chufangao/CTO huggingface dataset:
Clinical trial NCT04475991: Safety and Efficacy of Maraviroc and/or Favipiravir With Standard Therapy in Severe COVID-19 Adults
Official title: Phase2, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Maraviroc and/or Favipiravir Plus Standard Therapy in Adult Patients With Severe Non-critical COVID-19
Acronym: COMVIVIR
Sponsor: Hospital General de México Dr. Eduardo Liceaga (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: No more patients complying the selection criteria were available for recruitment
Enrollment: 19.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-07-13
Primary completion date: 2022-03-15
Completion date: 2022-03-25
Plan to share individual participant data: YES
IPD sharing description: Inter-institutional exchange of data
IPD time frame: Information will be shared upon completion of the study for collaborative purposes
IPD access criteria: Upon request
Clinical trial NCT03922139: Botox for the Treatment of Chronic Exertional Compartment Syndrome
Official title: OnabotulinumtoxinA (Botox) Effect on Pain and Return to Sport in Chronic Exertional Compartment Syndrome of the Anterior Leg: A Pilot Study
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: due to COVID-19
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-08
Primary completion date: 2021-12-15
Completion date: 2021-12-15
Plan to share individual participant data: NO
Clinical trial NCT02007239: Tocilizumab and Hemophagocytic Lymphohistiocytosis (HLH)
Official title: Cytokine Blockade With Tocilizumab in Patients With Cytokine Release Syndrome and Hemophagocytic Lymphohistiocytosis
Sponsor: Children's Hospital of Philadelphia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No subjects were enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-12-31
Primary completion date: 2021-05-31
Completion date: 2021-05-31
Clinical trial NCT04635735: Study of Ipilimumab After Stem Cell Transplantation in People With Relapsed/Refractory Multiple Myeloma
Official title: A Phase I/II Trial of Ipilimumab After CD34-Selected Allogeneic Stem Cell Transplantation for Patients With Relapsed/Refractory Multiple Myeloma
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Lack of accrual
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-12
Primary completion date: 2023-02-02
Completion date: 2023-02-02
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 NCT05516875: Open-Label Extension Study of ASTORIA
Official title: Open-Label Extension Study of JM-010 in Parkinson's Disease Patients With Dyskinesia
Sponsor: Contera Pharma A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-01-19
Primary completion date: 2024-05-22
Completion date: 2024-06-27
Plan to share individual participant data: NO
Clinical trial NCT03559985: Paracetamol and Neuropathic Pain
Official title: Analgesic Effect of Paracetamol in Neuropathic Pain Patients
Acronym: PAeoNy
Sponsor: University Hospital, Clermont-Ferrand (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recruitment difficulties
Enrollment: 43.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-20
Primary completion date: 2020-10-08
Completion date: 2022-08-31
Clinical trial NCT05201703: Fycompa in Catamenial Epilepsy
Official title: Pilot Study of Add-On Fycompa (Perampanel)Treatment for Catamenial Epilepsy
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Poor enrollment
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-09
Primary completion date: 2023-12-15
Completion date: 2023-12-15
Plan to share individual participant data: NO
Clinical trial NCT03653546: First Line Treatment in EGFR Mutation Positive Advanced NSCLC Patients with Central Nervous System (CNS) Metastases
Official title: A Randomized, Open-label, Controlled, Multi-Center Phase II/III Study to Assess the Efficacy and Safety of AZD3759 Vs. a Standard of Care EGFR TKI, As First Line Treatment to EGFR Mutation Positive Advanced NSCLC with CNS Metastases
Acronym: BM
Sponsor: Alpha Biopharma (Jiangsu) Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 492.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-29
Primary completion date: 2022-07-12
Completion date: 2022-07-12
Plan to share individual participant data: NO
Clinical trial NCT03588039: Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors
Official title: Phase 1 Study With Expansion Cohorts to Assess the Safety, Tolerability, and Activity of Oraxol (Paclitaxel + HM30181A) in Combination With Pembrolizumab in Subjects With Advanced Solid Malignancies
Sponsor: Athenex, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study terminated due to lack of funding
Enrollment: 34.0 (ACTUAL)
Number of arms: 8.0
Start date: 2018-10-25
Primary completion date: 2023-05-12
Completion date: 2023-05-12
Plan to share individual participant data: NO
Clinical trial NCT04172831: A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Official title: A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia
Acronym: RELIEF
Sponsor: Tonix Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 503.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-09
Primary completion date: 2020-10-29
Completion date: 2020-10-29
Limitations and caveats: Recruitment during COVID-19 pandemic
Clinical trial NCT03782792: Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis
Official title: Effisayil™ 1:Multi-center, Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety and Tolerability of a Single Intravenous Dose of Spesolimab (BI 655130) in Patients With Generalized Pustular Psoriasis (GPP) Presenting With an Acute Flare of Moderate to Severe Intensity
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 53.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-31
Primary completion date: 2020-09-23
Completion date: 2021-01-05
Baseline population: Randomized Set (RS): This patient set included all randomized patients.
Limitations and caveats: Due to the trial design, a large proportion of patients had received escape medication or non-randomized spesolimab by Week 4, based on worsening, insufficient response, or non-response. This should be taken into account for the interpretation of the results at Week 4. A large proportion of patients in both arms had been treated as non-responders at Week 4, and the true efficacy outcomes for the randomized treatment at this time-point were never observed for the analysis.
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT05590676: Metformin Treatment in Infants After Perinatal Brain Injury
Official title: A Phase I Safety and Feasibility of Metformin Treatment in Infants After Perinatal Brain Injury
Sponsor: The Hospital for Sick Children (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low recruitment
Enrollment: 1.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-05-02
Primary completion date: 2024-02-22
Completion date: 2024-02-22
Clinical trial NCT04391868: A Bioequivalence Study of Sildenafil Citrate Orally-Disintegrating Film Dosage Form
Official title: PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 3-WAY, 6-SEQUENCE CROSSOVER STUDY TO DEMONSTRATE BIOEQUIVALENCE OF SILDENAFIL ORALLY-DISINTEGRATING FILM 50 MG WITH OR WITHOUT WATER TO ORAL TABLET OF SILDENAFIL CITRATE (VIAGRA(Registered)) 50 MG UNDER FASTED CONDITION IN HEALTHY MALE PARTICIPANTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The project has been transferred to Viatris
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-01-30
Primary completion date: 2021-04-28
Completion date: 2021-04-28
Plan to share individual participant data: NO
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 NCT04568174: First in Human Study to Test the Safety and Preliminary Efficacy of PPSGG in Patients With Anti-MAG Neuropathy
Official title: First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of PPSGG (PN-1007) in Anti-MAG Neuropathy Patients
Sponsor: Polyneuron Pharmaceuticals AG (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Data don't support further development
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-17
Primary completion date: 2021-09-23
Completion date: 2021-09-23
Plan to share individual participant data: NO
Clinical trial NCT05473715: A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given in Customized Treatment Intervals in Patients With an Eye Disease Called Neovascular Age-related Macular Degeneration After Start of Treatment
Official title: A Parallel-group Phase 4, Open-label, Two-arm Study to Assess the Safety and Efficacy of Intravitreal (IVT) Aflibercept With Proactive Customized Treatment Intervals in Patients ≥50 Years of Age With No Fluid Due to Choroidal Neovascularization (CNV) Lesions Secondary to Neovascular (Wet) Age-related Macular Degeneration (nAMD) Following Treatment Initiation With Aflibercept
Acronym: XPAND
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Study terminated due to administrative reasons not related to efficacy or safety.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-04-25
Primary completion date: 2023-07-11
Completion date: 2023-07-11
Limitations and caveats: The trial was terminated due to administrative reasons not related to efficacy or safety.
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Clinical trial NCT04334148: Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine
Official title: Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)
Acronym: HERO-HCQ
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1360.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-22
Primary completion date: 2020-12-10
Completion date: 2021-01-09
Baseline population: Participants who completed the study
Limitations and caveats: The study was underpowered to detect a small treatment effect. The trial was novel and improved feasibility, particularly during a pandemic. Testing was not performed at all institutions per local policies in HCW. These events were defined as suspected cases and were combined with the confirmed cases in the primary outcome. This resulted in few confirmed COVID-19 infections; thus, our primary outcome was primarily suspected COVID-19 clinical infection.
Plan to share individual participant data: YES
IPD sharing description: Plan description: HERO-HCQ is funded by PCORI, the Patient-Centered Outcomes Research Institute. PCORI calls for the researchers PCORI funds to share their data sets and documentation for reanalysis and reuse. The policy advances PCORI's commitment to open science by encouraging use of data from the studies it funds to allow other researchers to verify and build on those findings to generate new evidence available to healthcare decision makers.
IPD time frame: July 2022
IPD access criteria: Individual investigators or teams of investigators seeking access to data from PCORI-funded studies must complete and submit a data request form to a PCORI-designated repository. The repository will independently review requests for data based on qualifications of the data requestors and the scientific merit of the request (see below). If the data request is approved, the data requestor's institution must enter into a Data Use Agreement (DUA) with the repository. More information is available here https://www.pcori.org/about-us/governance/policy-data-management-and-data-sharing
Clinical trial NCT03517722: A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study terminated early as a result of the outcome of the pre-planned Interim Analysis
Enrollment: 516.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-16
Primary completion date: 2020-11-05
Completion date: 2020-11-05
Limitations and caveats: Due to study termination, the open-label extension phase didn't reach the planned duration till Week 176. However, participants were assessed for safety up to Week 130 (that is, after study termination) and received study drug up to Week 113.
Clinical trial NCT03580369: A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Official title: A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Safety and Efficacy of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1072.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-10-17
Primary completion date: 2021-07-16
Completion date: 2022-06-14
Baseline population: Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.~Adults (1,034) + Adolescents (38) = Total (1,072)
Limitations and caveats: The difference of 4 subjects between RAN (1034) vs FAS (1030) is due to mis-randomization of 4 subjects. These subjects did not receive Ligelizumab and hence rightfully not included in FAS (though included in RAN).
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 NCT04388202: Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram
Official title: Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram (LEAP-SE): A Multicenter, Randomized, Blinded Outcome Study of EEG-guided Treatment With Sertraline Versus Escitalopram in Adults With Major Depressive Disorder
Acronym: LEAP-SE
Sponsor: Alto Neuroscience (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: No participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-15
Primary completion date: 2023-05-30
Completion date: 2023-05-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02408315: Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)
Official title: Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium
Acronym: IMPROVE
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 300.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-09-30
Primary completion date: 2017-11-30
Completion date: 2021-12-31
Plan to share individual participant data: YES
IPD sharing description: Will share as needed for IPD.
IPD time frame: After study completion and for 1 year after
IPD access criteria: Email contact to study contact.
Clinical trial NCT02956889: To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Advanced Basal Cell Carcinoma
Official title: A Single Arm, Phase II, Multicenter Study To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Patients With High Risk Or Locally Advanced Basal Cell Carcinoma Not Amenable To Radical Surgery
Acronym: virgilio
Sponsor: Istituto Clinico Humanitas (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: low recruitment rate
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-10-31
Primary completion date: 2019-02-28
Completion date: 2020-01-31
Plan to share individual participant data: NO
IPD sharing description: not planned
Clinical trial NCT03521934: Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients With Type 2 Diabetes POST Worsening Heart Failure
Sponsor: Lexicon Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study terminated due to business decision
Enrollment: 1222.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-15
Primary completion date: 2020-06-05
Completion date: 2020-06-05
Baseline population: Intent-to-treat (ITT) population included all randomized participants.
Limitations and caveats: Limitations of the trial such as small numbers of participants analyzed or technical problems leading to unreliable data.~The study was terminated prematurely due to business decision.
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.
Clinical trial NCT03714867: Pre-Operative Pregabalin for Post-Operative Pain in Head and Neck Cancer Surgery
Official title: Use of Single Dose Pre-Operative Pregabalin for Post-Operative Analgesia in Bilateral Head and Neck Cancer Surgery: A Randomized, Double-Blinded, Placebo-Controlled Trial
Sponsor: Augusta University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Inability to recruit patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-22
Primary completion date: 2020-07-07
Completion date: 2020-07-07
Clinical trial NCT04335461: Postop Pain Control in Hip Fracture Surgery: Fascia Iliaca Compartment Block Versus Fracture Block
Official title: Postoperative Pain Control in Extracapsular Hip Fracture Patients: Fascia Iliaca Compartment Block Versus Fracture Block
Sponsor: Montefiore Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Study was withdrawn. Study expired in IRB system and no patients enrolled as per institutional CTMS and IRB systems. Primary and Study Completion Dates reflect date IRB approval expired.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-08-05
Primary completion date: 2023-03-17
Completion date: 2023-03-17
Plan to share individual participant data: NO