chufangao/CTO huggingface dataset:
Clinical trial NCT05458375: Vaginal Estradiol Use in Pessary Care
Official title: Vaginal Estradiol Use in Pessary Management: A Randomized Controlled Trial
Sponsor: University of South Florida (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: There is a lack of potential study participants at our study site that would meet inclusion criteria, therefore, the study is not feasible and is being terminated.
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-12-29
Primary completion date: 2023-04-26
Completion date: 2023-04-26
Plan to share individual participant data: NO
Clinical trial NCT04680949: suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19
Official title: suPAR-Guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE-MORE Double-blind, Randomized, Phase III Confirmatory Trial
Acronym: SAVE-MORE
Sponsor: Hellenic Institute for the Study of Sepsis (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 606.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-23
Primary completion date: 2021-03-31
Completion date: 2022-02-06
Clinical trial NCT04555096: A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
Official title: A Pilot, Randomized, Placebo-Controlled Trial of GC4419 (Avasopasem Manganese) in Patients With Critical Illness Due to SARS-CoV-2 Infection (COVID-19)
Sponsor: Galera Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Participants are no longer receiving intervention
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-09
Primary completion date: 2021-05-28
Completion date: 2021-05-28
Baseline population: Baseline analysis population is the same.
Limitations and caveats: Study was terminated early due to the inability to enroll critically ill COVID 19 patients as the height of the pandemic was over and the sites that were open for enrollment to the clinical study were no longer treating these types of patients.
Plan to share individual participant data: NO
Clinical trial NCT05553639: HB-302/HB-301 Therapy in Participants With Metastatic Castration-Resistant Prostate Cancer
Official title: A Phase 1/2 Study of Replicating Arenavirus-based Vector(s) Encoding Prostate Cancer-Associated Antigens in Participants With Metastatic Castration-Resistant Prostate Cancer
Sponsor: Hookipa Biotech GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Decision by the company to terminate the H-300-001 study early for non-safety related reasons.
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-05-23
Primary completion date: 2024-04-29
Completion date: 2024-04-29
Clinical trial NCT02927262: A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission
Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FLT3/ITD AML in First Complete Remission
Sponsor: Astellas Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 98.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-10
Primary completion date: 2021-05-25
Completion date: 2024-02-19
Baseline population: The full analysis set (FAS) consisted of all participants who were randomized.
Plan to share individual participant data: YES
IPD sharing description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Clinical trial NCT03767270: Safety, Tolerability and PK/PD Evaluation of Intravenous Administration of MRT5201 in Patients With OTC Deficiency
Official title: A Phase 1/2 Single Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered MRT5201 in Subjects With Ornithine Transcarbamylase Deficiency
Acronym: STEP-OTC
Sponsor: Translate Bio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Program was discontinued.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-31
Primary completion date: 2022-07-31
Completion date: 2022-07-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04515849: A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus
Official title: A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled, and Open-label Comparator Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 247.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-08-31
Primary completion date: 2022-03-08
Completion date: 2022-03-08
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT03875482: A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 157.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-13
Primary completion date: 2020-02-20
Completion date: 2020-07-15
Baseline population: Intent-to-treat (ITT) population: all randomized participants
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: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT03781791: Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET)
Acronym: KARMET
Sponsor: Enterin Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 151.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-10
Primary completion date: 2021-12-14
Completion date: 2021-12-14
Plan to share individual participant data: NO
Clinical trial NCT04390217: LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia
Official title: A Phase 2 Study to Evaluate LB1148 for the Treatment of Pulmonary Dysfunction Associated With COVID-19 Pneumonia
Sponsor: Palisade Bio (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Company focused on other clinical programs
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-31
Primary completion date: 2021-12-31
Completion date: 2022-03-31
Plan to share individual participant data: NO
Clinical trial NCT03644823: Combinatory ImmunoTherapy-1 (Com-IT-1) Irradiation and PD-1 Blockade in Locally Advanced / Advanced NSCLC
Official title: Combinatory ImmunoTherapy-1 (Com-IT-1) Irradiation and PD-1 Blockade in Locally Advanced / Advanced NSCLC
Acronym: COM-IT-1
Sponsor: Oslo University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: slow recruiting
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-15
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT04679311: Treatment of Angiotensin Converting Enzyme Inhibitor-induced Angioedema
Official title: High Angiotensin Converting Enzyme Activity-containing Plasma for the Treatment of Angiotensin Converting Enzyme Inhibitor-induced Angioedema
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: End of funding period
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-22
Primary completion date: 2023-01-31
Completion date: 2023-01-31
Baseline population: No patients were randomized to the High ACE FFP. Study was terminated due to end of funding period.
Plan to share individual participant data: NO
Clinical trial NCT04571645: Dociparstat in Combination With Standard Chemotherapy for the Treatment of Acute Myeloid Leukemia
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dociparstat Sodium in Combination With Standard Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Acronym: AML
Sponsor: Chimerix (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study enrollment was terminated on 16 May 2022 due to slow recruitment.
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-30
Primary completion date: 2022-05-16
Completion date: 2022-05-16
Limitations and caveats: Due to low subject accrual, study enrollment was prematurely terminated on 16 May 2021. Therefore, formal statistical analyses were not performed, and no conclusions can be drawn about dociparstat with regards to efficacy.
Plan to share individual participant data: NO
Clinical trial NCT02805179: A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma
Official title: Phase II Study of High Dose Radiotherapy and Concurrent Temozolomide Using Biologically-Based Target Volume Definition in Patients With Newly Diagnosed Glioblastoma
Sponsor: University of Michigan Rogel Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-09-22
Primary completion date: 2020-02-06
Completion date: 2020-11-18
Clinical trial NCT03191786: A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy
Official title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab Compared With Chemotherapy in Patients With Treatment Naïve Advanced or Recurrent (Stage IIIb Not Amenable for Multimodality Treatment) or Metastatic (Stage IV) Non-Small Cell Lung Cancer Who Are Deemed Unsuitable for Platinum-Containing Therapy
Acronym: IPSOS
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 453.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-11
Primary completion date: 2022-04-30
Completion date: 2023-10-25
Clinical trial NCT03064854: PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients
Official title: Phase Ib, Multicenter, Open Label Study of PDR001 in Combination With Platinum Doublet Chemotherapy and Other Immunooncology Agents in PD-L1 Unselected, Metastatic NSCLS Patients (ElevatION:NSCLC-101 Trial)
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Recruitment halted prematurely due to competitive landscape for lung cancer therapies
Enrollment: 111.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-05-24
Primary completion date: 2021-07-28
Completion date: 2021-07-28
Plan to share individual participant data: NO
Clinical trial NCT05408871: Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases
Official title: Pilot Study of Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: PI changed institutions
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-02-21
Primary completion date: 2024-01-31
Completion date: 2024-01-31
Plan to share individual participant data: NO
Clinical trial NCT03283397: A Phase IIIb, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of EK-12 in Patients With RRMS
Official title: A Phase IIIb, Multi-center, International, Randomized, Assessor-blind, Active-controlled Parallel Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Neuropeptide Combination of Metenkefalin and Tridecactide (EK-12) in Comparison to Interferon Beta-1a (REBIF®) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
Sponsor: Bosnalijek D.D (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: During the Covid-19 pandemic, the study was unable to enrol further patients.
Enrollment: 301.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-26
Primary completion date: 2023-07-01
Completion date: 2023-07-01
Plan to share individual participant data: NO
Clinical trial NCT05065567: Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis
Official title: A Comparison of Haloperidol 5mg IM vs Droperidol 2.5mg and Ondansetron for the Treatment of Hyperemesis in Cannabis Hyperemesis Syndrome
Sponsor: Spectrum Health - Lakeland (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lost too many patients to follow up, unable to enroll enough patients
Enrollment: 38.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-08-30
Primary completion date: 2023-11-20
Completion date: 2023-11-20
Plan to share individual participant data: YES
Clinical trial NCT05887843: Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis
Official title: An Open-label, Single-Dose, Three-way Crossover Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents (12 to 17 Years of Age) and Young Adults (18 to 24 Years of Age) With Seasonal Allergic Rhinitis
Sponsor: Sandoz (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business decision (no safety concerns).
Enrollment: 38.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-06-08
Primary completion date: 2023-09-08
Completion date: 2023-09-08
Clinical trial NCT01876784: Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Study to Assess the Efficacy and Safety of Vandetanib (CAPRELSA™; SAR390530 (Formerly AstraZeneca ZD6474)) 300 mg in Patients With Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are Refractory or Unsuitable for Radioiodine (RAI) Therapy
Acronym: VERIFY
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 238.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-09-17
Primary completion date: 2015-08-30
Completion date: 2022-01-22
Baseline population: Analysis was performed on all randomized participants.
Limitations and caveats: This study was part of the drug acquisition where model-based PK analysis was not performed by the legacy company. Available PK descriptive statistics have been reported.
Clinical trial NCT02949843: Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations
Official title: Phase II Pilot Study Evaluating Strategies to Overcome Resistance at the Time of Progression for Patients With Non-small Cell Lung Cancers Harboring Major Oncogenic Drivers
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual, closed by IRB
Enrollment: 19.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-03-10
Primary completion date: 2018-01-08
Completion date: 2021-01-12
Clinical trial NCT03626545: Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy
Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Canakinumab in Combination With Docetaxel Versus Placebo in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancer (NSCLC) Previously Treated With PD-(L)1 Inhibitors and Platinum-based Chemotherapy (CANOPY 2)
Acronym: CANOPY-2
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was early terminated due to the lack of efficacy of study treatment observed in the analysis of the primary endpoint of the randomized part
Enrollment: 245.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-01-23
Primary completion date: 2021-01-08
Completion date: 2021-12-20
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 expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Clinical trial NCT03689374: A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes
Official title: Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed, Parallel-group, Randomised Trial in Subjects With Type 2 Diabetes
Acronym: SUSTAIN 11
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2274.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-01
Primary completion date: 2021-02-22
Completion date: 2021-02-22
Baseline population: Full analysis set included all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT05087914: Novel Non-opioid Post-surgical Pain Treatment in Females
Official title: Novel Non-opioid Post-surgical Pain Treatment in Females
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was not started, therefore recruitment did not happen
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-01
Primary completion date: 2023-12-30
Completion date: 2024-01-30
Plan to share individual participant data: YES