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UC Davis Health Clinical Studies

A Study of Experimental Brolucizumab vs Aflibercept for Visual Impairment Due to Diabetic Macular Edema

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The purpose of the study is to test the effectiveness and safety of experimental Brolucizumab. It will be tested in the treatment of subjects with visual impairment caused by Diabetic Macular Edema (DME). A complication of diabetes called diabetic retinopathy causes the diabetic macular edema. Diabetic macular edema is a progressive condition in the eye. If left untreated it may cause you to lose the central vision in your eye(s). In DME, the macula, which is the central part of your retina (the film in the back of your eye), is swollen. Abnormal blood vessels in the retina are a result of high level of blood glucose. These abnormal vessels are very fragile and therefore leak, blood and fluid. The fluid accumulation (swelling) is responsible for your vision loss. Experimental Brolucizumab blocks a molecule that is thought to be involved in the leakage of abnormal blood vessels. Brolucizumab is a medicine which has not yet been approved by the FDA for the treatment of people with your medical condition. The medicine being tested in this study is currently not “on the market.” It is not available for you to receive a prescription for and/or to buy in any country. In this study, you will receive either Brolucizumab or Aflibercept (EYLEA®) by an injection into your eye. Aflibercept (EYLEA®) is a currently available treatment for DME. The reason for this study is to find out whether those two medicines give similar relief from DME. Because we do not know which medicine is best, we need to make comparisons. You might be asked, through a questionnaire, to provide feedback on your personal experience in this trial. This is optional and will not impact the care you receive. It might help to improve the trial experience for others in the future. All other feedback will remain anonymous and confidential.

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

DDPP

Dementia and Diabetes Prevention Program

The purpose of this research study is to see if lifestyle changes can protect memory and thinking as we age. You would be randomized into 1 of 3 groups (like rolling dice) and put in either the (1) Aerobic Exercise Group, (2) the Diet Skills Group, or (3) the Waitlist Control Group. You start in one of these three groups, but eventually all participants complete both the Aerobic Exercise AND Diet Skills Groups. Aerobic Exercise Regimen: You will follow a structured program that includes exercise 3 times per week for about 30 minutes each time. The type of aerobic exercise will vary, but will primarily focus on in-class walking tutorials. You will work with a Personal Trainer to create your own physical activity program that will fit your needs and schedule. Your Personal Trainer will supervise you directly for the first 6 weeks. Once you are consistently and safely meeting your goals, your Personal Trainer will allow unsupervised exercise sessions. Diet Skills Intervention: You will attend weekly classes focused on incorporating heart healthy foods (e.g., fruits and vegetables) into your existing dietary plan. We will ask you to limit the number of calories you take in and will show you how to use portion control with the goal of losing body weight. You will also learn hands-on skills for preparing healthy meals at home in cooking classes led by professional chefs.

Exercise Program & Prevention
Any, age 60+

A Study of the Effects of Sweet Cherry Juice on Metabolism (converting food to energy) and Heart Health

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

This research study will test whether regular consumption of cherry juice improves cardiovascular (heart) and metabolic (converting food to energy) health. This study will involve: - daily consumption of study beverages, - tracking study beverage and food consumption in a food diary, - completion of 9 at-home dietary records, - one screening visit and 6 study visits. Here are some reasons you may not want to participate in this research: - You may find frequent test visits at the research center inconvenient and time consuming. - You may find it tedious to: -- drink study beverages, -- limit consumption of certain foods and beverages, -- complete dietary records and questionnaires. - You may find the following procedures uncomfortable: -- blood draws, -- the PAT procedure, -- continuous blood pressure monitoring (CNAP) -- MindWare electrode placement.

Dietary Supplement study
Any, age 20 to 65 years old

The Breast Cancer WEight Loss Study (BWEL Study)

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This study is being done to see if losing weight may help prevent breast cancer from coming back. Studies have found that women who were overweight or obese women when diagnosed with breast cancer have a greater risk of their breast cancer recurring. This is compared to women who were thinner when their cancer was diagnosed. At this time we do not know whether losing weight will reduce the risk of breast cancer returning. This study will help to show us whether weight loss programs should be a part of breast cancer treatment.

Other study, Phase 3
Female, age 18 years or older

Koa Family: California's Obesity Prevention Project

This study hopes to learn if a new whole health program improves the health of low-income mothers.

The purpose of this study is to learn if a new whole health program improves the health of low-income mothers. To be eligible for this study, you must be a woman between the ages of 18 and 47. You must be comfortable speaking and reading English and be a mother (or caregiver) whose youngest child is between the ages of 3 and 17. You also must live in a low-income household (at or below 185% of the Federal Poverty Level), live in the Mack Road neighborhood of Sacramento or the City of Woodland, and have a cell phone that can receive text messages.

Behavioral study
Female, age 18 to 47 years old

The Effects of Sucrose-sweetened Beverage in African-American and Caucasian Women (SAAC) Study

In this study, we hope to learn about the metabolism of koolaid beverages that contain added sucrose (table sugar).

The main goal of this research study is to learn about the metabolism of koolaid beverages that contain added sucrose (table sugar). We hope that what we learn will help patients in the future. As with all research studies, no one can guarantee that participating in a research study will help you. We invite you to take part in a research study if you: - identify as either an African-American or non-hispanic White woman. - are a woman between the ages of 18-45 years. - are a nonsmoker who does not have diabetes mellitus or liver, kidney or thyroid disorders. - do not take hypolipidemic, anti-diabetic, anti-hypertensive or anti-depression medication. - have a stable body weight during the prior 6 months

Biological Study
Female, age 18-45

A Study of the Effect of Orange Juice or Sugar-Sweetened Beverages on Risk Factors for Type 2 Diabetes and Cardiovascular Disease

In this study, the study team will provide meals and either sugar-sweetened beverages or orange juice.

In this study, we hope to learn more about the effects of drinking sugar-sweetened beverages or orange juice. The beverages will be given with meals that we provide. Therefore, we will know exactly what the meals consists of. The study team will provide meals and either sugar-sweetened beverages or orange juice. We will compare the effects that the beverages have on blood triglyceride and cholesterol levels. We will look at your body’s reaction to insulin (hormone which lowers blood sugar).

Other study
Any, age 18 to 50 years old

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

Testing the Impact of Biotin Supplements (vitamin that helps convert food into energy) on Thyroid Stimulating Hormone Test Results

This study hopes to determine if biotin (a vitamin found in dietary supplements) can interfere with a new assay.

Thyroid stimulating hormone (TSH) testing may be affected by biotin. Biotin is a water soluble B-vitamin often recommended as a dietary supplement. It can be found in a variety of other health products found on the market. Certain TSH assays may be affected by biotin and show falsely low results at certain levels of biotin. This study hopes to determine if biotin can interfere with a new assay. An assay is a blood test that looks for the presence of a substance and the amount of that substance. This assay has recently been approved by the FDA. We will compare the results with results from two different FDA approved assays that have no known interference from biotin.

Observational Study
Any, age 18 years of age and older
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