chufangao/CTO huggingface dataset:
Clinical trial NCT03020199: Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis
Official title: A Randomized, Multicenter STudy to Evaluate the Effect of Secukinumab 300 mg s.c. Administered During 52 Weeks to Patients Suffering From New-onset Moderate to Severe Plaque Psoriasis as Early Intervention Compared to Standard Treatment With Narrow-band UVB (STEPIn Study)
Acronym: STEPin
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study ended early due to few patients left in the long-term extension phase, hindering significant conclusions. This early termination did not impact the study's main or secondary goals, and the decision was not related to any safety concerns.
Enrollment: 196.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-27
Primary completion date: 2021-11-30
Completion date: 2023-06-16
Baseline population: Subject disposition and baseline characteristics and presented using Randomized Set.
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 NCT03151707: The Effects of Nicotinamide Riboside Supplementation on Brain NAD+/NADH Ratio and Bioenergetics
Official title: The Effects of Nicotinamide Riboside Supplementation on Nicotinamide Adenine Dinucleotide (NAD+/NADH) Ratio and Bioenergetics
Sponsor: Mclean Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Lack of funding and appropriate staff
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-10-01
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Limitations and caveats: Early termination leading to small numbers of subjects analyzed
Clinical trial NCT04588298: A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer
Official title: A Randomised, Open-Label, Parallel-Group, Pre-surgical Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2-negative Primary Breast Cancer (SERENA-3)
Acronym: SERENA-3
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 135.0 (ACTUAL)
Number of arms: 7.0
Start date: 2020-11-02
Primary completion date: 2023-06-19
Completion date: 2023-06-19
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 requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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 NCT04076423: A Phase IV Study to Assess the Impact of the Change of Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With HIV Infection
Official title: A Phase IV, Multicenter, Open and Randomized Study to Assess the Impact of the Change From Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With Type 1 HIV Infection. InSTINCT Study
Acronym: InSTINCT
Sponsor: Fundacion SEIMC-GESIDA (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 141.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-10
Primary completion date: 2023-06-15
Completion date: 2024-01-16
Clinical trial NCT05866926: Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
Official title: A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
Acronym: ADOREXT
Sponsor: Ferrer Internacional S.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: After the analysis of the main ADORE study it is concluded that there is no clinical benefit for the patients.
Enrollment: 206.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-03-06
Primary completion date: 2024-01-09
Completion date: 2024-02-22
Clinical trial NCT05062083: PET Imaging of Cyclooxygenase in Multiple Sclerosis
Official title: PET Imaging of Cyclooxygenases in Multiple Sclerosis
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: due to futility
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-06-07
Primary completion date: 2023-09-05
Completion date: 2024-01-30
Plan to share individual participant data: YES
IPD sharing description: .This study will also comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.
IPD time frame: 18 months after closure of protocol
IPD access criteria: Biomedical Translational Research Information System (BTRIS)
Clinical trial NCT04147650: Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome
Official title: A Randomized, Double-Masked, Vehicle-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution (VOS) in Subjects With Dry Eye Syndrome (DES)
Acronym: AUDREY
Sponsor: Aurinia Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 508.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-10-14
Primary completion date: 2020-09-17
Completion date: 2020-10-08
Plan to share individual participant data: NO
Clinical trial NCT04299438: Propranolol Rescue of Prolonged Labor
Official title: Propranolol Rescue of Prolonged Labor (PROPEL): A Randomized, Double-blind, Placebo-controlled Multicenter Investigation of Propranolol's Effect on Cesarean Delivery Rate Among Women With Prolonged Labor
Acronym: PROPEL
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Stopped at interim analysis
Enrollment: 164.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-14
Primary completion date: 2022-06-15
Completion date: 2022-07-15
Baseline population: trial stopped by DSMB after interim analysis
Plan to share individual participant data: NO
Clinical trial NCT04157114: MAP4343 Treatment for Alcohol Use Disorder
Official title: A Double-Blind, Randomized, Controlled Trial of MAP4343 Treatment, a Ligand of the Neurospecific Microtubule Associated Protein-2, for Alcohol Use Disorder
Sponsor: The Scripps Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The FDA requested Mapreg conduct an alcohol interaction study which was not feasible due to the COVID-19 pandemic.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-31
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT04290442: Adductor Canal Vs Adductor Canal Plus SPANK Block for Postoperative Pain in Knee Arthroplasty Surgery
Official title: A Prospective Randomized Parallel Study to Compare Post-operative Pain Control With Addition of Sensory Posterior Articular Nerve Block to Adductor Canal Block (SPANK) and Intraoperative Periarticular Infiltration in Total Knee Arthroplasty.
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: initially cessation due to covid, then fellow doing the study graduated with no time to complete the study; will take up again if a current fellow takes on the project
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-01
Primary completion date: 2021-03-15
Completion date: 2021-06-01
Plan to share individual participant data: NO
IPD sharing description: There is no plan to share individual participant data.
Clinical trial NCT03852901: Sodium-glucose Co Transporter 2 (sGLT2) Inhibitor and Endogenous Ketone Production
Official title: Sodium-Glucose CoTransporter 2 (sGLT2) Inhibitor and Endogenous Ketone Production
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-28
Primary completion date: 2020-11-12
Completion date: 2021-12-13
Clinical trial NCT01121120: Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant (PBSC) in Hodgkin, Non-Hodgkin Lymphoma or Multiple Myeloma Patients
Official title: Phase II Study Evaluating the Safety and Efficacy of TXA127 in the Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant in Patients With Hodgkin Lymphoma, Non-Hodgkin Lymphoma or Multiple Myeloma Undergoing Limited Reinfusion of CD34+ Cells
Acronym: TXA127-PBSC
Sponsor: Tarix Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Enrollment: 75.0 (ACTUAL)
Number of arms: 2.0
Start date: 2010-06-30
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Clinical trial NCT04433585: A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus
Acronym: ISLAND-SLE
Sponsor: Nektar Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 291.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-08-19
Primary completion date: 2023-01-10
Completion date: 2023-02-16
Plan to share individual participant data: NO
Clinical trial NCT03281304: A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
Official title: A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study terminated early due to business reasons, with the study already meeting its primary objective. The decision to terminate the trial was not based on any safety and/or efficacy concerns.
Enrollment: 140.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-16
Primary completion date: 2020-02-14
Completion date: 2022-03-18
Baseline population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
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 NCT05332405: SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow
Official title: SPY Angiography To Determine the Extent of Nerve Release After Nerve Decompression
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Obsolete study
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-05-26
Primary completion date: 2023-10-01
Completion date: 2024-04-01
Plan to share individual participant data: NO
IPD sharing description: IPD will only be used for this study
Clinical trial NCT05169437: Niraparib in the Treatment of Patients with Advanced PALB2 Mutated Tumors
Official title: A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
Acronym: PAVO
Sponsor: Tempus AI (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recruitment challenges
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-03-15
Primary completion date: 2024-08-06
Completion date: 2024-08-27
Clinical trial NCT04459715: A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)
Official title: A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study has crossed the pre-defined futility boundary at the Interim Analysis.
Enrollment: 730.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-07
Primary completion date: 2024-09-18
Completion date: 2024-09-18
Plan to share individual participant data: YES
IPD sharing description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
IPD time frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD access criteria: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Clinical trial NCT03718533: Study of Efficacy and Safety of Eltrombopag in Patients With Poor Graft Function
Official title: The ELTION Study - A Multicenter Open-label Interventional Study of Eltrombopag in Patients With Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation
Acronym: ELTION
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: In the context of COVID-19 pandemic, the benefit / risk ratio of the participation of a patient with pancytopenia could be compromised. The decision of this premature termination was not the consequence of any safety reason inherent to the drug.
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-17
Primary completion date: 2020-11-03
Completion date: 2020-11-03
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 NCT03688555: A Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis
Official title: A Randomized, Double-blind, Placebo-controlled, 12-week Treatment Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis
Sponsor: Idorsia Pharmaceuticals Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-19
Primary completion date: 2020-11-24
Completion date: 2020-12-01
Baseline population: This analysis set included all randomized participants who received at least one dose of the study treatment. Participants were evaluated according to the actual study treatment they received.
Limitations and caveats: The study was initially planned as a single-center study. The protocol had to be updated accordingly for approvals for the second site in Germany.~The p-values need to be cautiously interpreted due to the small study population size.~Recruitment was put on hold on during the COVID-19 pandemic from 30 March to 28 May 2020 in Germany and from 31 March 2020 to 11 June 2020 in Belgium. Recruitment was subsequently restarted.
Plan to share individual participant data: NO
Clinical trial NCT04485130: DISulfiram for COvid-19 (DISCO) Trial
Official title: DISulfiram for COvid-19 (DISCO) Trial: A Phase 2 Double-Blind, Randomized Placebo-Controlled Trial of Disulfiram Compared to Standard Care in Patients With Symptomatic COVID-19
Acronym: DISCO
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low COVID case numbers, competing COVID treatments available
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-18
Primary completion date: 2022-02-28
Completion date: 2022-02-28
Baseline population: The trial stopped early so we were unable to enroll for Cohort 2.
Plan to share individual participant data: YES
IPD sharing description: Planned sharing of de-identified individual participant data for the purposes of collaboration and meta-analyses.
IPD time frame: After publication of study results
IPD access criteria: De-identified data
Clinical trial NCT03988582: Safety and Effectiveness of EBV-specific Cytotoxic T Cells for the Treatment for EBV Lymphomas or Other EBV-associated Malignancies
Official title: A Phase II Trial of EBV-Specific Cytotoxic T Cells for the Treatment of EBV Lymphomas or Other EBV-associated Malignancies
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-06-11
Primary completion date: 2020-06-08
Completion date: 2020-06-08
Plan to share individual participant data: YES
IPD sharing description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Clinical trial NCT03517566: A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
Official title: A Randomized, Double-blind, Placebo-controlled Multicenter Dose Ranging Study to Assess the Safety and Efficacy of Multiple Oral ZPL389 Doses in Patients With Moderate to Severe Atopic Dermatitis (ZEST Trial)
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of efficacy
Enrollment: 293.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-11-14
Primary completion date: 2020-07-15
Completion date: 2020-08-06
Baseline population: All subjects to whom study treatment was assigned. Two Mis-randomized (mis-randomized in Interactive Response Technology (IRT)) subjects in the placebo group were excluded. Mis-randomized subjects were defined as cases where IRT was contacted by the site either prematurely or inappropriately prior to confirmation of the subject's final randomization eligibility and no study medication was administered to the subject.
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 NCT04042116: A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor
Official title: LIO-1: A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With An Advanced, Metastatic Solid Tumor
Sponsor: Clovis Oncology, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Company decision
Enrollment: 227.0 (ESTIMATED)
Number of arms: 6.0
Start date: 2019-07-29
Primary completion date: 2023-07-31
Completion date: 2024-01-31
Plan to share individual participant data: YES
IPD sharing description: De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.~Data will be provided by Clovis Oncology.
IPD time frame: Data will be made available to qualified researchers after the primary, secondary, and/or exploratory outcomes of the study are reported or published and for 1 year thereafter.
IPD access criteria: Requests for de-identified datasets will be made available to qualified researchers following submission of a methodologically sound proposal to medinfo@clovisoncology.com.