UC Davis Health Clinical Studies

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

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 the Experimental Combination of Dabrafenib, Trametinib, and Navitoclax For BRAF Mutant Melanoma or Solid Tumors

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The purpose of this study is to test the safety of navitoclax in combination with dabrafenib and trametinibat. It will be given at different doses to find out what effects, if any, it has on people. Dabrafenib blocks a protein caled BRAF. Trametinib blocks a protein called MEK. Both are drugs that individually have been shown to be effective for patients with BRAF-mutant melanoma. Given together, these two drugs have been shown to be more effective than dabrafenib for patients with BRAF-mutant melanoma. Navitoclax is a drug that makes tumor cells more likely to die in response to other treatments (like chemotherapy). It is an investigational drug (not FDA-approved) that has been studied in a number of diseases. All three drugs are in pill form and taken by mouth.

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

A Study of the Experimental Medicine Baricitinib (LY3009104) in Adults With Moderate to Severe Atopic Dermatitis

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The main reason for you to take part in this study is to help in answering the following research questions: • How experimental baricitinib (LY3009104) compares with placebo in helping patients with atopic eczema. • The safety of baricitinib and any side effects you might have when you take it. “Experimental” means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the FDA. The FDA is allowing the use of this drug for research.

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

Use of Hypertonic Saline (a concentrated salt solution) After Abdominal Trauma Surgery to Improve Wound Healing

This study will look at using a concentrated salt solution versus standard salt solution in IV's given after abdominal trauma surgery.

This study will examine using hypertonic saline (a concentrated salt solution). The study team wants to learn if it is better than standard intravenous (given through a vein) salt solutions. It will be used after abdominal trauma. We are investigating whether using hypertonic saline will improve wound healing. We hope it will also result in less injury to organs in the abdomen and decreased time in the ICU and/or the hospital.

Procedure study
Any, age 18 years or older
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