Clinical trials

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.

Fibrotic forms of interstitial lung disease (ILD) and chronic obstructive pulmonary disease (COPD) are chronic lung disease which often affect how well oxygen can get from the lungs into the blood. Low blood oxygen levels often leads to shortness of breath which can affect patients' activity levels and quality-of-life. Many people with fibrotic ILD and COPD only have low oxygen levels when they are walking or exercising. Oxygen that is only used for walking or exercise is called ambulatory oxygen therapy (AOT). Laboratory studies suggest that AOT improves shortness of breath and exercise ability. However, real-world studies of AOT have not shown similar results. AOT can be given to patients through different types of equipment, most commonly oxygen tanks or portable oxygen concentrators (POCs). While previous studies have suggested that AOT does not significantly improve patients' breathing or activity in the real-world, these studies most often gave all participants the same amount of oxygen with the same device. However, patients with ILD and COPD often have very different oxygen needs during exercise, and POCs and oxygen tanks are very different in how oxygen is administered. This trial will test the feasibility of a study to determine whether real-world activity, symptoms, and quality-of-life are different with the use of different oxygen equipment when oxygen therapy has been adjusted to meet each participants' oxygen needs. A total of 24 participants (12 with fibrotic ILD and 12 with COPD) who only have low oxygen levels with activity will be randomly assigned to 2-week periods using either no oxygen therapy or oxygen delivered by oxygen tanks or POC. This trial will provide preliminary data to support a larger clinical trial to further test how different AOT equipment titrated to meet individual patients' needs may affect real-world outcomes in people with ILD and COPD.

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.

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.

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.

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. 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.

The goal of this mixed-methods pilot study is to learn whether migration experiences, social bonds, and transnational ties shape HIV prevention decision-making, including HIV testing, HIV self-testing (HIVST), and pre-exposure prophylaxis (PrEP) uptake, among first-generation African immigrants aged 18 to 50 residing in New York and Massachusetts. The main questions it aims to answer are: * What relationship typologies and migration-related relational mechanisms influence HIV testing, HIVST, and PrEP decision-making among African immigrants? * Can a relationship-tailored HIV prevention intervention component, co-developed with the community, demonstrate feasibility and acceptability among African immigrants? * Does exposure to the prioritized intervention component show directional increases in HIV testing intention, willingness to use HIVST, interest in PrEP, and readiness for relationship-based prevention communication? There is no comparison group. All Aim 3 participants receive the same co-developed intervention component. Participants will: * Complete a qualitative interview (60-90 minutes) and/or a structured electronic survey (15-20 minutes) about their relationship experiences, migration history, and HIV prevention behaviors. * Take part in a 3-4 hour structured group deliberation session called a Palava Hut Conversation to co-develop and prioritize HIV prevention intervention ideas. * Complete a baseline survey, receive the prioritized intervention component in a structured Zoom session, and complete a follow-up survey with an optional 60-90 minute cognitive interview for a subset of participants.

Children with asthma from communities that experience health inequities frequently do not receive guideline-based asthma care, and as a result, account for a disproportionate percentage of asthma exacerbations, emergency department visits, and hospitalizations. Project ASTHMA (Aligning with Schools To Help Manage Asthma) tests the effectiveness of school-based health centers as a delivery model to improve health outcomes by providing children with guideline-based asthma assessments and preventive medication management, directly observed therapy of their preventive medication to support adherence, and self-management support. If successful, this multicomponent intervention will represent a cost effective and sustainable model to reduce asthma morbidity in historically marginalized communities, and has the potential to impact communities throughout the United States where over 2,500 school-based health centers operate.

Evaluate and compare the disinfecting efficacy of two supplementary antimicrobial protocols in teeth with apical periodontitis

The primary goal of this study is to establish a database of people with varying levels of hepatic fibrosis and various etiologies of liver disease for use in future research protocols.

The objective of this randomized controlled trial is to examine the efficacy of a new intervention to prevent postpartum smoking relapse and related health consequences through breastfeeding promotion. After the pre-test, ex-smokers who are still abstinent from smoking will be randomized into either the breastfeeding intervention or the attention placebo control group. The outcomes are postpartum smoking relapse, breastfeeding practices, and maternal and child health.

This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.

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.

We are testing the accuracy of Reichert's Tono-Vera tonometer by comparing measurements of IOP with this device and measurements with other commonly-used tonometers, including Goldmann Applanation and iCare.

Prediabetes affects over one-third of adults in the United States, placing them at a higher risk for developing type 2 diabetes and heart disease, which can lead to serious health complications and increased medical costs. Although a program called the Diabetes Prevention Program (DPP) has been shown to lower the risk of diabetes through healthy lifestyle changes, many people find it difficult to stick with these changes over the long term. This study seeks to find out if combining DPP coaching with continuous glucose monitoring (CGM) technology can help people stay on track with their health goals.

The goal of this study is to restore the activities of late descending signals with a noninvasive stimulation approach in combination with hand motor training to improve hand function in persons with cervical SCI. The main question it aims to answer is if the inputs to late descending signals above the level of injury and the output of residual late descending signals below the level of injury could be increased. Specifically, in the first part of the study, 30 participants will complete 2 randomized sessions to compare the effect of intermittent theta burst stimulation combined with paired corticospinal motoneuronal stimulation. In the second part of the study, 24 participants will complete either combined stimulation protocol or sham stimulation protocol with exercise training.

The goal of this clinical trial is to test if a modified peer-based motivational intervention (the Military PAIRS; MPAIRS) is reasonable and practical for military contexts. The main questions it aims to answer are: * Does it works to reduce SV? * Does it works to reduce risky drinking? To test this, participants will answer questions about their SV history and risky drinking. Then they will be given MPAIRS. After 1 month, they will be asked about their SV history and risky drinking again.