UC Davis Health Clinical Studies

A Study of Testing Tranexamic Acid After Traumatic Injury in Children

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We are inviting your child to take part in this research study if s/he has suffered an injury to his/her head or torso (also called the stomach or abdominal area). The purpose of this study is to learn more about an investigational drug called tranexamic acid (TXA). Investigational means the study drug being tested has not been approved by the United States Food and Drug Administration (FDA) for use in the United States. TXA is a drug that helps with the blood clotting process in the body. There are 4 main parts to this research study: 1. Receiving the study drug 2. Collection of several small blood samples collected over the first 24 hours of enrollment 3. Review of your child’s medical records 4. Responding to follow-up questions at different time points after enrollment through 6 months

Drug study, Phase 2
Any, age -1 to 17 years old

A Study of Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine

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Preterm babies are more likely to have developmental challenges. Your baby qualifies for developmental screening to identify any concerns. Your doctor may refer you and your baby for early intervention developmental therapy. The first developmental screening visit is between 6 and 9 months corrected gestational age. Prechtl’s assessment of general movements (GMA) is a method of observing and characterizing babies' movements. If a baby has abnormal patterns of movement they are at higher risk for developmental delay. This may help in identifying infants that would benefit from early intervention services sooner. Traditionally, GMA assessment is done by creating video recordings of babies moving at different ages. Experts review those recordings separately from a clinic visit. The goal of our research study is to see if it is possible to do general movements assessment via telemedicine. We will study whether watching the baby move during a telemedicine visit has the same conclusion as watching the same video as a recording. If this assessment can be done via telemedicine, it may be able to be completed faster, on more babies, especially those that live far away.

Other study
Any, age -1 to -1 years old

A Study of Reduced Therapy for Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma

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You are being asked to take part in this research study because you have been diagnosed with a cancer called medulloblastoma. This is a type of childhood brain tumor. This cancer is called “average-risk” or “Classic Medulloblastoma” because: - you are 3 years of age or older - the tumor is in the very back of the brain in an area called the posterior fossa - all or almost all of the tumor was removed by surgery - the cancer has not spread to other parts of your brain or spinal cord. The term, risk, refers to the chance of the cancer coming back after treatment. There are four main types of Medulloblastoma. They are set apart by the presence, absence, or changing levels of certain proteins and other molecules in the tumor cells. Some of these different types of cancer respond differently to current treatments. This study if for patients whose doctors think they have Classic Medulloblastoma of the WNT sub-type type. WNT-subtype medulloblastoma patients have had better survival than other types of medulloblastoma. WNT-subtype medulloblastoma can be found using a number of specialized molecular tests. People with WNT-subtype medulloblastoma will get less therapy than other types of medulloblastoma. So, we want to make sure that the diagnosis is correct before you are given any treatment on this research study. It is unknown whether less treatment will result in no change in the chance of cure or a decreased chance of a cure.

Drug study, Phase 2
Any, age 3 to 21 years old

A Study of Experimental Inotuzumab Ozogamicin for Younger Patients With CD22 Positive B Acute Lymphoblastic Leukemia

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In this study, we would like to test an experimental drug called inotuzumab ozogamicin (InO). InO is an antibody which is linked to a chemotherapy drug. Antibodies are large proteins which function to identify and remove foreign substances. Your cancer cells have molecules on the surface of the cell called CD22. InO searches for cancer cells with CD22 and once found, InO will attach itself to the cancer cell. Once attached, the chemotherapy is brought into the cell causing the cancer cell to die. InO is considered experimental because it is not approved by the FDA. It is only used in research studies like this one. InO has been shown to be well tolerated and effective against leukemia in adults. InO has only been given to a small number of children and there is limited information about the side effects children may experience. This study will help doctors understand the side effects InO has in children and how well InO works to get rid of the cancer.

Biological study, Phase 2
Any, age 1 to 21 years old

A Study of the Experimental Medicine OV101 For Fragile X Syndrome

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We invite you to take part in a research study because your child has a rare genetic disorder called Fragile X syndrome (FXS). You are being asked to give permission for your child to take part in the study. If you are a parent/legally authorized representative (LAR), you are being asked to take part in this study as detailed in this consent form. Before you decide if you want to take part, it is important for you to understand why the research is being done and what it will involve. Please read the following information carefully and discuss it with friends, family and physician if you wish. The study doctor or study staff will also explain the study to you.

Drug study, Phase 2
Male, age 13 to 22 years old
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