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Pediatric Hypothalamic Obesity Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Pediatric Hypothalamic Obesity conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Pediatric Hypothalamic Obesity Clinical research trials and Pediatric Hypothalamic Obesity health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Pediatric Hypothalamic Obesity. Pediatric Hypothalamic Obesity Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Pediatric Hypothalamic Obesity clinical trial. Subjects frequently get the best healthcare possible for their Pediatric Hypothalamic Obesity condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.

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Pediatric Hypothalamic Obesity



Pediatric Hypothalamic Obesity

For Condition: Obesity
Status: Not yet recruiting
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: This trial is being conducted in pediatric patients with Hypothalamic Obesity. This generally occurs in people who have had an injury to or tumor in their hypothalamus (gland or organ that secretes hormones). The purpose of this trial is to see how an investigational treatment controls the hormone insulin by lowering the level of insulin in the body resulting in a weight loss in children who are at least 6 years of age but less than 18 years of age. Some children in this trial will receive placebo. To qualify for this study, you and your child’s doctor must feel that your child’s weight is inadequately controlled within a year from the time of injury to the hypothalamus or tumor of the hypothalamus. This study will help to determine if an investigational treatment is of benefit in controlling a child’s weight.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 6 Years/18 Years
Genders: Both
Protocol Entry Criteria: - Male and female patients ages 6 to less than 18 - Patients who have experienced any form of cranial insult related to cranial trauma, or to a tumor or it’s treatment (i.e. surgery, radiation, and/or chemotherapy) - Patients who are at least one year out following therapy for their tumor - Patients who have severe cardiovascular dysfunction (for example cardiomyopathy, congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation) will be excluded - Patients with severe neurologic handicaps which preclude normal physical activity will be excluded. - Patients confined to bed and those patients who are wheelchair bound which prevents them from activities of daily living or normal physical activity, i.e. walking, will be excluded from the trial - Your child must be greater than 120% of their ideal body weight for their height or have a body mass index that is greater than or equal to 27.
Total Enrollment: 50

Location and Contact Information:


Additional Information:
Study ID Numbers:  CSMS995B2403; 
Study Start Date: March 2004
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076362

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