Muncie

Researchers are evaluating the COMPASS Across Settings CAST intervention to improve goal setting and achievement skills among autistic youth. The project addresses challenges in current education practices that have not reliably led to positive postsecondary outcomes for autistic students, despite legal requirements for transition services. CAST integrates three evidence-based interventions and provides coaching support to caregivers, students, and employment specialists to better align goals across home, school, and community settings. CAST starts with an initial joint session involving the student, caregiver, special education teacher, and pre-employment transition specialist to discuss the students postsecondary goals, preferences, challenges, and strengths. This informs personalized intervention plans targeting social, communication, and work behavior goals. Following this, four additional one-hour coaching sessions are delivered by investigators, including feedback and instructional support. The project includes development activities with focus groups in year one, a field test in year two, and a randomized controlled trial RCT in year three. Participants will engage in assessments including goal attainment scaling of Individualized Education Program IEP goals and postsecondary goal achievement measured three months and one year after high school. Other evaluations include fidelity assessments of coaching sessions, organizational connectedness, and transition plan quality. Data collection involves focus groups, interviews, social network analysis, and cost analysis. The total participation spans multiple years with varying activities in development, testing, and evaluation phases.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are studying vascular health in females with a normal body mass index BMI to understand how differences in body fat and muscle mass affect cardiovascular disease risk. This study focuses on females aged 18 to 50 who have a healthy BMI but may have varying body compositions. The goal is to evaluate resting vascular indicators and cardiovascular response to stress in this group. Participants will complete two separate study visits in a randomized order. During the high-fat meal trial, participants will fast, then consume two Jimmy Dean breakfast bowls high in fat, while vascular measurements and blood samples will be taken at baseline and multiple times after the meal. In the stress trial, participants will fast and then undergo a mental stress task, with vascular measurements and blood samples collected before and after the stress. Blood tests will measure factors like cholesterol, triglycerides, inflammatory markers, and epinephrine. Throughout the study, participants will have vascular assessments including flow-mediated dilation, pulse wave analysis, and pulse wave velocity. Blood will be drawn multiple times to analyze serum markers related to cardiovascular health and inflammation. Each vascular measurement requires resting quietly in a supine position. The study involves two main visits with detailed monitoring before and after interventions, and all data will be collected up to one year for ongoing analysis.

Researchers are investigating how replacing table sugar with fresh mango sugar affects blood sugar, insulin, and vascular health after eating breakfast. The study focuses on adults with a body mass index BMI between 18.5 and 35.0 and explores the impact of sugar type in realistic meals on metabolic and vascular responses, which are important for diabetes and heart disease risk. Participants will take part in four meal trials in a randomized order, consuming breakfasts that are either high or low glycemic and sweetened with fresh mango or table sugar. The meals include corn flakes with 2% milk or steel cut oats with water, with sugar content and calories closely matched. Each trial involves blood sampling and artery dilation measurements before and after the meal, along with surveys on meal acceptability and satiety. Throughout the study, participants will have blood samples taken at multiple times up to three hours after eating to measure glucose, insulin, triglycerides, and HDL cholesterol. Artery dilation will be assessed at various times post-meal using flow-mediated dilation. Additional assessments include a one-time body composition and bone density scan. The study continues for up to 1.5 years to evaluate these effects comprehensively.

Researchers are studying how a single high-fat meal affects gut, immune, and vascular health in people with metabolically healthy obesity and those with a normal weight but similar metabolic profiles. They also want to understand how taking a prebiotic fiber called inulin influences these health aspects in individuals with metabolically healthy obesity. This project includes two parts under one study approval, focusing on these specific groups and health markers. In part 1, participants with normal or obese body mass index BMI will complete a high-fat meal trial involving blood samples and vascular tests at multiple time points before and after the meal. The meal contains about 700 calories from fat, chocolate syrup, and protein powder. Part 2 involves only participants with obesity who will be randomized to receive either inulin supplements or a placebo for six weeks. Blood samples, stool samples, and vascular assessments will be collected at baseline and during follow-up visits. Participants will have various measurements taken, including blood tests to check biomarkers of inflammation and intestinal health, vascular function tests, and stool samples to analyze gut microbiome. Blood will be drawn multiple times within hours after the meal in part 1 and at intervals during the six-week supplement phase in part 2. The study will track changes in these markers over time to evaluate the impact of diet and supplementation on gut, immune, and vascular health. Participation may last up to two years for some outcome assessments.

Researchers are evaluating whether taking supplemental fiber for 9 weeks can improve vascular health in adults with obesity. They are also studying if the response differs between those with very few heart disease risk factors and those with several. This study focuses on individuals with a body mass index of 30 kgm2 or higher and groups them based on metabolic health status. Participants will consume inulin, a fiber supplement from chicory root, starting with 6 grams daily for one week, followed by 12 grams daily for eight weeks. They will dissolve the powder into a cool or room temperature beverage and drink it around the same time each day. The study includes assessments before starting, halfway through, and at the end of the intervention. During the study visits, participants will fast for about 10 hours before arriving in the morning. Researchers will collect blood samples and perform vascular tests including flow-mediated dilation and pulse wave velocity, along with body weight and composition measurements. Participants will also wear a blood pressure monitor for 24 hours and complete food records. Optional stool sample collection and special body scans will be done at the beginning and end of the study. The research team will monitor various blood markers and vascular health measures throughout the study, which lasts about 9 weeks.

Researchers are evaluating the medicine pelacarsen TQJ230 compared to a placebo in adults with atherosclerotic cardiovascular disease ASCVD who have high levels of lipoproteina and are already receiving inclisiran treatment to lower their LDL cholesterol. This study is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial with a parallel group design to assess the efficacy, safety, and tolerability of pelacarsen. Participants will be randomly assigned to receive either pelacarsen injections once a month for 12 months or placebo injections once a month for 6 months, followed by pelacarsen injections for the remaining 6 months during an open-label phase. All participants also receive background inclisiran treatment consisting of two initial loading doses three months apart, followed by doses every six months as per approved guidelines. During the study, participants will have regular visits and assessments including laboratory tests to measure lipoproteina levels and monitor safety. Researchers will track changes in lipoproteina concentration at baseline and six months, along with adverse events and treatment tolerability over up to 16 months. The trial aims to understand how pelacarsen affects lipoproteina levels and overall safety when combined with inclisiran in this patient group.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are conducting an observational study called XLPAD to evaluate the effectiveness and use of stent and non-stent therapies among patients with peripheral arterial disease PAD. This study aims to create a registry including data from procedures and clinical follow-ups, collecting information from patients treated since January 1, 2005, until 14,000 patients are enrolled. The study focuses on comparing outcomes like need for revascularization, surgical interventions, amputations, and safety events such as death, heart attack, stroke, and procedural complications over 12 months. Patients who receive endovascular interventions involving stents or percutaneous transluminal angioplasty PTA in specific leg arteries, including superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries, will be included. The study collects detailed background, lesion, intervention, and outcome data into an online system called REDCAP. Follow-up data is gathered at 6 and 12 months after the procedure, but follow-up visits are based on usual clinical care and not mandated by the registry. Treatment decisions, including use of stents or other therapies, remain at the discretion of the care team. Participants contribute by allowing the collection of their medical records, procedural details, and follow-up information. Data collected include patient characteristics, lesion features, treatment details, and clinical outcomes like walking distance and ankle-brachial index changes. Researchers will review events and outcomes up to 12 months post-procedure to assess treatment effectiveness and safety. The registry poses minimal risk since it observes routine care without altering treatments. Total participation duration depends on clinical follow-up timing, typically up to one year after the initial intervention.

Researchers are reviewing anonymous medical records from multiple centers to understand the outcomes of different treatments for chronic pain. This study includes several groups to assess how various approaches work in distinct patient subgroups. The focus is on patients who have had or may have spinal cord stimulation systems or other treatments like radiofrequency RF or intradiscal therapies IDS. The study looks at patients who have previously received spinal cord stimulation or other therapies and those who have switched to different treatments afterward. Treatments under review include Boston Scientific devices and non-Boston Scientific systems such as spinal cord stimulation, RF, and IDS. The data is retrospective, meaning it examines past patient experiences without introducing new treatments. Participants involvement consists of the analysis of their de-identified medical charts, with no active treatment or visits required. Researchers will measure responder rates approximately two years from the start of data collection to evaluate treatment outcomes. The study spans from April 2012 to December 2030, focusing on long-term clinical results in chronic pain management.