Johnson City

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

This research investigates how children with developmental language disorder (DLD) learn new words from context, a common way children acquire vocabulary without direct teaching. The study evaluates a new intervention combining two strategies that have shown promise in typically developing children: metalinguistic training focused on semantic inferencing and exposure to texts with varying semantic diversity. The goal is to understand how these combined approaches affect word learning in both children with DLD and those with typical development, aiming to improve evidence-based practices for vocabulary growth. The intervention involves three sessions where children participate in metalinguistic training that includes generating meanings for new words, explanations about these meanings, and feedback on accuracy. Words are presented in contexts with different levels of semantic diversity—no diversity (repeated stories), medium diversity (unique stories with the same global context), and high diversity (unique stories with different global contexts). This setup helps assess how semantic diversity influences word retention and learning. Participants will be assessed on their ability to infer meanings of untreated words before and after the intervention, and retention of word semantics will be measured one week after each session. The study includes children aged 7 to 11 years, with assessments conducted using the Measure of Semantic Knowledge (MSK). Researchers will monitor vocabulary retention, semantic inferencing skills, and the intervention's general effects, aiming to inform future clinical trials and best practices for children with and without developmental language disorder.

Researchers are evaluating the effects of dalcetrapib, a cholesterol ester transfer protein inhibitor, on cardiovascular risk in people who have recently been hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, placebo-controlled, randomized, double-blind study focuses on adults aged 45 years and older. Participants must be clinically stable and managed according to guidelines for low-density lipoprotein cholesterol (LDL-C). The study aims to measure the time to the first occurrence of any fatal or non-fatal myocardial infarction over an average follow-up of 30 months. Participants will be randomly assigned to receive either dalcetrapib 300 mg tablets or matching placebo tablets. The study includes a genetic screening phase to confirm the presence of the AA genotype using a specific genotype assay test. Screening and enrollment may start during hospitalization or after discharge, with randomization required within 12 weeks of the ACS event. Follow-up visits will be conducted virtually when possible every 3 months or as clinic visits until the study ends. If a participant stops the study medication early, assessments for study endpoints will continue every 3 months. Throughout the study, participants will undergo medical history reviews, genetic testing, and regular assessments to monitor cardiovascular events. Researchers will collect data on myocardial infarction occurrences as the primary outcome. Safety and adherence will be monitored through scheduled visits, and the study will continue until about 200 participants have experienced a primary event or until a planned interim analysis determines stopping. The total participation duration varies based on event occurrence but involves ongoing follow-up every 3 months after randomization.