North Chicago

Researchers are investigating how switching from menthol to non-menthol cigarettes affects markers of inflammation in the body, which can indicate cardiovascular disease risk. This study focuses on adult smokers who currently use menthol cigarettes and aims to understand changes in smoking behavior and personal responses related to smoking during the switch. The trial is designed to simulate the impact of a potential menthol cigarette ban by examining biological and behavioral changes over time. Participants will first continue their usual menthol cigarette smoking for one week to establish a baseline. Then, for the following four weeks, they will switch to study-provided non-menthol cigarettes that are brand-matched to their usual cigarettes. This switch is the main intervention to evaluate changes in inflammation and smoking habits. Throughout the five-week study, blood samples will be collected at baseline, week 1, week 3, and week 5 to measure biomarkers related to systemic inflammation and tobacco exposure. Participants will also use a smartphone app to report their smoking patterns and subjective experiences such as cravings and mood. The main outcomes include levels of high sensitivity C-reactive protein, fibrinogen, and a panel of cytokines, which will help assess the inflammatory response related to cigarette type.

Researchers are evaluating the effectiveness and safety of osimertinib tablets combined with Datopotamab Deruxtecan (Dato-DXd) intravenous infusion compared to osimertinib alone as a first treatment for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR gene mutations (Ex19del and/or L858R). This global Phase III, open-label, randomized study focuses on participants who have not received prior therapy for advanced disease. The goal is to show that the combination therapy improves progression-free survival compared to osimertinib alone. Participants will be randomly assigned to receive either osimertinib 80 mg orally once daily or osimertinib plus Dato-DXd at 6 mg/kg given by intravenous infusion every three weeks. Treatment will continue until the disease progresses, unacceptable side effects occur, or other reasons require stopping. Visits for assessments will occur every three weeks during treatment. For those on osimertinib alone or who discontinued Dato-DXd but continue osimertinib, visits will be every six weeks from cycle 7 to cycle 17, then every 12 weeks until disease progression or treatment stops. Participants receiving both drugs will have visits every three weeks. During the study, participants will undergo regular assessments including scans and laboratory tests to monitor their condition and treatment effects. Researchers will track progression-free survival through independent review about three years after the first participant is enrolled. The study is expected to last about eight years, with ongoing monitoring of safety and treatment tolerance throughout. Participants must attend scheduled visits for evaluations and treatment administration as outlined in the study plan.

Researchers are evaluating the effects of atorvastatin 40 mg compared to a placebo in older adults aged 75 years and above who live in the community without cardiovascular disease, dementia, or significant disability. This Phase 4 study aims to determine if statins can reduce death, dementia, persistent disability, mild cognitive impairment, and cardiovascular events. The study involves about 20,000 participants across roughly 100 US sites, including both VA and non-VA locations, with inclusion of English or Spanish speakers. Participants will be randomly assigned to receive either atorvastatin 40 mg daily or a matching placebo. The study drug will be mailed directly to participants every 90 days starting immediately after randomization and continuing as long as the participant remains on the study drug. Enrollment and follow-up may include in-person visits or telehealth options. Baseline assessments include physical function tests, cognitive and physical function phone screens annually, and blood samples for lipid panels and biorepository specimens. Lipid testing is repeated at 3 months in a subset of participants. During the study, researchers will collect data through phone assessments, electronic health records, Medicare records, and the National Death Index to monitor cognitive and physical function, cardiovascular events, and other outcomes. Participants will be followed for up to 5 years, with an estimated median follow-up of 3.8 years. Safety and adherence will be supported by centralized recruitment, retention efforts, and direct mailing of study medication, with ongoing monitoring for dementia diagnosis, disability, and cardiovascular events.

Researchers are investigating whether olomorasib combined with pembrolizumab is more effective than pembrolizumab plus placebo for participants with resected KRAS G12C-mutant non-small cell lung cancer (NSCLC) in part A. In part B, they are assessing if olomorasib combined with durvalumab is more effective than durvalumab plus placebo for participants with unresectable KRAS G12C-mutant NSCLC. This Phase 3 study may last up to 3 years for each participant.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.

Researchers are conducting a prospective non-interventional study to better understand the needs and treatment experiences of adolescents and adults with atopic dermatitis (AD). The study aims to assess safety and clinical outcomes of systemic AD treatments in real-world settings while exploring patient-specific factors such as age, skin color, flare triggers, previous treatment responses, comorbidities, and lesion characteristics. This study will take place across 10 countries in 4 geographic regions and will follow participants for 5 years. Participants who have a confirmed diagnosis of AD and are at least 12 years old will be included if they are prescribed and scheduled to start any systemic treatment for AD, including biologics, oral Janus kinase inhibitors, cyclosporine, and other immunosuppressants. The study involves monitoring patients who initiate or switch systemic treatments to evaluate treatment patterns over time. During the study, researchers will track a range of outcomes from baseline through up to 60 months, including the number of participants using AD treatments, treatment duration, treatment changes, and reasons for starting, interrupting, switching, or stopping treatments. Disease severity and control will be measured by tools like the Eczema Area and Severity Index and atopic dermatitis control tests. Patient-reported outcomes such as itch, skin pain, sleep disturbance, and overall severity impressions will also be assessed. The long follow-up allows for observing remission and the evolving treatment journey in diverse patients.