chufangao/CTO huggingface dataset:
Clinical trial NCT04319731: A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
Official title: A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
Sponsor: University of Utah (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-20
Primary completion date: 2020-06-09
Completion date: 2020-06-09
Clinical trial NCT03630367: Effects of L-Carnitine Supplementation on Respiratory Distress Syndrome
Official title: Effects of Adding L-Carnitine With Dexamethasone on Respiratory Distress Syndrome Development in Preterm Infants
Sponsor: Assiut University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Unavailability of the medication
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-03
Primary completion date: 2020-09-30
Completion date: 2020-10-31
Clinical trial NCT05121402: Safety and Efficacy Study of TLL018 in the Treatment of Ulcerative Colitis
Official title: A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of TLL018 for Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis
Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Decisions made by senior management of the company
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-12-30
Primary completion date: 2023-07-01
Completion date: 2023-12-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03686514: The Impact of Imprinting and Repeated Influenza Vaccination on Adaptive Immunity, Transcriptomics, and Metabolomics
Official title: The Impact of Imprinting and Repeated Influenza Vaccination on Adaptive Immunity, Transcriptomics, and Metabolomics
Acronym: FLU2
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study closed prior to completing year 3 of the study due to the COVID-19 pandemic.
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-22
Primary completion date: 2020-06-20
Completion date: 2020-06-20
Limitations and caveats: Due to the COVID-19 pandemic, this study was terminated prior to beginning year 3 of the study.
Clinical trial NCT03960554: The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
Official title: The Effects of 12-months of Denosumab on Bone Density, Quality and Strength in Prevalent Kidney Transplant Recipients
Acronym: ProliaKTx
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study lost funding
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-16
Primary completion date: 2021-12-02
Completion date: 2021-12-02
Limitations and caveats: Due to the COVID-19 pandemic, this study was terminated early and no Outcome Measure data was collected from participants.
Clinical trial NCT03956056: Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Insufficient funding/staff
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-13
Primary completion date: 2022-07-21
Completion date: 2023-07-06
Plan to share individual participant data: NO
Clinical trial NCT03131453: A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (AD).
Acronym: GS2
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: The study was terminated due to safety issues.
Enrollment: 1145.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-08-03
Primary completion date: 2020-03-26
Completion date: 2020-03-26
Baseline population: One patient was misrandomized and not included in the CNP520 50mg arm
Limitations and caveats: The study was terminated due to safety issues.
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT04824365: Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection
Official title: Two Week Sub-chronic Double-blinded Placebo Controlled Trial Designed to Determine if Sodium Pyruvate Nasal Spray Will Reduce the Symptoms, Duration and Replication of COVID-19 Infection
Sponsor: Cellular Sciences, inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-12
Primary completion date: 2022-08-12
Completion date: 2022-08-12
Limitations and caveats: The number of patients enrolled in this trial was small, thus decreasing the power of the statistical analysis.
Plan to share individual participant data: NO
Clinical trial NCT05692908: An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis
Official title: An Open-Label, Dose-Escalation Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Systemic AL Amyloidosis
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Sorrento Therapeutics filed for chapter 11 bankruptcy.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-09-30
Primary completion date: 2024-09-30
Completion date: 2024-11-30
Clinical trial NCT05375760: A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19
Official title: A Phase II Randomized, Open-label, Multicenter, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, a Combination Product of Two Monoclonal Antibodies (Tixagevimab and Cilgavimab), for Pre-exposure Prophylaxis of COVID-19
Acronym: ENDURE
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor terminated after review of FDA's request to halt further dosing (30Mar2023) given that AZD7442 is not active against \>99% of the currently circulating SARS-CoV-2 variants in the USA, the benefit risk assessment may not be favorable
Enrollment: 251.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-09
Primary completion date: 2023-10-04
Completion date: 2023-10-04
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT04732169: Cannabidiol for Treatment Resistant Depression
Official title: Cannabidiol for Treatment Resistant Depression
Acronym: CBD
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Investigator decided not to do study, due to insufficient funding.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-01
Primary completion date: 2021-07-09
Completion date: 2021-07-09
Plan to share individual participant data: YES
IPD sharing description: Plan to share protocol, consent, SAP,and CRS. Do not plan to share IPD,
IPD time frame: 3 years
IPD access criteria: Will share with public
Clinical trial NCT04171284: SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer
Official title: A Multicenter Randomized Double-blinded Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of SCT-I10A or Placebo Plus Docetaxel in Treating Advanced Squamous Non-small Cell Lung Cancer
Sponsor: Sinocelltech Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Strategy adjustments, independent of the safety and efficacy of the trial medication
Enrollment: 188.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-10-22
Primary completion date: 2023-02-23
Completion date: 2023-02-23
Plan to share individual participant data: NO
Clinical trial NCT04426201: InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )
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 Oncology Cohort
Acronym: ILIAD-7-US-O
Sponsor: Revimmune (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: POOR ACCRUAL
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-20
Primary completion date: 2022-06-30
Completion date: 2022-06-30
Plan to share individual participant data: NO
IPD sharing description: Publication
Clinical trial NCT02949830: A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)
Official title: A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety and Clinical Activity of Subcutaneously Administered ALN-AS1 in Patients With Acute Intermittent Porphyria Who Have Completed a Previous Clinical Study With ALN-AS1
Sponsor: Alnylam Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-10-31
Primary completion date: 2021-11-05
Completion date: 2021-11-05
Baseline population: Safety Analysis Set (SAS): All patients who received any amount of study drug.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03480867: Pre-operative RT and TMZ in Patients With Newly Diagnosed GBM Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA)
Official title: Pre-operative Radiation Therapy (RT) and Temozolomide (TMZ) in Patients With Newly Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA)
Acronym: PARADIGMA
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: competing study was opened by the surgeon after this trial was opened
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-03-31
Primary completion date: 2021-06-30
Completion date: 2023-11-30
Plan to share individual participant data: UNDECIDED
IPD sharing description: Upon official request approved by the Research Ethics Board (REB), some data may be shared depending on what needs to be shared.
Clinical trial NCT04727541: Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer
Official title: Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer
Acronym: NEOBIL
Sponsor: AIO-Studien-gGmbH (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Based on results of another phase II study with bintrafusp alfa in combination with gemcitabine plus cisplatin, that was discontinued as it was unlikely to meet the primary endpoint of OS, the recruitment for this study was stopped prematurely.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-08
Primary completion date: 2021-10-04
Completion date: 2022-01-05
Plan to share individual participant data: NO
Clinical trial NCT02109081: Dexamethasone and Postoperative Delirium
Official title: Dexamethasone and Postoperative Delirium
Sponsor: NorthShore University HealthSystem (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Investigator left institution
Enrollment: 200.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-04-30
Primary completion date: 2021-02-28
Completion date: 2021-02-28
Clinical trial NCT04088448: The Antidiabetic Metformin as a Novel Adjunct to Antidepressants in Major Depressive Disorder Patients
Official title: The Antidiabetic Metformin as a Novel Adjunct to Antidepressants in Major Depressive Disorder Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
Sponsor: Sadat City University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-01
Primary completion date: 2020-06-01
Completion date: 2020-06-01
Plan to share individual participant data: YES
Clinical trial NCT04684654: BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome
Official title: A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Dose Study on the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of Subcutaneous and Intravenous BMS-986325 Administration in Healthy Participants and Participants With Primary Sjögren's Syndrome
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Insufficient enrollment
Enrollment: 118.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-02-16
Primary completion date: 2023-07-25
Completion date: 2023-07-25
Clinical trial NCT03527576: Block Duration After Spinal Block and iv Dexamethasone.
Official title: Block Duration After Spinal Block and iv Dexamethasone: a Randomized Controlled Double-blinded Trial
Sponsor: Centre Hospitalier Universitaire Vaudois (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-01
Primary completion date: 2021-11-01
Completion date: 2022-04-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04576312: Safety of Ascending Doses of Niclosamide (UNI911 INHALATION) in Healthy Volunteers
Official title: Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults With COVID-19
Sponsor: UNION therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 64.0 (ACTUAL)
Number of arms: 8.0
Start date: 2020-06-29
Primary completion date: 2020-12-04
Completion date: 2020-12-04
Plan to share individual participant data: NO
Clinical trial NCT05128773: Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity
Official title: A Randomized, Multicenter, Double-blind, Phase 3 Study of Amcenestrant (SAR439859) Versus Tamoxifen for the Treatment of Patients With Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative or Positive, Stage IIB-III Breast Cancer Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity
Acronym: AMEERA-6
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision to prematurely stop the study, not linked to any safety concern
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-17
Primary completion date: 2022-10-13
Completion date: 2022-10-13
Baseline population: Analysis was performed on the randomized population.
Limitations and caveats: Due to premature discontinuation and closure of study decided by the Sponsor, only safety data were summarized and reported, and no efficacy data was collected.
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 NCT03977454: Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty
Official title: Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty: a Single Center Randomized Controlled Trail (RCT) Study
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 192.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-11
Primary completion date: 2021-06-19
Completion date: 2021-06-19
Baseline population: Patients deemed immediate postoperative revision were not included in any of the analyses.
Clinical trial NCT05324618: Tacrolimus Versus Hydrocortisone in Atopic Dermatitis
Official title: A Comparative Clinical Trial to Evaluate the Efficacy and Safety of Tacrolimus Versus Hydrocortisone in Treatment of Children With Atopic Dermatitis
Sponsor: Ain Shams University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 200.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-15
Primary completion date: 2022-11-20
Completion date: 2023-04-30
Clinical trial NCT02808871: Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)
Official title: Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients With Rheumatoid Arthritis Interstitial Lung Disease (TRAIL1)
Sponsor: Brigham and Women's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 123.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-07
Primary completion date: 2021-04-07
Completion date: 2021-04-07
Plan to share individual participant data: NO
Clinical trial NCT05477186: Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old
Official title: A Phase 1, Open-label, Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 180.0 (ACTUAL)
Number of arms: 7.0
Start date: 2022-08-12
Primary completion date: 2023-08-18
Completion date: 2023-08-18
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, 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 NCT02857218: Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Stage IIB-IIIC Esophageal Cancer
Official title: A Pilot Study Using a Novel Imaging of Lymph Nodes in Patients With Locally Advanced Esophageal Cancer Using Ferumoxytol Enhanced MRI
Sponsor: OHSU Knight Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Inadequate enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-27
Primary completion date: 2021-08-19
Completion date: 2021-08-19
Clinical trial NCT04003610: Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)
Official title: A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement (FIGHT-205)
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The reason this study was terminated was due to a business decision. There were no safety concerns that contributed to this decision.
Enrollment: 7.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-05-14
Primary completion date: 2021-04-18
Completion date: 2021-04-18
Baseline population: No participants were enrolled in the pemigatinib 13.5 mg treatment arm.
Limitations and caveats: The Sponsor made a decision unrelated to safety to halt study enrollment. Due to early termination of the study with only 7 participants, no analysis of efficacy endpoints was done.
Plan to share individual participant data: YES
IPD sharing description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Clinical trial NCT04214652: Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
Sponsor: Bausch Health Americas, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 180.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-27
Primary completion date: 2021-03-18
Completion date: 2021-03-18
Plan to share individual participant data: UNDECIDED