UC Davis Health Clinical Studies

Metabolic and Bio-Behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans

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Today, about 117 million people have one or more preventable, chronic diseases. Many relate to poor eating and physical inactivity. The Dietary Guidelines for Americans are an essential resource. It helps design and start food and nutrition programs that feed the American people. The Dietary Guidelines provide information for Americans make healthy choices for their families. Research is being done to help improve strategies for reversing these diseases. This research includes studies to better understand the role of diet and exercise as solutions for promoting health and preventing risk of chronic disease. This research will learn how important healthy body weight is for women at risk for diabetes, heart disease or stroke. Your participation in this research will provide valuable information. This will help provide the most helpful information for healthier living.

Other study
Female, age 35 to 64 years old

Radiation Therapy With or Without Experimental Trastuzumab For Women With Ductal Carcinoma After Lumpectomy

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This study will test radiation therapy to see how well it works with or without experimental trastuzumab. It will be give to women with ductal carcinoma who have undergone lumpectomy (surgery to remove breast lump). Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them. They can also carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma.

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

Experimental Nab-Paclitaxel and Durvalumab With or Without Neoantigen Vaccine for Metastatic Triple Negative Breast Cancer

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This study is being done to learn about the effects (good and bad) of using an individualized vaccine. It will be given along with a drug called durvalumab and standard chemotherapy. We are comparing these effects to the effects of using durvalumab and standard chemotherapy alone. We want to find out if the individualized vaccine is better or worse than the usual approach for your metastatic triple negative breast cancer. The usual approach is defined as care most people get for metastatic triple negative breast cancer.

Drug study, Phase 2
Any, age 18 years or older

A Study of Renal Anhydramnios Fetal Therapy (repeated infusions of replacement amniotic fluid into the womb)

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This research is being done to test repeated infusions of replacement amniotic fluid into the womb. We hope this can reliably rescue the lung function of fetuses that do not make urine, and as a result, have no amniotic fluid. This condition occurs when the fetus has a severe birth defect called congenital bilateral renal agenesis (CoBRA). It can also be caused by fetal renal failure (FRF). We hope to discover whether this fetal intervention can make early pregnancy renal anhydramnios, called EPRA, reliably survivable after birth. We are also doing this study to better understand what happens to EPRA fetuses in the womb that do not receive therapy. During EPRA, the fetus does not have well-developed or functional kidneys and does not make urine. Fetal urine makes up what we commonly call amniotic fluid. This fluid surrounds the fetus and performs many vital functions. The most important function of amniotic fluid is to allow development of the lungs. In normal fetal life, the fetus gets oxygen and releases carbon dioxide through the placenta. Because gas exchange occurs in the placenta, the lungs do not need to function in the womb. They do need to go through a complex developmental process to be ready to work after birth. This developmental process involves the formation of tiny sacs called alveoli in the lungs. They allow the baby to absorb oxygen from the air it breathes in and expel carbon dioxide from the air it breathes out once born. A critical part of the formation of these alveoli is the fluid that fills the lungs during fetal life. The fluid made by the fetus’s lungs causes the alveoli to stretch and grow. If there is no amniotic fluid in the womb, the lung fluid easily escapes from the lungs and cannot perform its vital function of making the alveoli grow. Normally, the amniotic fluid creates enough pressure in the womb to keep the lung fluid in the lungs. Since the amniotic fluid and the lung fluid connect when the fetus opens its mouth and windpipe, the pressure of the amniotic fluid pushes on the lung fluid. This pressure on the lung fluid must be present for the alveoli to develop correctly. Even if the baby’s lungs work well enough after birth for the baby to survive, the baby will still have no kidneys and need dialysis. A pediatric surgeon will need to place a dialysis catheter into the baby’s abdomen. This will allow fluid and toxins to be removed from the baby as a replacement for kidney function and urination. This process is commonly known as peritoneal dialysis. The baby may also need special assistance with feeding and breathing. All of this requires advanced neonatal care in a neonatal intensive care unit (NICU). It is likely that surviving babies will need to be in the NICU for several months before being able to go home. There are frequent challenges with peritoneal dialysis. This includes infection and dialysis catheter malfunction. Not all babies survive because of complications that can arise from peritoneal dialysis. Additionally, surviving babies will eventually need a kidney transplant to survive long-term. Current survival for infants with complete renal failure who survive to receive a kidney transplant is about 70-80%. Organs can come from either living or deceased donors. They require the baby to take medicine every day to prevent his or her body from rejecting the donated kidney. These babies also have problems with the urinary system that normally drains urine from the kidneys namely the bladder and the urethra. This will become an issue after kidney transplant because the urine will need a place to drain and be expelled. A urologic surgeon will need to be involved to help manage this. He or she may need to make a new bladder out of intestine or do other reconstructive surgery.

Procedure study
Female, age 18 to 60 years old

Experimental Combination of Abemaciclib (LY2835219) and Fulvestrant vs. Chemotherapy for HR Positive, HER2 Negative Breast Cancer

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This study will test how the experimental combination of abemaciclib plus fulvestrant works. It will be compared to chemotherapy in patients who have a specific type of breast cancer which may have spread to internal organs. This type of breast cancer is called advanced hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-). This is a Phase IV study. The study drugs, abemaciclib and fulvestrant, have been tested before. Abemaciclib is FDA-approved for your disease while chemotherapy is not a common approach. Experimental means that the drug being tested has not been approved for routine clinical use by the FDA. The FDA is allowing the use of this drug for research.

Drug study, Phase 4
Female, age 18 years or older

A Study of Experimental Tucatinib vs. Placebo Combined With Ado-trastuzumab Emtansine (T-DM1) for HER2+ Breast Cancer

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We’re asking you to take part in a clinical trial (study) because you have HER2 positive breast cancer that has started to spread or has already spread through your body. “HER2 positive” means that your cancer cells make a protein called HER2. This clinical trial uses an experimental drug. This means the Food and Drug Administration (FDA) hasn’t approved it for sale in the United States. This drug is called tucatinib. This trial also uses another drug called ado-trastuzumab emtansine (T-DM1). The brand name for T-DM1 is KADCYLA®. T-DM1 has already been approved by the FDA for treatment of your type of breast cancer. Your doctor might choose to talk with you about this treatment even if you’re not in this clinical trial. We are studying tucatinib plus T-DM1 to find out what the side effects are and if it works for treating HER2 positive breast cancer. A side effect is anything the drug does to your body besides treating your disease. We don’t yet know if tucatinib plus T-DM1 is better or worse than other treatments. Learning about the side effects of tucatinib plus T-DM1 and how it works will help us understand if tucatinib plus T-DM1 is better or worse than other treatments. We want to find out how effective tucatinib plus T-DM1 is compared to treatment with only T-DM1. To do this, we will compare 2 groups in this study. One group will get tucatinib plus T-DM1 and the other group will get a placebo plus TDM1. A placebo is a pill that doesn’t have any drug or medicine in it. We will choose your group randomly, like tossing a coin. This means that you might get tucatinib plus T-DM1 or you might get placebo plus T-DM1. We won’t know which group you’re in until the end of the clinical trial. Your doctor and the study staff won’t know which group you’re in either. Clinical trials include only people who choose to be in them. Please take as much time as you need to make this choice. You can talk with your friends and family about your options. You can also talk with other doctors and nurses you know. If you have any questions, ask your study doctor before making your choice. This form tells you about the risks and possible benefits of this clinical trial. It explains what will happen if you take part. Your study doctor will also explain the clinical trial to you. After you read this document and have your questions answered, we will ask you to decide if you want to be part of this clinical trial. This process is called informed consent. You have other options to consider for your breast cancer. Discuss these options with your doctor so that you know the risks and benefits of all your choices before you decide. When you understand the study, including the risks and benefits, you must sign this form if you want to take part in the study. We will give you a copy of the signed form to keep

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