Clinical trials

The study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. During the Intake, detailed consent and eligibility assessment will be completed. Participants who are eligible at the Intake will be randomized (within site and Intake Group) to R or IP Treatment and Assessment Groups. Participants will be followed for 3 months.

The EPPIC (Easing Pelvic Pain Interventions Clinical Research Program) study evaluates an ultra-brief, 4 session cognitive behavioral pain treatment transdiagnostic in design for urologic chronic pain syndrome (UCPPS) with clinical and practical advantages over existing behavioral therapies whose length and focus limits their adoption by clinicians and coverage for mechanistically similar comorbidities. A theoretically informed, practical, empirically grounded approach will systematically unpack CBT's working mechanisms, clarify for whom it works, ease dissemination, appeal to patients, providers, payers, and policy makers in the COVID-19 era favoring low resource intensity treatments, and reduce cost and inefficiencies associated with high intensity therapies whose complexity, length, and scarcity restricts uptake and impact.

Hepatitis C virus is a leading cause of morbidity and mortality globally with the highest prevalence and incidence among people with opioid use disorder. We aim to establish facilitated telemedicine as a standard of care treatment approach at 3 opioid treatment programs operated by the Catholic Health System. This study is a chart review data analysis to evaluate outcomes of facilitated telemedicine integrated into opioid treatment programs and to evaluate the number of individuals who initiate and complete treatment for hepatitis C virus infection.

The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.

This is a 17 - week study consisting of a one - week run - in period and a 16 - week intervention. The 16 - week pilot interventions aims to increase hydration in those beginning GLP - 1 RA therapy. Investigators aim to increase hydration to potentially decrease side effect severity, amount of side effects, and drug discontinuation associated with GLP - 1 RA therapy. The investigators are piloting to assess feasibility and preliminary efficacy of the intervention through examining participant retention, participant feedback, researcher and participant adherence to protocols, impact on hydration biomarkers, and participant reported GLP - 1 RA side effects.

Poor sleep quality and short sleep duration may be a mechanistic component of cognitive impairment in older adults, associated with a decline in brain-derived neurotrophic factor. Increasing the availability of nicotinamide adenine dinucleotide (NAD+) with supplementation of its precursor, nicotinamide riboside (NR), a form of vitamin B3 may increase the expression of brain-derived neurotrophic factor. This study proposes to examine the benefits of NR supplementation on sleep and cognitive function in older adults with comprehensive subjective and objective measures and to explore its impacts on serum brain-derived neurotrophic factor.

To determine the efficacy of inhaled isopropyl alcohol in treating nausea/vomiting among pediatric patients compared with the conventional ondansetron, or placebo treatment in a tertiary care pediatric emergency department.

Parkinson's disease, a common movement disorder that results from a breakdown in the brain, often leads to challenges with talking, but less is known about the relationship between difficulties with talking and difficulties with learning to understand speech. By linking these two abilities in individuals with Parkinson's disease using a precision medicine approach, this project seeks to build a basis for new therapies that help people with Parkinson's disease both understand better and speak more clearly.

African immigrants are underrepresented in health research in the United States. Barriers to research participation may include limited access to culturally and linguistically appropriate information, concerns about privacy, distrust of research institutions, stigma, and difficulty participating in traditional in-person activities. WhatsApp is commonly used within African immigrant communities, but there is limited evidence about how it can support meaningful engagement throughout the research process. This study will develop and test the WhatsApp Immigrant-Centered Research Engagement (WI-CARE) protocol. WI-CARE will provide researchers and community partners with structured guidance for using WhatsApp to engage African immigrants in research planning, recruitment, data collection, interpretation, and dissemination. The study has three aims. First, the research team will conduct surveys and focus groups to identify the WhatsApp features and engagement practices that facilitate or hinder participation in research. Second, the study team and African immigrant partners will use these findings to develop and refine the WI-CARE protocol. Third, the protocol will be tested through structured scenarios that simulate activities conducted during different stages of research. Participants will provide feedback about the acceptability, usability, feasibility, cultural relevance, privacy, trustworthiness, and quality of engagement supported by WI-CARE. The study will include adult African immigrants living in Connecticut, Maine, Massachusetts, Minnesota, Pennsylvania, and Rhode Island. Findings will be used to refine WI-CARE and inform the use of digital platforms to support equitable engagement of African immigrant communities in health research.

This is a single-visit study consisting of parent-child dyads attending a 2-hour session. The purpose of this research is to use the eating in absence of hunger (EAH) paradigm, to evaluate the association between parental EAH, food parenting, appetitive traits, and children EAH. It is hypothesized that both the parental EAH and the controlling food parenting will have a significant positive association with the children EAH. The results from this study will help us understand how food parenting, appetitive traits, and parental EAH influences the children EAH.

The purpose of this study is to assess the impact of the Early Childhood Friendship Project (ECFP) on changes in aggression/peer victimization subtypes, prosocial behavior, and social and academic competence with a teacher-implemented (with coaching) version of the program. Further, investigators will examine whether changes in executive functioning, emotion regulation, and hostile attribution biases indirectly account for the program effects. Investigators will test if physiological reactivity (skin conductance and respiratory sinus arrhythmia) serves as moderators of intervention effects. Data will be collected from 600 children (30 randomly assigned preschool classrooms) diverse in socioeconomic status and race/ethnicity. Investigators will use multiple methods (school-based observations, direct academic assessments, child interviews, physiological reactivity using two tasks, observer, caregiver, and teacher reports) to assess the efficacy of the program, hypothesized mechanisms, and role of physiology as a moderator of intervention effects. The duration of the effects will be tested at both 4 month and 12-month follow-up and will thus demonstrate the impact the program has on children's school readiness and transition to kindergarten. It is expected that preschool children randomly assigned to the ECFP intervention relative to the control condition will show significant and moderate reductions in physical and relational aggression/victimization at post-test and follow-up; the ECFP intervention group will also show increases in prosocial behavior, social competence, and academic competence, relative to the control group at post-test and follow-up (4-months at the end of preschool and 12 months after transitioning to kindergarten). Additionally, it is hypothesized that changes in executive functioning, emotion regulation, and hostile attribution biases will mediate treatment effects from baseline to respective follow-ups. It is anticipated that these hypothesis will be moderated by gender such that effects will be stronger for girls relative to boys. Finally, it is hypothesized that physiological reactivity will act as a moderator of intervention effects and of the executive functioning, emotion regulation, and hostile attribution biases mechanisms.

Obesity continues to be a major public health concern, and children who are overweight by age 5 are at increased risk for future obesity, highlighting the importance of early efforts to promote healthy eating and growth. The goal of this project is to test a new family-based approach to early childhood obesity prevention, specifically using pre-filled, online grocery shopping carts to make it easier for parents to select healthy foods like fruits and vegetables. This study will be the first to test whether such default shopping carts can help promote the purchasing and consumption of healthier foods, as well as healthier diets and weight outcomes, among parents with obesity and their 2-to-5-year-old children, offering the potential for a meaningful impact on the health of young children and their families.

Team Alice's Medication Safety and Empowerment Curriculum (MedSEC) helps older adults and caregivers learn how to safely manage medications. Many seniors take multiple medications, which can lead to harmful side effects or unnecessary treatments. This program, developed at the University at Buffalo, will be offered at senior centers in Western New York. It includes two interactive sessions that teach participants how to recognize medication risks and talk with their doctors about safer options. The curriculum uses videos, group discussions, and hands-on tools to build confidence and knowledge. It follows the "4Ms" of Age-Friendly Health Systems: What Matters, Medication, Mentation, and Mobility. A "Train-the-Trainer" model will help senior center staff continue the program long-term. The goal is to reduce medication harm, improve communication with healthcare providers, and support healthy aging in the community.

The purpose of this research is to assess how patients with cancer being treated with Immune Checkpoint Inhibitors (ICI) manage symptoms related to cancer and/or its treatment. Patients use a variety of ways to manage symptoms including traditional and alternative treatments including cannabis, acupuncture, etc. This research will have an important impact on our knowledge of cancer symptom management, and ultimately improve patient care and safety. Participants will complete online surveys and 7 days of ecological momentary assessments at 0, 1, 2, 4, 6, 9 and 12 month to compare the cannabis users and non cannabis users symptoms.

Safe sleep recommendations from the American Academy of Pediatrics (AAP) are designed to reduce the risk of sudden infant death syndrome (SIDS) and other sleep-related infant deaths. These recommendations include placing infants on their backs to sleep, using a crib or bassinet, avoiding soft bedding, and not sharing a sleep space with other people. Many families do not consistently follow all recommended safe sleep practices, particularly when infants are sick. Research has shown that educational programs provided in pediatric emergency departments can improve some safe sleep behaviors, but improvements have been limited and may not continue over time. Additional strategies are needed to help families adopt and maintain safe sleep practices. The purpose of this study is to determine whether a daily safe sleep tracking tool, used together with brief safe sleep education, can improve caregivers' adherence to recommended safe sleep practices compared with education alone. The information learned from this study may help healthcare providers develop more effective ways to promote safe sleep and reduce the risk of sleep-related infant deaths.

The goal of this randomized clinical trial is to investigate two different types of toothbrush bristles. The main questions it aims to answer are the effects of two different bristle types on: * how much plaque is on the teeth * how deep the space is between gums and teeth * how much gum and bone are attached to the teeth * whether the gums bleed when checked * if the gums get scratched or irritated Researchers will compare toothbrushes with tapered bristles to those with regular round bristles. Participants will be randomly assigned toothbrush A or B to use at home during the study.

The goal of this clinical trial is to learn how to increase the usage and acceptability of Food Is Medicine programs among families with young children experiencing food insecurity who receive Medicaid benefits. Food Is Medicine programs connect food and nutrition programs to the healthcare system to address health issues. Food Is Medicine programs include food prescription programs that are recommended to patients by healthcare providers. These programs are designed to increase the amount of fruit and vegetables people eat to improve their health. The program described here works with pediatric practices serving a high Medicaid population in Buffalo, NY to recruit families with children aged 2-6 who are experiencing food insecurity-not having reliable access to the food they need. The main questions it aims to answer are: * What food prescription program is used most completely and consistently by food insecure families with children aged 2-6? * How do the programs being tested impact the amount of fruits and vegetables children eat and the household's food and nutrition security status? Researchers will compare 2 experimental delivery Food Is Medicine programs, a meal kit program and a produce prescription program, to each other and a standard of care mobile market voucher program to understand which program works the best for families with young children. Participants will: * Receive 1 of 3 food prescription programs for 24 weeks (6 months) * Complete a short survey at different times throughout the program reporting how much of the food in the food prescription their family ate and why they didn't eat it all (if applicable). * Complete a phone survey about their family, their eating and shopping habits, and other health questions before they start the program, at the end of the program, and 6 months after the program ended. * Complete an online diet recall survey recording what their child aged 2-6 ate for a 24-hour period before they start the program, at the end of the program, and 6 months after the program ended.

The goal of this quasi-experimental study is to test if a smartphone app can help adolescents aged 14-20 quit e-cigarettes. The main questions it aims to answer are: * Can the app help adolescents manage cravings and increase their readiness to quit? * Does the personalized and real-time support provided by the app improve their success in quitting e-cigarettes? Researchers will compare two groups: an immediate-intervention group that starts using the app right away and a delayed-intervention group that begins after three months, to see if the timing of app access influences outcomes in e-cigarette cessation. Participants will: * Set personal goals and track their daily progress within the app. * Use a real-time "urge" feature that provides immediate support during cravings. * Engage with a chatbot for quick answers and motivational support around quitting. This study aims to create an accessible, personalized tool to help adolescents reduce or quit e-cigarette use, exploring its feasibility as a broader intervention model.

Hot climates such as in Phoenix, AZ commonly have individuals experiencing heat stroke, a life-threatening medical emergency. The dangerously high body temperature can result in death if not treated immediately with rapid body cooling. Rapid core temperature reduction within 30 min of diagnosis results in 100% survival and positive outcomes. While this is easily achieved with whole-body cold water immersion, this modality is not feasible in an ambulance. The Phoenix emergency medical services protocol consists of lying the patient on a large volume of ice. While this is somewhat effective, this cooling strategy results in a sub-optimal cooling rate, difficulty obtaining this large volume of ice, and a very wet ambulance as the ice melts. Recently, a company created a cooling strategy that utilizes a small amount of ice and a small amount of recirculated water to keep the patient cool. The purpose of this study is to determine the core temperature cooling rate of this cooling strategy and compare it to the cooling rate of the currently used Phoenix protocol.

The objective of this study is to test the effect of smoking cessation in pregnancy or in lactation on preventing rapid infant adiposity gain. Investigators propose a randomized, controlled experiment among smoking pregnant women from 1st prenatal care visit through 6 months of postpartum period. Two-phase randomization will be applied to separate the effects of smoking cessation in two different critical periods (i.e., pregnancy and lactation) on infant adiposity gain. Investigators will first randomly assign 40 smoking pregnant women into either the multicomponent intervention (N=30) or the education-only control group (N=10). The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support, while the control group will receive education only. At the end of pregnancy, investigators will further randomize successful quitters (estimated N=20) from the multi-component intervention group into either the continuous multi-component intervention group in lactation (N=10) or the education-only control group (N=10). All women and their newborns will be followed from enrollment to 6 months postpartum. The key outcomes include maternal smoking abstinence confirmed by urine-cotinine and infant gain in weight-for-length z-score. Specific Aim 1 is to examine the effects of maternal smoking cessation intervention in pregnancy on infant gain in weight-for-length z-score from birth to 6 months. Specific Aim 2 is to examine the effect of maternal smoking abstinence intervention in lactation and infant post-weaning gain in weight-for-length z-score among the women who have successfully quit smoking in pregnancy.

The purpose of this study is to develop a clinical database of individuals diagnosed with Krabbe disease in order to determine which symptoms herald the onset of clinical disease in the various phenotypes of Krabbe disease; to determine whether level of GALC enzyme activity, or a specific genetic mutation predict the clinical course; and to determine which neurodiagnostic tests predict onset and/or severity of the disease.

The goal of this study is to comprehend how mental fatigue could affect human gait. The main questions to answer are: * Does mental fatigue change how people walk? * How long does it take for walking patterns to return to normal after mental fatigue sets in? * What role do constructs like boredom, sleepiness, and motivation play in this relationship? To achieve this, participants will take part in the experiment, split into two sessions: Day 1 (online, about 25 minutes): Practice session. Participants will practice a computer task that will be used to induce mental fatigue in the next session. Day 2 (in-person, about 1.5 to 2 hours): Participants will wear several wearable sensors: motion sensors on their legs, feet, and back, sensor insoles in their shoes, a cap that measures brain activity, and glasses that track eye movement. After sensor placement, participants will walk in a straight line for 10 meters to measure their normal walking pattern. They will then complete a 32-minute computer task designed to induce mental fatigue. Afterward, participants will walk in a straight line for 10 meters again, rest for 3 minutes, and repeat this walk-and-rest cycle 3 more times. Participants will also answer short questions about how tired, bored, and alert they feel throughout the session.

This Phase 2 trial will to examine the efficacy of a brief dyad-based motivational interview (PAIRS MI) delivered to friend dyads with an active treatment-as-usual condition, and a 1-year follow-up.

This is a longitudinal, observational epidemiological study designed to estimate the prevalence of depression, anxiety, and behavior problems in children ages 18 months through 11 years with cystic fibrosis (CF).

The goal of this project is to compare different ways to schedule a workday to see if older workers should follow a specific work protocol to reduce strain on the heart and muscles across two consecutive days of work. Participants will come to the lab a total of six times. During four of the visits participants will complete a box carrying task, simulating unloading a delivery truck. This will take place in a hot and humid room to simulate being outdoors during the summer.