Diagnostic Fetal Imaging on a Novel MRI Scanner
We are seeking pregnant adults to participate in a study evaluating a novel, quieter MRI scanner. We hope to develop better ways for doctors to screen pregnancies for possible fetal problems and to make MRI of unborn babies more comfortable and even safer. Images will be collected at 3-6 fold lower magnetic field strength (0.55 Tesla) than a standard MRI. Participation in this study will involve being imaged on a lower field strength MRI scanner located in the Michelson Building at the USC University Park Campus. Participants will be compensated for their time.
A Placebo-controlled Study of a Targeted Immune Therapy Drug in Subjects with Moderate to Severe Ulcerative Colitis (UC)
The primary objective of this study is to study the effectiveness of a novel targeted immune therapy (biologic) called LY3074828 in treating moderate to severe ulcerative colitis. This study will take place over 120 weeks and all study visits and procedures will be provided at no cost to you. During the initial part of this study, patients will either receive LY3074828, or placebo ("dummy" treatment). Patients who receive placebo initially will have the opportunity to receive the study drug LY3074828 later in the study.
Long-Term Registry of Patients with Urea Cycle Disorders (UCDs)
The main goal of medical management of Urea Cycle Disorder (UCD) patients is to prevent chronic or acute hypperammonemic states leading to central nervous damage- which requires a restriction in dietary protein intake and using nitrogen scavenging agents if diet alone does not help the patients.The objective of this study is to characterize the demographic of the patient population diagnosed with UCD. Another objective is to track growth and neuro-cognitive outcomes for patients with UCDs. Patient participation includes the collection of retrospective and baseline data including ammonia and glutamine levels. Age appropriate questionaires will be given for completion by subject or parent. . Data will be collected on all individuals who are enrolled. The patient population are patients with an established or suspected diagnosis of UCD. The patient or legally acceptable representative must also sign and release an informed consent/HIPPA Authorization and medical records.The study procedures are for each study personnel to be trained for all documentation, baseline visits and enrollment for patients, and retrospective data for ammonia values obtained from the patient will be entered in the registry. The outcome variables will be the control of blood ammonia levels and the frequency of the serious adverse events (SAEs). Blood ammonium levels, and the frequency of hyperammonemic crisis will be observed during this study.The statistical analysis plan (SAP) will show details of all analysis and presentation of study data. Data will be shown to patients who attend the baseline visit, and analysis will be based on all the patients who are enrolled. Post baseline values or change from the baseline outcome variables will be summarized by UCD medication with statistics and graphical presentations.
The Medtronic CoreValve Evolut R US Clinical Study
Transcatheter aortic valve implantation (TAVI) has become a routine treatment option at specialized heart centers treating patients with severe aortic stenosis who are at high risk for surgical aortic valve replacement (SAVR). Medtronic has developed modifications to the Medtronic CoreValve System Transcatheter Aortic Valve frame and delivery catheter system to enable recapture of the device before it is fully released from the delivery system. These modifications are incorporated in the CoreValve Evolut R System.
The purpose of the study is to evaluate the safety and efficacy of the CoreValve Evolut R System in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement.
This is a prospective, single arm, historical controlled, multi-center study. This study will involve no more than 250 subjects in up to 25 sites. The study population includes males and females with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement. Subjects will be followed up to 5 years following implantation.
Study endpoints are safety endpoints and efficacy endpoints. Safety endpoints are: All-cause mortality rate, stroke (disabling) rate, incidence of permanent pacemaker implant rate at 30 days. Efficacy endpoints are: Device success rate, Resheath and recapture success rate, percent of subjects with mild prosthetic regurgitation at early post-implant, hemodynamic performance metrics at 30 days.
Statistics/analysis: Subjects who are taken to the procedure room for implantation will comprise the study population evaluated for the study objectives and associated endpoints. An initial analysis will be performed when both of the following conditions are met:
1. The first 150 consecutive implanted subjects have completed their 30 day follow-up.
2. A total of 25 resheath or recapture attempts inclusive of all valve sizes, have been performed.
The final analysis will be performed after a minimum of 150 subjects but no greater than 250 subjects are implanted with the study device and followed for 5 years.
All endpoints are descriptive and no statistical hypothesis test will be performed.
Biobehavioral Mechanisms Underlying Eating Regulation and Obesity Risk
The goal of this study is to better understand how brain functioning relates to mood and eating behaviors in real life. You may be eligible if you experience binge eating or have difficulties controlling your eating behavior.
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