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Sponsor Condition of Interest |
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Sleep for Stroke Management and Recovery Trial
University of Michigan
Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
TIA
Stroke
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA)
with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA
(1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after... expand
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. Type: Interventional Start Date: May 2019 |
Cryoablation for Monomorphic Ventricular Tachycardia Early Feasibility Study (EFS)
Adagio Medical
Sustained VT
The objective of this clinical study is to evaluate the safety and performance of the Adagio
VT Cryoablation System in the ablation treatment of Sustained Monomorphic VT (SMVT)
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The objective of this clinical study is to evaluate the safety and performance of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic VT (SMVT) Type: Interventional Start Date: Sep 2023 |
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Thomas G. Brott, M.D.
Carotid Stenosis
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent
multicenter, randomized controlled trials of carotid revascularization and intensive medical
management versus medical management alone in patients with asymptomatic high-grade carotid... expand
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed. Type: Interventional Start Date: Dec 2014 |
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
ECOG-ACRIN Cancer Research Group
Breast Screening
This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer screening
and may... expand
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment. Type: Interventional Start Date: Sep 2017 |
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
Boston Scientific Corporation
Aortic Stenosis
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for
transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis
who are indicated for TAVR.
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To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR. Type: Interventional Start Date: Jun 2019 |
The Syn-Sleep Study
CND Life Sciences
REM Sleep Behavior Disorder (iRBD)
In collaboration with approximately 8 centers that specialize in iRBD we will recruit a total
of 80 individuals for the study. All subjects will be enrolled into a 2-year longitudinal
study where skin biopsies will be performed at 3 sites on each patient at 12-month intervals... expand
In collaboration with approximately 8 centers that specialize in iRBD we will recruit a total of 80 individuals for the study. All subjects will be enrolled into a 2-year longitudinal study where skin biopsies will be performed at 3 sites on each patient at 12-month intervals (baseline, year 1, year 2). Plasma blood collection will be performed at 12-month intervals (baseline, year 1, year 2). Detailed quantified examination, cognitive evaluation, medical history, and questionnaires will be performed at each visit. Additional biomarker, imaging and clinical information (if available) will be obtained for the purpose of determining phenoconversion to clinically apparent synucleinopathy. Subjects enrolled in the study will have baseline evaluations and follow up visits at 12 and 24 months to define any changes to clinical diagnosis (clinical phenoconversion). Skin biopsies will be repeated at the 12- and 24-month follow up visits to determine the rate of P-SYN accumulation over time and the rates of nerve fiber degeneration within punch skin biopsies. Type: Observational Start Date: Sep 2022 |
remedē System Therapy Study
Respicardia, Inc.
Central Sleep Apnea
The purpose of this non-randomized post market study is to collect clinical data on the
safety and effectiveness of the remedē System in a real-world setting.
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The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting. Type: Observational Start Date: Jun 2019 |
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
Edwards Lifesciences
Tricuspid Regurgitation
Tricuspid Valve Insufficiency
Tricuspid Valve Disease
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System
in patients with symptomatic severe tricuspid regurgitation who have been determined to be at
an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the... expand
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team Type: Interventional Start Date: Dec 2019 |
MitraClip REPAIR MR Study
Abbott Medical Devices
Mitral Valve Regurgitation
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of
MitraClip™ device versus surgical repair in patients with severe primary MR who are at
moderate surgical risk and whose mitral valve has been determined to be suitable for
correction... expand
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. Type: Interventional Start Date: Jul 2020 |
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
LivaNova
Obstructive Sleep Apnea
OSA
Apnea
Apnea, Obstructive
Apnea, Obstructive Sleep
Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System
for the reduction of apnea and hypopneas in adult patients with moderate to severe
obstructive sleep apnea who have failed or are unwilling to use positive airway pressure
treatment.... expand
Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment. Type: Interventional Start Date: Jul 2021 |
ALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement
University of Texas Southwestern Medical Center
Cirrhosis, Liver
Transjugular Intrahepatic Portosystemic Shunt (TIPS)
ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS
is a longitudinal observational study of patients who are undergoing transjugular
intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will
provide clinical... expand
ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their standard of care in hopes of answering key clinical questions. Type: Observational [Patient Registry] Start Date: Jun 2019 |
Wellness Intervention for Smoking and HIV
University of Arizona
HIV
Sleep
Smoking Cessation
Cardiovascular Diseases
The investigators propose to use a parallel group, randomized controlled trial to test the
efficacy of a 13-week personalized approach to reducing smoking intervention versus a second
approach using a different health intervention on smoking cessation, healthy sleep metrics,... expand
The investigators propose to use a parallel group, randomized controlled trial to test the efficacy of a 13-week personalized approach to reducing smoking intervention versus a second approach using a different health intervention on smoking cessation, healthy sleep metrics, and biomarkers of cardiovascular risk in a sample of 200 treatment-seeking smokers who are adults living with HIV (ALHIV). To enroll in the study, treatment-seeking ALHIV smokers will undergo phone and in-person study eligibility assessments, including a history, physical examination, screening laboratory tests, and an overnight in-home objective sleep assessment. Eligible subjects (N=200) will be randomized to the 13-week Approach 1 (N=100) or Approach 2 (N=100) condition. All subjects will receive a 12-week course of varenicline (beginning in week 2) and 8 individual 15-minute smoking cessation counseling sessions [weeks 1, 2, 3 (target quit date), 5, 7, 9, 11, 13]. At each in-person counseling session, 30-45 minutes of Approach 1 or Approach 2 counseling will be provided as well. While receiving varenicline, the study team will monitor for side effects and changes to blood pressure at each study visit for safety reasons. Study measures are collected at all time points including EOT (week 13), and 6-month follow-up (6MFU). Type: Interventional Start Date: Nov 2021 |
Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by...
ECOG-ACRIN Cancer Research Group
ALK Gene Rearrangement
ALK Gene Translocation
ALK Positive
Stage IB Non-Small Cell Lung Carcinoma AJCC v7
Stage II Non-Small Cell Lung Cancer AJCC v7
This randomized phase III trial studies how well crizotinib works in treating patients with
stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation
in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make... expand
This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation. Type: Interventional Start Date: Mar 2015 |