UC Davis Health Clinical Studies

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 the Experimental Medicine F901318 for Invasive Fungal Infections in Patients Lacking Treatment Options

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We invite you to take part in this research study because your doctor has confirmed, or suspects, that you may have an invasive fungal infection (IFI). An IFI is a severe, life-threatening infection caused by a fungus. This study hopes to learn more about how well the investigational study drug, F901318 (also known as olorofim), is tolerated. We also hope to learn how safe it is for people with invasive fungal infections that have not improved with existing antifungal therapy. The study will also look at how the body processes the study drug (known as “pharmacokinetics”). The study drug is an experimental or investigational drug. This means the FDA has not approved it for treating IFI. The experimental study drug is an antifungal medication. It has been developed to treat serious fungal infections. It works by stopping a certain enzyme (protein) that is involved in the process of how fungi develop.

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

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

A Study of Stratification and Algorithm in Opioid Use in Shoulder Arthroplasty Patients

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We aim to better understand opioid use in patients having elective shoulder surgery. We plan to use a teaching session and pain contract to decrease opioid use after surgery. We hope to create a method for physicians to efficiently manage pain after surgery without causing opioid dependency. Elective shoulder surgery is on the rise, along with increased use of TSA in elderly patients. The need for determining optimal management without overprescribing narcotics has become very important. Decreased opioid use would mean decreased chance of having unwanted side effects of too much opioids. This inlcudes: - respiratory depression - nausea - sedation - driving restrictions - use by unintended individuals

Behavioral study
Any, age 18 years or older

A Study of Different Ways to Use Intravenous Fluids (given through a vein) and Vasopressors (blood pressure medicine) for Sepsis

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This study will test different ways to use “intravenous fluids” (fluids given through a small tube placed in your vein). It will also test using “vasopressors” (medicines that raise blood pressure) to treat “sepsis,” (a serious infection). We are asking you to be in this study because: a) you have been diagnosed with low blood pressure due to an infection and b) your blood pressure has stayed low after your doctors gave you fluids. We do not know which approach is better in this situation: a) starting medicines to raise blood pressure first and then giving more fluids (if needed), or b) giving a larger amount of fluids first and then giving medicines to raise blood pressure if needed. Right now, the choice of approach is left to the doctors. Some doctors use medicines to raise blood pressure followed by extra fluids. Others use extra fluids followed by medicines to raise blood pressure. Some doctors use a combination of the two. This treatment part of the study will last for 24 hours, and then we will follow you until you go back to where you live. We want to find out whether one of these approaches compared to the other can improve a patient’s chances of survival.

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

A Study of the Experimental Medicine Ropivacaine for Pain Control After Kidney Transplant

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This study is for patients scheduled to have kidney transplant surgery at the UC Davis Medical Center. It will compare two different methods for controlling pain after kidney transplant surgery. These methods are called TAP blocks and are designed to numb the nerves around the area of surgery. One method uses small implanted catheters to slowly give the anesthetic drug ropivacaine for two to three days after surgery. The other method uses a single injection of a long-acting anesthetic called liposomal bupivacaine. It lasts for two to three days after surgery. The study is designed to compare the effectiveness of these two different methods of decreasing pain. In addition, the study will compare the costs of these two different methods.

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

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
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