This is a prospective, multi-center, single-arm, early feasibility study that aims to evaluate the safety of the Impella BTR™ in adult patients requiring left-ventricular hemodynamic support, and to evaluate the effectiveness of the Impella BTR™ in supporting patients to recovery or their next therapy.
The purpose of this study is to see if the study drug, elezanumab, is safe and able to improve cognitive and/or motor functioning in an individual following the occurrence of acute ischemic stroke. This is a 52-week, Phase 2a, randomized, double-blind, parallel-group, placebo-controlled, multicenter proof-of concept study.
Rheumatoid arthritis (RA) is a chronic, slowly progressive condition for which numerous treatment options are available. The therapies vary in mechanism of action, mode of administration, side- effect (adverse event) profile, and cost. While consensus treatment guidelines are available, identifying an optimal treatment sequence is often based on clinician choice with treatment changes based on tolerability and short- term outcome. The N-of-1 trial will evaluate individual participant and aggregate data. Individual participants will be enrolled and randomized to a sequence of three U.S.
The proposed dyadic intervention will be one of the first to target the outcomes of both the HF patient and their spouse care partner simultaneously through a team-based intervention centered on shared appraisal, collaboration, communication and confidence to promote optimal dyadic health. The proposed study is, therefore, significant in addressing an important gap.
The purpose of this study is to see if the study drug, elezanumab, is safe and able to improve function in patients with acute traumatic cervical spinal cord injury (SCI).
The main objective of this study is to prospectively evaluate the effect of prophylactic intra-operative ventricular tachyarrhythmia ablation (VTA) at the time of left ventricular assist device (LVAD) implantation on post-implant total recurrent VTA events, after accounting for the competing risk of death, from discharge to an average follow-up of 18 months (with a minimum of 9 months) after LVAD implantation.
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL).
The primary objective for this early feasibility study is to assess safety and feasibility of the Impella ECP device in adult patients undergoing an elective high-risk percutaneous coronary intervention. To assess safety, special attention is being paid to the effect of the pump on the aortic valve
The MADIT S-ICD trial is designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when compared to those receiving conventional medical therapy.
Aortic stenosis (AS) affects over 12.6 million adults and causes an estimated 102,700 deaths annually. There is interest in novel approaches to identify valve disease earlier the disease course before symptoms occur. We previously used machine learning (ML) to develop a system for fully automated AS screening. Here we are validating the performance of this new method for identifying AS.
This is an observational study to assess the the burden of neuropathic involvement in wild-type transthyretin amyloidosis
This is a Phase 2 study investigating safety and tolerability of Inhaled Treprostinil in participants with Pulmonary Hypertension associated with Interstitial Lung Disease.
Aortic stenosis (AS) affects over 12.6 million adults and causes an estimated 102,700 deaths annually. There is interest in novel approaches to identify valve disease earlier the disease course before symptoms occur. We previously used machine learning (ML) to develop a system for fully automated AS screening. Here we are validating the performance of this new method for identifying AS.
We are investigating whether or not use of TENS device during IUD insertion reduces pain. We will record pain scores at different points in the IUD insertion procedure for patients who choose to use the TENS device and those who do not as part of this study. TENS device uses stickers (electrodes) on the skin to give gentle electrical pulse which has been shown to help with pain in some settings. This has not been studied for use with IUD insertion.
The goal of this protocol is to validate a non-contact technology with miniaturized radar integrated with a visible camera in a high-risk neonatal population to ultimately provide a safe alternative to current standard contact vital sign monitoring systems.
ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NIH StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
Percutaneous Coronary Intervention (PCI) involves positioning of a stent under Xray guidance to treat coronary arterial stenosis. It then requires intraprocedural assessment of stent positioning and deployment. Standard assessment is done using 2-dimensional angiography possibly augmented with stent enhancement algorithms (e.g. StentViz, GE HealthCare) and/or Intravascular Imaging such IVUS. IVUS brings excellent visualization and clinical information, but it is limited by catheter cost, workflow and time.
REACT-AF is a multicenter, prospective, randomized clinical trial comparing two treatment strategies for stroke prevention in patients with a history of paroxsymal or persistent atrial fibrillation and moderate stroke-risk.
This study is being conducted in healthy children from age 6 months to age 12 years. The study is looking at how well the Moderna mRNA vaccine works when given to healthy children for the prevention of COVID-19.
This is a Phase 3, open-label, follow-up study to evaluate the long-term safety and efficacy of sotatercept when added to background PAH therapy for the treatment of PAH. Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the PAH sotatercept clinical studies. Participants who have discontinued from a previous PAH sotatercept clinical study will not be eligible to enroll in this LTFU study.
