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.

Sexual and Gender Minority Adolescents' Preferences for HIV Pre-Exposure Prophylaxis Social Marketing Campaigns: Qualitative Preimplementation Study.

Background: Sexual and gender minority (SGM) adolescents in the United States are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is a highly effective biomedical HIV prevention method, but its awareness and uptake among SGM adolescents are low. There are no adolescent-centered PrEP social marketing campaigns in the United States that have the potential to increase awareness and interest in PrEP.

Isolation and Characterization of Antibodies Against Vascular Cell Adhesion Molecule-1 Reveals Putative Role for Ig-like Domains 2 and 3 in Cell-to-Cell Interaction.

The vascular cell adhesion molecule-1 (VCAM-1) plays an important role in inflammation, where it facilitates the recruitment of leukocytes to the inflamed area via leukocytes' VLA-4 and endothelial cells' VCAM-1 interaction. VCAM-1 expression is also upregulated in certain cancers. VCAM-1 has seven Ig-like domains, with domains 1 and 4 shown to be critical for VLA-4 binding.

An intimal-lumen model in a microfluidic device: potential platform for atherosclerosis-related studies.

Atherosclerosis is a chronic inflammatory vascular disorder driven by factors such as endothelial dysfunction, hypertension, hyperlipidemia, and arterial calcification, and is considered a leading global cause of death. Existing atherosclerosis models have limitations due to the absence of an appropriate hemodynamic microenvironment and interspecies differences . Here, we develop a simple but robust microfluidic intimal-lumen model of early atherosclerosis using interconnected dual channels for studying monocyte transmigration and foam cell formation at an arterial shear rate.