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Children clinical trials

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NCT ID: NCT01993992 Active, not recruiting - Anxiety Clinical Trials

Parental Anxiety and Its Relationship With Pediatric Patients' Post-operative Responses

Start date: December 2013
Phase: N/A
Study type: Observational

Post-operative delirium had multiple risk factors, such as pre-operative anxiety status, post-operative pain, and anesthetic method. We currently decrease pre-operative anxiety by parental accompanying until the children put to sleep. However, references indicate that parental anxiety can increase the post-operative delirium. Heart rate variability was used to measure the anxiety status of parents. We think sympathetic tone elevation measured by heart rate variability may not induce by anxiety alone, thus we want to explore this question by using Stat-Trait Anxiety Inventory questionnaire.

NCT ID: NCT01874847 Active, not recruiting - Clinical trials for Traumatic Brain Injury

PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin

PLAYGAME
Start date: September 2013
Phase: Phase 2/Phase 3
Study type: Interventional

PURPOSE: The long-term goal of this line of research is to develop rational, biologically based evidence for the treatment of post-concussion syndrome (PCS) in children. The objective of this application is to examine the effect of melatonin on the symptoms of PCS and its neurobiology using integrated neurodiagnostic techniques in children. OVERVIEW: PCS is a constellation of clinical symptoms including physical (i.e. headaches), cognitive (i.e. memory), and behavioral disturbances. PCS is associated with significant morbidity in the child and his/her family), and yet there are no evidence-based medical treatments available. This suggests an urgent need to develop novel treatment options to improve outcomes for children suffering from PCS. Melatonin has several relevant mechanisms of action, and neuroprotective effects. Recent research suggests that the explanations for persistent PCS symptoms may be due to alterations in neurotransmissions and neuronal circuitry, particularly involving the dorsolateral prefrontal cortex (DLPFC). Investigators have two specific aims: 1. To determine if treatment with melatonin improves PCS in children following mild traumatic brain injury. Hypothesis: treatment of mTBI children with PCS with 3mg or 10mg of oral melatonin for 28 days will result in a decrease in PCS symptoms as compared with placebo. Effects will be dose-dependent and may be independent of sleep effects. Methods: A randomized double blind, placebo controlled trial (RCT); Outcome measure is a PCS symptom questionnaire. A subsequent RCT will then be performed using the optimal melatonin dose at a second centre. 2. To understand the neurophysiological mechanisms of paediatric PCS and assess any resultant effects of treatment with melatonin. Methods: A case-controlled study within the RCT, using functional MRI and Transcranial Magnetic Stimulation to investigate the neurophysiological properties of paediatric mTBI before and after treatment; Treatment groups from the RCT will be compared with two control groups: i) normal controls and ii) asymptomatic mTBI children. SIGNIFICANCE: This study has the potential to 1) provide a safe and effective treatment for PCS and 2) will provide valuable information about the neurophysiological properties of the brain associated with PCS following mTBI in children and how these change with symptom resolution.

NCT ID: NCT01574352 Active, not recruiting - Obesity Clinical Trials

The Odense Overweight Intervention Study

OOIS
Start date: April 2012
Phase: N/A
Study type: Interventional

Strong and consistent evidence have shown that overweight, including obesity, is an important risk factor for the development of cardiovascular disease (CVD) in adults. Several studies have found an association between overweight in childhood and increased risk of morbidity and mortality later in life. The prevalence of overweight in children and adolescents has increased in recent years, and consequently it is important to identify effective approaches in the prevention and treatment of overweight in young individuals. Approaches such as resident weight loss camps have shown promising results. A residential camp setting provides an opportunity to increase and control exposure to, for instance, particular foodstuffs, beverages and physical activity opportunities. However, well-designed studies with sufficient participants are still needed on the reversal of overweight in childhood with increased focus on documenting predictors of behavior changes associated with decreases in overweight. This study is carried through as a randomized controlled trial which investigates the effect of participating in a 6 week health promoting resident for overweight fifth grade children camp followed by 46 weeks of family support. The study hypothesis is that participating in a 6 week resident camp and a following period of 46 weeks of child and family support will induce a reduction in body mass index (BMI). In addition it is expected that the intensity and duration intervention program is sufficient to cause changes in physiological parameters related to a reduced risk of lifestyle diseases.

NCT ID: NCT01536275 Active, not recruiting - Critical Illness Clinical Trials

Early Versus Late Parenteral Nutrition in the Pediatric Intensive Care Unit

PEPaNIC
Start date: June 2012
Phase: N/A
Study type: Interventional

In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the first week in critically ill children is beneficial, compared to the current standard of the early start of parenteral nutrition.

NCT ID: NCT01031407 Active, not recruiting - Children Clinical Trials

Cognitive Neuroscience of Autism Spectrum Disorders

Start date: February 21, 2010
Phase:
Study type: Observational

Background: - Autism spectrum disorders (ASDs) are a group of developmental disorders that affect communication, social interaction, and behavior. Relatively little is known about the relationship between genetics and behavior among these individuals and their close relatives. Researchers are interested in using interviews and rating scales to better understand these issues, as well as collecting brain scan data and genetic samples for testing and comparison. - By comparing test results and genetic samples from healthy volunteers, people with ASD, and parents (or caregivers or legal guardians) of the first two groups, researchers hope to better understand the neuroscience of ASD. Objectives: - To learn more about the brain in healthy people and in people with autism spectrum disorders. - To study genes that might be involved in autism spectrum disorders by collecting DNA samples from participants. Eligibility: The following groups of participants will be eligible for the study: - Individuals between 5 and 89 years of age who have autism spectrum disorders. - Healthy volunteers between 5 and 89 years of age. - Cognitively impaired children between 5 and 17 years of age. - Parents/caregivers/legal guardians of individuals in the above three groups. Design: - Participants will visit the National Institutes of Health Clinical Center for research tests, which will be administered over multiple visits. Researchers will determine the specific tests to be administered based on the medical history of the study participant. - Researchers will study the brain through interviews, tests of thinking and memory (neuropsychological tests), brain imaging with magnetic resonance imaging (MRI), and magnetoencephalography (MEG). - The study will also collect blood or saliva to obtain a DNA sample.

NCT ID: NCT00989547 Active, not recruiting - Type 1 Diabetes Clinical Trials

Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM)

Start date: September 2008
Phase: Phase 1
Study type: Interventional

Type 1 diabetes (T1D) is still associated with tremendous morbidity and premature mortality. Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. Unfortunately, there is presently no permanent cure for diabetes. Whole pancreas or islet cell transplantation is available only to a very limited number of patients and necessitates potential lifelong immunosuppressive therapy. Autologous stem cell transplants have been used successfully for ALL (acute lymphoblastic leukemia), AML (acute myeloblastic leukemia) and for the treatment of a variety of cancers including breast cancer and neuroblastomas, and more recently for the treatment of autoimmune disorders such as multiple sclerosis (MS), lupus-like disease, and rheumatic disorders. Recently it was shown that bone marrow-derived stems cells transplanted into diabetic mice led to reduced hyperglycemia within 7 days after transplantation and was sustained until they were sacrificed at 35 days post-transplantation. The investigators' goal is to transfuse autologous umbilical cord blood into 23 children (Germany 10 and 20 Controls) with T1D in an attempt to regenerate pancreatic islet insulin producing beta cells and improve blood glucose control. As secondary goals, the investigators aim to track the migration of transfused cord blood stem and study the potential changes in metabolism/immune function leading to islet regeneration.