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Source: nct - Phase: ongoing
nct MAJ Il y a 4 ans

What is the Maximum Amount of Carbohydrates That is Still Able to Induce Ketosis and Suppress Appetite? Two dietary approaches, very low energy diets (VLEDs) and ketogenic low carbohydrate diets (KLCDs), have the ability to suppress appetite. The suppression of appetite typically observed during these diets is believed (but not clinically proven) to be due to ketosis, a condition where circulating concentrations of ketone bodies are increased due to a higher production of ketones in the liver. Little is known about the potential mechanisms through which ketosis may lead to appetite suppression in VLEDs and KLCDs. A 'ketogenic diet' typically contains less than 50 grams carbohydrate per day, yet ketosis has been seen in subjects who consume diets with a carbohydrates ranging between 59-192 grams per day. Although an association between ketosis and appetite suppression has been established, the minimum level of ketosis and maximum carbohydrate intake that is still associated with appetite suppression remains unknown and should be explored. The ability to increase carbohydrate intake while maintaining a suppressed appetite will allow dieters to consume more carbohydrate-rich food that is beneficial for health without feeling more hungry. The aim of this study is, therefore, to identify the maximum carbohydrate intake that is still associated with appetite suppression in a low energy diet and to determine the impact of a higher carbohydrate intake on appetite suppression, body composition, and resting metabolic rate.

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nct MAJ Il y a 4 ans

Fenretinide Lym-X-Sorb + Ketoconazole + Vincristine for Recurrent or Resistant Neuroblastoma Currently there is no known effective treatment for recurrent or resistant neuroblastoma. Fenretinide is an anticancer agent that may work differently than standard chemotherapy. It may cause the buildup of wax-like substances in cancer cells called ceramides. In laboratory studies, it was found that if too much ceramide builds up in the neuroblastoma cells, they die. Fenretinide has been given by mouth as a capsule to many people, including children. When Fenretinide is given in capsules, very little of the drug is absorbed through the intestines into the body. This means patients have to take many capsules of fenretinide by mouth several times a day. In this study, a new oral preparation of fenretinide (called 4-HPR/LXS oral powder) is being tested to see if more fenretinide can be absorbed into the body. 4-HPR/LXS oral powder has been tested previously in a limited number of both children and adult cancer patients. Ketoconazole, commonly used to treat fungus infections, can increase fenretinide levels in the body by interfering with the body's ability to break down fenretinide. Ketoconazole will be given at the same time as the fenretinide powder. There is preclinical data that shows that combining fenretinide and vincristine prolonged survival in animal models, therefore, it is hoped that giving the vincristine with fenretinide will work better against the neuroblastoma that either drug given alone. About 70 children with neuroblastoma have been treated with various versions of the fenretinide powder to date, including about a dozen children that also took the fenretinide powder with ketoconazole, and no toxicities have occurred that limited the dosage and no serious or unexpected side effects occurred. However, vincristine has never been given with fenretinide or fenretinide plus ketoconazole before. Vincristine has been been given before with ketoconazole to both children and adults with neuroblastomas and other cancers.

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nct MAJ Il y a 4 ans

Comparison of Unilateral or Bilateral Fixation in the Treatment of LDD TLIF is a popular lumbar interbody fusion technique to perform anterior interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, an open approach is required, using bilateral pedicle screw fixation to provide stability as the gold standard. However, the increased stiffness of the fused segments will reduce the bone mineral content in adjacent vertebrae, and biomechanical studies have indicated that increased stress at the levels adjacent to the fusion may increase adjacent segment pathology. Therefore, unilateral pedicle screw fixation had been considered as a means to decrease the stiffness of the instrumented segment. Recently, researchers have shown that unilateral instrumented spinal fusion provides comparable results and is as effective as bilateral fixation. In addition, the cost-effectiveness of this approach is worthy of attention. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar degenerative diseases using instrumented TLIF with unilateral or bilateral pedicle screw fixation.

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Liesbeth Desender MAJ Il y a 4 ans

Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance Ongoing technological advances, especially in the field of image processing, have refined medical simulations to offer life-like replications of medical and surgical procedures in a variety of specialties. Patient-specific image data are incorporated into these simulations, and transformed into a 3D model. This enables the practitioner and his/her team to perform and practice 'real' cases on a virtual patient prior to performing the real procedure on the actual patient. This new technology has been referred to as 'patient-specific' rehearsal, also 'mission' or 'procedure' rehearsal. Research has already proven that simulated patient-specific rehearsal of a carotid artery stenting procedure may enhance surgical and team performance. The PROcedure rehearsal software can now also be used to practice patient-specific endovascular repair of infrarenal aortic aneurysms (EVAR). The ability to rehearse a challenging and complex procedure like EVAR may not only influence device selection based on preoperative planning, but also improve the technical performance of the surgeon/radiologist and the awareness and communication within the entire endovascular team. However, further research is needed to evaluate if this new technology may enhance clinical safety and efficiency, i.e. if patients actually benefit from physicians and team members conducting patient-specific rehearsals of EVAR interventions.

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Irene CM Cortese, M.D MAJ Il y a 4 ans

Oral Guanabenz for Multiple Sclerosis Background: - People with multiple sclerosis (MS) get lesions in their brain and spinal cord. These cause neurological symptoms and sometimes disability. Researchers want to see if a blood pressure drug called guanabenz can repair lesions and help people with MS. Objective: - To see if guanabenz is safe and well tolerated in people with MS. Eligibility: - People 18 55 years old with MS who have taken glatiramer acetate for the past year. Design: - Participants will be screened in a separate protocol. For 2 months, they will be examined and have magnetic resonance imaging (MRI) scans. This will decide if they are in the Stable or Active MS study group. - The study will last 5 months. There will be up to 11 visits, 5 overnight. - Visit 1: overnight stay at the clinic: - Medical history and physical exam. - Health questionnaire - Bladder ultrasound scan - Brain MRI - Electrocardiogram (EKG) to measure heart electrical activity - Blood will be drawn through an intravenous (IV) line. - Participants may have tests of strength, muscle tone, and movement. - They will get their first dose of the study drug, a tablet taken once a day. - Participants will take the study drug at home and keep a medicine diary. - The dose will slowly increase. Each time, participants will stay overnight at the clinic. They will have a physical exam, EKG, MRI, and IV blood draw. - Visit 6: Participants will have a physical exam, MRI, and blood drawn. They will get a schedule to slowly lower their drug dose and stop taking guanabenz. - Participants will have 2 final visits. They will have a physical exam, EKG, MRI, and IV blood draw.

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