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Heart failure is a harmful disease that is associated with high avoidable moribidity that can be treated with a cardiac resynchronization therapy device (CRT-D). Previous studies have shown links between CRT-D implants and reduced rates of morbidity in patients with heart failure with left bundle branch blockages (LBBB). However, there is limited amounts of evidence for the success of heart failure patients with non-LBBB. This prospective, multi-center study is looking at heart failure patients with non-LBBB that are implanted with CRT-D. 

This qualitative and feasibility study will involve the development, distribution, and evaluation of “period kits” for 15-25 pre-menarchal adolescents with intellectual and developmental disabilities (IDD) (e.g., autism, Asperger’s syndrome, and Down syndrome) in relieving stress and augmenting preparedness concerning menstruation and other imminent pubertal changes. 

This clinical investigation is intended to evaluate the safety and effectiveness of Abbott’s Amplatzer^TM Amulet^TM 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.

GO MOMS is a study that tracks maternal blood sugar levels in pregnancy and how the levels may predict the development of gestational diabetes (pregnancy-related high blood sugar) or relate to the size of a baby at birth. As not enough is known about who will get gestational diabetes and because treatment of gestational diabetes in later pregnancy does not make all of the complications go away, learning about the early pregnancy blood sugars may help us learn how to improve prenatal care in the future for healthier families.

The purpose of this study is to measure the effect of maternal diet and metabolism (how your body uses food for energy) on the growth of the baby, and how the placenta uses lipids.

This study will determine how the placenta is affected by glucose in early pregnancy.

The TRIOMPHE study is designed to further evaluate the safety and efficacy of the NEXUS™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic lesions involving the aortic arch including chronic dissections, aneurysms, penetrating aortic ulcers and intramural hematoma.

Premature infants can get a serious inflammatory condition, called necrotizing enterocolitis (NEC), that damages parts of the intestines. It is the most common cause of illness of the intestinal tract in premature infants in the first few weeks of life. It is a very serious condition that can lead to death in up to half of affected infants. There is no way to predict whether an infant will get NEC, and there are no reliable early warning signals. There is no established preventive treatment for NEC.

The purpose of this study is to study environmental risk factors and epigenetic processes as potential contributors to neurodevelopmental impairments in a group of individuals at very high risk by focusing on the relationship of prenatal exposure to placental inflammation markers and neonatal inflammation markers, the relationship of these inflammation markers to functional neuodevelopmental disorders and on the relationship of these markers to brain structural abnormalities.

The primary objective of the study is to evaluate the safety and efficacy of inhaled treprostinil in subjects with IPF. This study hypothesizes that inhaled treprostinil will have a positive effect on absolute FVC after 52 weeks of therapy as compared with placebo when administered to subjects with IPF.

To evaluate the systemic exposure of treprostinil after inhaled administration in subjects with idiopathic pulmonary fibrosis (IPF)

This is a Phase 3, randomized, double-blinded, placebo-controlled study to compare the efficacy and safety of sotatercept versus placebo when added to background pulmonary arterial hypertension (PAH) therapy for the treatment of PAH. The objective of this study is to evaluate the efficacy and safety of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH.

This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate sotatercept when added to background PAH therapy in newly diagnosed intermediate- and high-risk PAH patients.

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study. The objective of this study is to evaluate the effects of sotatercept treatment (plus maximum tolerated background PAH therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours, in participants with WHO FC III or FC IV PAH at high risk of mortality.

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.

It is hypothesized that inhaled RT234 will provide a therapeutic benefit for "as needed" (PRN) use in patients with WHO Group 1 Pulmonary Hypertension (PH) (Pulmonary Arterial Hypertension (PAH)) to improve exercise capacity and therefore performance in activities of daily living as well as reduce exertional symptoms (e.g., dyspnea) and their deleterious impacts on quality of life (QoL).

This is a Prospective, multi‐center, international, randomized controlled, post‐market trial.

To demonstrate that remibrutinib is superior to teriflunomide in reducing the frequency of confirmed relapses.

This study is being conducted in patients with refractory Mycobacterium Avium Complex (MAC), a serious condition which can cause damage to your lung, and is resistant to other treatments. The study is looking at how effective the study drug, Epetraborole in the treatment of refractory MAC. Epetrabole is a oral pill to be taken as 2 tablets one time daily by mouth. Details of study visits are explained below.

Obesity is a chronic, debilitating, multi-factorial disease that has reached worldwide pandemic proportions. The prevalence of obesity has tripled since the 1980s in many countries of the World Health Organization (WHO) European region. The WHO estimates that by 2015, 2.3 billion people will be overweight and over 700 million will be obese.