UC Davis Health Clinical Studies

A Study of Experimental Apixaban for Venous Thromboembolism (deep vein blood clot) in Children

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This research study will test the safety and effectiveness of the experimental medicine apixaban. Experimental apizaban is a new anti-clotting drug. It will be used in the treatment of these blood clots in children. Children in this study may receive either standard treatment or apixaban. Children who receive standard treatment may receive drugs currently used by doctors to treat blood clots. These drugs include: - vitamin K antagonists (drugs that keep the body from making proteins used in making blood clots) - low molecular weight heparins and unfractionated heparin (which prevent the body from making blood clots) The use of apixaban in this study is experimental because apixaban is not currently approved by the FDA to treat blood clots in children. However, it is approved to treat blood clots in adults.

Drug study, Phase 4
Any, age Up to 17 years old

Experimental Cisplatin and Combination Chemotherapy in Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery

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This research study is for people diagnosed with very low risk hepatoblastoma. Hepatoblastoma (HB) is a type of cancer that occurs in the liver. HB is considered very low risk when it is surgically removed at diagnosis. The term risk refers to the chance of the cancer coming back after treatment. Treatment for very low risk HB depends on how the cancer cells look under a microscope (histology). One type of histology is called well-differentiated fetal (WDF) histology. This usually requires surgery to remove the tumor, followed by close monitoring until signs or symptoms appear or change. Patients who do not have WDF histology also have surgery to remove the tumor. After surgery, these patients have chemotherapy (cancer fighting medicine) to kill any cancer cells that are left. A common treatment is a combination of 3 chemotherapy drugs called C5V: - cisplatin - 5-fluorouracil - vincristine Because hepatoblastoma is rare, there is limited research in this area. In this study, multiple research groups in Europe and Japan will combine efforts to study the treatment of patients with HB. Researchers want to find out if we can improve the treatment for subjects with very low risk HB. This study looks at how well cisplatin alone (without 5-fluorouracil and vincristine) works when it is given to children and young adults with very low risk HB after surgery. Success with giving cisplatin alone has been observed by European researchers. However, giving cisplatin without 5-fluorouracil and vincristine is experimental in North America. This study also looks at whether we can shorten the chemotherapy treatment given after surgery, from 4 cycles to 2 cycles. Shortening chemotherapy after surgery is also experimental. By removing 2 drugs and shortening chemotherapy, we may be able to reduce side effects during treatment or in the future.

Drug study, Phase [/2/,/ /3/]
Any, age -1 to 30 years old

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
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