UC Davis Health Clinical Studies

A Study of Experimental Ataluren for Nonsense Mutation Dystrophinopathy (nmDBMD)

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This study is for boys with Duchenne/Becker muscular dystrophy (DMD/BMD). The condition studied in this study is caused by a nonsense mutation in the dystrophin gene. Participants must have been treated with ataluren in a past clinical trial or treatment plan. The main goal of this study is to learn whether experimental ataluren is safe for patients with DMD/BMD. Experimental means that ataluren is not approved by the FDA to be used except in a research study. The FDA has allowed the use of ataluren in this study. We hope to find out if it could one day be made more widely available for doctors to prescribe it for patients with DMD/BMD.

Drug study, Phase 3
Male, age -1 years or older

A Study of Different Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders

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You have been asked to participate because you may have symptoms of: - Rapid-Onset Dystonia-Parkinsonism, - Atypical Parkinsonism, - Dystonia, or other movement disorders, specifically AHC (Alternating hemiplegia of childhood) - Cerebral Palsy patients Dystonia is a movement disorder with involuntary muscle contractions. These force certain parts of the body into abnormal, sometimes painful, movements or postures. Dystonia can affect any part of the body including the arms and legs, trunk, neck, eyelids, face, or vocal cords. You may also be asked to take part if you have a family member with Rapid Onset Dystonia-Parkinsonism (RDP) or other movement disorder. The purpose of this study is to find more information about the symptoms of RDP. We want to learn how many persons have it or the gene for it, and about how the symptoms may change over time. You are free to stop your participation at any time. Currently families with RDP have been identified in the United States and Europe.

Other Study
Any, age 2 years or older

A Study of the Experimental Prevena™ device (Incisional Negative Pressure Wound Therapy) for Soft Tissue Sarcoma Wounds

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Patients with sarcomas (tumor in bone or soft tissue) who receive radiation before surgery have a greater chance of complications in wound healing. This research study will test a wound dressing called Negative Pressure Wound Therapy (NPWT). NPWT is a wound sponge attached to a gentle suction device. It is more effective at preventing infection of the surgical wound than standard dry gauze wound dressing. The Prevena™ device (NPWT) is FDA approved for use on incisions. This will be considered the investigational dressing. The NPWT device is a foam sponge that is placed over the incision after surgery, and provides a low pressure gentle suction on the wound. It is sealed with an adhesive dressing. The traditional standard dry gauze dressing will be considered the control dressing for this study

Device study
Any, age 18 years or older

A Long-Term Safety and Tolerability Study of Experimental Givinostat in Duchenne Muscular Dystrophy

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This study will test the long-term safety and effectiveness of the experimental medicine Givinostat. It will be given to patients with Duchenne Muscular Dystrophy (DMD). This long-term study is for patients who have already participated in a study with Givinostat. It provides the opportunity for them to continue treatment. This study is for patients with Duchenne Muscular Dystrophy currently taking experimental Givinostat.

Drug study, Phase [2, 3]
Male, age 7 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 Study of the Experimental Neuro-Spinal Scaffold™ Device for Complete Thoracic AIS A Spinal Cord Injury

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The purpose of this study is to test the safety and benefit of a new medical device. This device is implanted into the injured spinal cord for a recent spinal cord injury. The procedure to implant the medical device may be added to the usual, standard treatment for spinal cord injury. The study doctor will attempt to perform your surgery as soon as possible. The medical device is experimental and is not approved by the FDA. There is no evidence that the medical device will be of any benefit to you. However, the study will look at whether the new medical device helps improve the medical condition of patients with recent spinal cord injuries.

Device study
Any, age 16 to 70 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 Medicine Idebenone for Duchenne Muscular Dystrophy (DMD)

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This study is for patients with DMD, who completed the SIDEROS study. The study doctor will determine if you are eligible for this SIDEROS-Extension study. In this study, a series of physical and laboratory tests will be done. This will check the safety and effectiveness of experimental idebenone. Any side effects will be checked by physical examination, including tests on the heart and by laboratory tests on blood and urine.

Drug study, Phase 3
Male, age 11 years or older
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