Clinical trials

Alcohol consumption, even at low levels, has been associated with increased breast cancer risk, but the biological mechanisms underlying this relationship remain unclear. This study will examine whether breast tissue may locally metabolize alcohol by measuring alcohol-related compounds in paired blood and breast milk samples from lactating women. The findings may help clarify alcohol-related biological pathways relevant to breast cancer risk and improve risk communication.

The goal of this feasibility study is to evaluate the preliminary impact of a mobile health application (app) called bpMedManage-R, designed to support hypertension medication self-management in persons with mild cognitive impairment (PwMCI) who live alone. The main questions this study aims to answer are whether the bpMedManage-R app shows preliminary impact on medication-related self-regulation (the ability to consistently take medications as prescribed) and self-efficacy (confidence in independently managing medication use). Participants will be randomized after a baseline assessment to the bpMedManage-R Immediate Group or the bpMedManage-R Delayed Group. Participants assigned to the Immediate Group will complete a 4-week baseline adherence period, at the end of which they will enter the intervention phase. A remote training session will be conducted to initiate the intervention phase, during which participants will download the app, learn to use it, and set up their medication schedule and reminders within the app with support from the study team. They will then use the app for 8 weeks to self-manage their medications, take part in brief weekly check-ins to review progress, and complete Outcome Assessment 1 at the end of the 8-week intervention phase. Participants assigned to the Delayed Group will complete a 12-week baseline adherence period, at the end of which they will complete Outcome Assessment 1. Subsequently, they will enter the intervention phase and will follow a process similar to that of the Immediate Group. At the end of the 8-week intervention phase, they will complete Outcome Assessment 2. Researchers will compare participants who receive the bpMedManage-R app intervention immediately to those assigned to the delayed control group.

This phase I clinical trial tests the feasibility and safety of a self-guided, mobile mindfulness-based intervention to reduce post-cesarean pain and prevent postpartum depression.

Dysphagia, or difficulty swallowing, is a common symptom of many neurological diseases but its treatment is not well established or easily accessible. To start addressing this gap, the researchers developed and validated a cost-effective wearable surface electromyography (sEMG) biofeedback sensor technology (i-Phagia), optimized to record muscle activity from the head/neck and provide biofeedback to patients and adherence data to clinicians during swallow therapy. This system has been developed with commercially available and widely used materials and the Purdue University IRB has determined that the device is non-significant risk device. The goal of this clinical trial is to learn if this biofeedback (using this new technology/i-Phagia) when used as an adjunct to a standard swallow therapy protocol works to improve swallowing function in patients post chronic stroke or diagnosed with Parkinson's disease. It will also help the investigators learn whether this therapy protocol is equally effective when provided in-person versus via telehealth. Finally, it will determine which patient factors may influence how well the treatment works. The main questions it aims to answer are: * Does biofeedback (using this new technology/i-Phagia) when used as an adjunct to a standard swallow therapy protocol works better than a standard of care treatment to improve swallowing function in patients post chronic stroke or diagnosed with Parkinson's disease? * Is completing the swallow therapy protocol at home (via telehealth) as effective as completing it in-person (in the clinic)? * What factors related to the patients (e.g., age, diagnosis, etc.) may influence how well the treatment works? Participants will: * Complete a 12-week swallow treatment protocol (12 treatment visits) either in-person or at home (via telehealth) * Complete 3 in-person evaluations (pre-treatment; post-treatment; and at a 12-week post treatment follow-up time point) * Exercise at home several days per week and keep a diary/log of their home exercise The hypothesis is that upon study completion, the efficacy of sEMG biofeedback-facilitated swallow therapy for both in-person and telehealth service delivery in two neurogenic dysphagia populations will have been established, and variables determining response to treatment will begin to be identified.

The research team is conducting a study to determine if a fall prevention program designed specifically for people who use wheelchairs and scooters can help people better prevent and manage falls compared to the standard of care. This study will compare two groups of participants: 1. One group will use the iROLL-O+ app, which offers personalized fall prevention tools and strategies. 2. The other group will receive fall prevention information from a well-known program developed by the Centers for Disease Control and Prevention (CDC), called STEADI, which stands for Stopping Elderly Accidents, Deaths, and Injuries. This study includes adults living with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS) who use a wheelchair or scooter every day. The research team aims to determine which approach is more effective in reducing falls and improving confidence in performing daily activities.

In a crossover design, 8 participants will receive caloric drinks containing stable isotopes. In one arm of the study, participants will consume 6 hourly drinks containing two stable isotopes. Repeated blood, breath, urine, and muscle biopsies will be taken. In the second arm, participants will consume 1 drink containing 75g glucose, labeled with two stable isotopes of glucose. Periodic blood and breath will be taken over three hours.

In this randomized controlled trial, 30 older adults (aged\> 65 years; 15 with T2D, 15 controls) will participate in a 12-week progressive exercise training program. They will undergo pre- and post-testing that includes body composition measures; oral glucose tolerance testing; cardiovascular fitness and muscle performance testing; dietary protein efficiency assessed using the indicator amino acid oxidation (IAAO) method; and a gut microbiota trial. The dietary protein efficiency trial will include repeated ingestion of crystallized amino acids (drink) containing stable isotopes, urine samples, and breath samples. The gut microbiome trial will consist of a single ingestion of a Mediterranean-based modeled meal enriched with 13C-phenylalanine (in the drink) and repeated blood draws. Participants will also be asked to give a fecal sample after the gut microbiome trial.

In the present semi-crossover randomized design, 15 recreationally active young adults (19-40 y) will receive stable isotope tracer infusions and perform a single bout of resistance exercise. Immediately after exercise, participants will ingest either 1 medium russet potato with skins and 2 ounce-equivalent lean ground beef combination (274 kcals, 19.3 g protein, 5 g fat, 37 g carbohydrates, and 4 g fiber), 2 slices of white bread and beef combination (262 kcals, 19.8 g protein, 6.8 g fat, 28 g carbohydrates, and 1.8 g fiber) or 2 ounce-equivalent beef (93% lean meat/7% fat; 110 kcals, 14.8 g protein, and 5 g fat). Repeated blood and muscle biopsies will be collected to determine whole body leucine kinetics, amino acid concentrations, anabolic signaling and myofibrillar protein synthesis rates during the trials.

Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities.

The current research is designed to implement and evaluate 5 Verbs for Couples, a new relationship education program that can be completed individually or by both partners together. Involvement will entail completing 3 surveys over a 2-month period. After completing the first survey, a subset of individuals will be randomly assigned to participate in a 3-session online program and answer questions about their experience in the program. The remaining individuals will receive access to the program approximately 2 months later, after completing the third survey.

The goal of this clinical trial is to determine if a new algorithm can improve speech perception for cochlear implant users. The main questions it aims to answer \[is/are\]: * Does the algorithm improve speech perception in noisy environments? * Does the algorithm allow listeners to determine where a sound is coming from? Participants will * Listen to and repeat sentences presented in the presence of noise * Indicate the location that sounds originated from

This study is a randomized controlled trial of the walking meditation intervention (iWalk) program, a multi-component intervention integrating walking meditation, education, and group sessions designed to enhance resilience in individuals with multiple sclerosis (MS). The objectives are to evaluate: 1. Recruitment capability and retention rates, 2. Acceptability and adherence to the intervention, 3. Feasibility of assessment procedures, and 4. Preliminary effects on psychological, physiological, and behavioral outcomes.

The study investigates the effects of alcohol consumption on social and individual behaviors using a within-subject design. Participants, aged 21-30, will attend two laboratory sessions approximately one week apart, participating as part of a dyad (pair). During one session, they will consume an alcoholic beverage, while in the other, they will receive a control beverage, with the order of conditions randomized. This design facilitates direct within-participant comparisons of behaviors and neural activity in intoxicated versus sober states. To achieve these aims, the study employs EEG technology to explore intra-brain and inter-brain dynamics during social interactions. Additionally, validated self-report questionnaires will capture data on mood, social bonding, and other psychological variables. The findings are expected to enhance understanding of alcohol's role in social reward processes and contribute to developing evidence-based prevention and intervention strategies for alcohol use disorder.

The purpose of this study is to assess the effectiveness after using a new individualized-health e-library app named SavvyHealth among people with multiple sclerosis.

The study will employ a combined laboratory-ambulatory design. Participants will engage in ambulatory assessment over the course of 14 days, wearing biosensors assessing transdermal alcohol concentration (TAC) and providing breathalyzer readings in real-world contexts. Also during this period, participants will attend three laboratory alcohol-administration sessions scheduled at one-week intervals, with alcohol dose and rate of consumption manipulated within and between participants, respectively. Laboratory visits will also double as ambulatory orientation, check-in, and close-out sessions.

The purpose of the study is to conduct a 6-month randomized controlled trial among Latinos ages 50+ at risk for cognitive decline and compare the efficacy of a remote-delivered, culturally tailored Latin dance program and strength training coupled with a Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) diet (IG) compared to a Latin dance and MIND diet program (CG) on cognitive performance, CVD risk factors, MIND diet adherence, physical activity, biomarkers, and psychosocial outcomes. Participants will: * Randomly be placed in the intervention (IG) or control group (CG) * Have 2 pre and post intervention testing visits * Have weekly sessions during the 6-month trial

This study is a multi-functional integrated research and education project to prevent losses in academic achievement, cognitive function, and behavioral health among at-risk youth. The study tests the effects of a 8-week nutrition and physical activity-based program (Integrated Childhood Activity and Nutrition \[ICAN\]) to prevent summer learning loss. Outcomes include standardized academic achievement as well as executive function among 6-10-year-olds affected by poverty. The nutrition component of the intervention involves daily consumption of a snack containing the carotenoid lutein, typically found in high quantities in green leafy vegetables. The physical activity components will involve group games or activities.

The goal of this observational study is to learn how the body processes ingested alcohol and how alcohol affects mood and blood sugar in both men and women after undergoing sleeve gastrectomy. The main question\[s\]it aims to answer are: * Are there differences in the way that ingested alcohol is handled in men versus women after sleeve gastrectomy? * What is the consequence of drinking alcohol on an empty stomach versus after a meal on blood sugar control after undergoing sleeve gastrectomy? Participants will participate in two types of alcohol tests (alcohol given orally or administered intravenously) after not eating anything overnight or after having a meal. Researchers will compare men and women who underwent sleeve gastrectomy with men and women who had no surgery, are of similar age and body composition, and have similar alcohol intake patterns.

This trial will examine whether interrupting 3.5 hours of sitting every 30 min with 6 min high intensity interval training (HIIT) breaks compared to light intensity interval training (LIIT) will improve brain health in cognitively normal older adults. This trial will test the feasibility of HIIT breaks to sitting. It will also address several important but unanswered questions: (1) Does interrupting sitting with short HIIT breaks improve frontoparietal function? (2) Can interrupting sitting with HIIT breaks improve cognitive functions?

The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves brain and heart health relative to a healthy control diet in middle-aged adults. Our research team will evaluate three different groups: the first group will be chosen using a predictive analytics model that predicts who will benefit most from the MIND diet, the second group will follow the MIND diet without being pre-selected, and the third group will eat a standard healthy diet to serve as a comparison. The main questions it aims to answer are: Does the MIND diet improve cognitive performance and heart health relative to a control diet? How does the health impact of the MIND diet in participants pre-identified through predictive analytics compare to those without such pre-selection? Which of the three groups - predictive analytics selected MIND diet group, standard MIND diet group, or healthy control - demonstrate the most significant improvements in cognitive and cardiovascular health over the course of the trial? Participants will: Consume one meal that follows the MIND diet or a control meal every day for 3 months. Visit the lab before and after the 3 months of meals for tests. Keep a record of the food they eat during the study.

The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves thinking ability and memory compared to a healthy control diet in persons with Multiple Sclerosis (MS). The main question it aims to answer is: Does the MIND diet improve cognitive performance relative to a control diet in persons with MS? Participants will: Consume one meal that follows the MIND diet or a control meal every day for 3 months, complete online surveys and cognitive testing before and after, and keep a record of the food they eat during the study.

The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves brain and heart health relative to a healthy control diet in middle-aged adults.The main questions it aims to answer are: Does the MIND diet improve cognitive performance and heart health relative to a control diet? Researchers will compare the MIND diet group to a control (a healthy diet that does not match the MIND diet) to see if the MIND provides more benefit to health. Participants will: Consume one meal that follows the MIND diet or a control meal every day for 3 months Visit the lab before and after the 3 months of meals for tests. Keep a record of the food they eat during the study.

This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children.

The current research is designed to implement and evaluate the ePREP relationship intervention with couples via the Cooperative Extension system.