UC Davis Health Clinical Studies

Study of Experimental Sulbactam-ETX2514 Infections Caused by Acinetobacter baumannii-calcoaceticus Complex

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We are doing this study to test the effectiveness and safety of the experimental drug sulbactam-ETX2514. It is being tested for the treatment of infections caused by A. baumannii bacteria. This type of infection is usually resistant to many existing drugs. New drugs are needed to effectively fight A. baumannii bacteria. The study drug is not approved for the treatment of infections due to A. baumannii. The study drug itself is made up of two chemicals, one is called ETX2514, an investigational antibiotic. The other chemical that makes up the study drug is called sulbactam, an FDA-approved antibiotic. The combination that is this study drug is called “ETX2514SUL.”

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

A Study of Experimental Therapy With Nivolumab For Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

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This study is being done to answer the following question: Can we safely and effectively treat your cancer with nivolumab given any of the following auto-immune diseases? -Rheumatoid arthritis -Polymyalgia rheumatica -Sjogrens -Ulcerative colitis -Crohn's disease -Systemic lupus erythroderma -Dermatomyositis -Multiple sclerosis Nivolumab is an antibody that can block signals that some types of tumors may use to suppress the immune system. We are doing this study because we want to find out if this approach is better or worse than the usual approach for your cancer and your auto-immune disease. The usual approach is defined as care most people get for their cancer while having an auto-immune disease. Treatment with nivolumab is considered experimental. It is not currently approved by the FDA for cancer in people with auto-immune diseases.

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

A Study of the Safety and Effectiveness of Experimental Lonafarnib / Ritonavir for Chronic Hepatitis D Virus Infection

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This study is for patients with chronic (long-lasting) hepatitis D virus (HDV) infection. Potential participants must be taking or be willing to begin taking nucleotide/nucleoside inhibitors (entecavir or tenofovir). These nucleotide/nucleoside inhibitors must be taken for at least 12 weeks to 6 months before beginning the study treatment. The purpose of this study is to determine whether the study drugs will reduce the amount of HDV in your blood. Other purposes of this study are: - to determine the effects of the study drugs on your liver - to determine if taking the study drugs makes your quality of life better - to evaluate the safety of the study drugs The Sponsor is conducting this study to find new treatments for HDV. This research study is designed to learn more about an investigational drug called lonafarnib. It is being developed to treat chronic HDV infection as well as other conditions. "Investigational" means lonafarnib is not yet approved by the FDA for prescription or over the-counter (OTC) use. Lonafarnib will be taken in combination with an approved drug called ritonavir. Ritonavir is commonly used in the treatment of hepatitis C at comparable dosing to what will be used in this study. In this study, ritonavir is used as a “booster” to increase the amount of lonafarnib in your body. A “booster” is a drug that prevents your body from breaking down lonafarnib, so it can work longer. Some patients in this study will take an interferon medicine approved for treating HBV and hepatitis C virus (HCV) infections. This medicine is called peginterferon-alfa-2a (abbreviated as PEG IFN-alfa-2a). PEG IFN-alfa-2a will be a potential added medicine in this study. We hope to determine if it improves the treatment outcome when taken with lonafarnib and ritonavir. Peginterferon-alfa-2a is a solution that is injected under the skin once per week.

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

A Study of the Experimental Medicine SUBA-itraconazole Compared to Standard Treatment for Endemic Mycoses (fungal infection)

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Treatment of fungal infections can be difficult. The majority require long courses of anti-fungal treatment, often requiring long-term therapy. This study will determine how safe, effective and well-tolerated an experimental fungal drug, SUBA-itraconazole, is. It will be compared to standard treatment with the drug itraconazole. Standard treatment is the medication normally given to patients with fungal infection. There are 2 arms (treatment groups) in this research study, ARM A and ARM B. You will be randomized by chance (1:1) to one of the two arms. You have an equal chance to be assigned to either arm. • ARM A: Open-label study drug treatment by mouth 2 capsules, with food, three times a day for 3 days, then two times a day until day 180 ARM B: Open-label conventional treatment (non-study drug) by mouth 2 capsules, with food, three time a day for 3 days, then two times a day until day 180

Drug study, Phase [/2/,/ /3/]
Any, age 19 years or older

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

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+
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