UC Davis Health Clinical Studies

A Study of Experimental Stereotactic Body Radiation Therapy (radiation treatment in a shorter amount of time) For Prostate Cancer

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This study will compare any good and bad effects of using stereotactic body radiation therapy (SBRT). SBRT gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment may prevent the tumor from returning but it could also cause side effects. This study will test whether using SBRT is better, the same, or worse than the usual approach.

Radiation study, Phase 3
Male, age 18 years or older

A Study of the Safety and Effectiveness of Experimental Tendyne Mitral Valve System for Mitral Regurgitation (backflow of blood)

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The purpose of this trial is to test a new investigational device called the Tendyne Mitral Valve System. The Tendyne Mitral Valve System is designed for the treatment of a diseased, damaged or malfunctioning mitral valve. This trial will study how safe and effective this device is to treat a leaking mitral valve. It will be compared to FDA-approved mitral valve repair and replacement devices. Mitral regurgitation happens when your heart’s mitral valve does not close tightly. This allows blood to flow backward in your heart. Stopping or decreasing mitral regurgitation helps blood to flow more efficiently through your heart and to the rest of your body. This study may help make this device more available to other people with mitral valve disease. The Tendyne Mitral Valve System includes the valve, a pad, and instrument set that allow Trial Doctors to implant the valve. The valve is placed within your natural mitral valve. The Tendyne Mitral Valve System is investigational and has not yet been approved for general, commercial use. It is approved by the FDA for use in this trial.

Device study
Any, age 18 years or older

Use of the "ACCU-CHEK® Inform II" System for Testing Blood Samples in Patients With Serious Illness

This study will show how accurate the "ACCU-CHEK Inform II" system works in seriously-ill adults, children, and babies.

This study will show how well the ACCU-CHEK Inform II system works. It will be used on seriously-ill adults, children, and babies. Blood will be collected from arteries (arterial blood), veins (venous blood), and heelstick (from the heel of the foot) samples. The study team also hopes to show that the ACCU-CHEK Inform II system meets laboratory testing requirements in the critical care setting. ACCU-CHEK Inform II Blood Glucose Monitoring System has not been cleared for testing in critically ill patients. It has been cleared by the FDA for use in other patient care settings. The overall goal of this study is to see how well this system works in patients that are critically ill.

Other study
Any, age 0 - 100

A Study of Experimental Treatment With Micropulse for Diabetic Macular Edema (build-up of fluid in the eye)

This study will test the effect of using the subthreshold micropulse diode laser (SML).

Diabetic macular edema (DME) is the term used for swelling in the central part of the retina. The retina is the light-sensitive tissue lining the back of the eye and is responsible for sharp, straight-ahead vision. The retina is nourished by blood vessels. These blood vessels can become weakened by diabetes. This causes the retina to become thickened or swollen. Swelling of the central part of the retina can cause vision loss. Some common treatment strategies for vision loss due to diabetic macular edema are: - laser treatment - intra-ocular injections with medications such as corticosteroids - anti-vascular endothelial growth factor (anti-VEGF) The purpose of this study is to test the effect of early treatment using the subthreshold micropulse diode laser (SML). This is a laser treatment that delivers laser energy in a “chopped” fashion allowing the tissue being treated to cool between pulses. Previous studies have shown that early intervention with SML may significantly improve or stabilize vision loss.

Device study
Any, age 18 years or older

Treatment of Heart Failure and Mitral Valve Regurgitation (backflow of blood in the heart) With the Experimental MVRx Arto System

This study will assess the safety and function of a new mitral valve repair system called the Arto System.

We invite you to take part in a research study because you have a condition called mitral regurgitation. This is a condition in which blood flows through the mitral valve in the incorrect direction during part of the cardiac cycle. The type of mitral regurgitation you have is called functional. It is caused by widening of the mitral valve opening. As the opening widens the valve leaflets no longer close as they should and blood leaks or regurgitates in the wrong direction. The preferred treatment of functional mitral regurgitation has not been definitively established. Your doctors have determined that, although you are healthy enough to undergo open heart surgery, it is not the best option for you. You may benefit from a new mitral valve repair system. This system uses catheters (transcatheter) to repair the valve instead of open heart surgery. This is an early feasibility research study to test the safety and performance for a new transcatheter mitral valve repair system. The safety and effectiveness of this device and therapy option have not been determined. You will be among the first patients in the world to be treated with this device. The purpose of this consent form is to help you decide if you want to be in the research study. The goal of this study is to assess the safety and function of a new mitral valve repair system called the Arto System. It will be used in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF). The study device is called the MVRx Arto system. The device consists of two parts: a delivery system and a permanent implant which stays in your heart after the procedure. The delivery system enables the doctor to get the implant to the left atrium of the heart. (The atria are the upper chambers of the heart). The permanent implant device is made up of a bridge with two anchors, one at each end of the bridge. The anchors hold the device in place by attaching into the wall of the heart. The bridge is then tightened to help the valve leaflets close tightly together and therefore helps reduce the flow of blood in the wrong direction.

Device study
Any, age 18 years or older
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