UC Davis Health Clinical Studies

A Study of Experimental Fenretinide (LAU-7b) for Cystic Fibrosis in Adults

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Cystic fibrosis (CF) is a multi-system disease affecting the respiratory tract. It involves the lungs, nose, and sinuses, pancreas, liver, sweat glands, and reproductive organs. The lungs often experience ongoing infection (usually with bacteria called Pseudomonas aeruginosa). It sustains out-of-control inflammation that results in irreversible damage. This is a research study of an experimental drug called fenretinide (LAU-7b). Experimental means that this drug has not been approved by the U.S. Food and Drug Administration (FDA). The study drug (LAU-7b) is a derivative of Vitamin A. The FDA has approved the testing of fenretinide in this study. Researchers hope that treatment with fenretinide will preserve lung function. We hope it will reduce the persistent inflammation in the lung. We also hope it improves the lung's capacity to defend against bacteria such as Pseudomonas aeruginosa. The main goals of this study are to determine if fenretinide: Is safe and well tolerated Improves lung function as measured by spirometry. Spirometry is a routinely performed test to measure lung function.

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

Primary Biliary Cholangitis with incomplete response or intolerant to ursodeoxycholic acid? Participate in a clinical trial

Help us evaluate if a new investigational drug is safe and effective in the treatment of PBC

We invite you to take part in a research study because you have primary biliary cholangitis (PBC) and you are not responding well enough to or can't tolerate ursodeoxycholic acid. You must have been taking a stable dose of ursodeoxycholic acid (UDCA) for the past twelve months, OR you're not able to tolerate UDCA due to side effects. This study will test the safety and efficacy of an investigational medicine called seladelpar. Previous research has shown that seladelpar may help treating the signs and symptoms of PBC, lower your alkaline phosphatase level, and decrease itching. Primary Biliary Cholangitis (PBC) is a autoimmune chronic liver disease that destroys the bile ducts within the liver. You will receive all study medication and study evaluations at no cost, and compensation for your time may be available.

Drug study, Phase 3
Any, age 18 to 75 years old

Help us design better tools to manage continuous IV immunotherapy in acute lymphoblastic leukemia. Participate in a research study

We aim to understand the experiences of patients, caregivers, and nurses with continuous IV immunotherapy

The goal of this study is to learn about the experiences of patients, caregivers, and nurses with continuous IV immunotherapy. We want to understand the needs and challenges in managing continuous IV immunotherapy and how information about this therapy was provided to the patients, caregivers, and nurses. We aim to improve how we educate and support patients, family members, and nurses with this therapy in the future. We hope that the insights from this study will help us develop digital health or other tools.

Observation, workshop
Any, age 18 year or over

A Study of the Experimental Medicine OV101 For Fragile X Syndrome

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We invite you to take part in a research study because your child has a rare genetic disorder called Fragile X syndrome (FXS). You are being asked to give permission for your child to take part in the study. If you are a parent/legally authorized representative (LAR), you are being asked to take part in this study as detailed in this consent form. Before you decide if you want to take part, it is important for you to understand why the research is being done and what it will involve. Please read the following information carefully and discuss it with friends, family and physician if you wish. The study doctor or study staff will also explain the study to you.

Drug study, Phase 2
Male, age 13 to 22 years old

A Study of the Safety and Effectiveness of Experimental Medicine Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

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The purpose of this research is to see if an experimental drug called vamorolone is effective and has fewer side effects than steroids. It will be studied in children with Duchenne muscular dystrophy (DMD). Boys with DMD experience progressive muscle weakness as they grow up. Steroids such as prednisone (or prednisolone) and deflazacort, are currently the only class of medication available to all boys with DMD. These medicines have been shown to prolong walking ability. Steroids have several side effects. Side effects include weight gain, behavioral problems, growth restriction, increased risk of bone fractures. We are doing this research study to see if vamorolone works in DMD and if it has fewer of these side effects.

Drug study, Phase 2
Male, age 4 to 7 years old

A Study of Experimental Medicine ADS-5102 For Multiple Sclerosis and Walking Impairment

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The purpose of this study is to look at the long-term safety and efficiency of experimental ADS-5102. It will be studied in patients with multiple sclerosis (MS) with walking impairment. "Experimental" means the study drug formulation being tested is not approved by the FDA. The active ingredient in ADS-5102 is called amantadine. Amantadine is FDA approved to help prevent and treat signs and symptoms of infection caused by some forms of the influenza virus. It is also approved as a treatment for Parkinson’s disease and other nervous system disorders. ADS-5102 is a formulation of amantadine that allows the drug to be taken up by the body slowly. This kind of formulation is called an extended release (ER) formulation. This allows the drug to be taken once a day. In MS, neurons of the central nervous system are damaged due to inflammation, and the communication of one neuron to another is impaired. Amantadine may improve the communication between neurons that has been impaired due to MS. Thereby, improve the central nervous system’s control of walking.

Drug study, Phase 3
Any, age 18 to 70 years old

HIV Post-Exposure Prophylaxis Uptake and Adherence Post-Sexual Assault

Looking for men and women who have been offered medications to prevent HIV following sexual assault

Thank you for your interest in taking part in the My Experiences Navigating Daily-life (MEND) research study. The purpose of this study is to get information about how and why people do or do not take HIV post-exposure prophylaxis (PEP) (medications to prevent HIV) in the four weeks after a sexual assault. Your participation will involve taking a survey via an internet-based web-application. Completing this survey means you consent to participate in this study. There are two parts to the survey: a screening section and the main survey. After finishing the screening section, you may or may not be selected to complete the main survey. The main survey will take about 30-45 minutes to complete. You can complete the survey two ways: (1) anonymously, or (2) you may choose to provide your email address to receive a gift card for your time.

Online survey
Any, age 18+

A Study of the Safety and Efficiency of Experimental Drug Maribavir in Transplant Recipients With Cytomegalovirus (CMV) Infection

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We invite you to take part in this research study because: - you have a viral infection, cytomegalovirus (CMV) - you have also received a solid organ transplant (SOT) or - you have received a hematopoietic stem cell transplant. A hematopoietic stem cell is an immature cell that can develop into all types of blood cells. The current antiviral treatment you are receiving is not improving the infection. The infection may have also become resistant to the current treatment. This research study will look at the safety and effectiveness of the experimental drug, maribavir. It will be compared to current anti-CMV therapy used to manage CMV infections. Maribavir has not yet been approved by the FDA. CMV is a common infection. In the US about 50-80% of the population has been infected with CMV by 40 years of age. CMV infection usually has no symptoms or only mild symptoms in healthy adults. However, serious disease occurs in individuals who are immunocompromised (weakened immune system). For example, patients that have received transplants. There is currently no cure or vaccine for CMV. This study will help determine whether an experimental drug, maribavir, is a safe and effective treatment for transplant recipients. We hope to learn if there are any unwanted effects on your health related to the use of experimental maribavir. In this study, you will be randomly assigned to either marivabir, the Study Drug, or current FDA approved drugs used to treat CMV infections: ganciclovir, valganciclovir, foscarnet, and cidofovir.

Drug study, Phase 3
Any, age 12 years or older

Investigating the Prevalence of Type II Glycogen-Storage Disease (Pompe Disease)

The study team hopes to learn more about how common Pompe disease truly is.

The study team hopes to learn more about the true occurrence of Pompe disease. Pompe disease is a rare genetic disease of the muscles. The results of this study will be compared to previous studies about the genetic occurrence of this disease. Type II glycogen-storage disease (Pompe disease) varies depending on ethnicity and geographic region. It is most common within the African American population, with an incidence of 1 in 14,000. In the U.S. more broadly speaking, the combined frequency of the three varieties of the disease is 1 in 40,000. Pompe disease causes muscle weakness and trouble breathing. It mostly affects the liver, heart, and muscles. Individuals with Pompe disease have a deficiency in the activity of an enzyme called GAA (acid alpha glucosidase). GAA normally breaks down a complex sugar called glycogen into a simpler sugar called glucose. Glucose is the main energy source for most cells. For this study, a 4mL blood sample will be analyzed. The study team will look for low GAA enzyme activity.

Other Study
Any, age 8 years or older