chufangao/CTO huggingface dataset:
Clinical trial NCT04037462: Induction of Sensecence Using Dexamethasone to Re-sensitize NSCLC to Anti-PD1 Therapy
Official title: Induction of Sensecence Using Dexamethasone to Re-sensitize NSCLC to Anti-PD1 Therapy
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-07
Primary completion date: 2022-02-23
Completion date: 2023-02-23
Limitations and caveats: We consented 3 participants and had one subject rescind consent leaving us with 2 enrolled participants. of the 2 participants only was was evaluable. Therefore, we do not have sufficient data to prove outcomes measures
Plan to share individual participant data: NO
Clinical trial NCT05393037: Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults Living With HIV
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 313.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-13
Primary completion date: 2023-07-13
Completion date: 2024-01-25
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04887064: Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment
Official title: An Open-label Single-dose Study to Evaluate the Pharmacokinetics of Sotorasib in Healthy Subjects and Subjects With Moderate or Severe Hepatic Impairment
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-04-22
Primary completion date: 2022-03-09
Completion date: 2022-03-09
Baseline population: Safety Population: All participants who received sotorasib and had at least 1 postdose safety assessment.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT03814148: Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension
Official title: Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension
Sponsor: EMS (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: The design of this protocol was rewritten due to regulatory recommendations.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-30
Primary completion date: 2020-06-30
Completion date: 2020-09-30
Clinical trial NCT03262142: Targeted AntiBiotics for Chronic Pulmonary Diseases
Official title: Targeted AntiBiotics for Chronic Pulmonary Disease: Can Targeted Antibiotic Therapy Improve the Prognosis of Pseudomonas Aeruginosa Infected Patients With Chronic Pulmonary Obstructive Disease, Non-cystic Fibrosis Bronchiectasis and Asthma? A Multicenter, Randomized, Controlled, Open-label Trial.
Acronym: Target-ABC
Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Slow recruitment
Enrollment: 51.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-10
Primary completion date: 2023-03-01
Completion date: 2023-03-01
Plan to share individual participant data: YES
Clinical trial NCT04607668: Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):
Official title: PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib Versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer
Acronym: PRESERVE1
Sponsor: G1 Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Despite achieving co-primary endpoints \& other secondary measures of myeloprotection \& tolerability, early anti-tumor efficacy data favor patients receiving placebo. Given the low likelihood of achieving PFS \& OS endpoints, G1 decided to discontinue
Enrollment: 326.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-16
Primary completion date: 2023-02-13
Completion date: 2023-03-31
Plan to share individual participant data: NO
Clinical trial NCT04480190: Neoadjuvant Therapy in Biliary Adenocarcinoma
Official title: Feasibility of Total Neoadjuvant Therapy in Resectable Biliary Adenocarcinoma
Sponsor: University of Cincinnati (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Difficulty accruing
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-04
Primary completion date: 2022-04-04
Completion date: 2022-04-04
Plan to share individual participant data: NO
Clinical trial NCT03901352: Study of Mirogabalin for Central Neuropathic Pain
Official title: An Asian, Multicenter, Randomized, Double-blind, Placebo-controlled, 14-week Study of Mirogabalin in Participants With Central Neuropathic Pain Followed by a 52-week, Open-label Extension
Sponsor: Daiichi Sankyo (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 300.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-12
Primary completion date: 2020-12-28
Completion date: 2020-12-28
Baseline population: Data were based on the modified Intent-to-Treat population (mITT). Mirogabalin starting dose and titration schedule were based on creatinine clearance per the Japanese drug insert. All mirogabalin patients who received any dose were assessed as 1 group for efficacy/safety as prespecified in the protocol. The sponsor considers it undesirable to conduct a separate analysis per dose level, as it would involve publishing completely separate analyses than the insert and report previously submitted.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Clinical trial NCT02384759: Aflibercept +/- LV5FU2 in First Line of Non-resectalbe Metastatic Colorectal Cancers
Official title: Phase II Randomized Trial Evaluting Aflibercept Associated With LV5FU2 Regimen as First Line Treatment of Non-resectalbe Metastatic Colorectal Cancers
Acronym: FOLFA
Sponsor: Federation Francophone de Cancerologie Digestive (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 117.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-05-31
Primary completion date: 2021-06-30
Completion date: 2021-06-30
Baseline population: Baseline population is the mITT population meaning all the patients randomized into the study and having received at least one dose of study treatment
Clinical trial NCT02656303: A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304
Official title: A Multi-Center, Open-Label, Compassionate Use Extension Study of Ublituximab (TG-1101) in Combination With Umbralisib (TGR-1202) for Patients Previously Enrolled in Protocol UTX-TGR-304
Sponsor: TG Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Strategic/Business Decision
Enrollment: 116.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-01-07
Primary completion date: 2022-05-26
Completion date: 2022-07-11
Baseline population: The Safety Population included all participants who were enrolled and received at least one dose of study drug.
Limitations and caveats: Due to sponsor's business decision, the clinical trial was terminated by the sponsor.
Clinical trial NCT04152837: Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
Official title: An Open-Label Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Previously Experienced Abnormal Liver Chemistry Test Results While Receiving Tolvaptan: The ALERT Study
Acronym: ALERT
Sponsor: Palladio Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The decision is based on a thorough reassessment of the commercial potential of lixivaptan as a potential best-in-class therapy for patients with ADPKD
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-09-02
Primary completion date: 2022-07-29
Completion date: 2022-07-29
Limitations and caveats: Efficacy and safety results are limited by the early termination of the trial and the small number of subjects. Early termination was due to a sponsor decision for reasons unrelated to safety.
Plan to share individual participant data: NO
Clinical trial NCT03759392: Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure With Reduced Ejection Fraction and Decreased Exercise Tolerance
Acronym: METEORIC-HF
Sponsor: Cytokinetics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 276.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-09
Primary completion date: 2021-11-08
Completion date: 2022-01-06
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 NCT05215977: Efficacy and Safety of MW031 in PMO Subjects
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study, Evaluating the Efficacy and Safety of Recombinant Fully Human Anti-RANKL Monoclonal Antibody in Postmenopausal Osteoporosis Subjects With Increased Bone Fracture Risk
Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 448.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-27
Primary completion date: 2021-09-27
Completion date: 2021-09-27
Plan to share individual participant data: NO
Clinical trial NCT04149821: Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy
Official title: Phase II Study of Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated due to low accrual
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-10
Primary completion date: 2022-01-21
Completion date: 2022-06-09
Baseline population: 0 subjects were enrolled in Cohort A.
Limitations and caveats: The study did not reach the target number of participants needed to achieve target power and statistically reliable results
Plan to share individual participant data: NO
Clinical trial NCT05473442: Study of EQU-001 for Uncontrolled Focal Onset Seizures
Official title: A Randomized Phase 2 Study of Adjunctive EQU-001 for Uncontrolled Focal Onset Seizures
Sponsor: Equilibre Biopharmaceuticals B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: insufficient funding to complete the study
Enrollment: 27.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-12-27
Primary completion date: 2023-07-01
Completion date: 2023-07-01
Clinical trial NCT04090229: A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis
Sponsor: ASLAN Pharmaceuticals (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 52.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-09
Primary completion date: 2021-10-28
Completion date: 2021-12-03
Plan to share individual participant data: NO
Clinical trial NCT03237572: Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer
Official title: Focused Ultrasound Therapy to Augment Antigen Presentation and Immune-Specificity of Checkpoint Inhibitor Therapy With Pembrolizumab in Metastatic Breast Cancer
Acronym: Breast-48
Sponsor: University of Virginia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low rate of enrollment
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-25
Primary completion date: 2022-06-01
Completion date: 2022-06-17
Clinical trial NCT05232864: Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis
Official title: A Three-year, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability in Patients With Active Lupus Nephritis
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study terminated by sponsor based on a futility analysis of the core study CAIN457Q12301
Enrollment: 31.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-22
Primary completion date: 2023-08-23
Completion date: 2023-08-23
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
Clinical trial NCT04811872: Placental Transfusion Effect on Hemodynamics of Premature Newborns
Official title: Evaluation of the Effect of Placental Transfusion on Hemodynamics in Premature Newborns
Sponsor: Alexandria University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 57.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-01-01
Primary completion date: 2021-09-01
Completion date: 2021-10-01
Clinical trial NCT04392141: Colchicine Plus Phenolic Monoterpenes to Treat COVID-19
Official title: Application of Colchicine Plus Herbal Phenolic Monoterpene Fractions to Treat COVID-19
Sponsor: Kermanshah University of Medical Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 120.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-01
Primary completion date: 2020-11-01
Completion date: 2020-11-01
Plan to share individual participant data: NO
Clinical trial NCT03093831: Phase II Study of Ibrutinib in Patients With Relapsed or Refractory Marginal Zone Lymphoma
Official title: A Phase II Investigator Sponsored Multi-Centre Trial of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Patients With Relapsed or Refractory Marginal Zone Lymphoma
Sponsor: National Cancer Centre, Singapore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study did not meet the objectives and terminated early on 17 Jul 2020 due to poor recruitment
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-07-08
Primary completion date: 2020-07-17
Completion date: 2020-07-17
Plan to share individual participant data: NO
Clinical trial NCT02440464: Allogeneic Hematopoietic Stem Cell Transplantation With Ixazomib for High Risk Multiple Myeloma (BMT CTN 1302)
Official title: Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib After Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma (BMT CTN 1302)
Sponsor: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 57.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-08-31
Primary completion date: 2020-10-01
Completion date: 2020-10-01
Baseline population: Participants who were transplanted and randomized are included.
Plan to share individual participant data: YES
IPD sharing description: Results will be published in a manuscript and supporting information submitted to the NIH Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).
IPD time frame: Within 6 months of official study closure at participating sites.
IPD access criteria: Available to the public
Clinical trial NCT01307579: Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia
Official title: A Randomized Open-Label Trial of Caspofungin Versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)
Sponsor: Children's Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 517.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-04-04
Primary completion date: 2018-06-30
Completion date: 2020-06-30
Clinical trial NCT04830969: Impact of Periodontal Therapy on Patients With Diabetes
Official title: Impact of Periodontal Therapy on Patients With Diabetes: A Pilot Study
Acronym: DMRCT
Sponsor: State University of New York at Buffalo (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 116.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-11-08
Primary completion date: 2021-01-28
Completion date: 2021-01-28
Baseline population: In this study, unit participant is assigned to Arms/Groups in all measures. For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each subject. And the outcome of each participant were analyzed in each Aim.
Plan to share individual participant data: NO
Clinical trial NCT02904772: Alipogene Tiparvovec for the Treatment of LPLD Patients
Official title: An Open Label, Multi-centre Trial of Alipogene Tiparvovec for the Treatment of LPLD Patients
Sponsor: UniQure Biopharma B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: uniQure, has decided not to renew the Marketing Authorization of Glybera in the EU. This decision is not related to any safety, efficacy or quality issue
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-31
Primary completion date: 2020-06-30
Completion date: 2020-09-30
Plan to share individual participant data: NO
Clinical trial NCT02540330: A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
Official title: An Open Label, Phase 2 Pharmacokinetic Study of Pre-Surgical Intramuscular and Intraductal Fulvestrant in Women With Invasive Breast Cancer or DCIS Undergoing Mastectomy or Lumpectomy
Acronym: 007
Sponsor: Atossa Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business decision (See Detailed Description)
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-03-31
Primary completion date: 2020-08-13
Completion date: 2020-08-13
Plan to share individual participant data: NO