Bloomington

Cognitive impairment related to dementia is often missed in primary care, especially among older adults from minority and socio-economically disadvantaged populations. Researchers are evaluating the 5-Cog brief cognitive assessment, a quick, simple, and standardized tool that takes less than 5 minutes and addresses cultural and logistical barriers. This pragmatic cluster-randomized trial aims to test whether the 5-Cog paradigm improves detection of new cases of cognitive impairment and dementia care in older adults with cognitive concerns. The study involves 22 primary care clinics in Bronx and Indiana, enrolling about 6,600 patients aged 65 and older who report cognitive concerns. Participants receive either the 5-Cog battery combined with a clinical decision-making tool or enhanced usual care, which includes cognitive concern screening. The 5-Cog battery includes tests like Picture Memory Impairment Screen, Motoric Cognitive Risk Syndrome diagnosis, and Symbol Match. Primary care physicians receive results and decision support but use their clinical judgment in care decisions. Participants undergo cognitive concern screening before their appointments. Researchers will review new cognitive impairment diagnoses and improvements in dementia care within 90 days after the primary care visit using electronic medical records. Additional evaluations include tests for reversible causes, medication changes, specialist referrals, and social support. The study also examines the 5-Cog paradigms implementation and cost-effectiveness, focusing on populations facing health disparities. Total participation duration varies by patient and clinic schedule.

Researchers are evaluating the Green Activity Program designed for people living with memory challenges and their study partners. The program includes outdoor nature activities such as dog walking, hiking, yoga, and gardening, aiming to help participants stay active and improve their health and well-being. This feasibility study focuses on whether participants can complete and enjoy the program, supporting their participation in nature activities. The study involves a single group of 40 pairs dyads consisting of individuals with memory challenges and their study partners. Over 12 weeks, participants engage in 4 to 8 virtual or phone sessions lasting 30 to 90 minutes each, plus 2 additional check-ins of 15 to 30 minutes. Outdoor activity professionals also participate by evaluating sites for safety and accessibility, receiving dementia training, and learning strategies to tailor activities and provide behavioral support. Participants complete evaluations before and after the 12-week program, including surveys, brief phone interviews, and physical activity and health assessments. Researchers measure feasibility, acceptability, behavior change, physical activity, well-being, social participation, depression, cognitive function, and other health-related outcomes. Feedback from study partners and outdoor professionals is also collected. The total study duration for participants may last up to one year to include all evaluations and follow-ups.

This research aims to compare two approaches for treating previously untreated amblyopia in children aged 3 to under 13 years. It evaluates whether using glasses and patching at the same time leads to similar improvements in vision as first using glasses alone, followed by patching only if needed. The trial focuses on children with amblyopia caused by differences in eye alignment or prescription errors. Children will be assigned randomly to one of two treatment groups one group will wear glasses full-time and add patching for 2 hours daily only if there is no improvement after glasses alone the other group will wear glasses and patch the weaker eye for 2 hours daily at the same time from the start. Vision tests will be done at baseline and follow-up visits every 8 weeks for up to 56 weeks. Participants will have their distance visual acuity measured with trial frames before and after getting their glasses to confirm eligibility. During the study, vision will be monitored to classify improvement or stability, guiding whether patching is needed in the sequential group. Outcomes include changes in vision clarity after 56 weeks and quality-of-life assessments. Regular visits help track progress and safety until study completion.

Researchers are evaluating whether replacing sugary sodas with unsweetened, flavored sparkling waters, progressively sugar-reduced sodas, or plain water can reduce added sugar intake and improve health in BlackAfrican American and Latine adolescents with obesity who prefer sweet-tasting beverages. The study focuses on adolescents aged 12 to 18 who have a strong liking for sweet beverages and consume sugary sodas regularly. The trial aims to understand if changing beverage preferences leads to better diet quality and cardiometabolic health. Participants will be randomly assigned to one of three groups replacing sugary sodas with flavored unsweetened sparkling water, replacing sodas with beverages that gradually reduce sugar content over four weeks ending with unsweetened sparkling water, or replacing sodas with plain still water as a control. The intervention lasts for four weeks, during which participants will replace all sugary sodas with their assigned study beverages. During the 8-week study period, participants will complete taste tests at baseline, week 2, week 4, and week 8 to assess their liking and perception of sweetness. Dietary recalls, body measurements including height, weight, and waist circumference, blood pressure readings, and blood samples measuring fasting glucose, insulin, and triglycerides will be collected at baseline, week 4, and week 8. Researchers will monitor compliance with beverage consumption and evaluate changes in sugar liking, diet quality, and cardiometabolic markers, including serum triglycerides and insulin resistance.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are studying how children with myopia view through spectacle lenses during various activities. The study focuses on understanding the specific area of the spectacle lens used by children aged 7 to 14 years while wearing myopia control glasses. This research is sponsored by SightGlass Vision, Inc. and aims to learn more about childrens viewing behavior to help improve lens designs for juvenile myopia. Participants will be randomly assigned to one of two groups, each using a different type of single vision, impact-resistant spectacle lens designed to control myopia progression. The treatments involve wearing these spectacle lenses, and the study includes a two-month observation period to assess how children use the lenses during daily activities. Throughout the study, participants gaze location while using the spectacles will be monitored, along with pupil size and activity levels measured through surveys or observation. Children will attend scheduled visits to track these outcomes and ensure adherence. The study plans to run until July 2027 and includes safety and visual acuity assessments to support the research findings.

Researchers are evaluating the measurements of ocular lipid layer thickness LLT taken by three commonly used clinical devices to compare their agreement and consistency. The study also aims to find which devices LLT measurements best correlate with established clinical indicators of dry eye disease severity. Participants with dry eye disease will have their lipid layer thickness measured using three different devices LipiView, Omnicad, and Bruder Ocular Surface Analyzer. These measurements will be taken during a single visit in a random order to ensure unbiased comparison. During the study visit, participants will undergo LLT measurement with all three devices. Researchers will analyze the measurements and compare them to clinical assessments of dry eye severity. The main outcome is the LLT measurement at baseline, alongside the correlation with clinical dry eye indicators. The study participation involves a single visit and does not include any treatment or long-term follow-up.

Researchers are investigating whether the COVID-19 pandemic has impacted peoples physical activity, fitness, blood pressure, sleep, and mental stress to understand its long-term effects on health. The study looks at how prior COVID-19 severity or post-acute sequelae of SARS-CoV-2 infection PASC might be linked to changes in cardiovascular health and overall wellness. Participants will take part in two visits at the Neurovascular Physiology Laboratory, with detailed data collected to explore these health aspects. During the first visit, participants complete questionnaires about their health behaviors, sleep, stress, diet, and mental well-being. They will then track their sleep and physical activity with wearable devices for about 14 days, record their diet for at least 3 days, and measure blood pressure and urine for 24 hours. The second visit involves returning devices and undergoing various tests, including body composition scans, cardiovascular health measurements, a fitness test on a stationary bike, blood and urine sample collection, and a cold-water hand test to assess nervous system response to stress. Participants involvement includes completing questionnaires, wearing tracking devices, and attending two study visits totaling about 6 hours. Researchers will measure blood pressure, sleep quality, diet, cardiovascular fitness, immune markers, and body composition. Safety is carefully monitored during exercise and testing. The primary outcomes focus on blood pressure measurements, while secondary outcomes include sleep duration and quality, and diet quality. The study aims to provide valuable insights into how COVID-19 affects long-term health.

Researchers are evaluating the CardioGard Embolic Protection Cannula in patients aged 60 and older undergoing different types of high-risk valve surgery, with or without coronary artery bypass grafting CABG. This prospective, multicenter, randomized controlled trial compares the safety and effectiveness of the CardioGard device to a standard aortic cannula during surgery. The study also includes an ancillary sub-study investigating the relationship between sleep disturbances and post-operative delirium in this patient population. Participants are randomly assigned in the operating room to either receive the CardioGard Embolic Protection Cannula, which combines standard blood flow with a suction mechanism to capture debris during surgery, or to a standard aortic cannula chosen by the surgeon. Randomization is stratified by surgical procedure and location. The enrollment period is expected to last 30 months, with follow-up extending for 12 months after the procedure. The ancillary sub-study includes about 300 participants and focuses on sleep patterns before and after surgery. During the study, patients undergo evaluations including neurological assessments, cognitive tests, and monitoring for events like ischemic stroke, acute kidney injury, delirium, and mortality within days and months after surgery. Researchers also track sleep quality and circadian rhythm disruptions using questionnaires and actigraphy. Safety and clinical outcomes are monitored throughout hospitalization and during follow-up visits up to one year. The primary outcomes include stroke, acute kidney injury, death, and delirium occurring shortly after surgery.

Researchers are investigating whether nightly eye drops containing 0.05% atropine can delay the onset of nearsightedness myopia in children aged 6 to 11 years who are at high risk of developing this condition. This study compares atropine drops to placebo drops in a randomized clinical trial involving 606 children across multiple centers. The main goal is to measure the two-year cumulative incidence of myopia and to see if atropine slows eye growth. Participants will be randomly assigned to receive either 0.05% atropine eye drops or placebo drops nightly in both eyes at bedtime. The study will last at least two years, during which children will be monitored every six months to assess the onset of nearsightedness and changes in eye growth. The atropine solution is specially prepared by a pharmacy, and the placebo matches the treatment minus the atropine. Throughout the study, children will visit the clinic every six months for eye exams using tools like the Myopia Master to measure eye shape and vision changes. Researchers will track the development of myopia, axial elongation, and progression of refractive error. Safety and adherence will be monitored, including a run-in period to ensure compliance with daily drops. The total participation time is at least two years, allowing thorough evaluation of the treatments effects.