chufangao/CTO huggingface dataset:
Clinical trial NCT04166773: A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
Acronym: SYNERGY-NASH
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 196.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-11-19
Primary completion date: 2023-12-11
Completion date: 2024-01-10
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 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 NCT03802630: Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion
Official title: An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion
Acronym: RAPTOR
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study was terminated by sponsor due to increased incidences of AEs of special interest (intraocular inflammation including retinal vasculitis and retinal vascular occlusion), in patients dosed brolucizumab 6mg every 4 weeks beyond 3 initial doses
Enrollment: 450.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-02
Primary completion date: 2021-07-26
Completion date: 2021-07-26
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 NCT03697824: Clinical Trial of Safety, Tolerability and Antitumor Activity of Genetically Engineered T Cells in Combination With Anti-Cancer Agents in Relapsed and Refractory Synovial Sarcoma Expressing New York Esophageal Antigen-1 (NY-ESO-1) and/or LAGE-1a
Official title: Open-Label Phase 1b/2a Clinical Trial to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered NY-ESO-1 Specific (c259) T Cells (GSK3377794) in Combination With Anti-Cancer Agents Including Pembrolizumab in HLA-A2+ Participants With NY-ESO-1 and/or LAGE-1a Positive Relapsed and Refractory Synovial Sarcoma
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Internal decision, study will be replaced with a larger monotherapy trial
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-25
Primary completion date: 2022-07-18
Completion date: 2022-07-18
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT02283905: Amphotericin-B and Voriconazole for Pulmonary Blastomycosis
Official title: Case Series of Continuously-infused Amphotericin-B and Follow-up Voriconazole Therapy for Severe Blastomycosis Pulmonary Infections
Acronym: BLASTO
Sponsor: University of Manitoba (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Poor enrollment numbers of patients
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-06-30
Primary completion date: 2020-09-25
Completion date: 2020-09-25
Plan to share individual participant data: NO
Clinical trial NCT04172597: A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies
Official title: A Phase 2 Study of Poziotinib in Patients With EGFR or HER2 Activating Mutations in Advanced Malignancies
Sponsor: Spectrum Pharmaceuticals, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Strategic business decision (unrelated to safety)
Enrollment: 1.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-12-23
Primary completion date: 2022-03-29
Completion date: 2022-03-29
Baseline population: The study was terminated by the Sponsor. Based on the low enrollment number (n=1), no data is reported here to protect and maintain participant privacy/confidentiality.
Plan to share individual participant data: NO
Clinical trial NCT04411914: Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid
Official title: A Phase 1B Double Blind, Placebo (PBO) Controlled, Pharmaco- Magnetic Resonance Spectroscopy (MRS) Inpatient Study of Clavulanic Acid (CLAV) 500, 750, 1000 mg Daily Repeated Administration in Early Remitted Cocaine Use Disorder Subjects
Sponsor: Temple University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-01
Primary completion date: 2021-11-23
Completion date: 2022-03-31
Plan to share individual participant data: NO
Clinical trial NCT05254236: Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated Vaccine in Healthy Adults in in Hong Kong
Official title: A Phase IIb, Randomized, Double-Blinded Trial to Evaluate the Immunogenicity and Safety Study of the Booster Dose Using the High or Medium Dose of COVID- 19 Vaccine (Vero Cell), Inactivated in Healthy Adults Who Have Completed Two Doses of mRNA Vaccine in Hong Kong
Sponsor: Sinovac Biotech Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Limited subjects
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-10
Primary completion date: 2022-03-10
Completion date: 2022-03-10
Clinical trial NCT02454855: Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients
Official title: Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (> = 70 Years) - PHRC-K13-170
Acronym: MEQAPAG
Sponsor: Centre Jean Perrin (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study stopped for futility after the DSMB.
Enrollment: 123.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-07-31
Primary completion date: 2021-05-31
Completion date: 2022-02-28
Clinical trial NCT05073484: Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients
Official title: A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6021 as Mono Therapy or in Combination With BAT1308 in Patients With Advanced Solid Tumors
Sponsor: Bio-Thera Solutions (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Based on the disclosed global research data on the same target drugs, the company has carefully considered and decided to terminate the project to optimize the existing research pipeline.
Enrollment: 13.0 (ACTUAL)
Number of arms: 9.0
Start date: 2021-10-29
Primary completion date: 2023-03-30
Completion date: 2023-03-30
Plan to share individual participant data: NO
IPD sharing description: no plan to share IPD
Clinical trial NCT05210088: PLAsticity, Security and Tolerance to Intermittent Hypoxic Conditioning Following Stroke
Official title: PLAsticity, Security and Tolerance to Intermittent Hypoxic Conditioning Following Stroke
Acronym: PLASTIHC
Sponsor: University Hospital, Grenoble (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: faisability
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2024-01-01
Primary completion date: 2024-01-01
Completion date: 2024-01-01
Plan to share individual participant data: YES
IPD sharing description: Data collected for the study, including deidentified individual participant data will be made available to others following the publication of this article, for academic purposes (e.g., meta-analyses) on request to the principal investigator, after the publication of the results of the present study.
IPD time frame: After the publication of the results of the present study.
IPD access criteria: Data collected for the study, including deidentified individual participant data will be made available to others following the publication of this article, for academic purposes (e.g., meta-analyses) on request to the principal investigator.
Clinical trial NCT04842292: Nebulized Heparin for COVID19-associated Acute Respiratory Failure
Official title: Utilization of Nebulized Heparin for Patients Receiving Mechanical Ventilation for COVID19-associated Acute Respiratory Failure
Sponsor: University of Kentucky (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of enrollment
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-20
Primary completion date: 2021-09-04
Completion date: 2021-09-04
Baseline population: Two participants were enrolled.
Plan to share individual participant data: NO
Clinical trial NCT02107118: Stem Cells for the Improvement of Erectile and Cardiac Function in Aging Men
Official title: H-34570: PHASE I Study: The Use of Autologous Adipose Tissue-Derived Mesenchymal Stem Cell (AdMSC) for the Improvement of Erectile and Cardiac Function in Aging Men
Sponsor: Baylor College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Contract issues
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-05-31
Primary completion date: 2020-03-31
Completion date: 2022-02-28
Clinical trial NCT02954523: Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations
Official title: Phase I/II Study of Dasatinib and Osimertinib (AZD9291) in Patients With Advanced Non-small Cell Lung Cancer With EGFR Mutations
Sponsor: Georgetown University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Lack of accrual
Enrollment: 10.0 (ACTUAL)
Number of arms: 5.0
Start date: 2016-10-31
Primary completion date: 2018-08-31
Completion date: 2023-03-03
Plan to share individual participant data: NO
Clinical trial NCT04718402: A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Gastric Carcinoma
Official title: A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Gastric Carcinoma
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The sponsor has adjusted its R\&D strategy.
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-30
Primary completion date: 2022-05-30
Completion date: 2022-05-30
Clinical trial NCT01996696: Prevention of Metabolic Syndrome and Increased Weight Using Metformin Concurrent to Androgen Deprivation Therapy and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate
Official title: Prevention of Metabolic Syndrome and Increased Weight Using Metformin Concurrent to Androgen Deprivation Therapy and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate
Acronym: PREMIUM
Sponsor: AHS Cancer Control Alberta (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Results of interim analysis indicate no statistically significant difference in the primary objective between the two arms at baseline and 12 months of follow-up.
Enrollment: 83.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-09-30
Primary completion date: 2020-11-30
Completion date: 2020-11-30
Plan to share individual participant data: NO
Clinical trial NCT05059301: A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above
Official title: A Phase 3, Randomized, Double-blind, Multi-country Study to Evaluate Consistency, Safety, and Reactogenicity of 3 Lots of RSVPreF3 OA Investigational Vaccine Administrated as a Single Dose in Adults Aged 60 Years and Above
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 770.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-10-01
Primary completion date: 2022-01-24
Completion date: 2022-06-30
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT03643952: Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
Official title: A Phase II Open-Label, Single-arm Clinical Trial to Study the Safety, Efficacy and Pharmacokinetics of MK-3009 (Daptomycin) in Japanese Pediatric Participants Aged 1 to 17 Years With Complicated Skin and Soft Tissue Infections or Bacteremia Caused by Gram-positive Cocci
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-06
Primary completion date: 2020-04-07
Completion date: 2020-04-07
Limitations and caveats: The study was concluded due to the difficulty of enrolling pediatric patients into the study during the COVID-19 pandemic. This study concluded enrollment with 18 participants, versus the 20 that were originally planned.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT02561481: Sulforaphane Treatment of Children With Autism Spectrum Disorder (ASD)
Official title: Sulforaphane Treatment of Children With Autism Spectrum Disorder (ASD)
Sponsor: University of Massachusetts, Worcester (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-12-31
Primary completion date: 2018-12-31
Completion date: 2020-01-31
Limitations and caveats: The sample size was limited to 45 children with ASD and we could not impute missing data for those participants who were lost to follow up.
Plan to share individual participant data: NO
Clinical trial NCT03971474: Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial)
Official title: A Phase II Randomized Study of Ramucirumab Plus MK3475 (Pembrolizumab) Versus Standard of Care for Patients Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)
Sponsor: SWOG Cancer Research Network (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 166.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-28
Primary completion date: 2022-04-14
Completion date: 2024-01-01
Baseline population: Participants who are eligible and evaluable for the primary analysis
Clinical trial NCT02899195: Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma
Official title: Open Label, Phase II Study of Anti - Programmed Death - Ligand 1 Antibody, Durvalumab (MEDI4736), in Combination With Chemotherapy for the First-Line Treatment of Unresectable Mesothelioma
Acronym: PrE0505
Sponsor: PrECOG, LLC. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 55.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-06-13
Primary completion date: 2020-02-16
Completion date: 2023-06-29
Plan to share individual participant data: NO
IPD sharing description: Data is proprietary.
Clinical trial NCT02975349: A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Results from the EVOLUTION clinical trials showed evobrutinib did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide in both studies.
Enrollment: 267.0 (ACTUAL)
Number of arms: 6.0
Start date: 2017-03-07
Primary completion date: 2018-01-24
Completion date: 2024-04-02
Baseline population: Modified Intent-To-Treat (mITT) analysis set included participants who belong to both Intent To Treat (ITT, consisted all participants who randomly allocated to a treatment, based on the intention to treat as randomized principle) and safety analysis sets (consisted all participants who receive at least 1 dose of trial treatment), and who have at least one baseline and one post-baseline magnetic resonance imaging (MRI) assessment.
Limitations and caveats: Reported p values are not adjusted for multiple testing.
Plan to share individual participant data: YES
IPD sharing description: Per company policy and with respect to the principles set forth by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Declaration of Helsinki, and applicable laws and regulations , we inform the public about the designs and results of our clinical trials in a timely and balanced manner, regardless of the outcome. We are committed to enhancing public health through responsible sharing of clinical trial data in a manner that is consistent with: safeguarding the privacy of patients; respecting the integrity of national regulatory systems; and maintaining incentives for investment in biomedical research.
IPD time frame: Within six months after the occurrence of an approval of a new product or a new indication for an approved product in both the European Union and the United States after January 1, 2014 If approval of a product is not sought, Merck shall make publicly available such data within eighteen months after the trial completion date. Data will not be shared for products and indications approved prior to January 1, 2014
IPD access criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researcher qualifications and legitimacy of the research purpose.
Clinical trial NCT03818607: A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH
Official title: A Randomized, Double-Blind, Active-Controlled Phase 3 Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Acronym: DAHLIA
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 42.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-22
Primary completion date: 2022-07-12
Completion date: 2022-07-12
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT04816071: Essential Amino Acid Supplementation in Older Adult COVID-19 Patients
Official title: Essential Amino Acid Supplementation in Older Adult COVID-19 Patients
Sponsor: University of Arkansas (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: PI no longer wanted to do the study
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-05-01
Primary completion date: 2021-05-01
Completion date: 2021-05-01
Plan to share individual participant data: NO
Clinical trial NCT05720052: A Study of MS-553 in Patients With Relapsed or Refractory B-cell Lymphoma
Official title: A Phase I/II Study to Evaluate the Safety and Efficacy of the MS-553 in Patients With Relapsed or Refractory B-cell Lymphoma
Sponsor: MingSight Pharmaceuticals, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study is terminated due to major protocol revisions.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-02-06
Primary completion date: 2023-11-28
Completion date: 2023-11-28