Coronavirus Disease 2019 (COVID-19) Real World Data Infrastructure: A Big-Data Resource for Study of the Impact of COVID-19 in Patient Populations With Immunocompromising Conditions.

Background: We developed a United States-based real-world data resource to better understand the continued impact of the coronavirus disease 2019 (COVID-19) pandemic on immunocompromised patients, who are typically underrepresented in prospective studies and clinical trials.

Methods: The COVID-19 Real World Data infrastructure (CRWDi) was created by linking and harmonizing de-identified HealthVerity medical and pharmacy claims data from 1 December 2018 to 31 December 2023, with severe acute respiratory syndrome coronavirus 2 virologic and serologic laboratory data from major commercial laboratories and Northwell Health; COVID-19 vaccination data; and, for patients with cancer, 2010 to 2021 National Cancer Institute Surveillance, Epidemiology, and End Results registry data.

Results: The CRWDi contains 4 cohorts: patients with cancer; patients with rheumatic diseases receiving pharmacotherapy; noncancer solid organ and hematopoietic stem cell transplant recipients; and people from the general population including adults and pediatric patients.

Review of Statistical Considerations and Data Imputation Methodologies in Psoriasis Clinical Trials.

Numerous clinical trials have established that various biologic and oral small-molecule therapies are efficacious in patients with psoriasis. However, as there are limited head-to-head trials, healthcare providers may compare results across multiple trials when providing treatment recommendations. Direct comparisons among agents are challenging because psoriasis trials differ in terms of study design, patient population, and data analysis methodologies.

Human iPSC Reprogramming Success: The Impact of Approaches and Source Materials.

Since their discovery, human induced pluripotent stem cells (hiPSCs) have been instrumental in biomedical research, particularly in the fields of disease modelling, drug screening and regenerative therapies. Their use has significantly increased over recent years driven by the ability of hiPSCs to provide differentiated cell models without requiring embryonic stem cells. Furthermore, the transition from integrating to non-integrating reprogramming methodologies has contributed to the increase in utilisation.

Assessment of oral health status among occupational chefs and pantry workers in Hyderabad city.

Background: The chefs and pantry workers environment plays a crucial role in the general and oral health. These workers have some unusual work timings and have a lot of stress and anxiety, and they also consume tobacco, alcohol, and smoke the cigarettes, which has a greater impact on oral health.

Material And Methods: A total of 86 kitchen workers (53 chefs and 33 pantry workers) of ten well-known restaurants in Hyderabad city were included.

Ethnic and racial differences in children and young people with respiratory and neurological post-acute sequelae of SARS-CoV-2: an electronic health record-based cohort study from the RECOVER Initiative.

Background: Children from racial and ethnic minority groups are at greater risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, but it is unclear whether they have increased risk for post-acute sequelae of SARS-CoV-2 (PASC). Our objectives were to assess whether the risk of respiratory and neurologic PASC differs by race/ethnicity and social drivers of health.

Methods: We conducted a retrospective cohort study of individuals <21 years seeking care at 24 health systems across the U.

Methylmercury in subarctic amphibians: environmental gradients, bioaccumulation, and estimated flux.

Rapid warming in polar regions is causing large changes to ecosystems, including altering environmentally available mercury (Hg). Although subarctic freshwater systems have simple vertebrate communities, Hg in amphibians remains unexplored. We measured total Hg (THg) in wetland sediments and methylmercury (MeHg) in multiple life-stages (eggs to adults) of wood frogs (Rana sylvatica) and larval boreal chorus frogs (Pseudacris maculata) from up to 25 wetlands near Churchill, Manitoba (Canada), during the summers of 2018-2019.

Pharmacokinetics of Nivolumab and Erythropoietin in a Rat Model of Diet-Induced Obesity.

Purpose: To investigate how obesity affects the pharmacokinetics of biologics in a rat model.

Method: Male Long-Evans rats were fed a high-fat diet from the age of 3 weeks and development of obesity was monitored by measuring body size and composition (fat and lean mass). The animals received nivolumab (1 and 8 mg/kg) or recombinant human erythropoietin (rHuEPO, 1000 IU/kg) by intravenous or subcutaneous injection.

Microstructure response of concentrated suspensions to flow reversal.

We study experimentally at the macroscopic and microstructure scale a dense suspension of non-Brownian neutrally buoyant spherical particles experiencing periodic reversals of flow at constant rate between parallel plates and tracked individually. We first characterize the quasi-steady state reached at the end of half periods. The volume fraction of particles increases from the walls to the center as a result of migration induced by the nonuniform strain rate.

Schizophrenia and retention in HIV care among adults insured through Medicaid in the United States: a population-based retrospective cohort study.

Background: People with schizophrenia spectrum disorders are at elevated risk of HIV, and people with both HIV and schizophrenia are at elevated risk of death compared to individuals with either diagnosis alone. Limited research has assessed the HIV care cascade, and in particular retention in care, among people with HIV (PWH) and schizophrenia in the U.S.

Opportunities for More Tailored Approaches to Genotoxicity Testing and Carcinogenicity Strategy for Oligonucleotide Therapeutics: Outcome of an Industry Survey.

The Oligonucleotide Nonclinical Working Group (WG) of the European Federation of Pharmaceutical Industries and Associations conducted an industry survey to understand current practices and regulatory expectations for genotoxicity and carcinogenicity assessment of oligonucleotide therapeutics (ONTs), along with historical genotoxicity testing results. The survey, involving 29 pharmaceutical and biotechnology companies, revealed a consistent absence of genotoxicity across a diverse range of oligonucleotide classes and chemistries, consistent with previous observations. Despite the lack of genotoxicity, companies continue to follow standard testing guidelines, with only limited divergence.

Intratumoral or Subcutaneous MK-2118, a Non-Cyclic Dinucleotide STING Agonist, With or Without Pembrolizumab for Advanced or Metastatic Solid Tumors or Lymphomas.

Background: We evaluated the non-cyclic dinucleotide stimulator of interferon genes agonist MK-2118 ± pembrolizumab in patients with advanced solid tumors or lymphomas.

Methods: This first-in-human study (NCT03249792) enrolled patients with refractory, advanced solid tumors or lymphomas. Patients received intratumoral (IT) MK-2118 100-20,000 µg (arm 1), IT MK-2118 900-15,000 µg plus intravenous (IV) pembrolizumab 200 mg every 3 weeks (Q3W; arm 2), or subcutaneous (SC) MK-2118 5000-150,000 µg plus IV pembrolizumab 200 mg Q3W (arm 4); arm 3 (visceral injection of MK-2118) was not pursued.

Coupling high-throughput and modeling approaches to streamline early-stage process development for biologics.

Platforms have long been implemented for downstream process development of monoclonal antibodies (mAbs) to streamline development and reduce timelines. These platforms are also increasingly being used for other complex biologics modalities. While development has traditionally been conducted at the lab bench scale in a sequential manner, automated miniaturized and parallelized approaches like RoboColumns and resin plates have also been implemented for chromatographic screening.

Trends and Association between Smoking and the Socio-Demographic Index Among 11 South American Countries, 1990-2019.

Objectives: To examine prevalence trends in the use of smoked tobacco products in 11 South American (SA) countries (i.e., Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Paraguay, Peru, Suriname, Uruguay, and Venezuela) and their association with country-specific socio-demographic index (SDI) over 30 years.

Arv1; a "Mover and Shaker" of Subcellular Lipids.

The composition of eukaryotic membranes reflects a varied but precise amalgam of lipids. The genetic underpinning of how such diversity is achieved or maintained is surprisingly obscure, despite its clear metabolic and pathophysiological impact. The Arv1 protein is represented in all eukaryotes and was initially identified in the model eukaryote as a candidate transporter of lipids from the endoplasmic reticulum.

Efferent compared to afferent neural substrates of the vergence eye movement system evoked via fMRI.

Introduction: The vergence neural system was stimulated to dissect the afferent and efferent components of symmetrical vergence eye movement step responses. The hypothesis tested was whether the afferent regions of interest would differ from the efferent regions to serve as comparative data for future clinical patient population studies.

Methods: Thirty binocularly normal participants participated in an oculomotor symmetrical vergence step block task within a functional MRI experiment compared to a similar sensory task where the participants did not elicit vergence eye movements.

The 2022 ADEA Climate Study in U.S. and Canadian Dental Schools and Allied Dental Programs: Methodological Considerations.

Objectives: From January 2020 to the end of August 2020, preliminary research gathered data about the need for and the feasibility of an ADEA-led joint Climate Study of dental schools and allied dental programs in the United States and Canada. Informed by these findings, the first ever ADEA-led joint Climate Study took place in 2022. The objectives of this manuscript were to describe the timeline of this climate study and provide information about its methodology, specifically about (a) who participated in this research, (b) what was assessed, (c) how the study was conducted, and (d) how the results were communicated.

Coping is a moderator of relationships between cognitive fatigue and cognitive variability in multiple sclerosis.

Objective: Mean levels of cognitive functioning typically do not show an association with self-reported cognitive fatigue in persons with multiple sclerosis (PwMS), but some studies indicate that has an association with cognitive fatigue. Additionally, coping has been shown to be a powerful moderator of some outcomes in multiple sclerosis (MS). To date, however, coping has not been considered as a possible moderator of the relationship between cognitive fatigue and cognitive in MS.

Efficacy and Safety Results With Rilzabrutinib, an Oral Bruton Tyrosine Kinase Inhibitor, in Patients With Immune Thrombocytopenia: Phase 2 Part B Study.

Current treatments for persistent or chronic immune thrombocytopenia (ITP) are limited by inadequate response, toxicity, and impaired quality of life. The Bruton tyrosine kinase inhibitor rilzabrutinib was evaluated to further characterize safety and durability of platelet response. LUNA2 Part B is a multicenter, phase 1/2 study in adults with ITP (≥ 3 months duration, platelet count < 30 × 10/L) who failed ≥ 1 ITP therapy (NCT03395210, EudraCT 2017-004012-19).

Sleep quality and cognitive functioning among Chinese older adults living in the US: a mixed-effects model analysis.

Background: Racial and ethnic disparities in sleep quality and cognitive health are increasingly recognized, yet little is understood about their associations among Chinese older adults living in the United States. This study aims to examine the relationships between sleep health and cognitive functioning in this population, utilizing data from the Population Study of Chinese Elderly in Chicago (PINE).

Methods: This observational study utilized a two-wave panel design as part of the PINE, including 2,228 participants aged 65 years or older who self-identified as Chinese.

Genomics yields biological and phenotypic insights into bipolar disorder.

Bipolar disorder is a leading contributor to the global burden of disease. Despite high heritability (60-80%), the majority of the underlying genetic determinants remain unknown. We analysed data from participants of European, East Asian, African American and Latino ancestries (n = 158,036 cases with bipolar disorder, 2.