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Pulsed Field Ablation (PFA) Vs Anti-Arrhythmic Drug (AAD) Therapy As a First Line Treatment for Persistent...
Boston Scientific Corporation
Persistent Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of pulsed field
ablation as a first-line ablation treatment for subjects with persistent atrial
fibrillation as compared to subjects who received an initial treatment with
anti-arrhythmic drugs. expand
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs. Type: Interventional Start Date: Dec 2023 |
Sleep for Stroke Management and Recovery Trial
University of Michigan
Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
Stroke
CPAP
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 (1)
reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after
the event, and (2) improves stroke outcomes... 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 (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 |
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 help reduce the need for... 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 |
Cryoablation for Monomorphic Ventricular Tachycardia
Adagio Medical
Sustained VT
The objective of this clinical study is to evaluate the safety and effectiveness of the
Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic
Ventricular Tachycardia (SMVT) expand
The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT) Type: Interventional Start Date: Sep 2023 |
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive...
Alliance for Clinical Trials in Oncology
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy drug, called DM1. Trastuzumab... expand
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Type: Interventional Start Date: Jan 2021 |
RECOVER-SLEEP: Platform Protocol
Duke University
Long COVID
Long COVID-19
Hypersomnia
Sleep Disturbance
The platform protocol is designed to be flexible so that it is suitable for a range of
study settings and intervention types. Therefore, the platform protocol provides a
general protocol structure that can be shared by multiple interventions and allows
comparative analysis across the interventions.... expand
The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices. This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance). Type: Interventional Start Date: Jul 2024 |
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 by MV repair surgery... 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 |
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 cardiac surgeon with... 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 |
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. expand
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 |
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 (baseline, year 1, year... 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 |
POLARx Post Approval Study (POLARx PAS)
Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
To collect clinical data on safety, effectiveness and procedural success of Boston
Scientific's Cardiac Cryoablation System (includes all BSC commercially available
POLARx/POLARx Fit catheters) when used to perform pulmonary vein isolation (PVI) in the
ablation treatment of de novo Atrial Fibrillation... expand
To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein isolation (PVI) in the ablation treatment of de novo Atrial Fibrillation (AF). Type: Interventional Start Date: Jun 2024 |
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 parameters and outcomes... 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 |
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 it very active and important... 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 |
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, and biomarkers of cardiovascular... 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 |