Recommendation for Clarifying FDA Policy in Evaluating "Sameness" of Higher Order Structure for Generic Peptide Therapeutics.

Recognizing the approach of a dramatic expansion of peptide therapeutics reaching the marketplace in recent years, led by GLP-1 receptor agonists such as semaglutide and liraglutide, the Center for Drug Evaluation and Research (CDER) branch of the US Food and Drug Administration (FDA) issued a final guidance in 2021 that was intended to assist generic drug producers in meeting Abbreviated New Drug Application (ANDA) obligations to establish "sameness" of their active peptide drug relative to that produced by innovator companies. Research and a published report by FDA scientists on best practices followed, which promulgated the use of nuclear magnetic resonance (NMR) and principal component analysis (PCA) and established a quantitative standard by which "sameness" of higher order structure for the applicant's peptide drug could be judged. A key requirement is that drug product samples be analyzed directly and non-invasively, a condition which in practice restricts sample modification to the addition of a small amount of deuterium oxide to allow signal lock and spectral data alignment (as required for NMR analysis).

Skin health of urban-living Aboriginal children attending a primary care Aboriginal Community Controlled Health Organisation clinic.

Background And Objectives: Despite increasing urbanisation, little is known about skin health for urban-living Aboriginal children and young people (CYP, aged <18 years). This study aimed to investigate the primary care burden and clinical characteristics of skin conditions in this cohort.

Method: A one-year retrospective cohort study of urban-living Aboriginal CYP presenting for general practitioner (GP) consultation at an Aboriginal Community Controlled Health Organisation (ACCHO) was conducted.

Integrating Social Determinants of Health in Machine Learning-Driven Decision Support for Diabetes Case Management: Protocol for a Sequential Mixed Methods Study.

Background: The use of both clinical factors and social determinants of health (SDoH) in referral decision-making for case management may improve optimal use of resources and reduce outcome disparities among patients with diabetes.

Objective: This study proposes the development of a data-driven decision-support system incorporating interactions between clinical factors and SDoH into an algorithm for prioritizing who receives case management services. The paper presents a design for prediction validation and preimplementation assessment that uses a mixed methods approach to guide the implementation of the system.

Skin health of Aboriginal children living in urban communities.

Background: Skin concerns are frequent among urban-living Aboriginal children, yet specialist dermatology consultations are limited with studies highlighting the need for improved cultural security. Through newly established paediatric dermatology clinics at two urban Aboriginal Community Controlled Health Organisations (ACCHOs), we aimed to describe clinic and patient data, including disease frequencies and associations, to inform dermatology service provision and advocacy.

Methods: A prospective cohort study of Aboriginal children and young people (CYP, 0-18 years) attending Aboriginal Health Practitioner (AHP) co-ordinated paediatric dermatology clinics at two urban ACCHOs.

LRIG1 engages ligand VISTA and impairs tumor-specific CD8 T cell responses.

Immune checkpoint blockade is a promising approach to activate antitumor immunity and improve the survival of patients with cancer. V-domain immunoglobulin suppressor of T cell activation (VISTA) is an immune checkpoint target; however, the downstream signaling mechanisms are elusive. Here, we identify leucine-rich repeats and immunoglobulin-like domains 1 (LRIG1) as a VISTA binding partner, which acts as an inhibitory receptor by engaging VISTA and suppressing T cell receptor signaling pathways.

Children's ethnic-racial identity and mothers' cultural socialization as protective in relations between sociocultural risk factors and children's internalizing behaviors.

Objectives: The present study examined whether sociocultural risk factors (i.e., mothers' risky behaviors, mothers' and grandmothers' ethnic discrimination, and family economic hardship) predicted children's internalizing behaviors.

Monitoring the composition, sources and spatial distribution of seafloor litter in the Adriatic Sea (Mediterranean Sea) through Fishing for Litter initiatives.

Although the seafloor is an important sink for marine litter, its less accessible environment makes seafloor litter the least studied component. Nevertheless, detailed monitoring of its composition and spatial distribution is urgently needed to develop appropriate mitigation strategies in areas exposed to multiple anthropogenic pressures, such as the Adriatic Sea. Commercial fisheries such as bottom trawls can serve as an opportunistic platform for collecting data on seafloor litter and help researchers in addressing the lack of data through Fishing for Litter initiatives.

A Call to Validate the Stress Continuum Model.

Introduction: Since the start of the Global War on Terrorism, exponential demands have been put on military personnel, their families, and the military health care system. In response to a Department of Defense Task Force on Mental Health, the U.S.

Safety and efficacy of Vitamin C, Vitamin E, and selenium supplementation in the oncology setting: A systematic review.

Objective: With rising rates of complementary and alternative medicine (CAM) use, the exploration of CAM integration into oncology treatments is becoming increasingly prevalent. Antioxidants have been proposed as potentially beneficial to prevent or treat cancer. However, evidence summaries are limited, and the United States Preventive Services Task Force has recently recommended the use of Vitamin C and E supplementation for cancer prevention.

Safety and efficacy of vitamin B in cancer treatments: A systematic review.

Background: With rising rates of complementary and alternative medicine use, the exploration of complementary and alternative medicine integration into oncology treatments is becoming increasingly prevalent. Vitamin B compounds including B1, B2, B3, B5, B6, B9, and B12, have all been proposed as potentially beneficial in cancer prevention and treatment as well as side effect management; however, many studies contain contradicting evidence regarding the utility of B vitamins within oncology. Thus, the aim of this study was to evaluate the safety and efficacy of Vitamin B supplementation in the oncology setting.

Interactions between COVID-19 family home disruptions and relationships predicting college students' mental health over time.

The present study tested whether family home disruptions during the COVID-19 pandemic in the Spring 2020 (Time 1; T1) informed mental health (i.e., posttraumatic stress disorder [PTSD], depressive, and anxiety symptoms) 7 months later in Fall 2020 at T2 and whether family relationship quality moderated relations.

Promoting resilience and psychological wellbeing of military providers: The Navy Medicine Caregiver Occupational Stress Control (CgOSC) program.

Military Medicine providers (sometimes referred to as caregivers) not only endure the stress of supporting the medical readiness of operational commands, they take on the continuous demands involved in providing direct care to military beneficiaries. Research shows that occupational stress and burnout impacts the health and wellbeing of providers, increases job turnover, and reduces the quality of patient care. Thus, interventions have aimed to reduce burnout and enhance the wellbeing of military providers.

Cultural Socialization and Ethnic-Racial Identity Mediated by Positive and Negative Conversations about Race: Exploring Differences among Asian American, African American, Latinx, Multiracial, and White Students.

The current study examined associations between cultural socialization and ethnic-racial identity via positive and negative conversations about one's ethnicity/race. Ethnic-racial differences between Asian American, African American, Latinx, Multiracial, and White students were explored. College students 18-22 ( age = 18.

ACR Appropriateness Criteria® Acute Pyelonephritis: 2022 Update.

Acute pyelonephritis (APN) is a severe urinary tract infection (UTI) that has the potential to cause sepsis, shock, and death. In the majority of patients, uncomplicated APN is diagnosed clinically and is responsive to treatment with appropriate antibiotics. In patients who are high risk or when treatment is delayed, microabscesses may coalesce to form an acute renal abscess.

Physical Activity Coaching via Telehealth for People With Parkinson Disease: A Cohort Study.

Background And Purpose: Physical activity (PA) has many known benefits for people with Parkinson disease (PD); however, many people do not meet recommended levels of frequency or intensity. We designed Engage-PD, a PA coaching program delivered via telehealth and grounded in self-determination theory to promote PA uptake and facilitate exercise self-efficacy in people with Parkinson disease. This study aimed to determine the feasibility and preliminary efficacy of Engage-PD, and to explore whether baseline characteristics were associated with outcomes.

Satisfaction with modes of telemedicine delivery during COVID-19: A randomized, single-blind, parallel group, noninferiority trial.

Background: Little is known about satisfaction with different modes of telemedicine delivery. The objective of this study was to determine whether patient satisfaction with phone-only was noninferior to video visits.

Methods: We conducted a parallel group, randomized (1:1), single-blind, noninferiority trial in multispecialty clinics at a tertiary academic medical center.

HealthCare educational differences in pain management, adverse childhood experiences and their relationship to substance use disorder education.

Background: In order to assist the State of Ohio in the United States in addressing the opioid epidemic, the Ohio Attorney General appointed experts in a variety of academic disciplines to the Scientific Committee on Opioid Prevention and Education (SCOPE). The focus of SCOPE is the application of scientific principles in the development of prevention and educational strategies for reducing substance use disorder (SUD). One area of focus for SCOPE was SUD education of healthcare professionals.

Characteristics of Active Duty Service Members Referred to the Navy's Weight-Management Program.

Introduction: Rates of overweight and obesity have increased in the military, particularly in the U.S. Navy.

Post-Traumatic Stress Disorder Treatment Outcomes in Military Clinics.

Introduction: Despite a wide literature describing the impact of PTSD on military personnel, there is limited information concerning the results of PTSD treatment within military clinics mental health. Having such information is essential for making predictions about service members' chances of recovery, choosing best treatments, and for understanding if new interventions improve upon the standard of care.

Materials And Methods: We reviewed data from the Psychological Health Pathways (PHP) database.

Racial discrimination and depressive symptoms mediated by conversations about race among students of color.

Racial discrimination is associated with adverse mental health outcomes among Students of Color. In order to address racial tensions, it is important to consider students' dialogues about race. The current study tested whether having positive and negative conversations about one's ethnic-racial group mediated the relation between racial discrimination at T1 and depressive symptoms 5 months later at T2 among 94 college Students of Color.

DrosoPhyla: Resources for Drosophilid Phylogeny and Systematics.

The vinegar fly Drosophila melanogaster is a pivotal model for invertebrate development, genetics, physiology, neuroscience, and disease. The whole family Drosophilidae, which contains over 4,400 species, offers a plethora of cases for comparative and evolutionary studies. Despite a long history of phylogenetic inference, many relationships remain unresolved among the genera, subgenera, and species groups in the Drosophilidae.

Implementation of an Enhanced Recovery after Surgery Pathway to Reduce Inpatient Opioid Consumption after Cesarean Delivery.

Objective: Opioid prescription after cesarean delivery is excessive and can lead to chronic opioid use disorder. We assessed the impact of an enhanced recovery after surgery (ERAS) pathway on inpatient opioid consumption after cesarean delivery.

Study Design: An ERAS pathway was implemented as a quality improvement initiative in December 2019.

Highly contiguous assemblies of 101 drosophilid genomes.

Over 100 years of studies in and related species in the genus have facilitated key discoveries in genetics, genomics, and evolution. While high-quality genome assemblies exist for several species in this group, they only encompass a small fraction of the genus. Recent advances in long-read sequencing allow high-quality genome assemblies for tens or even hundreds of species to be efficiently generated.