Muncie

Researchers are evaluating the COMPASS Across Settings (CAST) intervention to help autistic youth improve their goal setting and achievement skills related to their transition from high school to postsecondary life. Despite laws requiring transition services for students with disabilities, autistic students often do not have positive outcomes after school. CAST combines three proven interventions and adds coaching support for caregivers, students, and employment specialists to better align goals across home, school, and community settings, aiming to improve long-term success. CAST begins with a joint session involving the student, caregiver, teacher, and pre-employment specialist to discuss the student's postsecondary goals and challenges in areas like social skills and communication. This meeting guides personalized intervention plans focused on critical goals. After this, four more one-hour sessions provide coaching, progress monitoring, and support to adjust plans as needed. The intervention is tested through focus groups, a field trial, and a randomized controlled trial comparing CAST to usual services. Participants will attend assessments throughout the study, including evaluations of Individualized Education Program (IEP) goal achievement at the end of the school year and follow-ups on postsecondary goals one year after graduation. Researchers will collect feedback from caregivers, students, teachers, and specialists about transition plan quality and intervention use. They will also analyze service integration and costs to understand CAST's impact and feasibility over the study period.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are studying vascular health in females with a normal body mass index (BMI) to understand how different amounts of body fat and muscle mass affect cardiovascular risk. This study focuses on women aged 18 to 50 who have a BMI in the normal range (18.5-24.9 kg/m2) and are not pregnant or postmenopausal. The goal is to learn more about vascular function and cardiovascular reactivity in females with what is called "normal-weight obesity." Participants will be recruited from Ball State University and the surrounding community. Participants will complete two separate study visits arranged in a randomized crossover design. During one visit, they will consume a high-fat, Western-style meal consisting of two Jimmy Dean Breakfast Bowls. Blood samples and vascular measurements, including flow-mediated dilation, pulse wave analysis, and pulse wave velocity, will be taken before and multiple times after the meal to assess vascular response. At the other visit, participants will undergo a mental stress task with similar blood and vascular measurements taken before and after the stress exposure. Blood samples will be analyzed for markers such as triglycerides, HDL cholesterol, intestinal permeability, epinephrine, and inflammatory markers. Throughout the study, participants will lie quietly to acclimate before vascular tests and remain in a supine position during measurements. Blood samples will be collected via an intravenous catheter at specific time points up to four hours after the meal and up to 90 minutes after the stress task. The study will monitor vascular health indicators and cardiovascular reactivity for up to one year. Participants will be closely observed for safety and adherence during their visits.

Researchers are investigating how replacing table sugar with sugar from fresh mango affects blood sugar, insulin, and blood vessel responses after eating breakfast meals. The study focuses on healthy adults aged 18 to 45 with a body mass index between 18.5 and 35.0. Previous studies suggest mango might help lower blood sugar, but this study aims to confirm these effects within realistic mixed meals. The trial compares responses to high and low glycemic breakfasts sweetened either with fresh mango or table sugar. Participants will complete four meal tests in a randomized order, each involving a different breakfast: corn flakes with milk plus fresh mango, corn flakes with milk plus sucrose, steel-cut oats with water plus fresh mango, and steel-cut oats with water plus sucrose. The corn flakes meals represent high glycemic meals, and the oats represent low glycemic meals. The sugar content and calories are matched within each meal type to fairly compare the effects of mango versus table sugar. During each meal test, an intravenous catheter will be placed to collect blood samples before and at 0.5, 1, 2, and 3 hours after eating. Blood vessel function will be measured using a technique called flow-mediated dilation at baseline and at 1, 2, and 3 hours post-meal. Participants will complete surveys rating meal acceptability and feelings of fullness at various times. Additional measurements include body composition via DXA scan and analysis of blood markers like glucose, insulin, and triglycerides throughout the study lasting up to 1.5 years.

Researchers are investigating how a single high-fat meal affects gut, immune, and blood vessel functions in people with "metabolically healthy obesity" (obesity but mostly normal cardiometabolic health) and those with normal weight. They also want to understand how a prebiotic fiber called inulin influences these health aspects in individuals with metabolically healthy obesity. The study includes two parts under a single approval and identifier. In the first part, participants with either normal weight or obesity will consume a high-fat meal containing about 700 calories made of heavy cream, chocolate syrup, and protein powder. Blood samples and vascular tests such as flow mediated dilation, pulse wave analysis, and pulse wave velocity will be taken before and several times after the meal. Stool samples will also be collected at home. In the second part, participants with obesity will be randomly assigned to receive six weeks of either inulin supplementation or a placebo (maltodextrin). Blood samples, vascular assessments, and stool collections will be done at baseline and during the intervention at 2, 4, and 6 weeks. Participants will undergo multiple blood draws during the study to measure markers related to intestinal permeability, inflammation, and vascular health up to two years. Samples will also be used in lab experiments to examine effects on endothelial cells. Vascular tests will be repeated at various time points to monitor changes. Participants must be able to lie quietly in a dark room for vascular measurements. The study monitors these outcomes closely throughout the intervention and follow-up periods.

Researchers are studying how supplemental fiber impacts gut and vascular health in adults with obesity, focusing on differences between those with few versus multiple heart disease risk factors. The study involves individuals with a body mass index of 30 kg/m2 or higher, grouped by their metabolic health based on the number of metabolic syndrome risk factors. The goal is to see if fiber intake can improve markers related to vascular health and inflammation over a 9-week period. Participants will consume inulin fiber daily, starting with 6 grams per day for the first week, followed by 12 grams per day for the next eight weeks. The fiber is dissolved into a cool or room temperature liquid for easy consumption. The study includes three in-lab visits: at baseline before starting the fiber, at 5 weeks during the intervention, and at 9 weeks at the end of the intervention. During these visits, various vascular and body composition measurements will be taken. Participants will arrive fasting for around 10 hours at each visit. Blood samples will be collected and vascular tests like flow-mediated dilation, pulse wave analysis, and electrocardiograms will be performed. Body weight and composition will be measured using bioimpedance and dual-energy X-ray absorptiometry scans. After each visit, participants will wear a blood pressure monitor for 24 hours and complete a 3-day food diary. Optional stool samples will be collected at home after the first and last visits. The study will measure several blood markers and vascular function indicators over up to 1.5 years to assess the effects of fiber intake.

Researchers are investigating the effects of pelacarsen (TQJ230) compared to a placebo in adults with atherosclerotic cardiovascular disease (ASCVD) who have high levels of lipoprotein(a) (Lp(a)) and are also receiving inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C). The study is designed as a Phase 3 randomized, double-blind, placebo-controlled, multicenter trial with a parallel group structure, followed by an open-label treatment period. The aim is to assess the efficacy, safety, and tolerability of pelacarsen in this population. Participants will receive pelacarsen or placebo as a solution for subcutaneous injection using prefilled syringes. All participants will be given background treatment with inclisiran, starting with two loading doses spaced three months apart during the run-in period. Afterward, inclisiran will be administered every six months at Month 5 and Month 11. Following the double-blind phase, an open-label treatment period will continue, allowing further evaluation of the treatments. Throughout the study, participants will undergo assessments including measurement of lipoprotein(a) levels, with the primary outcome focusing on change in log-transformed Lp(a) concentration from baseline to six months. Laboratory tests will monitor LDL-C and other relevant markers. Safety and tolerability will be tracked continually, and standard care for cardiovascular risk factors such as hypertension and diabetes will be maintained. The study includes adults aged 18 to 80 years with established ASCVD and elevated lipid levels, ensuring ongoing monitoring and evaluation of treatment effects.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

This research aims to evaluate the effectiveness and usage of stent and non-stent therapies in patients with Peripheral Arterial Disease (PAD) who undergo endovascular interventions. The study focuses on comparing outcomes such as the need for further procedures, safety events including death or heart attack, and improvements in walking ability and symptoms over a 12-month period. It is designed as a large observational registry including data collected from January 2005 until 14,000 patients are enrolled across about 60 sites worldwide. Patients receiving either stents or percutaneous transluminal angioplasty (PTA) in specific leg arteries, including the superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries, are included. Those treated only in the external or common iliac arteries are generally excluded unless treated alongside these target arteries. Data collected includes patient background, lesion and procedural details, and follow-up clinical outcomes. Treatment decisions and follow-up visits are made according to routine clinical care and not mandated by the study. Participants’ data will be recorded at baseline and during follow-up visits at approximately 6 and 12 months after the initial procedure. The study collects information on walking ability, symptom severity, artery function tests, procedural success, and adverse events such as repeat interventions or amputations. Researchers will monitor outcomes to compare stent and non-stent therapies while ensuring minimal risk to patients as treatments follow standard clinical practice.

This research evaluates anonymous, previously collected medical data to review the outcomes of different treatment methods for chronic pain. The study is a retrospective review involving multiple centers and independent patient groups to compare results across various subgroups. The study examines clinical outcomes related to the use of spinal cord stimulation, radiofrequency (RF), and other implantable device systems from Boston Scientific and other manufacturers. Multiple cohorts will be analyzed based on the type of treatment system used. Participants' medical charts will be reviewed to measure response rates through approximately two years of follow-up. The study focuses on clinical results documented in patient records without any new treatment or intervention administered during the study.