The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self-breast exams, or they may be…
We are asking you to participate in a research study to learn if different ways of doing routine anesthesia and patient care before, during and after abdominal surgery can reduce breathing problems. The total time of the study is 3 months with daily visits by a member of our study team while you are in the hospital and 3 short follow-up calls after you…
In this study, we are trying to learn more about how stimulant medication produces an improvement in emotional lability (frequent mood changes and excessive emotional reactions) in patients with Attention Deficit Hyperactivity Disorder (ADHD.) Although ADHD is primarily associated with inattention, hyperactivity, and impulsivity, emotional ability plays a…
Thepurposeof the study is to test whether or not QPI-1002 could be used to lessen or prevent acute kidney injury after heart surgery. Another purpose is to better understand the safety of QPI-1002.
Children with Attention-Deficit/Hyperactivity Disorder (ADHD) are typically treated with two types of medications: stimulants and non-stimulants. These medications work in different ways to treat ADHD symptoms, but we do not fully understand the brain mechanisms underlying the medications' effects. This study will use MRI scanning to look at changes in…
The purpose of this study is to evaluate the short-term (1 year) and long-term (5 and 10 year) safetyand effectiveness of the JOURNEY II CR Total Knee System in patients with degenerative joint disease of the knee requiring primary total knee replacement. Clinical, radiographic, and health economic outcomes will be evaluated.
The Sponsor is conducting this study to find out how safe and effective the investigational drug (alsocalled a study drug) obeticholic acid (also known as OCA) may be in improving compensated cirrhosis caused by NASH. Currently, there are no therapies approved for the treatment of NASH. OCA (the brand name is Ocaliva) has been approved in several…
You are being asked to be part of this study because you have been diagnosed with a bulge or aneurysm in your iliac arteries, the vessels that supply blood to the lower half of your body. As an aneurysm expands, the walls become weak and may rupture, causing a major loss of blood with a high risk of death and other serious complications. To avoid this risk…
This is a 5-year, longitudinal, observational study of patients with NAFL or NASH designed to specifically address important clinical questions that remain incompletely answered from registration trials. The main purpose of this research study is to collect and study information on patients with NAFLD/NASH.The goal of this study is to observe any treatment…
Patients who have been diagnosed with decompensated nonalcoholic steatohepatitis (NASH) cirrhosis may be eligible to participate in this clinical trial. NASH is liver inflammation and damage caused by a buildup of fat in the liver. The main purpose of the study is to test the safety and efficacy of a drug called Emricasan (IDN-6556) in reducing the risk…
The study is designed to evaluate the safety and effectiveness of the InSpace device as a primary surgical treatment for a full thickness Massive Rotator Cuff Tears (MRCT) in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.
The purpose of this research study is to compare the safety and effectiveness of two drug-eluting stents that are used to open the blocked or narrowed blood vessel of the leg in patients with Peripheral Artery Disease (PAD): the ELUVIA Stent and the Zilver PTX Stent.