West Lafayette

Researchers are assessing the safety and effects of Ritlecitinib, a study medicine, for treating hidradenitis suppurativa (HS), a condition causing long-lasting, painful red skin lumps. This phase 2 study focuses on adults with moderate to severe HS who have not responded well to or cannot tolerate antibiotics. The goal is to compare experiences and outcomes between those receiving Ritlecitinib and those receiving a placebo. Participants will be randomly assigned to take either Ritlecitinib or a placebo pill once daily at home. The treatment involves an initial loading dose of Ritlecitinib for 8 weeks, followed by an 8-week maintenance dose, totaling 16 weeks of treatment. The placebo group will receive a matching pill with no active medicine. Over approximately 24 weeks, including screening and follow-up, participants will attend around 10 clinic visits for health evaluations, including physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. They will also track their medication intake and HS symptoms daily using an electronic diary on a mobile phone. The study will measure how many patients achieve at least a 50% improvement in HS symptoms by week 16 to evaluate treatment response and safety.

This research aims to evaluate the safety and tolerability of ALD-102 Solution when injected into the scalp of adults with alopecia areata, a condition causing hair loss. The study also investigates the preliminary effects of ALD-102 on hair regrowth by comparing it to a placebo (saline solution without the drug) or an untreated area. Participants are selected based on specific scalp lesion characteristics and age, and the study is conducted as a Phase 1B/2A clinical trial to gather initial safety and efficacy data. Participants will receive injections of ALD-102 Solution or placebo once every four weeks over an eight-week treatment period. Treatment areas on the scalp will be chosen to receive either the drug, placebo, or no treatment, with the number of injections varying by study cohort (ranging from 20 to 40 injections). The study uses an intraindividual design where each participant has different areas treated differently for comparison. Throughout the 24-week combined treatment and follow-up period, researchers will assess participant safety by monitoring for treatment-related adverse effects and injection site reactions using clinical assessments and numerical scales. Hair regrowth and tolerability will also be evaluated. Participants are expected to comply with study procedures, including attending scheduled visits and enduring multiple intradermal injections, while researchers closely observe and measure outcomes related to safety and preliminary efficacy.

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 effectiveness and safety of upadacitinib at different doses in adults with moderate to severe atopic dermatitis (AD) who have not responded adequately to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation, and some people require systemic treatments beyond topical therapies. This phase 3b/4 study aims to provide data on upadacitinib's impact on AD symptoms in this specific population. The study is conducted in two open-label periods. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg orally once daily or dupilumab 300mg by subcutaneous injection every two weeks. After two weeks, those on upadacitinib 15mg may have their dose increased to 30mg based on their response. Period 2 lasts 24 weeks, during which participants either continue their assigned dose or switch doses depending on their eczema severity scores. The entire treatment duration is 32 weeks with follow-up for 30 days after treatment ends. Participants will undergo regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires to evaluate treatment effects. The main outcome measured is the number of participants achieving at least a 90% improvement in their eczema severity index by week 8. The study includes a 35-day screening period before treatment begins and monitors safety and efficacy throughout the study duration.

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

Researchers are investigating the effects of a single 20-minute session of mindfulness-based high-intensity interval training (MF-HIIT), mindfulness only (MF-only), and high-intensity interval training only (HIIT-only) compared to sitting rest on executive function in children aged 10 to 12 years. The study aims to determine whether MF-HIIT improves executive function performance and brain activity more than MF-only, HIIT-only, or sitting rest. Brain function is assessed using the N2 and P3 components of event-related potentials during tasks measuring executive function. Participants will attend five laboratory visits spaced with at least two days in between. On Day 1, intelligence is evaluated using the Kaufman Brief Intelligence Test, and cardiorespiratory fitness is measured with a treadmill exercise test. On Days 2 to 5, participants will complete each of the four interventions in a randomized order: a 20-minute MF-HIIT session involving warm-up, intervals of exercise and mindfulness, and cool-down; a 20-minute mindfulness-only session with mindful intervals separated by rest; a 20-minute HIIT-only session with exercise and rest intervals; and a sitting rest session watching a HIIT video without mindfulness instructions. During intervention days, researchers will measure heart rate, physical exertion, and mood. Participants will perform tasks assessing inhibitory control and cognitive flexibility while wearing EEG caps to record brain activity. Outcomes include changes in task performance and brain event-related potentials before and after each intervention. The study compares the cognitive and brain function effects of MF-HIIT to the other conditions to understand its potential benefits for children's executive function.

Researchers are investigating the impact of low-level exposure to volatile organic compounds (VOCs), specifically tetrachloroethylene (PCE) and trichloroethylene (TCE), on the health of community members in Martinsville, Indiana. The study focuses on understanding contamination from groundwater and indoor air in residential and commercial buildings, which may pose health risks including effects on visual and neurocognitive functions and cancer rates. The goal is to empower the community by involving members in environmental health decisions and addressing concerns related to chemical exposure. The study includes an educational campaign aimed at encouraging residents to participate in indoor air testing to identify contamination levels in homes and individuals. Researchers will collect data on contamination exposure, community awareness, and perceptions about health risks. This information will guide the development of targeted educational efforts to reduce exposure to VOCs. The campaign and data collection span multiple years to track changes in concerns, awareness, and willingness to have homes tested. Participants will be adults aged 18 to 99 living in Martinsville. The study involves assessing changes in environmental health concerns, awareness of chemical exposure, and willingness to participate in home testing over periods ranging from one to five years. Researchers will monitor health effects through evaluations of neurocognitive function and cancer incidence compared to broader regional data. The research aims to provide long-term monitoring and community support to mitigate exposure risks and improve health outcomes.

Researchers are evaluating how replacing red meat with other protein sources affects certain toxins in the blood and urine of people with stage 3 chronic kidney disease. This study aims to understand the impact of red meat intake on serum and fractional urinary excretion of uremic toxins, including trimethylamine N-oxide, which are linked to kidney health. The trial includes adults aged 40 to 70 years who have moderate chronic kidney disease and meet specific kidney function criteria. Participants will first follow their usual diet for two weeks, then be randomly assigned to receive either a lacto-ovo vegetarian diet or the same diet with 20% of the protein replaced by red meat for three weeks. After this, there is a five-week period where participants return to their usual diet, followed by crossing over to the other diet for another three weeks. This single-blind, crossover feeding study allows comparison of the two diets within the same individuals. During the study, researchers will collect blood and urine samples at multiple time points to measure levels of trimethylamine N-oxide and other metabolites. Participants will also collect fecal samples at home. Safety and health status will be monitored throughout the study. The study will use statistical methods to analyze differences between diets, with a total of up to 15 participants involved.

\*\*\* STUDY DESCRIPTION \*\*\* Hearing in noisy environments is one of the most common challenges faced by individuals with hearing loss, and even people with normal hearing often struggle to understand speech in situations such as restaurants, classrooms, and busy public spaces. Modern hearing aids use advanced digital signal-processing strategies, especially deep neural network (DNN)-based noise reduction, to improve speech intelligibility in these difficult listening situations. However, these technologies vary widely in how well they work, and their benefits can depend on factors such as noise level, background type, and an individual's degree of hearing loss. This study examines how different noise-reduction strategies affect a listener's ability to understand speech across a range of real-world listening conditions. A monaural, omnidirectional configuration is to isolate single-microphone noise-reduction strategies without the benefit of directional hearing-aid processing. The research compares several processing modes, each representing a distinct noise-reduction algorithm or signal-processing approach. These modes include stronger and weaker forms of noise reduction as well as "off" conditions with no noise-reduction processing applied. Participants will complete listening tasks at several input signal-to-noise ratios (SNRs), representing easier and more difficult levels of background noise. All participants experience each condition in a controlled, fully counterbalanced order to reduce learning effects and bias. \*\*\* OVERVIEW OF THE LISTENING TASKS \*\*\* During the study, listeners complete speech-understanding tasks using the dual-sentence paradigm, a testing method developed to better reflect the real-world cognitive load of listening in noise. Traditional speech tests typically ask a listener to repeat a single sentence at a time. While useful, these single-sentence tasks often underestimate the difficulty of everyday listening, which requires people to monitor, remember, and respond to multiple pieces of information at once. The dual-sentence paradigm addresses this gap by presenting two sentences back-to-back within the same trial. The participant hears Sentence A, followed immediately by Sentence B, spoken by different talkers. The participant is asked to immediately repeat the first sentence and then type the second sentence. This structure increases cognitive demand by requiring the listener to hold more spoken information in working memory while simultaneously dealing with background noise. The approach provides a more sensitive measure of how signal-processing strategies affect not only audibility but also real-world listening effort, memory load, and speech comprehension. \*\*\* HOW NOISE-REDUCTION STRATEGIES ARE EVALUATED \*\*\* To evaluate the effects of each noise-reduction setting, participants complete the dual-sentence task at several SNRs - for example, easier (positive) SNRs where speech is louder than the noise, and harder (negative) SNRs where noise competes strongly with speech. Each noise-reduction mode is tested at every SNR, producing a full set of performance data for every combination of algorithm strength and noise difficulty. Speech understanding is measured using standard scoring methods for sentence recall tasks. Participants' responses are recorded, and accuracy is scored based on the number of keywords correctly repeated for each sentence. This allows the research team to quantify how different processing strategies influence speech intelligibility and cognitive load under controlled listening conditions. \*\*\* SCIENTIFIC RATIONALE AND EXPECTED CONTRIBUTIONS \*\*\* Deep neural network-based noise-reduction strategies have emerged in many commercial hearing devices, but their performance can vary depending on training data, model complexity, and how aggressively the noise is reduced. Some settings may improve intelligibility but distort the speech signal; others may reduce noise but introduce processing delays or artifacts that affect listener comfort. By systematically comparing multiple noise-reduction algorithms under identical conditions, this study aims to map how different strategies alter both speech understanding and listening difficulty. Findings from this research can help guide the development of more effective, listener-centered noise-reduction approaches for hearing aids. The results may also improve clinical recommendations by identifying which algorithm strengths work best in different noise environments. \*\*\* BROADER SIGNIFICANCE \*\*\* The ability to communicate in noisy surroundings has profound effects on social participation, work performance, and quality of life. Many hearing aid users continue to report difficulty in noisy environments despite technological advancements. A more detailed understanding of how listeners respond to different noise-reduction strategies, especially under the cognitively demanding dual-sentence paradigm, may help manufacturers design more supportive features and may assist clinicians in tailoring fittings to an individual's daily listening needs. This study ultimately seeks to support future improvements in hearing-aid design and programming by providing objective evidence on how advanced noise-reduction algorithms affect real-world speech understanding.

Researchers are studying the effects of different grain food diets on adults aged 21 to 60 years with Hemoglobin A1c levels between 5.7% and 6.4%. This 16-week randomized controlled trial aims to compare how diets with varying whole grain content and added sugar levels affect taste preferences, appetite, food and energy intake, body weight, blood pressure, and both short- and long-term blood sugar and fat levels. The study also explores how these diets impact the gut microbiome and its functions. Participants will be randomly assigned to one of four diet groups, each with a specific combination of whole grain servings and added sugar content: high whole grain with low sugar, low whole grain with low sugar, high whole grain with high sugar, or low whole grain with high sugar. All diets provide about 50% of energy from carbohydrates, with grain foods making up half of the carbohydrate portion. The study includes detailed monitoring of diet adherence and various health measures throughout the 16 weeks. Throughout the study, participants will undergo regular assessments including fasting blood tests, meal tolerance tests, body weight and composition measurements, continuous glucose monitoring, appetite and taste evaluations, blood pressure checks, and analysis of gut microbiota. These evaluations occur at multiple time points during the trial to track changes over time. Researchers will also monitor physical activity and diet compliance to understand how these factors relate to health outcomes.