Bloomington

Cognitive impairment related to dementia often goes undetected in primary care, especially among older adults from minority and socioeconomically challenged populations. Researchers developed the 5-Cog brief cognitive assessment, a simple, standardized test taking less than 5 minutes and not requiring informants. This study aims to test the effectiveness of the 5-Cog paradigm in increasing detection of new cognitive impairments and improving dementia care in older adults presenting with cognitive concerns. The study uses a pragmatic cluster-randomized trial design involving 22 primary care clinics in the Bronx and Indiana, enrolling 6,600 patients aged 65 and older with cognitive concerns. Participants will either receive the 5-Cog paradigm, which includes the 5-Cog battery (Picture Memory Impairment Screen, Motoric Cognitive Risk Syndrome diagnosis, and Symbol Match) paired with a clinical decision tool, or enhanced usual care, where cognitive concern screening results are provided to primary care physicians. During the study, new diagnoses of cognitive impairment and improvements in dementia care will be tracked over a 90-day period following presentation. Researchers will collect data through electronic medical records to measure new diagnoses of dementia or mild cognitive impairment and actions such as tests, medication changes, and referrals. The study also examines implementation challenges and cost-effectiveness, with particular attention to health disparity populations.

Researchers are evaluating the Green Activity Program, designed with input from people living with memory challenges and their study partners, to see if it is feasible and enjoyable. This program focuses on "green activities," which are nature-based activities like dog walking, hiking, outdoor yoga, and gardening that participants enjoy and can do with others or pets. The goal is to help people with mild cognitive impairment, Alzheimer's disease, or subjective cognitive decline stay active and improve their health and well-being. The study is a single-group pre/post feasibility trial lasting up to one year. It will recruit 40 pairs (dyads) of people living with memory challenges and their study partners, aiming for 30 pairs to complete a 12-week Green Activity Program. Feedback will be collected through anonymous surveys with outdoor activity professionals, brief phone interviews with participants and their partners, and informal conversations with occupational therapists delivering the program. The program's impact on sustained behavior change will be measured four weeks after the intervention. Participants will be involved in nature activities and monitored through surveys, interviews, and notes to evaluate the program's feasibility and acceptability. Researchers will assess completion rates and other feasibility measures throughout the study, as well as acceptability up to one month post-program. The total participation time may extend up to one year, including follow-up assessments and program refinement based on collected feedback.

Researchers are investigating whether treating children with amblyopia using spectacles and patching at the same time leads to similar vision improvement compared to treating first with spectacles alone and then adding patching if needed. This randomized Phase 3 trial focuses on children aged 3 to under 13 years who have not been treated for amblyopia before. The study looks at amblyopia caused by differences in eye focusing (anisometropia), eye misalignment (strabismus), or both. At the start, children's vision will be tested with trial glasses based on a recent eye exam. Eligible children will receive new glasses and return for a baseline visit after wearing them for at least 10 minutes to confirm eligibility. Then they will be randomly assigned to either the sequential group (glasses first, patching added if needed) or the simultaneous group (glasses and patching together). Follow-up visits will happen every 8 weeks for up to 56 weeks, with vision tested each time to track improvement or stability. Patching will be monitored using an occlusion dose monitor (ODM). Throughout the study, vision in the amblyopic eye will be regularly measured to assess changes. Participants will be categorized as improving or stable/worsening at each visit. Those with stable or worsening vision and remaining amblyopia in the sequential group will begin patching and continue follow-up visits. Treatment adjustments will be made based on investigator judgment. The main outcome is the average change in distance visual acuity in the amblyopic eye after 56 weeks of treatment. The study ends after the final 56-week visit.

Researchers are studying whether replacing sugary sodas with unsweetened, flavored sparkling waters, progressively reduced sugar sodas, or plain water can reduce added sugar intake and improve health in Black/African American and Latine adolescents ages 12 to 18 with obesity who prefer sweet-tasting drinks. The study focuses on these adolescents classified as "sweet-likers," who favor higher sugar concentrations in beverages. The goal is to see if changing the type of drinks affects their liking for sweetness and leads to better diet quality and cardiometabolic health. Participants will be randomly assigned to one of three groups for a 4-week period: replacing sodas with flavored unsweetened sparkling water, replacing sodas with beverages that gradually reduce sugar over time ending with unsweetened sparkling water, or replacing sodas with plain still water as a control. They will be asked to replace all their usual sugary sodas with the assigned study beverages during this time. After this intervention, there will be a 4-week follow-up period without study beverages. Throughout the 8 weeks, participants will complete taste tests at baseline, week 2, week 4, and week 8 to measure their liking of sugar concentrations and sweetness intensity. Researchers will also collect 24-hour dietary recalls, measure body size and blood pressure, and take blood samples to test glucose, insulin, and triglycerides at baseline, week 4, and week 8. The study aims to track changes in sugar liking and possible improvements in cardiometabolic markers over this period.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

This research aims to study where children with juvenile myopia look through their spectacle lenses during different activities. The study focuses on understanding the viewing behavior of children aged 7 to 14 who wear special spectacle lenses designed to control the progression of myopia, a condition of nearsightedness. The goal is to gain insights into how these lenses affect where children focus their gaze. Participants will use novel spectacle lens designs that are being evaluated for their potential to slow the progression of juvenile myopia. These lenses are compared with standard spectacle lenses, both intended to correct vision within a specified power range. The study involves wearing these lenses and observing how children interact with their environment through the lenses. During the study, researchers will measure where participants look through their glasses, their activity levels through surveys or observations, and pupil size over a two-month period. Children will be monitored to ensure they follow the study schedule and instructions, with assessments to track their viewing behavior and how the lenses perform in real-life use.

Researchers are evaluating the thickness of the eye's lipid layer using three commonly used diagnostic devices to understand their agreement and reliability. The study focuses on how well each device's measurements relate to the severity of dry eye disease, aiming to identify which device best reflects clinical signs of this condition. Participants will have their lipid layer thickness measured using three devices: LipiView, Omnicad, and the Bruder Ocular Surface Analyzer. Each participant undergoes measurements with these devices during a single visit to compare results directly. During the visit, participants will have their lipid layer thickness measured once at baseline. Researchers will assess the consistency between devices and how each measurement correlates with dry eye severity indicators. No additional treatments or long-term follow-up are involved in this study.

Researchers are studying how the COVID-19 pandemic has affected physical activity, fitness, blood pressure, sleep, and mental stress to better understand its long-term health effects. The study looks at whether the severity of prior COVID-19 infection or post-acute sequelae of SARS-CoV-2 infection (PASC) relate to reduced physical activity, impaired blood pressure regulation, poorer sleep, or increased mental stress. Participants will attend two visits at the Neurovascular Physiology Laboratory at Indiana University School of Public Health Bloomington. During the first visit, participants complete screening and health questionnaires about sleep, stress, mental health, diet, and physical activity. They then track their sleep and activity using wearable devices for about 14 days, record their diet for at least 3 days, and collect blood pressure and urine data over 24 hours. The second visit involves returning devices and undergoing several assessments including body composition scans, cardiovascular measures, a cycling fitness test, blood and urine sample collection, and a hand-in-cold-water test to evaluate how their nervous system responds to stress. Participants will be monitored for safety during all tests. Researchers will measure blood pressure at rest and during exercise, analyze blood and urine for various health markers, assess body fat, muscle, and bone density, and evaluate cardiovascular fitness through cycling tests. The study aims to understand how COVID-19 impacts cardiovascular and overall health, with a total time commitment of about 6 hours across both visits.

This is a prospective, multicenter, randomized controlled clinical trial that will evaluate the effectiveness and safety of the CardioGard embolic protection cannula compared to a standard cannula. The enrollment period is expected to last 30 months, and all patients will be followed for 12 months post procedure. RANDOMIZATION Patients will be randomized 1:1 to the embolic protection device or to a standard cannula in the operating room (OR) immediately after sternotomy and confirmation by the surgical team of the patient's suitability for the proposed intervention (CardioGard embolic protection device). Randomization will be with equal allocation and stratified by site and by procedure (i.e., isolated valve surgery or combined procedures, such as double valve or valve plus coronary artery bypass grafting, CABG). The randomization assignment will be controlled centrally and performed through a web-based data collection system that automates the delivery of the randomization codes. From the point of treatment assignment, primary efficacy will be analyzed by intention-to-treat; that is, the patients will be grouped by their assignments at randomization regardless of whether or not they actually received the treatment to which they were assigned. STUDY POPULATION The patient population for this trial consists of patients age ≥ 60 undergoing different types of valve surgery with or without CABG via full or minimal-access sternotomy using legally marketed valve(s). Specific inclusion and exclusion criteria are listed below. All patients who meet the eligibility criteria may be included in the study regardless of gender, race, or ethnicity. SUBSTUDY Sleep Disturbance Ancillary Sub-Study - Patients undergoing surgery for valvular heart disease (VHD) are at high risk for adverse events, including high rates of post-operative delirium (POD). Should circadian disruption be found to be an important predictor in this high-risk population, safe, low cost, and easy to administer therapies to regulate circadian rhythm such as light therapy could be evaluated in future studies The aims of this ancillary sub-study include: 1. To investigate the association between short sleep duration, less sleep regularity, and greater circadian rhythm disruption prior to surgery and POD within 7 days of VHD surgery. 2. To investigate the association between short sleep duration, less sleep regularity and greater circadian rhythm disruption (reduced melatonin and cortisol amplitudes) after surgery and POD within 7 days of VHD surgery. Approximately 300 EMPRO trial participants will be enrolled into the ancillary study. The study is being conducted in highly experienced clinical centers in the U.S. and Canada. The estimated enrollment period is 12-15 months. All eligible and consented patients in the parent EMPRO trial will be offered enrollment in this ancillary study through the parent trial consent process.

Researchers are evaluating whether nightly eye drops containing 0.05% atropine can delay the onset of nearsightedness in children at high risk for developing myopia. This randomized clinical trial involves children aged 6 to 11 years and aims to compare atropine drops to placebo drops over two years. The study also investigates whether atropine treatment slows eye growth, which is related to myopia progression. This is a phase 3, multicenter study recruiting 606 children from 14 clinical centers. Participants will be randomly assigned to receive either atropine sulfate 0.05% eye drops or placebo drops, both administered nightly in both eyes. The drops are compounded to ensure the placebo matches the treatment minus the atropine. The study includes a run-in period where participants must demonstrate adherence by using artificial tears at least 90% of the time. Participants are followed every six months for at least two years to monitor the development of nearsightedness and eye growth. Throughout the study, children will undergo regular eye exams including cycloplegic autorefraction and measurements of axial length using a device called Myopia Master. Researchers will track the incidence of myopia and changes in eye length over two years. Safety and adherence are monitored closely, and participants who meet the eligibility requirements at screening and baseline visits continue in the trial. The total participation time is at least two years with visits every six months to assess eye health and treatment effects.