chufangao/CTO huggingface dataset:
Clinical trial NCT03603080: Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy
Official title: A Prospective Randomized Study Evaluating the Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy
Sponsor: Hartford Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Difficulty with enrollment and then Covid pandemic
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-01
Primary completion date: 2022-09-01
Completion date: 2022-09-01
Plan to share individual participant data: NO
Clinical trial NCT04387240: Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19
Official title: Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19
Sponsor: Princess Nourah Bint Abdulrahman University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: did not get enough fund and IRB request
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-31
Primary completion date: 2022-09-30
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT04358458: First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
Official title: Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A First-in-Human, Open-label, Phase 1/2a Dose Escalation Trial With Dose Expansion Cohorts
Sponsor: Genmab (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to strategic evaluation of GEN3009 within context of Genmab's portfolio, decision not based on any safety or regulatory concerns.
Enrollment: 46.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-13
Primary completion date: 2022-11-21
Completion date: 2023-07-28
Baseline population: The Full analysis set (FAS) comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009.
Limitations and caveats: The trial was terminated due to strategic evaluation of GEN3009 within context of Genmab's portfolio, decision not based on any safety or regulatory concerns.
Plan to share individual participant data: NO
Clinical trial NCT05370040: THEMBA II T-Cell Vaccine: Vaccination With saRNA COVID-19 Vaccines
Official title: THEMBA II T-CELL Vaccine: A Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of Vaccination With saRNA COVID-19 Vaccines
Sponsor: ImmunityBio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Discontinued prior to enroll in Phase 2
Enrollment: 60.0 (ACTUAL)
Number of arms: 10.0
Start date: 2022-05-05
Primary completion date: 2024-03-11
Completion date: 2024-03-11
Limitations and caveats: The study was terminated early. Only the safety data is provided.~Only one adverse event table per AE category was presented to reduce data entry redundancy.
Clinical trial NCT04638634: Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
Official title: A Single Center, Phase 1, Single-Ascending Dose, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
Sponsor: CSL Behring (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: For business reasons, not a safety issue
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-02
Primary completion date: 2021-06-09
Completion date: 2021-06-09
Plan to share individual participant data: YES
IPD sharing description: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
IPD time frame: IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
IPD access criteria: Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
Clinical trial NCT03319537: Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma
Official title: Pevonedistat as a Single Agent and in Combination With Chemotherapy in Patients With Malignant Mesothelioma
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor terminated study agreement
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-05
Primary completion date: 2023-06-05
Completion date: 2023-06-05
Baseline population: No participants accrued to pevonedistat in combination with pemetrexed and cisplatin cohort
Clinical trial NCT06009237: A Study to Assess Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Participants
Official title: A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Subjects
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 24.0 (ACTUAL)
Number of arms: 5.0
Start date: 2023-08-23
Primary completion date: 2023-10-30
Completion date: 2023-10-30
Plan to share individual participant data: NO
Clinical trial NCT03534284: Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
Official title: Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (Sleep-HD)
Acronym: Sleep-HD
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 126.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-09-19
Primary completion date: 2022-10-17
Completion date: 2022-11-17
Plan to share individual participant data: NO
Clinical trial NCT04852367: PanDox: Targeted Doxorubicin in Pancreatic Tumours
Official title: PanDox: Feasibility of Enhanced Chemotherapy Delivery to Non-resectable Primary Pancreatic Tumours Using Thermosensitive Liposomal Doxorubicin (ThermoDox®) and Focused Ultrasound
Acronym: PanDox
Sponsor: University of Oxford (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Lack of recruitment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-16
Primary completion date: 2023-03-30
Completion date: 2023-03-30
Plan to share individual participant data: NO
IPD sharing description: Plan to anonymise patient data (assigned trial number) and results to be published in peer reviewed journal as anonymous data points/averaged data
Clinical trial NCT04533737: Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab
Official title: Efficacy and Safety Comparison of Brodalumab Versus Guselkumab in Adult Subjects With Moderate-to-severe Plaque Psoriasis and Inadequate Response to Ustekinumab
Acronym: COBRA
Sponsor: LEO Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The recruitment was terminated early due to delays and slow recruitment that significantly jeopardized the trial timelines. There were no safety concerns related to the early termination of the trial.
Enrollment: 113.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-17
Primary completion date: 2022-09-08
Completion date: 2022-12-07
Baseline population: ITT: All randomized subjects
Plan to share individual participant data: YES
IPD access criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
Clinical trial NCT04857931: Colchicine in HFpEF
Official title: A Biomarker Study Assessing the Effects of Colchicine on Inflammation and Extra-Cellular Matrix Turnover in Patients With Heart Failure and Preserved Ejection Fraction.
Acronym: COLpEF
Sponsor: Montreal Heart Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of funds to support opening of new sites to help patient recruitment, which was found to be more challenging than initially expected.
Enrollment: 14.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-06-17
Primary completion date: 2023-03-07
Completion date: 2023-03-07
Plan to share individual participant data: UNDECIDED
Clinical trial NCT01824823: Afatinib After Chemoradiation and Surgery in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck at High-Risk of Recurrence
Official title: A Randomized Placebo Controlled Phase II Trial of Afatinib (BIBW2992) as Adjuvant Therapy Following Chemoradiation in Patients With Head and Neck Squamous Cell Carcinoma at High Risk of Recurrence
Sponsor: Eastern Cooperative Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-06-30
Primary completion date: 2015-12-13
Completion date: 2020-12-31
Baseline population: All randomized patients
Limitations and caveats: Due to the small sample size, estimates on median DFS and 95% confidence intervals could be unreliable.
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 NCT03103490: 18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation
Official title: 18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Loss of funding
Enrollment: 45.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-08-02
Primary completion date: 2021-09-28
Completion date: 2021-09-28
Plan to share individual participant data: NO
Clinical trial NCT04157751: A Study to Test the Effect of Empagliflozin in Patients Who Are in Hospital for Acute Heart Failure
Official title: A Multicentre, Randomised, Double-blind, 90-day Superiority Trial to Evaluate the Effect on Clinical Benefit, Safety and Tolerability of Once Daily Oral EMPagliflozin 10 mg Compared to Placebo, Initiated in Patients Hospitalised for acUte Heart faiLure (de Novo or Decompensated Chronic HF) Who Have Been StabilisEd (EMPULSE)
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 530.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-18
Primary completion date: 2021-05-28
Completion date: 2021-06-02
Baseline population: Randomised Set (RS), including all randomised patients.
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 NCT04602078: Study of Atezolizumab Combined With Split-dose Gemcitabine Plus Cisplatin in Urothelial Carcinoma
Official title: Phase II, Multicenter, Non-randomized, Single-arm, Open-label Trial of Atezolizumab in Combination of Split-doses of Gemcitabine Plus Cisplatin in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Acronym: AUREA
Sponsor: Spanish Oncology Genito-Urinary Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 66.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-23
Primary completion date: 2024-02-02
Completion date: 2024-02-02
Plan to share individual participant data: NO
Clinical trial NCT04007406: DP13 - A Phase II Study in Patients With Primary Aldosteronism
Official title: DP13 - A Phase II Study in Patients With Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of DP13, Over an 8-week Treatment Period
Sponsor: Damian Pharma AG (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-11-21
Primary completion date: 2022-05-02
Completion date: 2022-05-02
Plan to share individual participant data: NO
Clinical trial NCT04495179: A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.
Official title: A Phase II, Open-label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination With Durvalumab and in Combination With Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC)
Acronym: AARDVARC
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-04
Primary completion date: 2021-11-01
Completion date: 2022-08-08
Baseline population: Safety analysis set consisted of all patients who received at least one dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
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 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 NCT02045446: Maintenance Chemotherapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Chemotherapy for Stage IV Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II Trial
Official title: Maintenance Chemotherapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Chemotherapy for Stage IV Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II Trial
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-02-28
Primary completion date: 2022-02-17
Completion date: 2022-05-02
Clinical trial NCT03194542: A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion Dependence
Official title: A Phase-2 Study To Determine Efficacy and Safety of Luspatercept in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Anemia With or Without Red Blood Cell-Transfusion Dependence
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 95.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-15
Primary completion date: 2022-07-18
Completion date: 2022-07-18
Clinical trial NCT03859427: A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Official title: A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)
Acronym: ARROW2
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 454.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-08
Primary completion date: 2023-03-31
Completion date: 2023-03-31
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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
Clinical trial NCT03885661: Vascepa to Accelerate Lipoprotein Uptake and Elimination
Official title: Vascepa to Accelerate Lipoprotein Uptake and Elimination (VALUE): An Open-Label, Mechanistic, Randomized, Controlled, Single-Center Trial of AMR101 in Patients With Dyslipidemia
Acronym: VALUE
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-11
Primary completion date: 2018-08-31
Completion date: 2021-06-30
Clinical trial NCT05055258: A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of 3 Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II
Acronym: KVD824-201
Sponsor: KalVista Pharmaceuticals, Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated by Sponsor due to adverse events reported
Enrollment: 33.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-09-27
Primary completion date: 2022-10-27
Completion date: 2022-10-27
Plan to share individual participant data: NO
Clinical trial NCT04797650: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Acronym: THRIVE-AA2
Sponsor: Concert Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 517.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-06-10
Primary completion date: 2022-06-08
Completion date: 2022-06-29
Baseline population: All randomized participants included all participants who were randomized in the study.
Plan to share individual participant data: NO
Clinical trial NCT02659800: Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas
Official title: A Phase I and Pilot Study of the Effect of rhIL-7-hyFc (NT-I7) on CD4 Counts in Patients With High Grade Gliomas and Severe Treatment-related CD4 Lymphopenia After Concurrent Radiation and Temozolomide
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\]
Enrollment: 12.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-10-30
Primary completion date: 2022-03-30
Completion date: 2023-10-03
Plan to share individual participant data: NO
Clinical trial NCT03920293: Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 175.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-12
Primary completion date: 2021-05-11
Completion date: 2023-05-25
Baseline population: Full Analysis Set: All randomized participants who received at least 1 dose of study drug.