Analysis of time to regulatory approval in an exception from informed consent trial in trauma patients.

Background: The interactive media-based approach to community consultation and public disclosure (CC/PD), a key step when conducting exception from informed consent (EFIC) clinical trials, is intended to be completed in 4 months. This analysis characterizes the process, from initiation of CC/PD activities to institutional review board approval, to better understand the barriers and how these can be mitigated.

Methods: This is a retrospective post hoc analysis of data collected as part of the CC/PD campaigns conducted for a large trial involving up to 90 trauma centers in the United States.

Parent-Reported Outcome Measures for Individuals with Fragile X Syndrome: Clinically Meaningful Change Thresholds.

Estimating meaningful change thresholds (MCT) on clinical outcome assessments is an important consideration when evaluating treatments. In fragile X syndrome (FXS) research, there has been no consensus on how to define MCT's on several commonly used outcome measures. The purpose of the current study was to determine clinically relevant MCT's of caregiver-rated assessments using data from a phase 3 clinical trials of arbaclofen (Berry-Kravis et al.

Volunteering in Young Adulthood: Complex Associations With Later Health and Well-Being Outcomes.

Purpose: To investigate whether in volunteering from adolescence to young adulthood are associated with subsequent health and well-being outcomes in adulthood.

Design: Longitudinal cohort study.

Setting: National Longitudinal Study of Adolescent to Adult Health.

Quality effects of home acquisitions in residential aged care.

Objective: The recent consolidation of the Australian residential aged care market has raised concerns about the potential adverse effects of acquisition activity on quality of care (QoC). We examined changes in QoC outcomes within acquired homes and the influence of the acquiring providers' characteristics on these post-acquisition outcomes.

Methods: A retrospective observational study was conducted using de-identified data sets obtained under the legal authority of the Royal Commission into Aged Care Quality and Safety.

Cell-free DNA methylation analysis as a marker of malignancy in pleural fluid.

Diagnosis of malignant pleural effusion (MPE) is made by cytological examination of pleural fluid or histological examination of pleural tissue from biopsy. Unfortunately, detection of malignancy using cytology has an overall sensitivity of 50%, and is dependent upon tumor load, volume of fluid assessed, and cytopathologist experience. The diagnostic yield of pleural fluid cytology is also compromised by low abundance of tumor cells or when morphology is obscured by inflammation or reactive mesothelial cells.

Outcomes From a Physician Health Center.

This retrospective cohort study describes the population of physicians seeking medical evaluation in a dedicated physician health center and identifies factors associated with needing practice restrictions. Participants had an initial evaluation between January 1, 2016, and December 31, 2022. We report personal and professional demographics and types of medical conditions in this cohort.

Cell-Free DNA Methylation Analysis as a Marker of Malignancy in Pleural Fluid.

Background: Diagnosis of malignant pleural effusion (MPE) is made by cytological examination of pleural fluid or histological examination of pleural tissue from biopsy. Unfortunately, detection of malignancy using cytology has an overall sensitivity of 50%, and is dependent upon tumor load, volume of fluid assessed, and cytopathologist experience. The diagnostic yield of pleural fluid cytology is also compromised by low abundance of tumor cells or when morphology is obscured by inflammation or reactive mesothelial cells.

Pan-tissue mitochondrial phenotyping reveals lower OXPHOS expression and function across cancer types.

Targeting mitochondrial oxidative phosphorylation (OXPHOS) to treat cancer has been hampered due to serious side-effects potentially arising from the inability to discriminate between non-cancerous and cancerous mitochondria. Herein, comprehensive mitochondrial phenotyping was leveraged to define both the composition and function of OXPHOS across various murine cancers and compared to both matched normal tissues and other organs. When compared to both matched normal tissues, as well as high OXPHOS reliant organs like heart, intrinsic expression of the OXPHOS complexes, as well as OXPHOS flux were discovered to be consistently lower across distinct cancer types.

Review of particle deposition to and removal from clothing, skin, and hair after a radioactive airborne dispersal event.

Explosive Radiological Dispersal Devices (RDD) - aka dirty bombs - are seen as a credible method to carry out a radiological terror attack. After exploding a radioactive source, the radionuclide-laden plume will be blown downwind of ground zero, with particles falling out and potentially depositing on people caught in and under the cloud. Some of these people may not show any sign of radiation sickness and therefore not realize they have been contaminated and may take the radioactive particulate with them on their daily activities, thus spreading the radioactive particulate outside the initially contaminated area.

Health Related Quality of Life in Autistic Youth and Their Families.

Purpose: The construct Quality of Life (QoL) involves a range of factors related to one's well-being. Individuals on the autism spectrum have been previously reported to have lower QoL. The purpose of the present study is to examine QoL in autistic individuals and their families and to evaluate associations between QoL and measures of functioning using the PedsQL 4.

The impact of cross-jurisdictional patient flows on ascertainment of hospitalisations and cardiac procedures for ST-segment-elevation myocardial infarction in an Australian population.

Introduction: The patient journey for residents of New South Wales (NSW) Australia with ST-elevation myocardial infarction (STEMI) often involves transfer between hospitals and these can include stays in hospitals in other jurisdictions.

Objective: To estimate the change in enumeration of STEMI hospitalisations and time to subsequent cardiac procedures for NSW residents using cross-jurisdictional linkage of administrative health data.

Methods: Records for NSW residents aged 20 years and over admitted to hospitals in NSW and four adjacent jurisdictions (Australian Capital Territory, Queensland, South Australia, and Victoria) between 1 July 2013 and 30 June 2018 with a principal diagnosis of STEMI were linked with records of the Australian Government Medicare Benefits Schedule (MBS).

Exploring associations among morphometric measurements, genetic group of sire, and performance of beef on dairy calves.

Sire selection for beef on dairy crosses plays an important role in livestock systems as it may affect future performance and carcass traits of growing and finishing crossbred cattle. The phenotypic variation found in beef on dairy crosses has raised concerns from meat packers due to animals with dairy-type carcass characteristics. The use of morphometric measurements may help to understand the phenotypic structures of sire progeny for selecting animals with greater performance.

Improving Environmental Health in Schools.

School environmental conditions have immediate and long-term effects on student health and learning. Relying on disconnected, inconsistent, voluntary, or unenforced environmental standards has not resulted in sufficient protection of students from toxic insults. Furthermore, the United States public school system was not prepared to navigate a potentially deadly infectious disease like COVID-19.

Dirty bomb source term characterization and downwind dispersion: Review of experimental evidence.

Dirty bombs are considered one of the easiest forms of radiological terrorism, a form of terrorism based on the deliberate use of radiological material to cause adverse effects in a target population. One U.S.

Development of an improved standard reference material for folate vitamers in human serum.

The US National Institute of Standards and Technology (NIST) developed a Standard Reference Material® (SRM®) 3949 Folate Vitamers in Frozen Human Serum to replace SRM 1955 Homocysteine and Folate in Human Serum. The presence of increased endogenous levels of folic acid and 5-methyltetrahydrofolate (5mTHF) in SRM 3949, enhanced folate stability via addition of ascorbic acid, and inclusion of values for additional minor folates are improvements over SRM 1955 that should better serve the clinical folate measurement community. The new SRM contains folates at three levels.

The quality effects of agency staffing in residential aged care.

Objectives: In Australia, temporary agency workers are a relatively small but enduring component of the residential aged care workforce. However, evidence from other countries suggests reliance on agency workers has a detrimental effect on the quality of care (QoC). We examined whether QoC outcomes differ for Australian residential aged care facilities (RACFs) based on their reliance on agency care staff.

Bioenergetic Phenotyping of DEN-Induced Hepatocellular Carcinoma Reveals a Link Between Adenylate Kinase Isoform Expression and Reduced Complex I-Supported Respiration.

Hepatocellular carcinoma (HCC) is the most common form of liver cancer worldwide. Increasing evidence suggests that mitochondria play a central role in malignant metabolic reprogramming in HCC, which may promote disease progression. To comprehensively evaluate the mitochondrial phenotype present in HCC, we applied a recently developed diagnostic workflow that combines high-resolution respirometry, fluorometry, and mitochondrial-targeted nLC-MS/MS proteomics to cell culture (AML12 and Hepa 1-6 cells) and diethylnitrosamine (DEN)-induced mouse models of HCC.

Individual and Combined Effects of Paternal Deprivation and Developmental Exposure to Firemaster 550 on Socio-Emotional Behavior in Prairie Voles.

The prevalence of neurodevelopmental disorders (NDDs) is rapidly rising, suggesting a confluence of environmental factors that are likely contributing, including developmental exposure to environmental contaminants. Unfortunately, chemical exposures and social stressors frequently occur simultaneously in many communities, yet very few studies have sought to establish the combined effects on neurodevelopment or behavior. Social deficits are common to many NDDs, and we and others have shown that exposure to the chemical flame retardant mixture, Firemaster 550 (FM 550), or paternal deprivation impairs social behavior and neural function.

Liquid biopsy, using a novel DNA methylation signature, distinguishes pancreatic adenocarcinoma from benign pancreatic disease.

We tested the ability of a novel DNA methylation biomarker set to distinguish metastatic pancreatic cancer cases from benign pancreatic cyst patients and to monitor tumor dynamics using quantitative DNA methylation analysis of cell-free DNA (cfDNA) from blood samples. The biomarkers were able to distinguish malignant cases from benign disease with high sensitivity and specificity (AUC = 0.999).

Development of Kudzu (Pueraria Montana var. lobata) Reference Materials for the Determination of Isoflavones and Toxic Elements.

Background: In collaboration with the Office of Dietary Supplements at the National Institutes of Health, the National Institute of Standards and Technology issued a suite of botanical matrix reference materials (RMs) and Standard Reference Material® (SRM) for determination of isoflavones and toxic elements in kudzu dietary supplement ingredients.

Objective: RM 8650 Pueraria montana var. lobata (Kudzu) Rhizome, SRM 3268 Pueraria montana var.