chufangao/CTO huggingface dataset:
Clinical trial NCT02579863: Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab (MK-3475) in Participants With Newly Diagnosed Treatment Naive Multiple Myeloma (MK-3475-185/KEYNOTE-185)
Official title: A Phase III Study of Lenalidomide and Low-Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Newly Diagnosed and Treatment Naïve Multiple Myeloma (KEYNOTE 185).
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated early due to business reasons
Enrollment: 310.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-10-19
Primary completion date: 2018-07-09
Completion date: 2020-07-13
Baseline population: The analysis population included all randomized participants.
Limitations and caveats: The MK-3475-185 study was stopped/terminated early. Endpoint statistics may be biased due to the incomplete treatment and follow-up of participants after study termination
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05535023: Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx Squamous Cell Carcinoma
Official title: Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI Request
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-24
Primary completion date: 2023-07-25
Completion date: 2023-07-25
Clinical trial NCT03989349: Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
Sponsor: Galderma R&D (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 787.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-30
Primary completion date: 2022-02-23
Completion date: 2022-09-26
Baseline population: The ITT population consisted of all randomized participants.
Plan to share individual participant data: NO
Clinical trial NCT05513391: Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
Official title: Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine Compared With Egg-Based Standard-Dose Quadrivalent Influenza Vaccine in Children 3 to 8 Years of Age.
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision to prematurely stop the study. This decision was made without any safety concerns.
Enrollment: 366.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-10
Primary completion date: 2023-10-03
Completion date: 2023-10-03
Baseline population: Analysis was performed on all participants randomized by study interactive response technology to one of the study groups.
Limitations and caveats: Sponsor decision to prematurely stop the study. This decision was made without any safety concerns.
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 NCT03389412: The Effect of Selecting Treatment With Desmopressin or Alarm to Children With Enuresis Based on Home Recordings.
Official title: The Effect of Clinical Characterization of Children With Monosymptomatic Nocturnal Enuresis on the Efficacy of Desmopressin and Alarm Therapy.
Acronym: DRYCHILD
Sponsor: University of Aarhus (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 324.0 (ACTUAL)
Number of arms: 6.0
Start date: 2017-10-01
Primary completion date: 2023-01-03
Completion date: 2023-01-03
Plan to share individual participant data: YES
Clinical trial NCT03462641: Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm
Official title: Modulation of GABA-A Receptors and Axial Motor Impairments in Parkinson Disease-Flumazenil Arm
Sponsor: University of Michigan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-09
Primary completion date: 2021-06-04
Completion date: 2021-06-04
Baseline population: This is a per protocol analysis. Only the 28 participants that actually completed the entire study are included.
Limitations and caveats: Our participants were predominantly male, which is often the case with Parkinson's disease (PD) patient population since PD is known to affect males at a greater rate. This means that our findings may not generalize as well to population of female PD patients.
Plan to share individual participant data: NO
Clinical trial NCT01495598: Pomalidomide for Kaposi Sarcoma in People With or Without HIV
Official title: A Phase I/II Study of the Safety, Pharmacokinetics and Efficacy of Pomalidomide (CC-4047) in the Treatment of Kaposi Sarcoma in Individuals With or Without HIV
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 28.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-01-10
Primary completion date: 2022-05-17
Completion date: 2022-05-17
Plan to share individual participant data: YES
IPD sharing description: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.~All collected IPD will be shared with collaborators under the terms of collaborative agreements.
IPD time frame: Clinical data available during the study and indefinitely. All collected IPD will be available after primary analysis have been published.
IPD access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
Clinical trial NCT04356677: Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19
Official title: An Open-Label Study to Evaluate the Safety and Efficacy of VIRAZOLE® (RIBAVIRIN FOR INHALATION SOLUTION, USP) in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19
Sponsor: Bausch Health Americas, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Due to pandemic status changing in Canada prior to investigative sites being initiated for participation, and that concurrent participant recruitment in the global study BHC-RIB-5401-GL will achieve target enrollment across all countries.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-31
Primary completion date: 2021-08-31
Completion date: 2021-08-31
Clinical trial NCT02564380: Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients With Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC)
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients With Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC)
Acronym: PRIMUS
Sponsor: AIO-Studien-gGmbH (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Since trial start in Jan. 2016 only 41 patients could be recruited until planned date of end of follow up period. Under consideration of this fact the recruitment of the planned 130 patients was not possible within a reasonable recruitment period.
Enrollment: 41.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-19
Primary completion date: 2020-05-23
Completion date: 2020-11-23
Clinical trial NCT04623255: Study of Plasma Exchange in Severe COVID-19
Official title: A Randomised Controlled Trial of Plasma Exchange With Standard of Care Compared to Standard of Care Alone in the Treatment of Severe COVID-19 Infection (COVIPLEX)
Acronym: COVIPLEX
Sponsor: University College, London (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-16
Primary completion date: 2022-01-31
Completion date: 2022-01-31
Baseline population: Note: 23 patients with severe COVID-19 were randomised. One patient withdrew from the study 1 day after randomisation and their data has been excluded from the analysis. 11 were randomised to the treatment group receiving at least one course of Plasma Exchange (PEX).11 were assigned to the control group receiving only standard of care treatment (SOC). There were no follow-up data for a further two participants (1 from each arm) and hence they were omitted from this analysis.
Plan to share individual participant data: NO
Clinical trial NCT03483363: Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds
Official title: Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: recruitment issues
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-09
Primary completion date: 2022-01-02
Completion date: 2022-01-02
Clinical trial NCT03446807: Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism
Official title: Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism
Sponsor: Loma Linda University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor Decision to terminate
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-31
Primary completion date: 2023-07-01
Completion date: 2023-07-01
Plan to share individual participant data: YES
IPD sharing description: Lundbeck is funding this study and will be providing the study drug. If Lundbeck requests, they will be provided with protocol, statistical analysis plan, clinical study report, and any other study data they request. All adverse events will be reported to Lundbeck.
IPD time frame: The data will be available to Lundbeck from the start of the study through it's completion.
IPD access criteria: This material will be provided to Lundbeck in person, not electronically.
Clinical trial NCT03151304: A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes
Official title: A Two-Stage, Open-Label Phase 2 Study of Pracinostat and Azacitidine in Patients With IPSS-R High and Very High Risk Myelodysplastic Syndromes Previously Untreated With Hypomethylating Agents
Sponsor: Helsinn Healthcare SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor's decision as at the completion of the primary analysis, the data were considered mature
Enrollment: 64.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-06-01
Primary completion date: 2020-12-01
Completion date: 2020-12-01
Clinical trial NCT05435846: Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation
Official title: A Multicenter Phase I/Ib Study of Capmatinib Plus Trametinib in Patients With Metastatic MET Exon 14 Skipping Mutation Positive NSCLC
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: slow accrual
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-10
Primary completion date: 2023-11-30
Completion date: 2024-05-31
Plan to share individual participant data: NO
Clinical trial NCT04637555: Open-label Extension Study for CLCZ696G2301 (PARADISE-MI)
Official title: A Multicenter Study to Evaluate the Long-term Safety and Tolerability of Open-label LCZ696 in Patients With Acute Myocardial Infarction Who Previously Participated in CLCZ696G2301 (PARADISE-MI)
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: CLCZ696G2301E1 extension study did not start as the core study (CLCZ696G2301) did not meet the primary endpoint.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-05-26
Primary completion date: 2023-06-01
Completion date: 2023-06-01
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 NCT04898348: A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis
Sponsor: KoBioLabs (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No patients recruited
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-14
Primary completion date: 2023-07-28
Completion date: 2023-07-28
Plan to share individual participant data: NO
Clinical trial NCT04359862: Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection
Official title: Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection
Acronym: SEVO-COVID19
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Low recruitment ratio
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-16
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Plan to share individual participant data: NO
Clinical trial NCT02666547: 68Ga-NODAGA-RGD PET/ CT for Tumoral Neoangiogenesis
Official title: Value of PET/ CT in the 68Ga-NODAGA-RGD for the Evaluation of the Tumoral Neoangiogenesis
Sponsor: University of Lausanne Hospitals (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: lack of resources
Enrollment: 42.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-03-31
Primary completion date: 2023-08-31
Completion date: 2023-09-30
Plan to share individual participant data: NO
Clinical trial NCT02371590: Lenalidomide and Obinutuzumab for Previously Untreated CLL
Official title: A Phase 2 Clinical Trial To Evaluate Lenalidomide And Obinutuzumab For The Treatment Of Patients With Not Previously Treated Chronic Lymphocytic Leukemia
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study Not Activated Due to Contract Issues
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-02-28
Primary completion date: 2019-12-31
Completion date: 2022-12-31
Clinical trial NCT04890548: Study to Evaluate the Effects of AZD3427 in Patients With Heart Failure
Official title: A Mechanistic Study to Evaluate the Vasodilatory Effects of AZD3427 in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF) and Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study start up timelines delayed into late autumn, and with COVID cases rising in the UK, the feasibility of successfully recruiting the study and ethical concerns about starting a study that AZ may not be able to complete.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-23
Primary completion date: 2022-08-02
Completion date: 2022-08-02
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.~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 refer 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 NCT03122652: Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated Syndrome
Official title: Multi-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS Study
Acronym: TERIS
Sponsor: Centre Hospitalier Universitaire de Nice (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 125.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-25
Primary completion date: 2019-02-05
Completion date: 2022-10-04
Plan to share individual participant data: NO
Clinical trial NCT01954979: Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD)
Official title: A Phase I Study of Abatacept in the Treatment of Patients With Steroid Refractory Chronic Graft Versus Host Disease (cGVHD)
Sponsor: Beth Israel Deaconess Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 56.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-03-27
Primary completion date: 2023-06-01
Completion date: 2024-01-16
Clinical trial NCT05381974: The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD
Official title: The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was terminated due to difficulty recruiting patients who met inclusion/exclusion criteria. No participants received the intervention.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-09-15
Primary completion date: 2023-06-01
Completion date: 2023-06-01
Clinical trial NCT02558010: Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
Official title: Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
Sponsor: Medical College of Wisconsin (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 58.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-01
Primary completion date: 2022-01-01
Completion date: 2023-01-01
Clinical trial NCT05538624: A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary
Official title: A Phase 1/2 Open-Label, Multicenter, Dose Escalation and Expansion Study of AVB-001, an Intraperitoneally Administered, Cell-Generated, Human IL-2 Immunotherapy in Patients With Platinum-Resistant, High-Grade, Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube
Sponsor: Avenge Bio, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision to close study
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-09
Primary completion date: 2024-04-01
Completion date: 2024-04-10
Plan to share individual participant data: NO
Clinical trial NCT04061876: First Line Therapy for High Risk Acute GVHD
Official title: Ruxolitinib in Combination With Corticosteroid as First Line Therapy for the Treatment of High Risk Acute Graft-Versus-Host Disease
Sponsor: Chinese PLA General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 198.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-25
Primary completion date: 2022-08-01
Completion date: 2023-06-30
Plan to share individual participant data: NO
Clinical trial NCT03021590: Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori
Official title: Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori
Sponsor: Damascus Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: No Participants Enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-01
Primary completion date: 2021-12-31
Completion date: 2022-01-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04052620: Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study
Official title: A Randomized, Double Blind, Multi Center, Active-controlled, 2 Treatment Arm, Parallel Group Non Inferiority Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Versus 1.16% Gel in Subjects With Acute Ankle Sprain
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 313.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-24
Primary completion date: 2020-11-12
Completion date: 2020-11-12
Baseline population: Intent-to-treat (ITT) population: Comprise all randomized participants. This population was based on the treatment to which the participant was randomized. Any participant who received a treatment randomization number was considered to have been randomized.
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 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 grated, when justified, for up to another 12 months.