West Lafayette

Researchers are evaluating the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition that causes long-lasting painful red lumps on the skin. The study focuses on participants who have not responded well to or cannot tolerate antibiotics for HS. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how Ritlecitinib compares to placebo in treating this condition. Participants will be randomly assigned to take either Ritlecitinib or a matching placebo by mouth once daily at home. The study includes a loading dose of Ritlecitinib for the first 8 weeks, followed by a maintenance dose for the next 8 weeks, totaling 16 weeks of treatment. The placebo group will follow the same schedule with a pill that looks like the study medicine but contains no active drug. Throughout the study, participants will have about 10 clinic visits over approximately 24 weeks, including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until Week 16. At these visits, health status will be reviewed through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also record daily medication intake and HS symptoms using a mobile eDiary. Researchers will measure skin response and safety outcomes to assess the effects of the study medicine compared to placebo.

Researchers are evaluating ALD-102 Solution in adults with alopecia areata to determine its safety, tolerability, and effect on hair regrowth. This first-in-human clinical trial compares ALD-102 injections in the scalp to placebo injections and untreated areas. The study aims to understand treatment-related side effects and hair regrowth outcomes in affected scalp areas. Participants receive injections of ALD-102 Solution or placebo once every 4 weeks over an 8-week treatment period. Different scalp areas are selected for treatment, placebo, or no treatment depending on the cohort. The study includes multiple injections per treatment area, with dosing adjusted by cohort. This randomized, triple-blind study monitors participants for adverse effects and drug levels. Throughout the trial, participants undergo clinical assessments, local tolerability evaluations, and safety monitoring for 24 weeks. Skin biopsies and blood samples are collected to measure ALD-102 concentrations. Researchers track hair regrowth and adverse events using standardized scales and assessments. Participants are required to follow study procedures and maintain consistent hair styling during the study duration.

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.

This research aims to evaluate the effectiveness and safety of upadacitinib at different doses for adults with moderate to severe atopic dermatitis AD who have not responded well to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation. The study includes approximately 200 adults aged 18 to less than 64 years, all current dupilumab users with a history of inadequate response. The trial is conducted in two periods to compare upadacitinib 15mg to dupilumab 300mg and adjust doses based on clinical response. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg tablets once daily or dupilumab 300mg subcutaneous injections every two weeks for eight weeks. Participants on upadacitinib 15mg may have their dose increased to 30mg after two weeks depending on response. Period 2 lasts 24 weeks, during which participants continue or adjust doses based on their Eczema Area and Severity Index EASI response at Week 8. Participants may remain on their assigned dose or switch doses accordingly. Participants attend regular visits at hospitals or clinics during the 35-day screening, 8-week Period 1, and 24-week Period 2, plus a 30-day follow-up. Assessments include medical exams, blood tests, monitoring for side effects, and questionnaires. Researchers measure outcomes such as the percentage achieving at least a 90% reduction in eczema severity EASI 90 at Week 8. The study monitors treatment effects and safety carefully throughout the 32-week treatment and follow-up period.

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

Researchers are evaluating the effects of a single 20-minute session of mindfulness-based high-intensity interval training MF-HIIT, mindfulness only, and high-intensity interval training HIIT only compared to sitting rest on executive function EF in children aged 10 to 12 years. The study aims to find out if MF-HIIT improves EF and brain function more than the other conditions using measurements like event-related potential during cognitive tasks. This randomized crossover trial involves healthy children without cognitive or neurological disorders and assesses intelligence and fitness before interventions. Participants will visit the laboratory on five separate days with more than two days between visits. On Day 1, they will complete intelligence testing and a treadmill exercise test. On Days 2 to 5, participants will experience each intervention MF-HIIT, mindfulness only, HIIT only, and sitting rest. Each 20-minute session includes specific protocols with warm-up, exercise or mindfulness intervals, and cool-down periods. Heart rate, perceived exertion, and affect will be monitored during the sessions. During the intervention days, participants will complete tasks measuring inhibitory control and cognitive flexibility while wearing an EEG cap to record brain activity. Outcome measures include speed and accuracy of inhibition and shifting, and brain components N2 and P3. Additional assessments involve mindfulness state, heart rate, and exertion ratings. These measures are taken before and after each 20-minute intervention. The study will compare cognitive and brain function outcomes across the different interventions to understand their effects on childrens executive function.

This research focuses on the community of Martinsville, Indiana, where groundwater is contaminated with volatile organic compounds, mainly tetrachloroethylene PCE and trichloroethylene TCE. These chemicals have also been found in indoor air in some buildings, raising concerns about their impact on residents health. The study aims to better understand the effects of low-level exposure to these compounds and to support the community in deciding on actions to reduce risks. Participants will receive an educational campaign designed to encourage involvement in environmental testing, particularly indoor air testing. The study involves measuring contamination levels in residents and their homes, assessing community concerns, studying effects on visual and neurocognitive functions, and comparing cancer rates locally to wider areas. The campaign and study results will help design targeted efforts to lower exposure. During the study, researchers will track changes in residents concerns about contamination, awareness of chemical exposure, and willingness to have their homes tested over several years. Assessments will include surveys and environmental testing to monitor exposure and health impacts. The study is led by Purdue University and will run through May 2028, involving adults living in Martinsville.

Researchers are investigating how replacing part of the protein in a lacto-ovo vegetarian diet with red meat affects people aged 40 to 70 who have stage 3 chronic kidney disease. The study aims to explore changes in blood and urine levels of uremic toxins, including trimethylamine N-oxide, which may impact kidney health. This pilot crossover trial will involve up to 15 participants to better understand the effects of different protein sources. Participants will first have a 2-week baseline period consuming their usual diet, followed by two 3-week diet periods in random order. One period involves a lacto-ovo vegetarian diet, and the other replaces 20% of the protein in that diet with red meat. Between these diet phases, there is a 5-week washout period where participants return to their typical diet. The study uses a single-blind crossover design to compare the metabolic effects of these diets. Throughout the 13-week study, participants will provide blood, urine, and stool samples at multiple points, including before and during the diet periods. Researchers will measure various health markers such as serum trimethylamine N-oxide, other uremic toxins, gut microbiota, blood pressure, cholesterol, glucose, and kidney function indicators. Participants will also report gastrointestinal symptoms and stool consistency. These assessments will help evaluate how diet changes influence kidney disease-related factors.

This research aims to understand how different noise-reduction technologies in hearing aids affect a persons ability to hear speech in noisy environments. The study focuses on people with mild-to-moderate cochlear hearing loss and compares various noise-reduction algorithms, including stronger and weaker settings, as well as no noise reduction, across different background noise levels. The goal is to identify which noise-reduction strategies help improve speech understanding the most, especially in challenging listening situations. Participants will complete listening tasks using a dual-sentence method that simulates real-world listening demands by requiring them to recall two sentences presented back-to-back amid background noise. Each participant experiences all noise-reduction settings off, low, high at different signal-to-noise ratios SNRs, ranging from easier conditions where speech is louder than noise to harder ones where noise dominates. The study uses a monaural, single-microphone hearing aid configuration to isolate noise-reduction effects without directional hearing aid processing. During the study visit, which lasts about 1 to 2 hours, participants speech understanding is assessed by scoring how accurately they recall keywords from the sentences under each condition. This allows researchers to measure both immediate and delayed speech recall as indicators of speech intelligibility and cognitive effort. The findings may help improve hearing aid design and guide clinical fitting by showing how different noise-reduction algorithms impact speech comprehension and listening difficulty in everyday noisy settings.

Researchers are evaluating the effects of eating different types of grain foods with varying whole grain and added sugar content in adults aged 21 to 60 years. This 16-week randomized controlled trial aims to understand how diets with whole grain versus refined grain and different sugar levels impact taste preferences, appetite, energy intake, body weight, blood pressure, blood sugar levels, and blood fats. The study will also explore how these diets affect gut microbiome composition and function while controlling for added sugars, saturated fats, and sodium. Participants will be randomly assigned to one of four diet groups, each differing in whole grain servings and added sugar levels high whole grain with low sugar, low whole grain with low sugar, high whole grain with high sugar, and low whole grain with high sugar. All diets will have about 50% carbohydrate, 35% fat, and 15% protein energy content, with grain foods making up half of the carbohydrate portion. The diets will be followed over the 16 weeks, with specific servings of grain foods prescribed according to the assigned group. Throughout the study, participants will undergo various assessments including fasting blood tests, meal tolerance tests, body weight and composition measurements, continuous glucose monitoring, dietary intake tracking, taste preference testing, appetite ratings, physical activity monitoring, blood pressure measurements, and microbiota analysis. These evaluations will occur at baseline and several time points during the 16 weeks to monitor changes. Compliance with the diet will also be tracked to ensure adherence. The primary outcome is blood sugar control at 12 weeks, with multiple secondary outcomes related to appetite, taste, energy intake, body weight, blood pressure, and blood fats.