UC Davis Health Clinical Studies

A Study of Experimental Treatment with OrcaGraft for Allogeneic (donor) Transplant in Hematologic Malignancies (blood cancers)

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This research study will test if experimental OrcaGraft can be safely given to patients. It will be studied as a stem cell transplant in patients with blood cancers and pre-cancerous conditions. We are doing this research because some transplants can cause complications. One complication is called graft-versus-host-disease (GVHD). GVHD causes donor cells to attack recipient tissues. OrcaGraft is designed to minimize or eliminate potential complications and provide a safer transplant. This study will see if OrcaGraft is safe to use. We will also collect data about the best dose of cells that make up a part of OrcaGraft. This could provide data to make the composition of OrcaGraft better in the future. This study is being done at UC Davis Health and at other sites around the U.S.

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

A Study of Experimental Stem Cell Injection for Central Retinal Vein Occlusion (vision loss due to decreased blood supply in eye)

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Central retinal vein occlusion (CRVO) is an eye condition often associated with permanent loss of vision. CRVO blocks the blood supply to the retina. The retina is the part of the eye that captures the images that the eye sees and transmits the information to the brain. This blockage can damage your retina causing vision loss. In this study, we aim to learn more about a new procedure that involves injecting your own (autologous) stem cells into the eye. This approach is investigational and we do not have a lot of information about it. However, this stem cell procedure was used in a smaller study of 9 patients with different eye diseases including 1 patient with CRVO. The study was conducted by the same team led by Dr. Susanna Park at UC Davis. The aim of the current larger study is to get more information about this new procedure for patients with vision loss from CRVO. All participants will be randomly assigned to 1 of 2 groups. Both groups will receive one stem cell injection in the study eye. You will not be told which group you are in until the end of the study. Group 1 will have a bone marrow aspiration and stem cell injection during Study Period 1 or at the beginning of the study. During Study Period 2 or around 6 months into the study, Group 1 will have a sham or fake aspiration and a sham or fake injection. Group 2 will have a sham or fake aspiration and a sham or fake injection during Study Period 1 or at the beginning of the study. During Study Period 2 or around 6 months into the study, Group 2 will have bone marrow aspiration and stem cell injection.

Biological study, Phase [1, 2]
Any, age 18 years or older

An Exercise Study Testing Muscle Mitochondria (energy production) in Chronic Kidney Disease

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The purpose of this research study is to find out if exercise improves how well the mitochondria work. We also want to know if exercise improves ability to perform physical tasks. Finally, we will also test several components in the blood which may be related to physical abilities. We are doing this research because exercise may improve the overall balance of these components. What we learn in this study may help us to better understand the mitochondria and muscle in people with kidney disease. We hope to use this knowledge to improve their ability to be active and independent.

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

The LIFT Study: Telemedicine Breastfeeding Support

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This research study hopes to make sure that mothers have ongoing support to establish successful breastfeeding after leaving the hospital. It will test the effect of telemedicine breastfeeding support on breastfeeding duration. You are invited to be in this study because you delivered a late preterm infant and intend to breastfeed. If you decide to be in the study, you will be randomly assigned to a study group. One group will receive standard of care. The other group will receive 4 telemedicine breastfeeding support visits in addition to regular care. Here are some reasons you may not want to participate in this research: - completing surveys may take time, - you may not want to participate in telemedicine visits. This research will help understand the effectiveness of breastfeeding support practices. It will test a telemedicine lactation support intervention.

Behavioral study
Any, age -1 years or older

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

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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

A Study of Outpatient Cervical Preparation to Reduce Induction Duration in Pregnant Women

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This study is to compare 2 groups in nulliparous women undergoing cervical ripening for induction of labor. The study hypothesis is that outpatient cervical preparation with a foley catheter can reduce the induction of labor (IOL) time interval from admission to delivery by 50%. A 30 ml transcervical foley catheter is a safe mode of cervical preparation in the outpatient setting, as concluded in Diederen et al, Sciscinoe et al, and Kelly et al. Findings from studies on nulliparous, term, singleton vertex (NTSV) showed patients can be applied to a wide variety of maternity unit sizes as discussed by Main et al. No previous study has evaluated the effectiveness of outpatient cervical preparation in the NTSV population by PUBMED search. Further, no previous study has assessed patient satisfaction cervical preparation in the outpatient setting and no previous study has evaluated whether outpatient cervical preparation has an impact on the length of stay and cost of hospitalization. This study will explore these important questions with the goal of improving current practices in labor induction to be more patient-centered, pragmatic, and cost-effective.

Other study
Female, age 18 years or older

A Randomized Trial Comparing Monocryl(absorbable) vs. Nylon (traditional) Suture Closure in Carpal Tunnel Surgery

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This research study hopes to determine if there is a significant difference in using two different types of sutures (stitches): - subcuticular (under the skin) Monocryl (absorbable) vs - traditional Nylon sutures (stitches) These sutures will be used after open carpal tunnel decompression surgery. Both types of suture are commonly used in clinical practice. There is no objective data about which is “better”.

Procedure study
Any, age 18 years or older

A Study of Experimetnal Tabelecleucel After Failed Standard Treatment for Solid Organ Transplants With Epstein-Barr Virus

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This is a research study for patients with EBV-associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD). The study is for patients after a solid organ transplant (SOT) that didn’t respond to rituximab therapy with or without chemotherapy. This study will use a new treatment called tabelecleucel (also known as ATA129). Epstein-Barr Virus (EBV) is the virus that causes mononucleosis, also known as “mono”. Almost all adults have had EBV. For most people, EBV never causes a health problem. For people whose immune system is not working properly EBV can cause certain diseases where cells grow abnormally. This may happen in people who have had a transplant and those who have immune disorders. EBV-associated Post-Transplant Lymphoproliferative Disease (EBV-PTLD) can occur after a solid organ transplant (SOT). EBV infects immune cells in your blood, called B cells. In patients who have had an SOT, their immune system is suppressed because of the transplant. These infected immune cells can become cancerous. This research study is for patients who have EBV-PTLD following an SOT. It has not responded well to treatment with rituximab or rituximab and chemotherapy. Participants will receive experimetnal tabelecleucel. This is a product containing special immune allogeneic cells. The cells are called EBV-Cytotoxic T Lymphocytes (EBV-CTLs). They are made in the laboratory starting with cells from a healthy person who is immune to EBV. Your treatment will be selected specifically for you from a library of frozen tabelecleucel. It will be matched using certain human leukocyte antigens (HLAs). Treatment with tabelecleucel is experimental and is not approved by the FDA for use in the general public. It has been approved for testing in clinical trials. Tabelecleucel is made by taking donor cells from a healthy person. The cells that fight EBV (EBVCTLs) are grown in a laboratory for several weeks. They are then stored in a freezer until they are matched to a patient needing treatment. The cells are not genetically modified. This process is repeated using multiple donors in order to create a library of tabelecleucel products.

Biological study, Phase 3
Any, age -1 years or older
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