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NCT ID: NCT03447899 Completed - Clinical trials for Non-Accidental Traumatic Head Injury to Child

Longitudinal, Multi-Dimensional Assessment of Recovery and Added Benefit of a Behavioral Health Intervention for Children With Abusive Head Trauma

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

Family dynamics and caregiver responses to a child with traumatic brain injury are implicated both as precipitating events as well as factors influencing outcomes of abusive head trauma (AHT). However, no family behavioral health intervention exists to meet the unique needs of families with infants and very young children with AHT. The study was initially designed as a randomized controlled trial (RCT) to assess the efficacy of an evidence-based behavioral intervention to improve outcomes for families and children with AHT. However, rates of recruitment were so low that the investigators and funder amended the study to be intervention only (with IRB approval). At that time, there were five participants and only one had been assigned to the intervention arm. Only one additional family was recruited, and that family did not complete study measures prior to the time at which the intervention would start and did not receive the intervention. The investigators did examine outcomes in multiple dimensions, including clinical, cognitive, family, caregiver, child behavior, and service usage over time but connot compare to patients not receiving the intervention. The investigators were not able to examine characteristics of patients and families best suited for this behavioral health intervention.

NCT ID: NCT03447782 Completed - Clinical trials for New Daily Persistent Headache (NDPH)

Endogenous Modulation and Central Sensitization in New Daily Persistent Headache ( NDPH ) in Children

EMCS-NDPH
Start date: July 23, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

New daily persistent headache (NDPH) is a primary headache disorder characterized by the daily and unremitting headache pain patients experience with a distinct onset. Despite the known significant impairment associated with NDPH, the process by which some patients with NDPH recover within months while others do not is unknown. The investigators propose to refine the clinical definition and suggest a novel mechanism underlying new daily persistent headache (NDPH) in adolescents. They further aim to investigate low-dose naltrexone for the treatment of new daily persistent headache. Healthy controls will also be enrolled in order to investigate the existence of a biomarker for NDPH. Adolescents ages 10-17 will be recruited from Boston Children's Hospital Pediatric Headache Program.

NCT ID: NCT03447574 Completed - Clinical trials for Development of Non-invasive Protocol

Fluid Volume During Fluid Shifts

Start date: June 27, 2018
Phase: N/A
Study type: Interventional

This study is designed to answer the question of if several non-invasive methods are comparable to the invasive clinical gold standard of radiolabeled albumin in terms of detecting changes in fluid volume. It is broken into two studies: Aim 1 Study A is designed as a pilot phase to develop the non-techniques, and Aim 2 Study B is comparing these techniques to the gold standard.

NCT ID: NCT03447535 Completed - Clinical trials for Oppositional Defiant Disorder With Familial Setting

Better Understand Children and Adolescents' Intrafamilial Oppositional Defiant Disorder

TOPi
Start date: December 1, 2017
Phase: N/A
Study type: Observational

Oppositional Defiant Disorder (ODD) is defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) as: "A pattern of angry/irritable mood, argumentative/defiant behavior, or vindictiveness lasting at least 6 months exhibited during interaction with at least one individual who is not a sibling." "The disturbance in behavior is associated with distress in the individual or others in his or her immediate social context (e.g., family, peer group, work colleagues), or it impacts negatively on social, educational, occupational, or other important areas of functioning." Children with "classic" oppositional defiant disorder, except for mild forms, show symptoms in several settings (at home, at school, with peers). In this study, the investigators will consider the specifics of children presenting "intrafamilial" oppositional defiant disorder (IODD). These children's symptoms are confined to only one setting: the home. Therefore, the aim of this study will be to characterize children with intrafamilial oppositional defiant disorder. The investigators want to understand the differences between IODD and classical forms of ODD in terms of psychiatric comorbidities, medical histories and cognitive abilities. They also investigate what clinicians currently do to help these families.

NCT ID: NCT03447496 Completed - Clinical trials for Lateral Condyle Fractures,Humerus,Jakob? Classification,Reduction

Surgical Treatment for the Displaced Jakobâ…¡ Classification Humerus Lateral Condylar Fractures in Children

JCHLCF
Start date: January 1, 2018
Phase:
Study type: Observational

Multi-center Study on Surgical Treatment for the Displaced Jakobâ…¡ Classification Humerus Lateral Condylar Fractures in Children.

NCT ID: NCT03447223 Completed - Clinical trials for Attention-deficit/Hyperactivity Disorder

Gut Microbiome and Serum Metabolome Alterations in ADHD Patients

ADHD
Start date: March 20, 2018
Phase:
Study type: Observational

Host-microbe interactions play a key role in brain development and function and in the etiology of neurodevelopmental disorders. Attention-deficit/hyperactivity disorder (ADHD) is a heterogeneous disorder that affects 1 in 20 children and results in poor life-time outcomes. However, the etiology of ADHD is unclear and its diagnosis and treatment are still challenging. Different factors reported to be associated with the risk of developing ADHD and/or linked to different ADHD manifestations have also been linked to shifts in gut microbiota composition, suggesting a link between the microbiota and the disorder. Here, we will perform a metagenome-wide association study and serum metabolomics profiling in a cohort of control and ADHD, 6-15 years, Chinese individuals. We aim to identify ADHD-associated gut microbial species linked to changes in circulating metabolites. We also aim to find the possible intervention strategy in ADHD by targeting the gut microbiota.

NCT ID: NCT03447119 Completed - Health Education Clinical Trials

Living Well With a Disability Curriculum Adaptation Evaluation Plan

Start date: March 24, 2018
Phase: N/A
Study type: Interventional

The purpose of this proposal is to implement a joint project with Georgia Southern University and the Effingham County Navigator Team to improve the quality of life of families with a child with a disability in southeast Georgia. The final outcome of this project will be a new curriculum, Living Well Together, which builds on a previous implementation of the Living Well with a Disability curriculum in Bulloch County.

NCT ID: NCT03447002 Completed - Clinical trials for Premature Ventricular Contraction

Urine Levels of Metanephrin and Normetanephrin in Patients With Frequent Ventricular Premature Complex

Start date: February 15, 2018
Phase:
Study type: Observational

Enhanced automaticity process is the underlying mechanism for arrhythmias due to excess catecholamines. Catecholamines may increase in patients with PVC. Metabolites of catecholamines are metanephrine and normetanephrine. Our aim is to measure 24 hours urine levels of metanephrine and normetanephrine.

NCT ID: NCT03446937 Completed - Clinical trials for Neonatal Respiratory Distress Syndrome

Effect of Antenatal Corticosteroids on Neonatal Morbidity.

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

It will be a randomized controlled trial. There will be two study groups. Study group 1 will be given dexamethasone while study group 2 will be given betamethasone. The control group will be given placebo.

NCT ID: NCT03446885 Completed - Clinical trials for Attention Deficit Disorder With Hyperactivity

Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With ADHD

Start date: April 1, 2018
Phase: Phase 4
Study type: Interventional

There has been little research on the third area of impairment noted in the Diagnostic and Statistical Manual of Mental Disorders - "occupational functioning." Individuals with ADHD experience job-related impairments including a greater likelihood of being unemployed and not enrolled in school and for those that were employed they were in a lower status occupation, relative to typically-developing comparison peers. The current literature on analogue workplace settings and the effects of lisdexamfetamine dimesylate includes office-based tasks similar to school seat work. Unfortunately, this is inconsistent with the typical work environment most common for individuals with disabilities such as ADHD where food preparation is the most common job following high school. Therefore, medication effects in this type of setting, most common for individuals with ADHD entering the workforce, need to be studied. The investigators propose to study workplace behavior in an analogue work setting in a laboratory "pizza place." Individuals with ADHD will participate in an interview with a supervisor each day, have a list of deliveries that need to be managed, deal with situations that require occupational judgment and appropriate customer service, and drive to make deliveries accurately and on-time. These behaviors can be reliably assessed within the laboratory. Twenty young adults will participate in two "workdays" within a randomized, double-blind, placebo-controlled design wherein participants will be administered placebo and .3 mg/kg lisdexamfetamine dimesylate in a counter-balanced order.