North Chicago

Researchers are evaluating the FlowPath Lung Test, a non-invasive flow cytometry diagnostic tool that analyzes sputum samples to detect early-stage lung cancer in high-risk adults. This study focuses on individuals aged 50 to 80 years who have lung nodules measuring greater than 6 mm and less than 30 mm in diameter, identified by low-dose computed tomography LDCT. The goal is to assess the tests sensitivity and specificity in detecting lung cancer in this population. Participants provide sputum samples for the FlowPath Lung Test within six weeks of their baseline CT scan showing lung nodules. The study includes standard medical treatment and follow-up care as per institutional protocols. The nodules considered are new, increasing, or stable for up to six months, with the most suspicious nodule sized within the specified range. The study follows participants for up to 24 months to monitor outcomes. During the study, participants undergo sputum sample collection and routine standard-of-care follow-up with their healthcare providers. Researchers evaluate the FlowPath Lung Tests ability to detect early-stage lung cancer using the baseline sputum sample and follow-up data over two years. Participants medical information related to their standard care is collected with consent, and safety monitoring is conducted throughout the study period, which lasts until July 2029.

This research aims to study how switching from menthol to non-menthol cigarettes affects markers of inflammation in the body, which can indicate risk for heart disease. The study focuses on adult smokers who currently use menthol cigarettes and investigates changes in their smoking behavior, feelings related to smoking, and biomarkers of inflammation as a subclinical measure of cardiovascular health. Participants who smoke menthol cigarettes will take part in a five-week study. The first week is a baseline period where they continue smoking menthol cigarettes. Then, for the following four weeks, they will switch to study-provided non-menthol cigarettes that closely match their usual brand. Researchers will collect blood samples at four points to analyze inflammation markers and tobacco exposure. Participants will also report their smoking patterns and subjective experiences using ecological momentary assessment methods. During the study, participants will visit regularly for blood sample collection and assessments of smoking behavior, cravings, and feelings related to smoking. The primary outcomes include measuring high sensitivity C-reactive protein, fibrinogen, and a cytokine panel after four weeks of switching cigarettes. Secondary measures include blood pressure and heart rate. The total participation time is five weeks, including baseline and switching periods, with ongoing monitoring of biomarkers and subjective responses.

Researchers are evaluating the safety and effectiveness of combining osimertinib tablets with Datopotamab Deruxtecan intravenous infusion compared to using osimertinib tablets alone as a first treatment for participants with locally advanced or metastatic non-small cell lung cancer NSCLC that has specific EGFR mutations Ex19del andor L858R. This global Phase III, open-label, randomized study targets participants who have not yet received treatment for advanced disease and aims to assess how well this combination works and how safe it is over an estimated 8-year event-driven study duration. Participants will be randomly assigned to one of two groups one will receive osimertinib 80 mg orally once daily combined with Datopotamab Deruxtecan 6 mgkg by intravenous infusion every three weeks, while the other will receive osimertinib 80 mg orally once daily alone. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping. During treatment, visits occur every three weeks. For those receiving osimertinib alone or who stop Datopotamab Deruxtecan but remain on osimertinib, visits become every six weeks from cycle 7 to cycle 17 and then every twelve weeks until disease progression or stopping treatment. Participants will undergo regular assessments including scans and tests to monitor disease status and treatment effects as per the study schedule. Researchers will measure progression-free survival, overall survival, response rates, and other outcomes related to the cancer and treatment effects. Safety and drug levels will also be monitored. Participants can expect frequent visits and evaluations throughout the study, lasting up to about eight years or until specific stopping criteria are met.

Researchers are evaluating the impact of atorvastatin, a cholesterol-lowering drug, on preventing death, dementia, and persistent disability in adults aged 75 years and older who do not have cardiovascular disease or dementia. This large, randomized, placebo-controlled phase 4 study aims to understand the benefits of statins in older adults living in the community. The trial also examines secondary outcomes such as mild cognitive impairment and cardiovascular events. Participants will be randomly assigned to receive either atorvastatin 40 mg daily or a matching placebo. The study plans to enroll about 20,000 participants from around 100 sites across the U.S., including both VA and non-VA locations. The treatment will continue for up to 5 years, with the median follow-up estimated at 3.8 years. Study drugs will be mailed directly to participants every 90 days to support adherence, and telehealth enrollment options are available. Participants will undergo initial assessments including physical function tests and blood draws for lipid panels. Follow-up assessments will occur annually by phone to monitor cognitive and physical function, with in-person visits if needed. Cardiovascular events and other health outcomes will be tracked through electronic health records and national databases. The main outcomes measured include the number of participants without new diagnoses of dementia or persistent disability after 4 years. Safety and adherence are monitored through regular contact and data collection throughout the study period.

Researchers are evaluating whether olomorasib combined with pembrolizumab or durvalumab is more effective than these immunotherapies alone in participants with KRAS G12C-mutant non-small cell lung cancer NSCLC. The study focuses on two groups those with resected NSCLC and those with unresectable NSCLC. This Phase 3 trial aims to assess disease-free survival and progression-free survival among these participants over an estimated period of up to 3 years. Participants will receive either olomorasib or a placebo orally along with pembrolizumab or durvalumab administered intravenously for up to one year. After this combination phase, participants continue with olomorasib or placebo alone for up to a total of three years of treatment. The study includes randomized, double-blind groups to compare these combinations in both resected and unresectable NSCLC. During the study, participants undergo regular assessments to monitor disease progression, overall survival, and quality of life using questionnaires and imaging. Researchers measure outcomes such as disease-free survival, progression-free survival, response rates, and symptom changes related to NSCLC. The study also tracks safety and health impacts over the treatment period, which may last up to three years for each participant.

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.

Researchers are conducting a prospective non-interventional study to better understand the needs and experiences of adolescent and adult patients with atopic dermatitis AD who start or switch any systemic treatment. The study aims to assess patient journeys and evaluate the safety and clinical outcomes of systemic AD treatments in real-world settings across multiple countries and geographical regions. Patient-specific factors such as age, skin color, flare triggers, previous treatment responses, comorbid conditions, and lesion characteristics will be studied to gain a broad understanding of treatment impact. Participants in this observational study will be those who initiate or switch systemic treatments for AD, including biologics, oral Janus kinase JAK inhibitors, cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil, based on country-specific prescribing information and standard of care. Treatments will be prescribed by investigators according to usual medical judgment, without any experimental intervention from the study. This study will follow participants for up to five years to observe treatment patterns and outcomes. During the study, participants will have their treatment utilization, treatment duration, switching, dose modifications, and reasons for changes recorded. Researchers will also measure changes in the severity and extent of AD using tools like the Eczema Area and Severity Index EASI, Body Surface Area BSA, Investigators Global Assessment, and patient-reported outcomes such as itch, skin pain, sleep disturbance, and overall disease control. Other assessments include quality of life, work productivity, comorbid conditions, and adverse events. The study will provide long-term observational data over a period of up to 60 months.