chufangao/CTO huggingface dataset:
Clinical trial NCT03841526: Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D
Official title: Phase 2 Randomized Placebo-Controlled Double-Blind Parallel Study to Evaluate Glucagon RTU (Glucagon Injection) Compared to Standard of Care for Prevention of Exercise-Induced Hypoglycemia During Regular Aerobic Exercise in Adults With T1D
Sponsor: Xeris Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 48.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-08-22
Primary completion date: 2020-04-02
Completion date: 2020-04-02
Baseline population: Baseline information is presented for the Safety population for the CRC Phase (Period 1) of the study, this includes all randomized subjects who received at least one dose of study drug.
Plan to share individual participant data: NO
Clinical trial NCT03482752: Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis
Official title: An Open-label, Non-controlled, Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis Patients
Acronym: IMPALA-X
Sponsor: Savara Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: SAV006-03 was initiated before the evaluation of the IMPALA study (NCT02702180) results. Considering these results and authority advice there would not be adequate efficacy and safety data from SAV006-03 and the study was terminated.
Enrollment: 60.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-16
Primary completion date: 2021-01-14
Completion date: 2021-01-14
Limitations and caveats: No hypothesis/statistical testing was planned for any of the endpoints of this study but only descriptive statistics were to be used. Efficacy endpoints were secondary endpoints. Due to early study termination, only limited efficacy data were available for evaluation and in general, no firm conclusion based on efficacy data are applicable. No deaths occurred during the study but 1 participant died due to COVID-19 24 days after last dose, i.e. outside the definition of 'treatment-emergent'.
Plan to share individual participant data: NO
Clinical trial NCT04431219: First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients
Official title: First in Human Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Ascending Intravenous Doses of LIS1 in Kidney Transplanted Patients
Sponsor: Xenothera SAS (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-26
Primary completion date: 2022-03-28
Completion date: 2022-03-28
Clinical trial NCT03968198: Administration of Adipose-derived Stem Cells (ASC) in Patient With Critical Limb Ischemia.
Official title: Autologous Transplantation of Adipose Tissue Derived Mesenchymal Stroma/Stem Cells (ASC) in Patients With Critical Limb Ischemia.
Acronym: ACellDREAM2
Sponsor: University Hospital, Toulouse (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: organizational difficulties for the collection of adipose tissue and for the supply of the experimental drug
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-04
Primary completion date: 2023-03-10
Completion date: 2023-03-10
Plan to share individual participant data: NO
Clinical trial NCT02415556: Memory Aid by Intranasal Insulin in Diabetes (MemAID)
Official title: Memory Advancement by Intranasal Insulin in Type 2 Diabetes
Acronym: MemAID
Sponsor: Beth Israel Deaconess Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 289.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-10-06
Primary completion date: 2020-05-31
Completion date: 2020-05-31
Baseline population: Of 244 randomized participants, 223 participants completed baseline assessment.
Plan to share individual participant data: NO
Clinical trial NCT04438382: Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis
Official title: Optimizing Immunosuppression for Steroid-Refractory Anti-PD-1/PD-L1 Pneumonitis
Sponsor: Eastern Cooperative Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-07
Primary completion date: 2023-12-21
Completion date: 2023-12-21
Baseline population: Only one patient was enrolled on this study. Due to the concern on confidentiality, individual data is not reported due to confidentiality reasons.
Limitations and caveats: Only one patient was enrolled on this study. Due to the concern on confidentiality, individual data was not reported.
Plan to share individual participant data: YES
IPD sharing description: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Clinical trial NCT02478320: Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors
Official title: A Proof-of-Concept Study for Ilorasertib (ABT-348) Activity in Patients With CDKN2A-Deficient Advanced Solid Cancers: a Phase II Basket Trial
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study terminated due to company's decision to discontinue drug development
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-05
Primary completion date: 2022-05-12
Completion date: 2022-05-12
Baseline population: Part 2 Tumor-specific expansion (trial was terminated before this part was reached)
Clinical trial NCT03285308: A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
Sponsor: Allergan (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The Relamorelin program is being terminated solely based on a business decision.
Enrollment: 336.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-29
Primary completion date: 2020-07-08
Completion date: 2020-07-08
Baseline population: ITT Population included all randomized participants.
Plan to share individual participant data: NO
Clinical trial NCT05009732: A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects
Official title: A Randomized, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects
Sponsor: Suzhou Kintor Pharmaceutical Inc, (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor's decision
Enrollment: 139.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-30
Primary completion date: 2023-02-06
Completion date: 2023-07-14
Plan to share individual participant data: NO
Clinical trial NCT03192969: A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)
Official title: A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell Arteritis
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Business objectives have changed
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-07-15
Primary completion date: 2020-06-07
Completion date: 2021-11-23
Clinical trial NCT05101915: Study of a Nebulised Nitric Oxide Generating Solution in Patients With Mycobacterium Abscessus
Official title: Phase II Open Label Study of a Nebulised Nitric Oxide Generating Solution in Patients With Mycobacterium Abscessus Pulmonary Disease
Acronym: NOMAB
Sponsor: Papworth Hospital NHS Foundation Trust (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: TSC recommended early termination due to lack of futility of the trial.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-01
Primary completion date: 2024-01-31
Completion date: 2024-04-23
Clinical trial NCT04699968: A Trial of SHR-1701 With or Without Famitinib in Patients With Advanced or Metastatic NSCLC
Official title: Phase II Clinical Trial of SHR-1701 With or Without Famitinib in the Treatment of Advanced or Metastatic NSCLC
Sponsor: Jiangsu HengRui Medicine Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor R \& D Strategy Adjustment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-15
Primary completion date: 2021-11-15
Completion date: 2021-11-15
Clinical trial NCT03722472: Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults
Official title: A Phase 1, Double-Blind, Randomized Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Single-Vial Lyophilized ID93 + GLA-SE Vaccine Administered Intramuscularly in Healthy Adult Subjects
Sponsor: Access to Advanced Health Institute (AAHI) (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 48.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-02
Primary completion date: 2020-06-15
Completion date: 2020-06-15
Baseline population: males and females, ages 18-55 inclusive
Plan to share individual participant data: NO
Clinical trial NCT00533949: High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Official title: A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer
Sponsor: Radiation Therapy Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 544.0 (ACTUAL)
Number of arms: 4.0
Start date: 2007-11-30
Primary completion date: 2013-06-30
Completion date: 2022-05-20
Baseline population: All eligible patients who did not withdraw consent.
Limitations and caveats: Cetuximab arms were added after the study opened, therefore the first 34 patients were excluded from cetuximab analysis. High dose RT arms closed early (at n=474), therefore later patients enrolled to low dose RT arm were excluded from RT analysis.
Clinical trial NCT03569475: Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder
Official title: A Double-blind, Placebo- and Active-controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Pediatric Patients 7-17 Years With Major Depressive Disorder
Sponsor: Allergan (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 501.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-07-06
Primary completion date: 2021-03-01
Completion date: 2021-03-01
Baseline population: Safety Population included all participants in the Randomized Population who received at least 1 dose of double-blind investigational product.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing, please refer to the link below.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT02816437: FMT for MDRO Colonization in Solid Organ Transplant
Official title: Fecal Microbiota Transplantation for the Treatment of Multidrug-Resistant Organism Colonization in Solid Organ Transplant Recipients
Acronym: FMT
Sponsor: University of Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: safety
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-07-31
Primary completion date: 2022-10-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT05056727: A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
Official title: A Phase 3, International, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on CKD Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
Acronym: STABILIZE-CKD
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study started enrollment in Sep 2021 and despite huge efforts the rate of patient enrollment continued to be below target such that the completion of the study within a reasonable timeframe was deemed very unlikely.
Enrollment: 716.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-30
Primary completion date: 2024-02-07
Completion date: 2024-02-07
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the 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 NCT06460194: Treatment of Frostbite Sequelae With Botulinum Toxin A
Official title: Botulinum Toxin A in the Treatment of Frostbite Sequelae - a Randomized, Double Blind, Placebo-controlled Study
Sponsor: University Hospital of North Norway (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No Participants Enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-30
Primary completion date: 2023-07-31
Completion date: 2024-06-10
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05399550: Study to Evaluate The Safety and Efficacy of Balovaptan in Participants With Acute Ischemic Stroke at a High Risk of Developing Malignant Brain Edema
Official title: A Phase II, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate The Safety and Efficacy of Balovaptan in Patients With Acute Ischemic Stroke at High Risk of Developing Malignant Cerebral Edema
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor's decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-22
Primary completion date: 2022-11-17
Completion date: 2022-11-17
Clinical trial NCT02946996: Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Official title: Randomized Phase II Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Sponsor: Medical University of South Carolina (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Investigator retired from clinical practice prior to enrollment goal being met.
Enrollment: 41.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-12-28
Primary completion date: 2023-12-05
Completion date: 2024-08-19
Plan to share individual participant data: NO
Clinical trial NCT04784455: Nomacopan (rVA576) in Transplant Associated Thrombotic Microangiopathy
Official title: Multicentre Study of Nomacopan (rVA576) in Paediatric Haematopoietic Stem-Cell Transplant Associated Thrombotic Microangiopathy
Sponsor: AKARI Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The early termination of this study is a business decision following a portfolio reprioritization plan. The decision is not related to any Efficacy, Safety or Clinical concerns regarding Nomacopan/rVA576
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-01
Primary completion date: 2024-05-15
Completion date: 2024-05-15
Plan to share individual participant data: NO
Clinical trial NCT04477993: Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19
Official title: Randomized, Double-Blind Clinical Trial of Ruxolitinib in Patients With Acute Respiratory Disorder Syndrome Due to SARS-CoV-2 Infection
Acronym: RUXO-COVID
Sponsor: University of Sao Paulo General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-14
Primary completion date: 2021-03-29
Completion date: 2021-03-29
Clinical trial NCT03616964: A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
Acronym: BRAVE II
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 778.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-08-02
Primary completion date: 2021-09-24
Completion date: 2021-10-20
Baseline population: All randomized participants who received at least one dose of study drug.
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 NCT02939014: Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)
Official title: A Phase 2, Single-Arm, Open-label Study of Brentuximab Vedotin in Chinese Patients With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 39.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-11-07
Primary completion date: 2018-08-02
Completion date: 2020-02-03
Baseline population: Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT03179410: PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer
Official title: PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer
Acronym: PICK-NEPC
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-02-01
Primary completion date: 2020-01-09
Completion date: 2020-12-18
Clinical trial NCT04209205: Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Psoriatic Arthritis
Acronym: INVIGORATE 2
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 381.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-29
Primary completion date: 2022-05-17
Completion date: 2022-05-17
Baseline population: Randomized set
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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