UC Davis Health Clinical Studies

A Study of Experimetnal VarIthena on Wound Healing in Venous Leg Ulcers (VLU)

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The purpose of this registry is to look at how experimental Varithena® injectable foam works. It will be given to patients who have chronic venous insufficiency (commonly known as “varicose veins”) with leg wounds. The decision to provide you with such medication has been left up to your treating physician and is not being driven by or impacted by this study. The purpose of this project is to collect data about your leg wounds. We hope to learn the impact of treatment on the rate of healing, the rate of repeated wounds, as well as the impacts to your level of pain and quality of life.

Drug study
Any, age 18 years or older

A Study of Experimental Magnesium Infusion for Pain Management in Critically Ill Trauma Patients

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Magnesium is a naturally occurring mineral that is important for your body and brain. Magnesium sulfate (study drug) is a medication containing magnesium. It is commonly used to improve low blood levels of magnesium. Magnesium sulfate has also proven to be successful in managing pain before and after surgery. This drug has primarily been used for pain control in patients undergoing surgery. Patients in the ICU with injuries also need good pain control. Using magnesium may decrease the need for narcotics (pain relievers). It may also provide another non-narcotic drug for pain control. The purpose of this study is to test the effectiveness of continuous, intravenous (into or within a vein using a needle) administration of magnesium sulfate. This will be compared to intravenous normal saline (salt solution).

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

A Study of Museum-Based Experiences to Reduce Social Isolation and Pain

Can participating in museum programs help individuals with chronic pain feel more socially connected? Help us find out!

This research study will develop and evaluate museum-based programs. These programs will aim to address loneliness and social isolation among individuals with chronic pain. Over 100 million American adults suffer from chronic pain. This is more than those with heart disease, cancer, and diabetes combined. Chronic pain is complex. It affects the body, the mind, and social interactions. Previous studies show that social disconnection can cause pain to feel more intense. Studies also show that social connection can help decrease the intensity of pain. Museums may be able to reduce isolation and give people a sense of social connection. We hope to learn if museum engagement in individuals with chronic pain can decrease feelings of social disconnection and the unpleasantness of chronic pain.

Other Study
Any, age 18+

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 Cytomegalovirus (CMV) Vaccine (HB-101) in Kidney Transplant Patients

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The purpose of this clinical research study is to see if an investigational anti-Cytomegalovirus (CMV) vaccine known as HB-101 is safe to use and helps patients. The main purpose of this study is find out:  How well HB-101 could protect from significant CMV infections.  The side effects of HB-101. CMV is a common infection that can be dangerous when your defense against commonly mild infections is low. For example, this can happen in patients who receive a kidney from a donor. Most people whose immune system is working well with CMV infection have no symptoms. If any, symptoms are mild illness such as fever, sore throat, fatigue, and swollen glands. However if your immune system is weak, CMV can affect your lung, gut, eye or other organs and can create severe damages. This study involves the use of an new investigational anti-CMV vaccine known as HB-101. HB-101 is a vaccine that is believed to prevent CMV infection after kidney transplant by forming antibodies and stimulating your immune cells against CMV. This vaccine doesn’t contain eggs or mercury. HB-101 contains a Genetically Modified Organism (GMO). The vaccine uses genes from two different viruses, but it can’t reproduce any infectious viruses in your body. The HB-101 vaccine is constructed from parts of a LCMV. The parts of the LCMV used is not alive and cannot reproduce or give you an infection. When HB-101 vaccine is introduced inside your body, it tricks your body in thinking it has CMV. It teaches your immune system to make antibodies to protect you against CMV infection. The HB-101 vaccine is not live and can’t spread in your body or outside your body in the environment.

Biological study, Phase 2
Any, age 18 to 99 years old

A Study of Experimental Blood Derived Autologous Angiogenic Cell Precursor (type of stem cell) Therapy for Critical Limb Ischemia

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Peripheral Artery Disease (PAD) is a common, progressive circulatory disease. It sometimes advances to Critical Limb Ischemia (CLI). CLI symptoms can be painful and lead to sores and in some cases amputation. This study will test the safety and effectiveness of injecting Angiogenic Cell Precursors (ACPs) into the muscles of your leg and foot. ACPs are specific stem cells collected from your blood. This experimental study treatment will be used to relieve symptoms of Critical Limb Ischemia.

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

A Study of Experimental PLX PAD for Critical Limb Ischemia (severely obstructed arteries limiting bloodflow to limbs)

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This study will test if experimental PLX-PAD is safe, well tolerated and effective for the treatment of critical limb ischemia (CLI). This study is for people with CLI, who are not considered good candidates for surgery or other procedures designed to increase blood flow. CLI is a severe form of peripheral artery disease (PAD). It is caused by atherosclerosis (hardening of the arteries due to plaques in their inner walls). When the blood vessels that supply blood to the leg narrow, this leads to insufficient blood and oxygen supply to the leg tissues. CLI may be characterized by pain in the foot or leg even when lying at rest. It can also involve foot and leg wounds, which sometimes lead to infection and tissue death. This may lead to the amputation of toes, foot or leg. PLX-PAD is an experimental medicine. This means that it is not approved for use by the FDA, other than in research studies. PLX-PAD is a cellular therapy, meaning that it contains living cells which are injected into the patient’s muscles. These cells come from a human placenta (the organ that connects the fetus to the uterus). It is collected in a sterile procedure during a planned cesarean section, from healthy female volunteers who donated it. All placenta donors complete a comprehensive questionnaire on their risk of being infected or being a carrier of infectious diseases. Their blood is tested for a vast panel of infectious diseases. Since this research uses human cells, the process for obtaining the cells and preparing them for use is subject to the highest standards. PLX-PAD cells are added to a fluid which contains: - dimethyl sulfoxide (DMSO), - human serum albumin (human blood protein) - PlasmaLyte (salts solution). The control solution contains: - dimethyl sulfoxide (DMSO), - human serum albumin (human blood protein) - PlasmaLyte (salts solution) The control solution does not contain the PLX-PAD cells and is not expected to make your disease better.

Biological study, Phase 3
Any, age 45 to 99 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
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