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.
The primary objective is to evaluate the efficacy of levosimendan TNX-103 compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance from Day 1 to Week 12. This is a multicenter, parallel, double-blind study in subjects with PH-HFpEF and will be screened for a 1:1 ratio to receive an oral dose of 2 mg/day levosimendan or placebo for Weeks 1 to 4 and 3 mg/day for Weeks 5 to 12.
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, symptomatic AS. The primary objective is to demonstrate the safety and effectiveness of the Medtronic TAVR system (on the background of GDMT) is superior to GDMT alone.
This study is to evaluate Safety & Tolerability of multiple doses of an experimental i.v. medication (called AP-SA02) in Phase 1b and to evaluate Efficacy, Safety & Tolerability of multiple doses of the same experimental medication in Phase 2a, as compared to Placebo in patients with certain bacterial infection (bacteria named Staphylococcus aureus) of your blood stream. The experimental drug or Placebo will be given in addition to any treatment given for the Blood stream infection by Staphylococcus aureus.
This is a randomized, phase 2, double-blind, placebo-controlled study of KER-012 in combination with background therapy in participants with PAH of World Health Organization (WHO) Group 1, functional class II-III. Participants will be randomly assigned in a 2:2:2:3 ratio to receive KER-012 (Dose A), KER-012 (Dose B), KER-012 (Dose C), or placebo by subcutaneous injection (SC) every 4 weeks for a period of 24 weeks in the placebo-controlled treatment period of the study while on background therapy.
This clinical investigation is intended to evaluate the safety and effectiveness of Abbott’s AmplatzerTM AmuletTM Left Atrial Appendage (LAA) occluder device (“Amulet device”) compared to commercially available non-vitamin K antagonist oral anticoagulant (NOAC) drugs in patients with non-valvular atrial fibrillation (AF) who are at increased risk for ischemic stroke and who are tolerant of long-term NOAC therapy.
A prospective, multi-center, 2:1 randomized (AGENT to POBA), controlled, single-blind, superiority trial. Up to 40 sites in the United States, at least 480 subjects will be enrolled in the trial. An interim analysis will be performed prior to the end of the initial enrollment of 480 patients. The final sample size may be increased up to a maximum of 600 subjects enrolled in the trial.
This study aims to learn more about the investigational drug, ASTX727, and another drug, venetoclax, when given in combination. It also aims to evaluate potential pharmocokinetics (PK) interactions for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
The primary purpose of the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination therapy.
