Bayesian design of clinical trials with multiple time-to-event outcomes subject to functional cure.

With the continuous advancement of medical treatments, there is an increasing demand for clinical trial designs and analyses using cure rate models to accommodate a plateau in the survival curve. This is especially pertinent in oncology, where high proportions of patients, such as those with melanoma, lung cancer, and endometrial cancer, exhibit usual life spans post-cancer detection. A Bayesian clinical trial design methodology for multivariate time-to-event outcomes with cured fractions is developed.

Understanding the opioid syndemic in North Carolina: A novel approach to modeling and identifying factors.

The opioid epidemic is a significant public health challenge in North Carolina, but limited data restrict our understanding of its complexity. Examining trends and relationships among different outcomes believed to reflect opioid misuse provides an alternative perspective to understand the opioid epidemic. We use a Bayesian dynamic spatial factor model to capture the interrelated dynamics within six different county-level outcomes, such as illicit opioid overdose deaths, emergency department visits related to drug overdose, treatment counts for opioid use disorder, patients receiving prescriptions for buprenorphine, and newly diagnosed cases of acute and chronic hepatitis C virus and human immunodeficiency virus.

Differences in brain volume in individuals with mild cognitive impairment and normal cognition across different anatomical regions: The Atherosclerosis Risk in Communities (ARIC) study.

Background: Mild cognitive impairment (MCI) represents a stage between cognitively normal and Alzheimer's disease. Despite much published research on MCI, there continues to be a knowledge gap of volumetric brain changes in MCI versus cognitively normal (CN) in racially diverse, community-based samples.

Objective: The study aimed to understand differences in volume of selected brain regions in individuals with MCI versus those who are cognitively normal.

Assessing plasma-activated water as an acidic and sanitizer solution in clean-in-place (CIP) and comparing efficacy with other traditional CIP chemicals.

Cleaning-in-place (CIP) is the most commonly used cleaning and sanitation procedure for removing fouling deposits. Traditional CIP includes a series of chemical cleaning cycles, including alkaline, acid, and sanitizer. However, these chemicals are hazardous to the environment and employees.

Clin-STAR Corner: Rehabilitation for Older Adults With Heart Failure.

Heart failure is a major contributor to morbidity, mortality, and healthcare costs, especially among older adults. Despite a large body of evidence supporting the benefits of cardiac rehabilitation, less than 30% of eligible Medicare beneficiaries participate in cardiac rehabilitation. Thus, it is essential to examine alternatives, such as physical rehabilitation, a rehabilitation approach that focuses on physical activity and function.

Deployment and transcriptional evaluation of nitisinone, an FDA-approved drug, to control bed bugs.

Background: Bed bugs are blood-feeders that rapidly proliferate into large indoor infestations. Their bites can cause allergies, secondary infections and psychological stress, among other problems. Although several tactics for their management have been used, bed bugs continue to spread worldwide wherever humans reside.

Sex-specific effects on the heart from combined exposure to simulated galactic cosmic radiation and hindlimb unloading.

Future long duration space missions will expose astronauts to higher doses of galactic cosmic radiation (GCR) than those experienced on the international space station. Recent studies have demonstrated astronauts may be at risk for cardiovascular complications due to increased radiation exposure and fluid shift from microgravity. However, there is a lack of direct evidence on how the cardiovascular system is affected by GCR and microgravity since no astronauts have been exposed to exploratory mission relevant GCR doses.

Obsessive-compulsive symptoms in individuals with a history of eating disorders.

Background: OCD symptoms are well documented in anorexia nervosa (AN) and to a lesser extent in bulimia nervosa (BN), yet remain virtually unstudied in binge-eating disorder (BED).

Methods: In this cross-sectional observational study, 5927 participants with lifetime eating disorders (EDs) (i.e.

Consensus recommendations for measuring the impact of contraception on the menstrual cycle in contraceptive clinical trials.

Objective: We sought to develop consensus recommendations for measurement and analysis of data on contraceptive-induced menstrual changes (CIMCs) in contraceptive clinical trials. We built upon previous standardization efforts over the last 50 years and prioritized input from a variety of global experts and current regulatory authority guidance on patient-reported outcomes.

Study Design: We completed a formal consensus-building process with an interdisciplinary group of 57 experts from 30 organizations and 14 countries in five global regions who work across academia, nonprofit research organizations, the pharmaceutical industry, and funding agencies.

Diffusion-weighted arterial spin labeling MRI to investigate mannitol-induced blood brain barrier disruption.

Purpose: Diffusion-weighted arterial spin labeling (DW-ASL) MRI has been proposed to determine the rate of water exchange (K) across the blood brain barrier (BBB). This study aims to further evaluate K MRI by comparing it with standard dynamic contrast-enhanced (DCE) MRI and histology in association with mannitol-induced disruption of the BBB.

Methods: DW-ASL was measured using a multiple b-value MRI protocol in normal rats at three post-labeling delays (N = 19), before and after intra-carotid injection of mannitol to disrupt BBB in one hemisphere (N = 13).

Perceived organizational support for the treatment of opioid use disorder and its association with primary care provider treatment willingness and medication prescribing.

Introduction: Buprenorphine is a highly effective medication for opioid use disorder (MOUD; OUD), which can be prescribed alongside naloxone in the primary care setting as part of a harm reduction approach to OUD. Despite this potential, implementation challenges have limited adoption of MOUD. To address barriers at the organizational level, we need better tools to measure perceived organizational support for the treatment of OUD and use of MOUD in the primary care setting.

Different forms of stigma and rural primary care professionals' willingness to prescribe buprenorphine.

Introduction: Buprenorphine and other medications for opioid use disorder (MOUD) are highly effective but substantially under prescribed in the rural United States. Among the most cited barriers to buprenorphine prescribing is stigma, yet little progress has been made in developing successful strategies to reduce stigma and increase access to life-saving medication. One of the key challenges to developing successful implementation strategies is understanding the different types of stigma that limit implementation.

Future directions in the evaluation and management of newly diagnosed metastatic cancer.

There is a much debate regarding optimal selection in patients with metastatic cancer who should undergo local treatment (surgery or radiation treatment) to the primary tumor and/or metastases. Additionally, the optimal treatment of newly diagnosed metastatic cancer is largely unclear. Current prognostication systems to best inform these clinical scenarios are limited, as all metastatic patients are grouped together as having Stage IV disease without further incorporation of patient and disease-specific covariates that significantly impact patient outcomes.

Porous carbon nanosheets integrated with graphene-wrapped CoO and CoNx as efficient bifunctional oxygen electrocatalysts for rechargeable zinc-air batteries.

The development of advanced bifunctional oxygen electrocatalysts for the oxygen reduction reactions (ORR) and oxygen evolution reactions (OER) is crucial for the practical application of zinc-air batteries (ZABs). Herein, porous carbon nanosheets integrated with abundant graphene-wrapped CoO and CoNx (CoO/CoNx-C) were successfully fabricated through a simple one-step pyrolysis. With convenient porous channel and large accessible surface, abundant CoO/CoNx species and graphene wrapping structure, CoO/CoNx-C exhibited a half-wave potential of 0.

Female agency and probable depression in the perinatal period and beyond: Longitudinal findings from rural Pakistan.

In Pakistan, a setting with high gender inequality, the relationship between female agency and mental health has not been studied longitudinally or beyond a defined life stage like pregnancy. Using data from the Bachpan cohort of mother-infant dyads in Pakistan, we investigated female agency and depression at two life stages: perinatal (third trimester to 6-months postpartum; n = 1154) and beyond (3- to 4-years postpartum). Modified Poisson models estimated adjusted prevalence ratios (PR) for probable depression (PHQ-9) associated with female agency (freedom of movement and participation in household decision-making) at the two life stages.

Estimating the generation time for influenza transmission using household data in the United States.

The generation time, representing the interval between infections in primary and secondary cases, is essential for understanding and predicting the transmission dynamics of seasonal influenza, including the real-time effective reproduction number (Rt). However, comprehensive generation time estimates for seasonal influenza, especially since the 2009 influenza pandemic, are lacking. We estimated the generation time utilizing data from a 7-site case-ascertained household study in the United States over two influenza seasons, 2021/2022 and 2022/2023.

Renal Tubular Acidosis: Core Curriculum 2025.

Renal tubular acidoses (RTAs) are a subset of non-anion gap metabolic acidoses that result from complex disturbances in renal acid excretion. Net acid excretion is primarily accomplished through the reclamation of sodium bicarbonate and the buffering of secreted protons with ammonia or dibasic phosphate, all of which require a series of highly complex and coordinated processes along the renal tubule. Flaws in any of these components lead to the development of metabolic acidosis and/or a failure to compensate fully for other systemic acidoses.

Prenatal metal(loid) exposure and preterm birth: a systematic review of the epidemiologic evidence.

Background: Preterm birth (PTB) is a common pregnancy complication associated with significant neonatal morbidity. Prenatal exposure to environmental chemicals, including toxic and/or essential metal(loid)s, may contribute to PTB risk.

Objective: We aimed to summarize the epidemiologic evidence of the associations among levels of arsenic (As), cadmium (Cd), chromium (Cr), copper (Cu), mercury (Hg), manganese (Mn), lead (Pb), and zinc (Zn) assessed during the prenatal period and PTB or gestational age at delivery; to assess the quality of the literature and strength of evidence for an effect for each metal; and to provide recommendations for future research.

Multidimensional library for the improved identification of per- and polyfluoroalkyl substances (PFAS).

As the occurrence of human diseases and conditions increase, questions continue to arise about their linkages to chemical exposure, especially for per-and polyfluoroalkyl substances (PFAS). Currently, many chemicals of concern have limited experimental information available for their use in analytical assessments. Here, we aim to increase this knowledge by providing the scientific community with multidimensional characteristics for 175 PFAS and their resulting 281 ion types.

AGA Clinical Practice Guideline on the Prevention and Treatment of Hepatitis B Virus Reactivation in At-Risk Individuals.

Background & Aims: Hepatitis B reactivation (HBVr) can occur due to a variety of immune-modulating exposures, including multiple drug classes and disease states. Antiviral prophylaxis can be effective in mitigating the risk of HBVr. In select cases, clinical monitoring without antiviral prophylaxis is sufficient for managing the risk of HBVr.

Implementation of An Advance Care Planning Intervention in Dialysis Clinics.

Rationale & Objective: Sharing Patient's Illness Representations to Increase Trust (SPIRIT) is an evidence-based advance care planning intervention targeting dialysis patients and their surrogate decision-makers. To address SPIRIT's implementation potential, we report on a process evaluation in our recently completed five-state cluster-randomized trial.

Study Design: A descriptive study of implementation within a randomized clinical trial.

Arterial Stiffness and Subsequent Incidence of CKD and Kidney Function Decline in a Large Longitudinal Community Cohort: The Atherosclerosis in Communities (ARIC) Study.

Rationale & Objective: Arterial stiffness is associated with prevalent chronic kidney disease (CKD). Whether arterial stiffness is prospectively associated with incident CKD is inconclusive.

Study Design: Longitudinal cohort study.