chufangao/CTO huggingface dataset:
Clinical trial NCT04736628: A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease
Official title: Randomised, Double-blind (Within Dose Groups), Placebo Controlled and Parallel Group Trial to Investigate the Effects of Different Doses of Oral BI 685509 Given Over 20 Weeks on UACR Reduction in Patients With Non-diabetic Kidney Disease
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 261.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-04-27
Primary completion date: 2023-08-15
Completion date: 2023-09-21
Baseline population: Randomised Set (RS): this patient set included all entered and 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 NCT03699956: RRx-001 Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond in Patients With Small Cell Lung Cancer
Official title: A Phase 3, Controlled, Open-label, Randomized Study of RRx-001 Administered Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond Small Cell Lung Cancer
Acronym: REPLATINUM
Sponsor: EpicentRx, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: RRx-001 will be studied under a new global, phase 3 clinical trial
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-24
Primary completion date: 2022-08-11
Completion date: 2024-03-01
Plan to share individual participant data: NO
Clinical trial NCT03789643: Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial Hypertension
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JTT-251 Administered for 24 Weeks to Participants With Pulmonary Arterial Hypertension (RELIEF-PAH)
Acronym: RELIEF-PAH
Sponsor: Akros Pharma Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Corporate decision, priority change
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-03-31
Primary completion date: 2021-03-31
Completion date: 2021-06-30
Plan to share individual participant data: NO
Clinical trial NCT05307679: A Study to Evaluate the Safety and Efficacy of Basmisanil Treatment in Children Aged 2-14 Years With Dup15q Syndrome
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of 52 Weeks of Treatment With Basmisanil in Participants Aged 2 to 14 Years Old With Dup15q Syndrome Followed by a 2-Year Optional Open-Label Extension
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated due to sponsor decision and not related to safety or tolerability.
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-12-16
Primary completion date: 2024-03-04
Completion date: 2024-03-04
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 NCT04142060: Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-Positive/Her2-Negative Metastatic BC
Official title: Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-Positive/Her2-Negative Metastatic Breast Cancer
Acronym: ARIANNA
Sponsor: SOLTI Breast Cancer Research Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of effectiveness
Enrollment: 34.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-01
Primary completion date: 2022-10-10
Completion date: 2022-10-10
Plan to share individual participant data: NO
Clinical trial NCT03491007: Neurosteroids in PTSD - Biomarkers to Therapeutics
Official title: Neurosteroids in PTSD - Biomarkers to Therapeutics
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: PI obtained outside employment that was not compatible with this award
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-08
Primary completion date: 2020-11-16
Completion date: 2020-11-16
Plan to share individual participant data: NO
Clinical trial NCT03731117: FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU
Official title: FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU
Acronym: FURTHER
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Study end date exceeded and insufficient number of subjects needed for analysis. 11 patients included / 70 theoretical patients
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-15
Primary completion date: 2020-12-07
Completion date: 2020-12-07
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03970694: Neoadjuvant Chemoradiotherapy Versus Neoadjuvant Chemotherapy For Unresectable Locally Advanced Colon Cancer
Official title: Neoadjuvant Chemoradiotherapy Versus Neoadjuvant Chemotherapy For Unresectable Locally Advanced Colon Cancer: An Open, Multi-centered, Randomize Controlled Phase 3 Trial.
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Significant differences in conversion rate as well as R0 resection rate between the two groups.
Enrollment: 49.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-11
Primary completion date: 2022-05-30
Completion date: 2022-06-05
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04735796: Study of LM-102 in Subjects in Advanced Tumors
Official title: A Phase I, First-in-Human, Open-Label, Dose Escalation Study of LM-102 Injection in Subjects With CLDN18.2-Positive Advanced Solid Tumors
Sponsor: LaNova Medicines Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business strategy changed
Enrollment: 9.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-05-27
Primary completion date: 2022-05-19
Completion date: 2022-05-19
Clinical trial NCT03540199: Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Kidney Cancer
Official title: Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Kidney Cancer
Sponsor: Fuda Cancer Hospital, Guangzhou (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No participant enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-04-10
Primary completion date: 2020-05-20
Completion date: 2020-09-10
Clinical trial NCT02768337: Cambridge Brain Mets Trial 1
Official title: Cambridge Brain Mets Trial 1: A Proof-of-principle Phase 1b/Randomised Phase 2 Study of Afatinib Penetration Into Cerebral Metastases for Patients Undergoing Neurosurgical Resection, Both With and Without Prior Low-dose, Targeted Radiotherapy
Acronym: CamBMT1
Sponsor: Cambridge University Hospitals NHS Foundation Trust (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Slow recruitment
Enrollment: 26.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-03-10
Primary completion date: 2020-08-12
Completion date: 2021-08-12
Clinical trial NCT04728698: Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress
Official title: Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Replaced by a different protocol.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-31
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Clinical trial NCT03861936: BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence
Official title: BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 2b, Multicenter, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study
Sponsor: Allergan (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 150.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-16
Primary completion date: 2020-04-03
Completion date: 2020-07-02
Baseline population: Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received study treatment and had at least 1 postbaseline Masseter Muscle Prominence Scale (MMPS) assessment.
Plan to share individual participant data: YES
IPD sharing description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
IPD time frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
IPD access criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
Clinical trial NCT02992340: Varlitinib in Combination With Gemcitabine and Cisplatin for Treatment naïve Advanced or Metastatic BTC
Official title: A Multicentre, Phase 1B/2 Study of Varlitinib in Combination With Gemcitabine and Cisplatin for Treatment naïve Advanced or Metastatic Biliary Tract Cancer.
Sponsor: ASLAN Pharmaceuticals (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor decided to terminate the study and not proceed to Phase 2.
Enrollment: 204.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2016-12-13
Primary completion date: 2020-06-16
Completion date: 2020-11-24
Plan to share individual participant data: NO
Clinical trial NCT03066778: A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)
Official title: A Phase 3 Randomized, Double-Blind, Placebo-controlled Trial of Pembrolizumab (MK-3475/SCH900475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for the First-line Treatment of Subjects With Extensive Stage Small Cell Lung Cancer (KEYNOTE-604)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 453.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-02
Primary completion date: 2019-12-02
Completion date: 2021-09-21
Baseline population: All participants randomized by intention to treat (ITT).
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04166929: Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS
Official title: Haploidentical Stem Cell Transplantation With or Without NK Cell Infusion in Refractory/Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndrome:The BigEMINy Study
Acronym: Bigeminy
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: low recruitment
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-15
Primary completion date: 2023-09-28
Completion date: 2023-09-28
Clinical trial NCT03999840: Eculizumab to Cemdisiran Switch in aHUS
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Cemdisiran (ALN-CC5) Following Withdrawal of Chronic Eculizumab Therapy in Patients With Atypical HUS at High Risk of Recurrence
Acronym: DANCE
Sponsor: Mario Negri Institute for Pharmacological Research (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Due to the COVID global pandemic Sponsor has not received the economic support necessary for the study conduction.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-31
Primary completion date: 2024-01-31
Completion date: 2024-03-31
Plan to share individual participant data: NO
Clinical trial NCT03598816: PolyImmune {Durvalumab (MEDI4736) and Tremelimumab} & Vaccine Orchestrated Treatment for Patients With Advanced/Metastatic Renal Cell Carcinoma
Official title: A Randomized Phase II PIVOT-RCC (PolyImmune {Durvalumab (MEDI4736) and Tremelimumab} & Vaccine Orchestrated Treatment for Patients With Advanced/Metastatic Renal Cell Carcinoma) Trial
Acronym: PIVOT-RCC
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: FDA Contingencies unresolved
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-31
Primary completion date: 2022-12-31
Completion date: 2024-05-31
Plan to share individual participant data: NO
Clinical trial NCT03751124: Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Official title: An International Phase 3 Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Sponsor: Myovant Sciences GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 229.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-16
Primary completion date: 2021-02-19
Completion date: 2021-10-20
Baseline population: mITT population: all participants randomized to treatment who had taken at least one dose of study treatment (relugolix plus E2/NETA or placebo).
Plan to share individual participant data: NO
Clinical trial NCT02307513: A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease
Official title: A Phase 3, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Study, Followed by an Active-treatment Phase to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Subjects With Active Behcet's Disease
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 207.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-12-30
Primary completion date: 2017-09-25
Completion date: 2020-07-17
Baseline population: The intent to treat (ITT) population was defined as all randomized participants who received at least 1 dose of investigational product (IP). Participants were included in the treatment group to which they were originally randomized.
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 NCT04200365: A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD)
Official title: A Pilot Study of INCB039110 (Itacitinib) for the Treatment of Steroid Refractory Chronic Graft-Versus-Host Disease
Sponsor: SCRI Development Innovations, LLC (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow enrollment and PI departure
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-05
Primary completion date: 2023-09-07
Completion date: 2023-09-07
Clinical trial NCT05418673: A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122/DNL151 in Participants With Parkinson's Disease and Pathogenic LRRK2 Variants
Acronym: LIGHTHOUSE
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-26
Primary completion date: 2023-07-27
Completion date: 2023-07-27
Baseline population: Full analysis set (FAS) included all randomized participants who had received at least 1 dose of study treatment. Since a low number of participants were enrolled in the study and some of the participants have been rolled over to the 283PD201 (NCT05348785), the data was reported as a pooled group to avoid the identification of individual participants and to maintain the blinding.
Limitations and caveats: Sponsor decided to stop study based on operational and strategic considerations and not for reasons related to efficacy/safety. Due to the early cessation of the study before participants reached the time window for efficacy assessments, efficacy analysis was not possible.
Plan to share individual participant data: YES
IPD sharing description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Clinical trial NCT03513471: Early Phase Administration of Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation
Official title: Early Phase Administration of Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation
Acronym: EarlyAna
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: The risk of inhaled allergen challenge and anakinra treatment outweigh benefits to participants with allergic asthma due to the COVID-19 pandemic.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-09
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Clinical trial NCT04547140: Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) Plus Standard Medical Treatment (SMT) Versus Placebo Plus SMT in Hospitalized Subjects With COVID-19
Sponsor: Grifols Therapeutics LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study Stopped for Futility
Enrollment: 57.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-29
Primary completion date: 2021-12-13
Completion date: 2022-01-28
Baseline population: Intent-to-Treat (ITT) population included all participants who were randomized.
Limitations and caveats: Study was early terminated due to lack of efficacy (futility).
Plan to share individual participant data: NO
Clinical trial NCT03959592: Macular Pigment and Visual Performance in Glaucoma Patients
Official title: Macular Pigment and Visual Performance in Glaucoma Patients
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Preliminary analysis showed no benefit of the investigational supplement.
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-21
Primary completion date: 2021-11-09
Completion date: 2021-11-09
Plan to share individual participant data: NO