chufangao/CTO huggingface dataset:
Clinical trial NCT02192502: Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients
Official title: A Randomized Controlled Investigation of the Effects of 6% Hydroxyethylstarch 130/0.4 (Voluven) on Renal Function in Patients Having Aortic Valve Replacement With or Without Coronary Artery Bypass Grafting
Acronym: SHARP
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 149.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-03-31
Primary completion date: 2018-02-28
Completion date: 2020-02-29
Clinical trial NCT04847232: Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
Official title: An International, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The event rate observed in the study continued to be below primary assumptions, so that the completion of the study within a reasonable timeframe was deemed very unlikely.
Enrollment: 2698.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-30
Primary completion date: 2024-03-07
Completion date: 2024-03-07
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 de-identified 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 NCT03834506: Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)
Official title: A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1030.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-02
Primary completion date: 2022-06-20
Completion date: 2023-07-18
Baseline population: The baseline analysis population consisted of all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05438602: A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System
Official title: AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE NIRMATRELVIR/RITONAVIR IN NONHOSPITALIZED PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH SYMPTOMATIC COVID-19 WHO ARE IMMUNOCOMPROMISED
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 158.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-08-03
Primary completion date: 2023-07-17
Completion date: 2023-11-13
Baseline population: Safety population included all randomised participants who received at least 1 dose of the study intervention.
Limitations and caveats: For outcome measure data have not been reported for RP separately, since there was 1 participant each in 2 arms (Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day and Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 day), it could have led to re-identification of RP participants. In other sections of results data for RP and MSP have been combined.
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 NCT04085991: Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer
Official title: Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer
Acronym: CROSSBOW
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Drug no longer available
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-31
Primary completion date: 2023-01-15
Completion date: 2023-01-15
Plan to share individual participant data: NO
Clinical trial NCT03756129: Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression
Official title: A Multi-center, Randomized, subject-and Investigator Blinded, Placebo-controlled, Active Comparator, Parallel-group Proof of Concept Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Patients With Treatment-resistant Depression
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 70.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-02-08
Primary completion date: 2020-03-23
Completion date: 2020-03-23
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 NCT04677179: A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Official title: An Adaptive Phase 2, Randomized, Double Blind, Placebo Controlled Study of LY3471851 (NKTR 358) in Patients With Moderately to Severely Active Ulcerative Colitis
Acronym: INSTRUCT-UC
Sponsor: Nektar Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study terminated due to enrollment futility.
Enrollment: 81.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-03-22
Primary completion date: 2022-08-09
Completion date: 2022-08-09
Baseline population: All randomized participants.
Plan to share individual participant data: NO
Clinical trial NCT03252093: Evaluation of the Safety and Efficacy of Ang-(1-7) to Enhance Cognitive Function in Participants Undergoing CABG
Official title: A Randomized, Placebo-controlled, Double Blind Evaluation of the Safety and Efficacy of Angiotensin 1-7 (Ang-(1-7)) to Enhance Cognitive Function in Participants Undergoing Coronary Artery Bypass Graft (CABG) Surgery.
Sponsor: University of Arizona (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Due to funding
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-20
Primary completion date: 2022-11-15
Completion date: 2022-11-15
Clinical trial NCT04178902: A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma
Official title: A First In Human Study of the MCL-1 Inhibitor, ABBV-467
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-19
Primary completion date: 2021-04-16
Completion date: 2021-04-16
Plan to share individual participant data: NO
Clinical trial NCT04538833: GM1 in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel
Official title: Monosialoganglioside in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel : a Multicenter, Double-blind, Randomized Controlled Phase II Clinical Trial
Sponsor: Henan Cancer Hospital (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: In the clinical treatment, no patient with a score of less than 38(FACT Ntx Score) points after 1-2 weeks of application of albumin bound paclitaxel in this project, therefore, there is no suitable subject after screening
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-09
Primary completion date: 2022-08-22
Completion date: 2022-08-22
Clinical trial NCT03760445: HDM201 Added to CT in R/R or Newly Diagnosed AML
Official title: A Phase I/II Multi-center Study of HDM201 Added to Chemotherapy in Adult Subjects With Relapsed/Refractory (R/R) or Newly Diagnosed Acute Myeloid Leukemia (AML)
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: It was determined that the study design may not be optimal given the changing AML treatment landscape.
Enrollment: 0.0 (ACTUAL)
Number of arms: 8.0
Start date: 2019-11-15
Primary completion date: 2021-07-22
Completion date: 2023-06-13
Plan to share individual participant data: UNDECIDED
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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.
Clinical trial NCT04464174: Ipatasertib Plus Non-Taxane Chemotherapy for Advanced or Metastatic Triple-Negative Breast Cancer
Official title: A Multicenter, Open-Label, Non-Comparative, Three-Arm, Phase IIa Trial of Ipatasertib (GDC-0068) in Combination With Non-Taxane Chemotherapy Agents for Taxane-Pretreated Unresectable Locally Advanced or Metastatic TNBC Patients
Acronym: PATHFINDER
Sponsor: MedSIR (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 54.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-10-08
Primary completion date: 2023-11-10
Completion date: 2023-11-10
Plan to share individual participant data: NO
Clinical trial NCT02073838: Ribavirin and Hedgehog Inhibitor With or Without Decitabine in AML
Official title: A Phase II, Multi-center, Open Label, Randomized Study of Ribavirin and Hedgehog Inhibitor With or Without Decitabine in Acute Myeloid Leukemia (AML)
Sponsor: Jewish General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-05-31
Primary completion date: 2022-11-30
Completion date: 2022-11-30
Clinical trial NCT01413620: Vitamin E Supplementation in Burn Patients
Official title: Vitamin E Supplementation in Burn Patients
Sponsor: Shriners Hospitals for Children (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-08-31
Primary completion date: 2017-08-31
Completion date: 2021-08-31
Plan to share individual participant data: NO
Clinical trial NCT01949311: Open-label Study of Dupilumab in Patients With Atopic Dermatitis
Official title: An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2733.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-10-10
Primary completion date: 2022-06-27
Completion date: 2022-06-27
Clinical trial NCT03521232: A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis
Official title: A Phase I/IIA, Open-Label, Three-Stage Study to Investigate the Safety, the Efficacy and the Pharmacokinetics of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Procto-Sigmoiditis
Sponsor: Entero Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Covid-19
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-15
Primary completion date: 2022-09-19
Completion date: 2022-10-04
Plan to share individual participant data: NO
Clinical trial NCT04031846: Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (PNEU-PED-EU-1)
Acronym: PNEU-PED-EU-1
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1184.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-04
Primary completion date: 2021-08-05
Completion date: 2021-08-05
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05079451: Broadly Neutralizing Antibodies 3BNC117-LS & 10-1074-LS to Prevent Relapse During ATI
Official title: A Phase I, Open-Label Study of the Safety and Ability of Broadly Neutralizing Antibodies 3BNC117-LS and 10-1074-LS in Combination to Durably Prevent Viral Relapse During a Monitored Analytical Treatment Interruption
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Protocol Withdrawal
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2024-01-01
Primary completion date: 2024-01-15
Completion date: 2024-02-15
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie results in the publication, after deidentification.
IPD time frame: Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.
IPD access criteria: * With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.
Clinical trial NCT03442751: Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus
Official title: A Phase III, Multi-center Study to Evaluate the Safety and Efficacy of Epithelium-on Corneal Collagen Cross-linking in Eyes With Progressive Keratoconus
Sponsor: Glaukos Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 201.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-06
Primary completion date: 2019-11-01
Completion date: 2020-08-10
Baseline population: Subjects with progressive keratoconus in at least one eye (study eye). Subjects may contribute more than one eye if both eyes qualify. Eyes vs. subjects were randomized to the treatment arms.
Plan to share individual participant data: NO
Clinical trial NCT05333289: A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults
Official title: Phase 1/2, Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1020 and mRNA-1030 Candidate Seasonal Influenza Vaccines in Healthy Adults
Sponsor: ModernaTX, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 572.0 (ACTUAL)
Number of arms: 8.0
Start date: 2022-04-06
Primary completion date: 2022-11-22
Completion date: 2022-11-22
Baseline population: The Randomization Set consisted of all participants who were randomly assigned.
Clinical trial NCT04839965: Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen
Official title: A Randomized, Double-Blinded, Placebo Controlled Phase II Study to Evaluate the Safety and Efficacy of IV Ampion in Adult COVID-19 Patients Requiring Oxygen Supplementation
Sponsor: Ampio Pharmaceuticals. Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The AP-017 study was prematurely terminated by the sponsor after an interim analysis.
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-05
Primary completion date: 2022-02-07
Completion date: 2022-04-04
Limitations and caveats: The AP-017 study was prematurely terminated by the sponsor after an interim analysis.
Clinical trial NCT02926248: Effect of Colchicine on Range of Motion After Manipulation Under Anesthesia for the Stiff Total Knee Replacement
Official title: Effect of Colchicine on Range of Motion After Manipulation Under Anesthesia for the Stiff Total Knee Replacement: A Prospective Randomized Controlled Trial
Acronym: Colchine MUA
Sponsor: Hospital for Special Surgery, New York (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: SUSPENDED 
Why stopped: Continuing IRB review was not submitted. Study was inactivated with the institutional IRB.
Enrollment: 112.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2016-05-31
Primary completion date: 2020-03-21
Completion date: 2021-03-31
Plan to share individual participant data: NO
Clinical trial NCT02506517: A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene
Official title: Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies
Sponsor: University Health Network, Toronto (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-08-31
Primary completion date: 2023-05-04
Completion date: 2023-05-04
Clinical trial NCT03678428: FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM
Official title: FUDR/Oxaliplatin HAI Plus Irinotecan Chemotherapy vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Production halt of FUDR in China
Enrollment: 92.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-31
Primary completion date: 2022-10-31
Completion date: 2022-12-31
Clinical trial NCT03926130: A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease
Acronym: VIVID-1
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1158.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-23
Primary completion date: 2023-08-23
Completion date: 2023-10-02
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT03764774: A Study of LY3463251 in Healthy Participants
Official title: A Randomized, Placebo-Controlled, Subject- and Investigator-Blind, Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetics Study of LY3463251 in Healthy and Overweight Healthy Subjects
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Trial was terminated due to an insufficient benefit/tolerability ratio
Enrollment: 118.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-12-06
Primary completion date: 2020-12-07
Completion date: 2020-12-07
Plan to share individual participant data: NO
Clinical trial NCT04432766: A Phase 1/2 Study to Assess Safety and Efficacy of BAT2020 in Hospitalized COVID-19 Patients
Official title: A Phase 1/2, Multi-Center, Randomized Study to Assess Safety, Pharmacokinetics, Immunogenicity, and Efficacy of BAT2020 in Hospitalized Patients Infected With SARS-CoV-2 (COVID-19)
Sponsor: Bio-Thera Solutions (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: strategic decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-10-20
Primary completion date: 2021-01-20
Completion date: 2021-08-18
Clinical trial NCT03945188: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Acronym: ELEVATE UC 52
Sponsor: Arena Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 433.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-13
Primary completion date: 2022-02-08
Completion date: 2022-02-16
Baseline population: Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study treatment.
Plan to share individual participant data: NO
Clinical trial NCT02813655: Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
Official title: Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
Acronym: ESYBRECHE
Sponsor: Hospices Civils de Lyon (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Interim analysis and decision of the independent committee, investigators and sponsor (futility) (2023/10/05)
Enrollment: 46.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-31
Primary completion date: 2022-11-30
Completion date: 2022-11-21