The objective of the study is to evaluate the safety and efficacy of the JenaValve Pericardial TAVR system when treating patients with aortic regurgitation. Aortic Regurgitation is a condition that develops when the heart's aortic valve does close tightly, therefore the blood leaks back into the heart chamber. The JenaValve Pericardial TAVR system will…
Are you suffering from persistent symptoms that began after you were diagnosed and treated with antibiotics for Lyme Disease? This new research study aims to test a new form of treatment for people with persistent symptoms despite antibiotic treatment for Lyme disease. This treatment involves stimulating a nerve on the surface of your ear. This is called…
We are conducting a research study on the effect of high insulin levels on the buildup of excessive liver fat ("fatty liver disease") in people at risk for type 2 diabetes. We are seeking adult volunteers, ages 18-65, who have obesity with a body mass index of 30-45, and have been diagnosed with, or are at risk for, prediabetes and metabolic…
Have you been treated for Lyme Disease but continue to have brain fog or other cognitive problems? This research study will assess a non-medication non-invasive intervention to improve cognitive functioning in people with persistent cognitive problems despite prior antibiotic treatment for Lyme Disease. Participants will complete this 4 week intervention at…
This patient case registry for Lyme and other Tick-borne Diseases is a component of the Clinical Trials Network that was launched in 2021 by a grant from the Steven and Alexandra Cohen Foundation. The registry will gather general information such as demographics, medical history, and current functional status. This information will help researchers to…
We are conducting a research study on how insulin controls blood sugar in both healthy people and those at risk of type 2 diabetes. We are seeking adult volunteers, aged 18-65, who have body mass indices either in the lean range (18-25 kg/m2) or in the obesity range (30-45 kg/m2) but who do not have prediabetes or diabetes. Participants will undergo a…
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women ofreproductive age, affecting about 7% of this population when using the strictest diagnostic criteria and frequently presents in adolescence and young adulthood. Diagnostic features of PCOS includehyperandrogenism and ovulatory dysfunction. Additionally, both obese and…
This study is for individuals who have Cushings disease and want to join voluntarily in this study to find out if a study drug called osilodrostat (LCI699) is safe and has beneficial effects in people who have Cushings disease. Cushings disease is a rare but debilitating disease. Cushings disease is caused by a benign tumor of the pituitary gland. The tumor…
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of…
The purpose of this study is to determine if measuring blood levels of proteins called POMC, AgRP, and chromogrannin A (CGA) can be used to diagnose and track tumor growth and recurrence in patients that have ACTH-dependent Cushing's syndrome, non-secreting pituitary tumors, and other neuroendocrine tumors. We invite you to participate if you have: a…
This prospective, multicenter trial is looking at the investigative device called the ACURATE Transcatheter Aortic Valve System for TAVR to see if it is safe and effective in treating patients with severe symptomatic native aortic stenosis. The ACURATE Transcatheter Aortic Valve System for TAVR is designed for iliofemoral access and delivery of a self-…
Aortic stenosis (AS) or narrowing of the arteries remains one of the most common valvular diseases in the Western population requiring intervention. The deterioration of the aortic valve is more common in the older population and usually along with coronary artery disease (CAD) requires the need for treatment. This is a study that is collecting safety and…
This is a prospective, multicenter, non-randomized, single-arm, open-label clinical study, sponsored by Pi-Cardia. Fifteen (15) patients with symptomatic severe Aortic Stenosis (narrowing of the aortic valve) who are considered operable but are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement…
The study is to determine whether aortic valve replacement is helpful for patients who have moderate-severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. Subjects will be randomly assigned, l to one of two groups: (1) Treatment…
The purpose of these studies is to gain an understanding of the mechanisms that promote weight loss and improved glucose control. The ultimate goal is to identify therapeutic pathways for obesity and diabetes as a way to optimize surgical procedures and discover novel non-surgical targets for safe and effective drug therapy. Participants with obesity will…
We are recruiting healthy volunteers, aged 18-65, for a research study on the buildup of excessive liver fat ("fatty liver disease") in people with or at risk for type 2 diabetes because their bodies are resistant to the actions of the blood sugar-lowering hormone, insulin. To do this, we seek to induce temporary insulin resistance in 10-12…
The study is to determine whether aortic valve replacement is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms.
Are you suffering from chronic fatigue that began after you were diagnosed and treated with antibiotics for Lyme Disease? This new treatment research study investigates whether disulfiram, commonly known as "Antabuse", has the potential to be used as a treatment option for patients experiencing chronic post-treatment Lyme symptoms. This well-known…
The objective of this study is to collect outcome data on valve performance and a pre-specified TAVR care pathway. Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment for patients with severe aortic stenosis who are at extreme, high, or intermediate surgical risk. Since CoreValveTM became commercially approved…
Polycystic ovary syndrome (PCOS) is a common disorder. Young women with PCOS have irregular or absence of menstruation and excessive acne and or hair on their bodies. They may have multiple cysts on their ovaries. Adolescents and women affected with PCOS are at risk of developing abnormalities in their blood including high fat, low HDL cholesterol (good…
The CDC estimates that 10-20% of patients with Lyme disease will go on to have chronic symptoms despite having had appropriate treatment, a condition known as Post-Treatment Lyme Disease Syndrome (PTLDS). While there is currently no known cure, various therapies are being investigated. One promising approach is the practice of meditation and yoga which have…
The purpose of this study is to confirm the effectiveness and safety of LCI699 in treating patients with Cushing's disease. Patients will be treated with the invesitigational drug LCI699 at doses up to 60 mg a day, and possibly for a short period of time with placebo. A placebo is a dummy drug ("pill") with no active medicine inside.
This study is for patients who have been diagnosed with acromegaly and have been treated with the injectable medications ocreotide or lanreotide for at least 6 months. You should have had the same dose for at least 4 months, and be adequately controlled. The purpose of this study is to compare the safety and effectiveness of an investigational new drug…
This is a research study for subjects who have had gastric bypass surgery at least one year ago, and currently have type 2 diabetes. This study is looking at the treatment of diabetes after gastric bypass surgery. About 40% of patients do not experience diabetes remission after gastric bypass surgery. Of the patients who initially go into remission, about…
The purpose of this study is to investigate how well weekly injections of the growth hormone drug NNC0195-0092 works in adults with growth hormone deficiency. Growth hormone deficiency is a disorder that involves the pituitary gland (a small gland located at the base of the brain). The gland produces growth hormone and other hormones (chemical messengers of…