chufangao/CTO huggingface dataset:
Clinical trial NCT05110599: Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth
Official title: Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth: a Randomised, Double-blind, Placebo-controlled Study as Investigator-Initiated Trial
Sponsor: University of Zurich (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow recruitment and expired study medication.
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-12
Primary completion date: 2023-08-25
Completion date: 2023-10-01
Clinical trial NCT05655130: Distal Radius Steroid
Official title: Effects of Peri-Operative Glucosteroid Administration on Outcomes Following Distal Radius Fracture
Sponsor: Indiana Hand to Shoulder Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low participation rate
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-06
Primary completion date: 2023-05-02
Completion date: 2023-05-02
Plan to share individual participant data: NO
Clinical trial NCT02465593: A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer
Official title: A Phase Ib/II Study of PEP503 (Radioenhancer) With Radiotherapy, in Combination With Concurrent Chemotherapy for Patients With Locally Advanced or Unresectable Rectal Cancer
Sponsor: PharmaEngine (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-06-30
Primary completion date: 2021-07-28
Completion date: 2021-07-28
Clinical trial NCT02532660: Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode
Official title: Fase III Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode
Acronym: LABCATTCJUSS
Sponsor: Laboratório Catarinense SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Recruitment difficulties due to monocentric study
Enrollment: 111.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-07-02
Primary completion date: 2022-06-01
Completion date: 2022-06-01
Clinical trial NCT04447404: DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
Official title: A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of DUR-928 in Subjects Infected With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
Sponsor: Durect (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: low enrollment
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-21
Primary completion date: 2021-03-04
Completion date: 2021-03-04
Baseline population: Study terminated early due to lack of enrollment.
Limitations and caveats: Early study termination led to small number (n=2) of subjects and in one treatment group.
Clinical trial NCT01421069: Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Official title: AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014)
Acronym: CLIPPER2
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 109.0 (ACTUAL)
Number of arms: 1.0
Start date: 2011-10-10
Primary completion date: 2021-02-04
Completion date: 2021-02-04
Baseline population: Full analysis set (FAS) included all enrolled participants from parent study B1801014 (NCT00962741) who received at least 1 dose of investigational product in parent study, regardless of whether they received any investigational product during the extension study.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04248712: Antihistamines in Eosinophilic Esophagitis
Official title: A Phase II, Randomized, Placebo-controlled Study Evaluating the Efficacy of Antihistamines in the Treatment of Eosinophilic Esophagitis (the ATEE Study)
Acronym: ATEE
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: low enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-10
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Baseline population: Terminated study due to low enrollment. No subjects enrolled in the Placebo group
Limitations and caveats: Terminated study due to low enrollment. No subjects enrolled in the Placebo group
Plan to share individual participant data: NO
Clinical trial NCT02099825: Medication Enhanced Rapid Therapy
Official title: Medication Enhanced Rapid Therapy
Acronym: MERiT
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: COVID and staffing issues
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-01-13
Primary completion date: 2022-10-31
Completion date: 2022-10-31
Clinical trial NCT04794803: Reparixin in COVID-19 Pneumonia - Efficacy and Safety
Official title: Study on the Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With COVID-19 Pneumonia
Sponsor: Dompé Farmaceutici S.p.A (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: The sponsor has decided to start with a separate protocol for phase 3 and therefore this study was terminated with only phase 2.
Enrollment: 56.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-05
Primary completion date: 2020-11-27
Completion date: 2021-02-02
Baseline population: The Full Analysis Set (FAS), which consisted of all randomized subjects who received at least one dose of the IMP. The FAS population was analyzed according to intention to treat (ITT) principle, i.e. by treatment allocation regardless the occurrence of intercurrent events.
Clinical trial NCT03668392: Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL)
Official title: Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL)
Acronym: ALL2518
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: low enrollment rate
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-25
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04012333: The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial
Official title: The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial
Acronym: EFFORTcombo
Sponsor: RWTH Aachen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: PI left site
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-30
Primary completion date: 2022-03-31
Completion date: 2022-03-31
Plan to share individual participant data: NO
Clinical trial NCT04562155: Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough
Official title: Randomized, Double-blind, Parallel Group, Phase 2b Dose-finding, Efficacy and Safety Study of 12-week Twice Daily Oral Administration of BAY 1817080 Compared to Placebo in the Treatment of Refractory and/or Unexplained Chronic Cough (RUCC)
Acronym: PAGANINI
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 310.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-10-02
Primary completion date: 2021-06-22
Completion date: 2021-07-23
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Clinical trial NCT04901806: Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors
Official title: A Phase 1/2 Study of PBI-200 in Subjects With NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors
Sponsor: Pyramid Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor terminated development of PBI-200
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-20
Primary completion date: 2023-07-26
Completion date: 2023-07-26
Plan to share individual participant data: NO
Clinical trial NCT05244473: A Safety Study of Brentuximab Vedotin in Participants With HIV
Official title: A Phase 1, Single-blind, Dose-escalation Study to Assess the Safety and Tolerability of Brentuximab Vedotin (ADCETRIS®) in Subjects With Human Immunodeficiency Virus (HIV)
Sponsor: Seagen Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study withdrawn due to low patient accrual.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-12-31
Primary completion date: 2024-05-31
Completion date: 2024-05-31
Clinical trial NCT03343678: This Study in Patients With Chronic Lymphocytic Leukaemia is Done to Determine a Safe and Effective Dose of BI 836826 in Combination With Venetoclax
Official title: An Open-label, Multi-centre, Phase Ib Trial to Determine the Dose of Intravenous BI 836826 in Combination With Oral Venetoclax in Chronic Lymphocytic Leukaemia Patients Who Are Eligible for Treatment With Venetoclax
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Company strategic decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-01-17
Primary completion date: 2018-05-25
Completion date: 2020-11-25
Clinical trial NCT03778073: Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma
Official title: A Phase 1 Study of Cosibelimab (TG-1501) in Subjects With Relapsed or Refractory Lymphoma
Sponsor: TG Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic/Business Decision
Enrollment: 18.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-04-17
Primary completion date: 2022-05-03
Completion date: 2022-08-01
Clinical trial NCT00738777: Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer
Official title: A Randomized, Prospective Trial of 2-6 Weeks Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer: Anastrozole +/- Fulvestrant or Tamoxifen Exposure - Response in Molecular Profile (AFTER-study).
Sponsor: The Netherlands Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: in preparation for an amendment
Enrollment: 250.0 (ESTIMATED)
Number of arms: 4.0
Start date: 2008-07-31
Primary completion date: 2022-06-30
Completion date: 2024-06-30
Clinical trial NCT03083665: A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Subjects (>=16 to 80 Years of Age) With Partial Seizures With or Without Secondary Generalization
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 449.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-08-22
Primary completion date: 2022-06-30
Completion date: 2022-06-30
Baseline population: Baseline Characteristics refer to the Randomized Set (RS) which consisted of all study participants who were randomized to investigational medicinal product (IMP).
Plan to share individual participant data: YES
IPD sharing description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD time frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Clinical trial NCT01953926: Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Official title: An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations
Acronym: SUMMIT
Sponsor: Puma Biotechnology, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated to align with the sponsor's current development plans for neratinib. The decision was not based on any new efficacy or safety data for neratinib.
Enrollment: 582.0 (ACTUAL)
Number of arms: 6.0
Start date: 2013-09-30
Primary completion date: 2023-01-02
Completion date: 2023-01-02
Plan to share individual participant data: YES
IPD sharing description: Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.~In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.~Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.~Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.
IPD time frame: Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
IPD access criteria: Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.~Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
Clinical trial NCT05827068: A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
Official title: A Phase 1/2, Randomized, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults 50 to 75 Years of Age
Sponsor: ModernaTX, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 700.0 (ACTUAL)
Number of arms: 7.0
Start date: 2023-03-27
Primary completion date: 2023-11-20
Completion date: 2023-11-20
Clinical trial NCT04277546: Open-label Extension Study of Brazikumab in Ulcerative Colitis
Official title: A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE)
Acronym: Expedition
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.
Enrollment: 57.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-03
Primary completion date: 2023-10-10
Completion date: 2023-10-10
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.
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 NCT04345692: A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients
Official title: A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients
Acronym: OAHU-COVID19
Sponsor: Queen's Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: RECOVERY Trial results - no efficacy
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-26
Primary completion date: 2020-08-31
Completion date: 2020-08-31
Plan to share individual participant data: NO
Clinical trial NCT02452385: Phase 1 Study of CM082 in Patients With wAMD
Official title: Phase 1 Study of CM082 in Patients With wAMD: Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy
Sponsor: AnewPharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: Sponsor requirements
Enrollment: 56.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2015-03-31
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Clinical trial NCT02720523: A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
Official title: A Phase 2b/3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Japanese Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
Acronym: SELECTSUNRISE
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 197.0 (ACTUAL)
Number of arms: 6.0
Start date: 2016-03-22
Primary completion date: 2017-08-03
Completion date: 2022-06-07
Baseline population: The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.
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 visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT04738175: Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
Official title: A Randomized, Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: A different study will be conducted.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-30
Primary completion date: 2021-11-30
Completion date: 2021-11-30