chufangao/CTO huggingface dataset:
Clinical trial NCT03235544: A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
Official title: A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)
Acronym: (CITADEL-205)
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 162.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-11-20
Primary completion date: 2021-03-03
Completion date: 2024-04-30
Baseline population: Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of parsaclisib.
Plan to share individual participant data: YES
IPD sharing description: Individual participant data (IPD) will be made available to interested researchers after the end of study, a thorough analysis, and the publication of the data in the clinical study report (CSR). As required, results of the data will be posted to ClinicalTrials.gov. Upon request, individual investigators may obtain IPD from the sponsor. The format for data delivery will be determined between sponsor and investigator.
IPD time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Clinical trial NCT03075462: A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients
Official title: An Open, Non-randomised, Multi-centre Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination With Apatinib in Patients With Recurrent Ovarian Cancer or Triple Negative Breast Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 98.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-03-09
Primary completion date: 2021-08-22
Completion date: 2021-12-13
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04059445: Mandibular Furcation II Regeneration
Official title: Biphasic Calcium Phosphate and a Collagen Membrane or Biphasic Calcium Phosphate and Enamel Matrix Proteins, in the Regenerative Treatment of Furcation Grade II Defects
Acronym: FURC-II-REGEN
Sponsor: University of Oslo (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Recruitment problem
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-15
Primary completion date: 2023-11-27
Completion date: 2023-11-27
Clinical trial NCT04729088: Pharmacokinetics Trial of Isosorbide Mononitrate 0.5% Gel for Intra Anal Application in Healthy Subjects
Official title: Phase I Clinical Trial to Evaluate the Pharmacokinetic Profile of a Formulation With Isosorbide Mononitrate 0.5% Gel - Manufactured by Sanus Pharmaceutical Ltda, to Intra Anal Application in Healthy Males and Females' Subjects
Sponsor: Biolab Sanus Farmaceutica (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The sponsor will no longer develop the experimental drug.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-20
Primary completion date: 2020-12-20
Completion date: 2020-12-20
Clinical trial NCT04746612: First in Human Study to Evaluate the Safety, Tolerability of HH30134 in Advanced Solid Tumors
Official title: A Phase I, Multi-centre, Open-Label, First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH30134 in Patients With Advanced Solid Tumours
Sponsor: Haihe Biopharma Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor business decision
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-08
Primary completion date: 2023-03-24
Completion date: 2023-03-24
Plan to share individual participant data: NO
Clinical trial NCT04387617: A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones
Official title: Effect of Cannabidiol Oil on Postoperative Pain After Ureteroscopy for Urinary Calculi
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 90.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-15
Primary completion date: 2022-01-31
Completion date: 2022-01-31
Plan to share individual participant data: NO
Clinical trial NCT04021277: PS101-mediated ACT With Chemotherapy in Liver Metastases From Cancer of Gastrointestinal Origin
Official title: Phase I Trial of the Combination of PS101-Mediated Acoustic Cluster Therapy (ACT) With Chemotherapy for Treatment of Liver Metastasis In Patients With Solid Tumours With an Expansion Cohort in Metastatic Colorectal And Pancreatic Cancer
Acronym: ACT
Sponsor: EXACT Therapeutics AS (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business reason
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-17
Primary completion date: 2024-08-27
Completion date: 2024-09-24
Plan to share individual participant data: NO
Clinical trial NCT03203642: Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD
Official title: A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney Disease
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-12
Primary completion date: 2022-01-25
Completion date: 2022-01-25
Baseline population: Analysis was performed on modified Intent-To-Treat (mITT) population which included all randomized participants who receive at least 1 dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT03331146: Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass
Official title: Randomized, Controlled, Double-blinded Pilot Study: Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Principal Investigator made aware of similar studies that have already been published.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-01
Primary completion date: 2019-06-01
Completion date: 2020-12-01
Clinical trial NCT04330495: Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection
Official title: Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection
Sponsor: Instituto de Investigación Marqués de Valdecilla (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: * Care pressures on the investigator team during the COVID-19 pandemic.~* Subsequent appearance of scientific evidence on the lack of efficacy of hydroxychloroquine in the treatment or prophylaxis of COVID-19 infection.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-06
Primary completion date: 2020-11-06
Completion date: 2021-08-27
Plan to share individual participant data: UNDECIDED
Clinical trial NCT01889199: Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women
Official title: Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-04-30
Primary completion date: 2023-07-06
Completion date: 2023-07-06
Plan to share individual participant data: NO
Clinical trial NCT05008913: Human Absorption, Distribution, Metabolism, and Excretion Study of [14C]Adavosertib
Official title: A Phase I, Open-Label, Non-Randomised Study of the Absorption, Distribution, Metabolism, and Excretion of Adavosertib After a Single Oral Dose of [14C]Adavosertib to Patients With Advanced Solid Tumours
Acronym: ADME
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study terminated because the clinical development programme for Adavosertib has been discontinued
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-01
Primary completion date: 2021-11-16
Completion date: 2021-11-16
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 requests 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 refer 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 NCT04556734: Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study, With a 28-Week Open-Label Extension, to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Alopecia Areata
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-29
Primary completion date: 2023-06-07
Completion date: 2023-06-07
Baseline population: DB Treatment Period randomized set included all randomized participants, irrespective of whether they received any study drug. OLE Safety set (SAF) included all participants who received at least 1 dose of study drug. Participants in DB treatment period and OLE period are not exclusive. Eligible participants from DB treatment period entered OLE period after completing treatment in DB treatment period.
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 NCT05135624: SP16 as a Therapeutic for COVID-19 Induced ARDS
Official title: SP16 as a Therapeutic for SARS-CoV-2 Induced ARDS
Sponsor: Serpin Pharma, LLC (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Trial was terminated due to lack of patients.
Enrollment: 2.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-12-01
Primary completion date: 2023-06-30
Completion date: 2023-06-30
Plan to share individual participant data: NO
Clinical trial NCT05233696: Radiotherapy in Combo With Chemo and Immunotherapy in Patients With PD-L1 Positive Metastatic TNBC
Official title: Phase II Study of Radiotherapy in Combination With Chemotherapy and Immunotherapy in Patients With PD-L1-Positive Metastatic Triple-Negative Breast Cancer
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Low Accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-04
Primary completion date: 2022-12-01
Completion date: 2022-12-01
Plan to share individual participant data: NO
Clinical trial NCT04219358: Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis
Official title: Evaluation of Topical Application of 5% Imiquimod, 0.05% Imiquimod and 0.05% Nanoencapsulated Imiquimod Gel in the Treatment of Actinic Cheilitis: a Randomized Controlled Trial
Sponsor: Hospital de Clinicas de Porto Alegre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study terminated because of COVID19 pandemics.
Enrollment: 49.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-03-23
Primary completion date: 2020-06-24
Completion date: 2021-08-24
Plan to share individual participant data: NO
Clinical trial NCT02659527: PET/MRI in Patients With Suspected Prostate Cancer
Official title: Randomized Assessment of Patients With Clinically Suspected Prostate Cancer After Multiparametric Metabolic Hybrid Imaging to Evaluate Its Potential Clinical Domain: A Prospective, Randomized, Multi-arm, Multi-treatment Clinical Trial
Sponsor: Medical University of Vienna (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 220.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-31
Primary completion date: 2022-05-31
Completion date: 2022-08-31
Clinical trial NCT05120622: Trial of Local Cystoscopic Injection of Tremelimumab Plus Systemic Durvalumab for High Risk Non-Muscle Invasive Bladder Cancer
Official title: Phase I/II Trial of Local Cystoscopic Injection of Tremelimumab Plus Systemic Durvalumab (MEDI4736) for High Risk Non-Muscle Invasive Bladder Cancer
Acronym: Rideau
Sponsor: University of British Columbia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Withdrawal of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-01
Primary completion date: 2022-05-01
Completion date: 2022-05-01
Plan to share individual participant data: NO
Clinical trial NCT01434472: High-Dose Y-90-Ibritumomab Tiuxetan Added to Reduced-Intensity Allogeneic Stem Cell Transplant Regimen for Relapsed or Refractory Aggressive B-Cell Lymphoma
Official title: A Phase II Trial of High-Dose 90Y-Ibritumomab Tiuxetan (Anti-CD20) Followed by Fludarabine and Low-Dose Total Body Irradiation and HLA-Matched Allogeneic Hematopoietic Transplantation for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma
Sponsor: Fred Hutchinson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated due to insufficient funding
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2011-11-16
Primary completion date: 2020-05-06
Completion date: 2020-05-06
Clinical trial NCT05260008: Study Assessing Pain Relief After Replacement of the Knee
Official title: A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty
Acronym: SPARK
Sponsor: Allay Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Based on positive data from the dose-ranging portion of the study, Sponsor decided as of May 28, 2024 not to move forward with the previously designed global ATX101-TKA-003 study.
Enrollment: 112.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-06-07
Primary completion date: 2024-01-15
Completion date: 2024-01-15
Plan to share individual participant data: NO
Clinical trial NCT03777579: A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC
Official title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of JS001 (Anti-PD-1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel as First-line Therapy for Patients With Primarily Diagnose or Recurrent and Metastatic Triple-Negative Breast Cancer
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: trial handovered to another sponser.
Enrollment: 375.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2018-12-21
Primary completion date: 2019-12-30
Completion date: 2020-07-30
Plan to share individual participant data: NO
Clinical trial NCT03833427: Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (MK-5618-001)
Official title: A Phase 1b Multi-center Clinical Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors.
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 7.0
Start date: 2019-03-18
Primary completion date: 2022-06-28
Completion date: 2022-06-28
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03245008: Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain
Official title: A Phase 2/3 (Placebo-Controlled, Double-Blind, Comparative) Study on MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain
Sponsor: Mitsubishi Tanabe Pharma Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 626.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-09-08
Primary completion date: 2019-12-14
Completion date: 2021-03-09
Baseline population: The pooled placebo group (N=204) and the pooled MT-5547 1 mg q4w group (N=203) showed the total number of participants randomized to each group before and after the protocol amendment.~The number of participants who were randomized to the placebo group (N=165) and the MT-5547 1 mg q4w group (N=165) after the protocol amendment were not shown in the table below because they are included in the respective pooled groups. A total of 626 participants were enrolled into this study.
Clinical trial NCT03895996: Safety, Tolerability and Potential Efficacy of AVT001 in Patients With Type 1 Diabetes
Official title: A Phase 1 / 2 Double-Blind, Randomized, Placebo Controlled Study of Safety, Tolerability and Potential Efficacy of AVOTRES Cell-Based Therapy (AVT001) in Patients With Type 1 Diabetes
Sponsor: Avotres Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-20
Primary completion date: 2022-05-17
Completion date: 2023-12-19
Plan to share individual participant data: NO
Clinical trial NCT04045613: Derazantinib and Atezolizumab in Patients With Urothelial Cancer
Official title: An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations
Acronym: FIDES-02
Sponsor: Basilea Pharmaceutica (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 95.0 (ACTUAL)
Number of arms: 7.0
Start date: 2019-08-02
Primary completion date: 2022-10-04
Completion date: 2022-10-04
Plan to share individual participant data: NO
Clinical trial NCT03650452: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic Encephalopathies
Acronym: ELEKTRA
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 141.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-08
Primary completion date: 2020-06-09
Completion date: 2020-07-20
Baseline population: Randomized Analysis Set included all participants who were randomized into the study.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT03226080: GA/Spinal vs. GA/Spinal/NMB for Operative Repair of Hip Fracture
Official title: Combined General and Spinal Anesthesia vs. Combined General and Spinal Anesthesia With Neuromuscular Blockade for Operative Repair of Hip Fractures
Sponsor: Loyola University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Study terminated with IRB on 20Feb2019 due to lack of enrollment.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-19
Primary completion date: 2019-08-31
Completion date: 2020-08-31
Plan to share individual participant data: NO
Clinical trial NCT02554253: The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
Official title: The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction in Patients 75 Years of Age or Older and Undergoing Cardiac Surgery
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 52.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-09-30
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Baseline population: 52 patients were enrolled. 3 patients did not complete the study. 1 patient was found to be ineligible after enrollment, 1 patient transitioned to a procedure that was in the exclusion criteria, and one patient received both the induction medications. This resulted in 25 patients for analysis in the ketamine group and 24 patients in the Propofol group.
Limitations and caveats: Not powered to detect differences in acute kidney injury. A larger study will be needed.