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.
Diabetes Brain Study: A study to better understand the link between diabetes and brain health
Alzheimer’s disease is a brain disease that affects memory, thinking, and behavior, and causes severe memory loss over time, known as dementia. Diabetes increases the risk of developing Alzheimer’s disease and related dementias. Latinos have a higher risk of developing both diabetes and Alzheimer's but are underrepresented in research. We are studying the relationship between diabetes and brain health, and we hope to learn which diabetes-related brain measures best predict reduced brain function (cognitive decline). We want to improve prevention and treatment options for everyone.
Why do women use cannabis during pregnancy?
<p><strong>What does this study focus on?</strong></p><p>Cannabis is the most commonly used substance during pregnancy, yet little is known about why women use cannabis use during pregnancy.</p><p><strong>What is the goal of this study?</strong></p><p>The goal of this study is to talk and listen to Black, Indigenous, and People of Color (BIPOC) women who are using or have used cannabis during pregnancy to better understand: 1) their motivations for using cannabis during pregnancy, and 2) their use patterns during pregnancy.</p><p><strong>Why are we conducting this study?</strong></p><p>We hope to: 1) understand the barriers to receiving care facing BIPOC women who use cannabis during pregnancy, and 2) identify opportunities to improve public health knowledge around maternal cannabis use.</p>
The Genetics of Liver Fat (GoLF): Contributions of Genes and Liver Fat to Diabetes Risk in Mexican Americans
<p>Diabetes affects millions of people in the United States, and Latinos are at higher risk. The liver plays an important role in regulating blood sugar. At the University of Southern California (USC), we are seeking participants for an ongoing study to investigate how differences in your genes impact liver fat levels, and how these levels affect diabetes risk. We want to improve the understanding of diabetes, obesity, and fatty liver disease, and work toward developing better ways to treat and prevent these diseases. </p><p>This is a collaborative study between Kaiser Permanente Southern California (KPSC) and the University of Southern California (USC), sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).</p>
A novel, comprehensive approach to post-stroke gait rehabilitation
The purpose of this study is to understand how individuals control their walking after stroke while using visual information about their walking and while walking at different speeds. We hope to learn how people learn new walking patterns when parts of the brain are damaged and how this may change at different walking speeds.
Lupus patients on Twitter: What do they think about using Twitter to engage them with their health?
It is estimated that at least 5 million Americans have the autoimmune disease lupus, with more than 16,000 new cases of lupus being reported annually in the U.S. Many patients take to Twitter to share their disease experience. With this study, we want to better understand Lupus patients who use Twitter and hear from them whether Twitter could be used as a tool to engage them with healthcare and research. This study is restricted to Lupus patients on Twitter who were contacted by the study team.
Tracking Obsessive-Compulsive Disorder (OCD) symptoms and predicting response to treatment using Fitbit, neuroimaging, and smartphone surveys.
<p>Obsessive-Compulsive Disorder (OCD) is a chronic, impairing disorder characterized by unwanted obsessions and/or compulsions. Not all persons with OCD are alike, resulting in a wide variety of symptoms, illness course, and response to treatment. The purpose of our OCD research study is to better understand differences in OCD symptoms and to predict both illness course and response to treatment. By comparing data from participants with OCD and healthy volunteers without OCD, we hope to provide enhanced treatments to future patients.</p>
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