UC Davis Health Clinical Studies

A Study of the Experimental Medicine Edasalonexent in Boys With Duchenne Muscular Dystrophy

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This research study will test the effectiveness and safety of experimental edasalonexent. It will be studied in patients with Duchenne Muscular Dystrophy (DMD). An experimental drug is one that has not been approved by the FDA to treat this condition. A mutation (error) in the gene for dystrophin causes DMD. In DMD, dystrophin is not present in the muscle cells. Dystrophin is a protein that helps muscle cells keep their structure. Without dystrophin, muscle contractions damage the membrane around individual muscle cells. This results in cellular degeneration (decline) and inflammation (swelling). It also prevents cellular regeneration (new cells). Over time, the cycle will cause the muscle to be replaced with fibrotic tissue (scar tissue) and fat.

Drug study, Phase 3
Male, age 4 to 7 years old

A Study Of Experimental Cannabidiol in Children and Adolenscents With Fragile X Syndrome (CONNECT-FX Study)

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Fragile X Syndrome (FXS) is a genetic condition caused by a mutation in the Fragile X mental retardation 1 (FMR1) gene. This mutation is thought to cause changes the “endocannabinoid system” in the central nervous system. Disruption in this pathway can lead to FXS symptoms such as: - mild to severe intellectual or developmental disability, - speech and language difficulties, and - behavioral, social and emotional difficulties. Cannabidiol (CBD) is part of the Cannabis/Marijuana plant. It does not have the commonly known effects on the brain that recreational marijuana has. It may affect the endocannabinoid pathway. The Drug Product ZYN002 is a pharmaceutically manufactured CBD. It is being developed as a clear gel that can be applied to the skin (called transdermal delivery). This provides consistent, controlled levels of CBD in the blood when it is given once or twice a day. The purpose of this study is to test the safety and effectiveness of ZYN002 transdermal gel in patients with FXS. There are currently no FDA approved medications shown to treat FXS. ZYN002 is an experimental treatment. This means that it is not approved by the FDA and must be tested to see if it is an effective treatment.

Drug study, Phase [2, 3]
Any, age 3 to 17 years old

A Study of Oral vs Transdermal (through skin patch) Oxybutynin for Post-surgical Bladder Pain and Urgency in Children

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After bladder surgery, most patients have urinary urgency (the feeling of having to urinate). Doctors may give a medication to help treat or prevent this feeling. The medication Ditropan (oxybutynin) relaxes the bladder muscle and is currently given. This research study will test if oxybutynin works better in the oral form (liquid) or given through a skin patch (transdermal). Ultimately, we want to find the best form of the medicine for our patients to feel better after surgery.

Drug study, Phase 3
Any, age 4 to 8 years old

A Study of the FamilyLink Videoconferencing System and Breastfeeding

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This research study will determine whether viewing your baby while pumping changes the amount and/or content of your breastmilk. We also want to learn if viewing your baby changes your experience with pumping. You are invited to be in this study because you are a mother of a patient in our Neonatal Intensive Care Unit (NICU) who is currently pumping breastmilk. FamilyLink is a videoconferencing software used to view your baby remotely. Participation in this study will involve three sessions pumping breastmilk while using FamilyLink. Three sessions will be done without using FamilyLink. After each session you will complete a short survey and bring your pumped milk into the NICU. Which sessions you use FamilyLink for will be randomly assigned.

Behavioral study
Female, age -1 years or older

The LIFT Study: Telemedicine Breastfeeding Support

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This research study hopes to make sure that mothers have ongoing support to establish successful breastfeeding after leaving the hospital. It will test the effect of telemedicine breastfeeding support on breastfeeding duration. You are invited to be in this study because you delivered a late preterm infant and intend to breastfeed. If you decide to be in the study, you will be randomly assigned to a study group. One group will receive standard of care. The other group will receive 4 telemedicine breastfeeding support visits in addition to regular care. Here are some reasons you may not want to participate in this research: - completing surveys may take time, - you may not want to participate in telemedicine visits. This research will help understand the effectiveness of breastfeeding support practices. It will test a telemedicine lactation support intervention.

Behavioral study
Any, age -1 years or older
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