: Study was terminated due to Sponsor decision (all except 1 patient were off-treatment and 2 patients were in survival follow-up).
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04766996: PROUD Study - Preventing Opioid Use Disorders
Official title: PROUD Study - Preventing Opioid Use Disorders
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Loss of surgery team member deemed the study procedures impossible to achieve, and no replacement could be found in a timely manner to complete trial as initially planned.
Enrollment: 57.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-05-17
Primary completion date: 2021-12-27
Completion date: 2021-12-27
Baseline population: Baseline information is not available for the retrospective control group as the study was terminated prior to creating this study arm. Only minimal, optional, demographic information was collected from professional staff to maintain anonymity among respondents and to ease their burden of study related activities.
Limitations and caveats: This study aimed to enroll a total of 170 participants. Due to staffing issues and the coronavirus disease 2019 (COVID-19) pandemic, this trial was terminated early and therefore the retrospective data was not collected.
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie the results reported in peer reviewed publication(s) will be shared after de-identification.
IPD time frame: Data will be available for sharing beginning 6 months and ending 36 months following article publication.
IPD access criteria: Data will be available for sharing with investigators whose proposed use of the data have been approved by an independent review committee identified for that purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in Emory University's data warehouse but without investigator support other than deposited metadata. Information regarding the Emory Dataverse can be found at: http://sco.library.emory.edu/dataverse/index.html