UC Davis Health Clinical Studies

A Study of Experimetnal VarIthena on Wound Healing in Venous Leg Ulcers (VLU)

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The purpose of this registry is to look at how experimental Varithena® injectable foam works. It will be given to patients who have chronic venous insufficiency (commonly known as “varicose veins”) with leg wounds. The decision to provide you with such medication has been left up to your treating physician and is not being driven by or impacted by this study. The purpose of this project is to collect data about your leg wounds. We hope to learn the impact of treatment on the rate of healing, the rate of repeated wounds, as well as the impacts to your level of pain and quality of life.

Drug study
Any, age 18 years or older

Safety and Dose Study of an Experimental Viral Vector Used for Gene Transfer in Hemophilia A Participants

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This study will test a study drug called experimental BAX 888. It is known as a gene transfer product for people with severe hemophilia A. This is a first-in-human clinical research study, which means BAX 888 has not been tested in human subjects before. The use of BAX 888 in this research study is investigational. This means that BAX 888 has not been approved by the FDA to treat hemophilia A. There is currently not enough information to know how well BAX 888 works to treat conditions like hemophilia A. This will be examined in this clinical research study. The main goals of this study are: • To investigate the safety of BAX 888 when it is given as a single infusion (a slow injection into a vein) to subjects with hemophilia A. • To investigate the optimum amount of BAX 888 necessary for the human body to produce enough Factor 8. • To look at how BAX 888 affects your immune system and the activity of clotting Factor 8 in your blood. • To answer scientific questions about gene transfer for hemophilia A.

Drug study, Phase [/1/,/ /2/]
Male, age 18 to 75 years old

A Study to Evaluate an Experimental Tricuspid Valve Repair System (TRILUMINATE Study)

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This research study will test the performance of the experimental tricuspid valve repair system. It will be given with standard of care drug therapy. The study team will compare this experimental treatment to standard of care drug therapy alone. You are being asked to take part in this study because you have moderate or greater tricuspid regurgitation (TR). You have been determined to have symptoms due to heart failure despite treatment. TR occurs when your tricuspid valve does not close properly. This causes blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward. The Study consists of two arms: Randomized Arm and a Single Arm. An independent committee will review screening results and randomly assign participants to each treatment group.

Device study
Any, age 18 years or older

A Study of Engineered Donor Grafts (TregGraft) for Allogeneic Transplantation for Hematologic Malignancies (blood cancer)

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You are being asked to take part in a research study of a type of blood stem cell transplant called TregGraft. TregGraft is being tested as a possible treatment of blood cancers and conditions highly likely to turn into blood cancer. TregGraft is an experimental therapy, meaning that it is not approved by the FDA. TregGraft is the study treatment in this research study. You will not receive TregGraft. Rather, it is the blood cell transplant that will be given to the recipient and will be made from your blood cells. A key part of TregGraft are healthy blood-forming cells. These will be isolated from your blood cells. When placed in the recipient’s bloodstream, they will grow and make new healthy red blood cells, white blood cells, and platelets. TregGraft also includes other specific white blood cell populations including regulatory T cells. These will also be isolated from your blood cells. When given to transplant recipients, they may prevent some of the known complications of blood cell transplants. One example is graft-versus-host disease (GVHD), a condition that involves the immune attack on recipient tissues by donor cells. TregGraft also includes “conventional” T cells, that may help fight infection or cancer, but also carry a risk of causing GVHD.

Biological study, Phase 1
Any, age 18 to 65 years old

A Study of Experimental AB-205 in Adults With Lymphoma Undergoing Autologous (from self) Stem Cell Transplantation

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You are invited to be in this study because you have lymphoma. A clinical trial is a type of research study. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer. Clinical trials include only people who choose to take part. This is a first in-human study. The purpose of this research is to find out if the experimental product, AB-205, is safe. AB-205 is made up of engineered (modified) human endothelial cells. The endothelial cells are cells that line the inside of blood vessels including the umbilical cord. AB-205 is made from human umbilical endothelial cells that are collected from the umbilical cord of a healthy newborn baby. This research study will test the safety of a single dose infusion of AB-205, given after a bone marrow transplant. The study goal is to test the highest dose of AB-205 to be given in humans with Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL). Patients are in a chemo-sensitive remission undergoing high-dose therapy (HDT), with or without radiation. Participants have an autologous stem cell transplant. This is a type of transplant in which a person’s own stem cells are taken, preserved and returned to them.

Biological study, Phase 1
Any, age 18 years or older

A Study of the Safety and Activity of Experimental GS-6207 Injection for HIV-1 Infected Adults

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The purpose of this study is to test the experimental medicine GS-6207 (referred to as study drug). We hope to determine how it affects the HIV infection in your body and how long the study drug stays in your body. The safety and how well the study drug is tolerated will also be determined by using: - physical exams, - laboratory tests, and - any symptoms or problems you might experience during the study.

Drug study, Phase 1
Any, age 18 to 65 years old

A Study of Experimental RVT-1201 for Pulmonary Arterial Hypertension (ELEVATE 1)

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Pulmonary Arterial Hypertension, also known as PAH, is a serious, and rare, disease. It causes shortness of breath with activity, fatigue and weakness. Other symptoms may include chest pain, dizziness and swelling of the ankles and feet. These symptoms are caused by a decrease in oxygen-rich blood flow that is sent from the lungs to the rest of the body. In patients with PAH, the blood vessels in the lung are diseased and become thick and narrow. This causes an increase in the pressure that your heart must pump against to push blood through your lungs. There is currently no cure for PAH, but there are treatments available that help improve symptoms. Standard treatment for PAH includes the use of drugs known as vasodilators. These act to: - open the blood vessels in the lungs, - improve blood flow through the lungs and - reduce the higher than normal pressures in the blood vessels of the lungs. They may reduce your symptoms and slow the disease from getting worse. In order to be able to participate in this study you will have to be already taking at least one of these vasodilator drugs. In patients with PAH, vasodilator drugs are sometimes combined with diuretics (also called “water pills”). These remove the excess fluid that tends to build up in the body in patients with PAH. Sometimes, vasodilator drugs are also combined with anticoagulants. These are drugs which affect how your blood clots and/or oxygen support. There are experimental (not approved) drugs that are being studied in clinical trials in patients with PAH. RVT 1201 is one of those experimental drugs. It is being tested to understand if it may be a useful addition to treatment for patients who are already taking vasodilators for their PAH symptoms. Before this study, RVT-1201 has not been given to any patients with PAH. The researchers who are conducting the study hope to learn several important things from this study: · To understand the side effects of RVT-1201 in patients with PAH and to see if they are similar to the side effects experienced by healthy volunteers · To better understand how RVT-1201 impacts serotonin levels in patients with PAH. Serotonin is a substance that occurs naturally in your body. It is mainly found in your intestines but also in your central nervous system and appears to affect and/or regulate a number of body functions. Increased serotonin levels in the lung are thought to be one of the potential causes of PAH · To study how the body processes RVT-1201 · To see if RVT-1201 may improve your PAH symptoms (for example, to see if it improves your shortness of breath or your ability to exercise)

Drug study, Phase 2
Any, age 18 to 75 years old

A Comparison Study of the Experimental Edwards PASCAL Device and Abbott Mitraclip for Mitral Regurgitation

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This study will test the safety and performance of the Edwards PASCAL Transcatheter Mitral Valve Repair System. It will be compared to the Abbott MitraClip Transcatheter Mitral Valve Repair System in patients with mitral regurgitation. Mitral regurgitation (MR) is a condition when your heart’s mitral valve does not close tightly. This causes blood to flow backwards in your heart. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. There are two major categories of mitral regurgitation: 1) Degenerative Mitral Regurgitation (DMR), also known as Primary MR. This occurs when there is a problem or injury involving the valve or leaflets themselves. 2) Functional Mitral Regurgitation (FMR), also known as Secondary MR. This occurs when the valve itself is normal, but problems with the heart muscle keep the valve leaflets from fully closing. You have been asked to be a part of this study because despite medical therapy for your MR, you have been determined to have symptoms due to heart failure. The PASCAL and MitraClip Systems are designed to reduce the amount of mitral regurgitation without the need for surgery. It is unknown whether the amount of reduction in regurgitation that is achieved using the PASCAL implant system will benefit you. The PASCAL System is an experimental device. This means the PASCAL system has not yet been approved by the FDA for commercial sale. The PASCAL System has been approved for commercial sale in Europe. The MitraClip System is approved in the United States for patients with: - moderate to severe DMR at risk for surgery - symptomatic heart failure with moderate to severe FMR.

Device study, Phase 3
Any, age 18 years or older

Analysis of Both Sex and Device Specific Factors on Outcomes in Patients With Non-Ischemic Cardiomyopathy

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We invite you to take part in a research study because your doctor has determined that you have non-ischemic cardiomyopathy. This is the weakening of the heart muscle. It is not caused by coronary artery disease or heart attack. This study is for patients who have recently received an ICD or CRT-D implant. Cardiac rhythm devices help the heart function better. They relieve symptoms and treat life threatening arrhythmias (irregular heart beats). The study is being done to better understand ICD or CRT-D implant. These devices are used to prevent sudden cardiac death. They are give to patients who have not yet experienced a cardiac arrest (heart attack) or life threatening arrhythmias (abnormal heart beats). The outcomes will be evaluated to determine if there are differences between the ICD and CRT-D devices. We will also study the differences in effectiveness between men and women.

Other Study
Any, age 18 years or older

Study of Using "Omics" (genes, metabolites, and proteins from blood and heart tissue) to Learn More About Heart Disease

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This study is being done to find ways to better understand and identify Heart Failure. We are interested in studying “Omics.” This is the study of all molecules, such as genes, metabolites, and proteins in blood, stool, urine and cells of the heart. We will use Omics studies and clinical information to create a comprehensive evaluation of Heart Failure. This will allow us to learn if there are better ways to determine how your heart is doing. Through "Omics" studies, we can identify thousands of genes, metabolites, and proteins. This will help us search for early signs of cardiovascular disease. What we learn can be used to guide treatments and lessen the problems associated with heart disease.

Other study
Any, age 21 years or older
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