chufangao/CTO huggingface dataset:
Clinical trial NCT00982111: First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin
Official title: A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
Acronym: INSPIRE
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 633.0 (ACTUAL)
Number of arms: 2.0
Start date: 2009-11-02
Primary completion date: 2012-11-14
Completion date: 2020-12-23
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 assigned 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 NCT04938180: A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients
Official title: A Phase 2, Adaptive, Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Intravenous AMB-05X in Subjects With Tenosynovial Giant Cell Tumor
Sponsor: AmMax Bio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Further enrollment was halted in November 2021, enrolled subjects completed the study. Sponsor stopped further recruitment in this intravenous study to focus on intra-articular route of administration in subjects with tenosynovial giant cell tumor.
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-16
Primary completion date: 2022-04-20
Completion date: 2022-05-17
Baseline population: A total of 48 subjects were planned. However, enrollment into the study was stopped in November 2021 after 4 subjects were enrolled to focus more on AMB-05X intra-articular administration.
Limitations and caveats: A decision was made in November 2021 to stop further enrollment into the study to allow development to focus on AMB-05X intra-articular administration for TGCT. A total of 4 subjects had been enrolled into the study at the time the decision to cease further enrollment was made, limiting the ability to interpret the resulting data.
Plan to share individual participant data: NO
Clinical trial NCT03785067: Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study
Official title: Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study
Acronym: TRIDENT COG
Sponsor: The George Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Contractual and financial issues.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-27
Primary completion date: 2021-02-03
Completion date: 2021-02-03
Clinical trial NCT03225105: M3541 in Combination With Radiotherapy in Solid Tumors
Official title: A Phase I, Open-label, Uncontrolled, Multicenter, Dose-escalation Study of M3541 in Combination With Palliative Radiotherapy in Subjects With Solid Tumors
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated early per sponsor decision to halt further development of M3541 due to pharmaceutical and PK/pharmacodynamics properties that precluded further clinical development.
Enrollment: 15.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-09-06
Primary completion date: 2019-09-02
Completion date: 2020-04-27
Baseline population: Safety analysis set included all participants who received at least 1 dose of M3541.
Limitations and caveats: The study was terminated early per sponsor decision to halt further development of M3541 due to pharmaceutical and PK/pharmacodynamics properties that precluded further clinical development.
Clinical trial NCT04741204: Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer
Official title: Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer Response to Neoadjuvant Treatment
Acronym: METBC
Sponsor: Woman's (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Limited staff to carry out study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-30
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Plan to share individual participant data: NO
Clinical trial NCT04123067: Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke
Official title: Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke: Effects on the Stress-Immune Response
Sponsor: Milton S. Hershey Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Temporarily suspended due to Pandemic.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-01
Primary completion date: 2021-04-07
Completion date: 2021-04-07
Baseline population: Pioglitazone Group contains 0 participants because the Responsible Party terminated the study following the enrollment of first study subject
Limitations and caveats: Study was terminated early due to lack of funding and Responsible Party relocating to another institution
Plan to share individual participant data: NO
Clinical trial NCT04867226: Effectiveness of Colchicine Among Patients With COVID-19 Infection
Official title: Effectiveness of Colchicine Among Patients With COVID-19 Infection
Sponsor: Hawler Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 100.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-08
Primary completion date: 2021-06-18
Completion date: 2021-06-18
Clinical trial NCT04552899: A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
Official title: A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis
Acronym: STARSCAPE
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated by Sponsor as the futility analysis outcome indicated that the study was unlikely to meet the predefined primary objective of the study. No new safety concerns were identified.
Enrollment: 665.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-19
Primary completion date: 2023-02-10
Completion date: 2023-02-10
Baseline population: The randomized population included all randomized participants.
Limitations and caveats: This study was terminated early based on the futility analysis which concluded that zinpentraxin alfa was unlikely to meet its primary endpoint.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).~For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT02708849: The Sustained Effects of Ketamine
Official title: The Sustained Effects of Ketamine
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-06-30
Primary completion date: 2020-03-31
Completion date: 2020-03-31
Clinical trial NCT04652102: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older
Official title: COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older
Sponsor: CureVac (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 39680.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-12-11
Primary completion date: 2022-06-10
Completion date: 2022-06-10
Baseline population: Safety Analysis Set: Included all participants randomized into Phase 2b or 3 who received at least one dose of CVnCoV or placebo.
Clinical trial NCT03484962: Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Liver Cancer
Official title: Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Liver Cancer
Sponsor: Fuda Cancer Hospital, Guangzhou (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-03-25
Primary completion date: 2020-05-25
Completion date: 2020-08-25
Clinical trial NCT04814368: A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (OA)
Official title: A Randomized, Four-arm, Canakinumab Placebo-controlled, Participant, Investigator and Sponsor-blinded Study Investigating the Safety, Tolerability and Efficacy of Intra-articular Canakinumab Followed by Intra-articular LNA043 in Patients With Knee Osteoarthritis
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 23.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-08-27
Primary completion date: 2024-06-24
Completion date: 2024-06-24
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 study in line with applicable laws and regulations.~This study data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT02586025: Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate Pertuzumab in Combination With Docetaxel and Trastuzumab as Neoadjuvant Therapy, and Pertuzumab in Combination With Trastuzumab as Adjuvant Therapy After Surgery and Chemotherapy in Patients With Early-Stage or Locally Advanced HER2-Positive Breast Cancer
Acronym: PEONY
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 329.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-03-14
Primary completion date: 2017-10-23
Completion date: 2022-03-14
Baseline population: Intent-to-Treat (ITT) population included all participants who were enrolled regardless of whether they received any study treatment.
Clinical trial NCT03960008: Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant
Official title: A Randomized Multi-Center Phase III Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as a Bridge to Transplant in Hepatocellular Carcinoma.
Acronym: SBRTvsTACE
Sponsor: Lahey Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: This study was closed early due to lack of enrollments and insufficient funding.
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-01
Primary completion date: 2024-02-28
Completion date: 2024-02-28
Limitations and caveats: This study closed to accrual early, with the limited number of participants, we were unable to analyze the data.
Clinical trial NCT04540874: A Study in Healthy Japanese Men to Test How Different Doses of BI 894416 Are Tolerated
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 894416 Versus Placebo in Healthy Male Japanese Subjects (Single-blind, Randomized, Placebo-controlled Within Dose Group)
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: due to company decision
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-05
Primary completion date: 2020-11-12
Completion date: 2020-11-12
Baseline population: Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of investigational medicinal product. The treatment assignment will be determined based on the first treatment the subjects received.
Limitations and caveats: The study was terminated by the sponsor after the first dosage group (25 mg BI 894416), only a subset of the analyses planned in the protocol was performed. No dose-proportionality analysis was done. Secondary endpoints were analysed descriptively only.
Plan to share individual participant data: NO
IPD sharing description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: http://trials.boehringer-ingelheim.com/
Clinical trial NCT03662074: Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer
Official title: Phase II Pilot Study of Subsequent Line Gemcitabine and Nivolumab for Advanced SCLC
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: After interim analysis decided not to move forward with continuing the trial.
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-07
Primary completion date: 2020-10-07
Completion date: 2022-02-03
Clinical trial NCT03822091: Terlipressin Infusion Alone Vs Terlipressin With Noradrenaline Infusion In The Treatment of Hepatorenal Syndrome Type 1
Official title: Comparison of The Effectiveness of Terlipressin Infusion Alone Vs Terlipressin With Noradrenaline Infusion In The Treatment of Hepatorenal Syndrome Type 1
Sponsor: PGIMER (UNKNOWN)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-28
Primary completion date: 2020-01-30
Completion date: 2020-01-30
Plan to share individual participant data: NO
Clinical trial NCT04782245: Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List
Official title: Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List: a Multicenter, Double-blind, Randomized Clinical Trial.
Acronym: ARCADIA-HF
Sponsor: Hospices Civils de Lyon (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: New recommandations
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-30
Primary completion date: 2024-04-30
Completion date: 2024-04-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05013385: A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction
Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, Phase IIa Trial to Evaluate Spesolimab (BI 655130) Efficacy in Patients With Fibrostenotic Crohn's Disease
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-09
Primary completion date: 2022-05-31
Completion date: 2022-05-31
Baseline population: Enrolled patients: Fibrostenotic Crohn's Disease patients who were eligible to enter the Lead-In period of the trial.
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 NCT03871348: A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Official title: A Phase 1 First-in-Human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR441000 Administered Intratumorally as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor terminated the study for non-safety reasons
Enrollment: 77.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-01-03
Primary completion date: 2022-07-25
Completion date: 2024-02-21
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 NCT04840199: A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.
Official title: Randomized, Controlled Trial to Evaluate the Anti-inflammatory Efficacy of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical Outcomes
Acronym: ELICIT
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 44.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-02
Primary completion date: 2023-11-30
Completion date: 2023-11-30
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie results in the publication, after de-identification.
IPD time frame: Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.
IPD access criteria: * With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism with data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://submit.mis.s-3.net/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.
Clinical trial NCT04472000: Can Vitamin C Reduce the Risk of Postoperative Shoulder Stiffness?
Official title: Can Vitamin C Reduce the Risk of Postoperative Shoulder Stiffness? A Multi-center, Double-blinded, Randomized and Placebo-controlled Study
Acronym: VitC
Sponsor: Lindenhofgruppe AG (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study had to be stopped due to difficulties in recruiting patients.
Enrollment: 46.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-27
Primary completion date: 2023-05-16
Completion date: 2024-04-21
Plan to share individual participant data: NO
Clinical trial NCT04027348: Palliative Management of Inoperable Malignant Bowel Obstruction
Official title: Palliative Management of Inoperable Malignant Bowel Obstruction: A Prospective, Open Label, Phase-2 Study at an NCI Comprehensive Cancer Center
Sponsor: Roswell Park Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: low accrual
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-26
Primary completion date: 2021-09-03
Completion date: 2021-09-03
Plan to share individual participant data: NO
Clinical trial NCT02546440: Study on Therapy With Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)
Official title: Phase IIA Study on Therapy With the NF-κB Inhibiting and Apoptosis Inducing Drug Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)
Acronym: DMF-CTCL
Sponsor: Universitätsmedizin Mannheim (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-09-30
Primary completion date: 2021-09-30
Completion date: 2022-09-30
Clinical trial NCT02401074: Airway Temperature
Official title: Role of Airway Tissue Temperature in Asthma Exacerbation
Acronym: RATE
Sponsor: University of Kentucky (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study was withdrawn prior to patient enrollment due to COVID-19, funding termination and lack of eligible study participants.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-08
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Plan to share individual participant data: NO