Developing a cost-effective and efficient safety case management solution for data coordinating center projects.

A centralized safety function can support multiple clinical trials and provide efficient, standardized processes for the management of serious adverse events. From 2017 to 2022, the centralized safety desk used pharmacovigilance software compliant with FDA regulations, including 21 CFR Part 11. This software assisted with processing safety cases for regulated clinical trials, including allowing capture of event data, and provided process flow management, documentation storage, and transmission of safety reports to FDA.

Optimizing fuel treatments for community wildfire mitigation planning.

Fuel management is undertaken to mitigate the adverse consequences of wildfire. Finite mitigation budgets demand selective prioritization of forest stands for targeted fuel reduction treatments. A range of modeling methods have been used to identifiy optimal fuel treatment plans at various spatial and temporal scales of investigation; however, strategic analysis of fuel management alternatives can involve a range of limitations and challenges, including the prevalence of one-time solutions, static models lacking dynamic adaptability, and challenges in accounting for the stochastic nature of fire behaviour.

Long-term survival in a dog with probable thyroid storm.

Key Clinical Message: Thyroid storm is a rare, life-threatening endocrine emergency that may occur in dogs. With rapid identification and early aggressive therapy, long-term survival is possible.

Abstract: The aim of this paper was to describe the successful emergency management and long-term survival of a dog with probable thyroid storm.

Hospitalizations Among Children and Youth With Autism in the United States: Frequency, Characteristics, and Costs.

National estimates of hospitalization diagnoses and costs were determined using the 2016 HCUP Kids' Inpatient Database. Children and youth with autism were hospitalized over 45,000 times at over $560 million in costs and 260,000 inpatient days. The most frequent principal diagnoses for hospitalizations of children and youth with autism were epilepsy, mental health conditions, pneumonia, asthma, and gastrointestinal disorders, which resulted in almost $200 million in costs and 150,000 inpatient days.

Framing the front door: co-creating a home health care assessment of service need for children with disabilities.

This paper details the co-creation of a home health assessment tool for children with disabilities in the context of state-level systems change from traditional Medicaid to Medicaid managed care. A community based, sequential, mixed methods design was used to co-develop the assessment. A process evaluation highlighted community members' experiences with Medicaid managed care.

A Provider-Facing eHealth Tool for Transitioning Youth With Special Health Care Needs From Pediatric to Adult Care: Mixed Methods, User-Engaged Usability Study.

Background: There is a need for medical education on health care transitions for youth with special health care needs. The Texas Transition Toolkit (the tool) supports providers through a one-stop shop for researching literature on care transitions, a catalog of care transition tools, and guides for developing care transition programs.

Objective: This study aims to assess the functionality and usability of the tool with providers working with transition-aged children and youth with special health care needs (representative users).

Examining frequent emergency department use among children and adolescents with autism spectrum disorder.

This study used data for 5.9 million individuals with 9.1 million emergency department visits from all hospitals in the state of New York to explore frequent emergency department use between children and adolescents with autism spectrum disorders and those without autism spectrum disorders.

Use of Coronary Computed Tomography for Calcium Screening of Atherosclerosis.

Coronary artery calcium (CAC) scoring serves as a highly specific marker of coronary atherosclerosis. Based on the results of multiple large-scale, longitudinal population-based studies, CAC scoring has emerged as a reliable predictor of atherosclerotic cardiovascular disease (ASCVD) presence and risk assessment in asymptomatic patients across all age, sex and racial groups. Therefore, the measurement of CAC is useful in guiding clinical decision-making for primary prevention (e.

Neutrophil adhesion in brain capillaries reduces cortical blood flow and impairs memory function in Alzheimer's disease mouse models.

Cerebral blood flow (CBF) reductions in Alzheimer's disease patients and related mouse models have been recognized for decades, but the underlying mechanisms and resulting consequences for Alzheimer's disease pathogenesis remain poorly understood. In APP/PS1 and 5xFAD mice we found that an increased number of cortical capillaries had stalled blood flow as compared to in wild-type animals, largely due to neutrophils that had adhered in capillary segments and blocked blood flow. Administration of antibodies against the neutrophil marker Ly6G reduced the number of stalled capillaries, leading to both an immediate increase in CBF and rapidly improved performance in spatial and working memory tasks.

Harness Suspension Stress: Physiological and Safety Assessment.

Unlabelled: : Hanging motionless in a full body harness may result in unwanted events, such as acute hypotension and syncope, which has been termed harness suspension stress (HSS). The etiology of HSS has not been explored, and it is unknown if the type of harness influences the HSS response.

Objectives: Evaluate hemodynamics, subjective discomfort, and biological markers of muscle damage during 30-minutes suspension; and evaluate differences between harness attachment (frontal or dorsal).

Satiety and memory enhancing effects of a high-protein meal depend on the source of protein.

Objective: High- protein diets have become increasingly popular with various touted benefits. However, the extent to which protein quantity and source affects cognitive functioning through altering postprandial amino acid profiles has not been investigated. Further, whether all protein sources are similarly anorexigenic is uncertain.

Synthetic, organic compound vepoloxamer (P-188) potentiates tissue plasminogen activator.

Objective: Poloxamer-188 is a synthetic, organic compound that acts by binding hydrophobic pockets on damaged lipid bilayers in the circulation. P-188 reduces blood viscosity and confers anti-inflammatory and cytoprotective effects. Vepoloxamer (Mast Therapeutics, San Diego, Calif) is a purified version of this compound that has limited side effects.

Ice Climbing Festival in Sochi 2014 Winter Olympics: Medical Management and Injury Analysis.

Objective: Sports ice climbing (SIC) is developing rapidly as an independent sport with Olympic potentials. To date there has been no prior systematic evaluation of injury risks and injury patterns in a SIC-specific setting.

Methods: This paper reports injury statistics collected during the Ice Climbing Festival, which was held during the XXII Winter Olympics in Sochi, Russia.

The influence of geographic isolation on late preterm infant and mother outcomes.

Purpose: Risk of adverse outcome in late-preterm infants (born between 34 and 36 weeks and 6 days' gestation) is heightened for those living in geographic isolation (GI). We examined the relationships between GI and several mother and infant outcomes.

Subjects And Design: This was a tricenter cross-sectional study of 38 English-speaking late-preterm infant/mother dyads admitted to neonatal intensive care in a predominately rural Midwestern state.

The effects of a harness safety system during maximal treadmill run testing in collegiate middle- and long-distance runners.

This study compared the results of graded maximal treadmill testing with and without a safety harness (SH) spotting system among collegiate middle- and long-distance runners. Thirteen (n = 8 men, n = 5 women) collegiate runners completed 2 randomly selected maximal treadmill tests. One trial used an SH, and one trial used no harness.

Rate of fall in blood glucose and recurrent hypoglycemia affect glucose dynamics and noradrenergic activation in the ventromedial hypothalamus.

Noradrenergic activity in the ventromedial hypothalamus (VMH) is increased and activates a sympathoadrenal response during hypoglycemia. How the rate at which hypoglycemia develops affects local glucose concentrations and norepinephrine (NE) release was evaluated by placing microdialysis probes into the VMH of male Sprague-Dawley rats receiving insulin (20 mU·kg(-1)·min(-1)) and variable glucose infusions. During a first episode of hypoglycemia, interstitial glucose concentrations in the VMH generally declined at the same rate as plasma glucose; however, the faster hypoglycemia developed, the greater the magnitude of the initial NE release in the VMH (r(2) = 0.

Intracerebroventricular administration of soy protein hydrolysates reduces body weight without affecting food intake in rats.

Some studies suggest that increased consumption of soy protein hydrolysates may cause body weight loss but the mechanism of action is unknown. The objective of this investigation was to determine whether intracerebroventricular (i.c.

Orexin-induced feeding requires NMDA receptor activation in the perifornical region of the lateral hypothalamus.

Food intake is stimulated following administration of orexin-A into the perifornical region of the lateral hypothalamus (LH/PFA). Orexin neurons originating in the LH/PFA interact with a number of hypothalamic systems known to influence food intake, including glutamatergic neurons. Glutamatergic systems in the LH/PFA were demonstrated to initiate feeding through N-methyl-d-aspartic acid (NMDA) receptors.

Noradrenergic activity in the paraventricular nucleus and macronutrient choice during early dark onset by zinc deficient rats.

Carbohydrate is a preferred macronutrient of rats during the early dark phase and associated with an increase in norepinephrine (NE) and neuropeptide Y (NPY) in the paraventricular nucleus (PVN). Macronutrient choice is altered during zinc deficiency (ZD). The relationship between NE activity in the PVN and macronutrient choice during early dark was evaluated in rats fed zinc adequate (ZA) or ZD diet for 14 days.

ATP-sensitive K(+) channels regulate the release of GABA in the ventromedial hypothalamus during hypoglycemia.

OBJECTIVE-To determine whether alterations in counterregulatory responses to hypoglycemia through the modulation of ATP-sensitive K(+) channels (K(ATP) channels) in the ventromedial hypothalamus (VMH) are mediated by changes in GABAergic inhibitory tone in the VMH, we examined whether opening and closing K(ATP) channels in the VMH alter local GABA levels and whether the effects of modulating K(ATP) channel activity within the VMH can be reversed by local modulation of GABA receptors. RESEARCH DESIGN AND METHODS-Rats were cannulated and bilateral guide cannulas inserted to the level of the VMH. Eight days later, the rats received a VMH microinjection of either 1) vehicle, 2) the K(ATP) channel opener diazoxide, 3) the K(ATP) channel closer glybenclamide, 4) diazoxide plus the GABA(A) receptor agonist muscimol, or 5) glybenclamide plus the GABA(A) receptor antagonist bicuculline methiodide (BIC) before performance of a hypoglycemic clamp.

Orexin A in the rostrolateral hypothalamic area induces feeding by modulating GABAergic transmission.

The neuromodulatory peptides orexin A and B are important central nervous system regulators of appetite. We previously identified the rostral lateral portion of the hypothalamus as an area important to orexin A feeding regulation. As gamma-aminobutyric-acid (GABA) within the lateral hypothalamus also mediates feeding, we sought to determine the relationship between orexin and GABA signaling within this site.