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UC Davis Health Clinical Studies

Experimental Risankizumab vs. Placebo For Moderate to Severe Hidradenitis Suppurativa (painful lumps under skin)

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You have been asked to participate in a research study of an experimental drug called risankizumab. An investigational drug is one that has not been approved for sale in the United States by the U.S. Food and Drug Administration (FDA). The purpose of this study is to test the safety and effectiveness of two different doses of risankizumab (180 mg and 360 mg). It will be compared to placebo. It is for patients with moderate to severe Hidradenitis Suppurativa.

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

Study of Experimental JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis

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You are being asked to take part in this research study because you have atopic dermatitis (AD). This is also known as atopic eczema, which may be of moderate to severe intensity as evaluated by the study doctor. The purpose of this research study is to test the efficacy and safety of two doses of the study drug (PF-04965842). They will be compared to a placebo when taken together with medicated and non-medicated therapy applied to the skin. Researchers will compare the results of taking the higher dose, lower dose, and placebo to see if there are any differences, when taken with the background medication. PF04965842 is an experimental drug. An experimental drug is one that is not approved by the FDA for use in this country. A placebo looks like the study drug but does not contain any active ingredients. Researchers use a placebo to see if the study drug works better or is safer than not taking anything. PF-04965842 is a blocker of an enzyme called Janus kinase (JAK). JAK acts like a switch for the cells of the immune system (the body’s defense against infection and inflammation). By turning off this switch, the cells of the immune system should produce fewer chemicals believed to cause AD. However, there is no guarantee that participating in this study will help your AD.

Drug study, Phase 3
Any, age 12 to 17 years old

Safety and Effectiveness of Experimental Upadacitinib vs. Dupilumab in Adults With Moderate to Severe Atopic Dermatitis

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This study will compare the effectiveness and safety of experimental upadacitinib (ABT-494) and dupilumab. This study is for the treatment of adults (18-75 years of age) with moderate to severe atopic dermatitis (AD). This is a double-blinded study. Neither you nor your study doctor will know to which study group you were assigned. In order to keep the study blinded, you will be taking both tablets and injections and you will be assigned to one of the following treatment groups: Upadacitinib 30 mg tablets + placebo pre-filled syringe; OR Dupilumab 300 mg + placebo tablet Placebo pre-filled syringe is a syringe without any active substance that looks like dupilumab. Placebo tablet is a pill without any active substance that looks like upadacitinib.

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

Effectiveness and Safety of Experimental Secukinumab Doses in Patients 90kg-or-greater with Severe Chronic Plaque-type Psoriasis

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This study will test a higher dose of experimental secukinumab. We hope to learn if it is safe and effective in psoriasis patients with higher body weight. It will compare the following two treatment groups: - a secukinumab low dose group (alternating doses of 300 mg secukinumab and placebo every 2 weeks) and - a secukinumab high dose group (300 mg every 2 weeks). A placebo is a dummy drug with no active medicine inside. Treatment will be delivered using pre-filled syringes. You can find more information about the study treatment in Section 4.2. below titled “What happens during study treatment?” Secukinumab is a medicine which has been approved by the FDA for the treatment of people with your medical condition. The 300 mg every 4 weeks dose being tested in this study is the approved dose (available for you to receive a prescription for) in the United States. The 300 mg every 2 weeks dosing regimen being tested in this study is not currently approved. Secukinumab is a type of medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to other specific proteins. In this case, immune system hormones called “cytokines” that your body produces. The cytokine is a “messenger” protein in the body. Secukinumab binds to it and reduces the activity of interleukin-17A (IL-17A). IL-17A is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17A causes symptoms of plaque-type psoriasis.

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

A Study to Compare Experimental Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

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Clostridium difficile infection (CDI) is caused by a type of bacteria called Clostridium difficile. It causes an infection in your gut (digestive tract). People with CDI need antibiotics to get better. Once you have had CDI you are more likely to get the infection again. Repeat CDI happens because the antibiotics often damage the healthy bacteria in the gut that help protect you from infection, as well as the bacteria that causes CDI. The study medication under investigation in this study, called ridinilazole. It is thought to have the ability to target the bacteria that causes CDI without causing as much damage to the healthy bacteria. This may reduce the chance of CDI returning. In this study, we will test how safe ridinilazole is and how well it works at treating CDI and stopping it from returning over a period of 3 months. The study will compare ridinilazole to vancomycin, which is an existing antibiotic often used to treat CDI. Ridinilazole is an investigational drug. This means that it is experimental and is not yet approved by theFDA to treat CDI. Ridinilazole works only in the gut as a narrow spectrum antibiotic. It specifically kills Clostridium difficile bacteria. This means less damage to the natural bacteria in the gut which could mean less likelihood of the infection returning.

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

Study to Test the Effectiveness and Safety of Experimetnal Baloxavir Marboxil in Hospitalized Patients With Severe Influenza

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The purpose of this research study is to compare the effects of the study drug when added to the normal standard-of-care you get for the flu. Standard of care therapy is the treatment you would normally receive to treat flu. For example: - Tamiflu®, - Relenza® (other name includes Dectova®), or - Rapivab® (other names include Rapicata™, Peramiflu™, and Alpivab™). We are doing this research to see if adding a new study drug along with standard antiviral drug is safe and effective. It will be compared to using standard antiviral drug alone. In this study, you will get standard-of-care therapy plus baloxavir marboxil (the study drug) or placebo. A placebo looks like a drug but has no active ingredient. Baloxavir marboxil is an experimental drug. This means it has not been tested in patients for the treatment of severe flu that requires hospital treatment. Baloxavir marboxil (brand name Xofluza®) has been approved by the health authority in the United States of America for the treatment of flu, as well as Japan. Applications for approval in other countries are either completed, ongoing or planned.

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

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+
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