Clinical trials

This pilot study aims to evaluate dental caries experience in children ages 8-12 years old through comparing the use of a powered versus manual toothbrush, while using a standardized fluoride toothpaste as the control over the course of one year.

Although research documents the concerning rates of mental and behavioral health problems (e.g., substance use/initiation) among Indigenous LGBTQ2S+ youth, there is very little known about how to prevent these deleterious issues that devastate Indigenous communities. The study will include \~40 families (Lakota LGBTQ2S+ youth and caregivers) in Rapid City, SD (20 families (10 FAP; 10 wait-list control) and on the nearby Pine Ridge Indian Reservation (10 FAP; 10 wait-list control). Following the baseline survey, families will be randomly assigned to the treatment or wait-list control. Participants will complete an immediate post-test and 6-month follow-up survey to test the hypotheses that FAP will lead to changes in targets, specifically increases in caregiver accepting behaviors, youth and caregiver connection to Lakota culture, family bonding, and youth future orientation and decreases in caregiver rejecting behaviors, caregiver harsh parenting, and youth internalized homo/bi/transphobia compared to the control condition. We will also examine the hypotheses that there will be reductions in deleterious primary outcomes (depressive symptoms, anxiety symptoms, suicidality) and secondary outcomes (alcohol and drug use/initiation and dating and sexual violence victimization and perpetration) among youth in the treatment conditions compared to the control condition. Additionally, we will assess the acceptability and feasibility of the FAP via program observations, post-session surveys, and exit interviews.

The overall goal of this project is to conduct both a process and rigorous outcome evaluation of The Set Me Free Project (SMFP)'s READY to Stand (RTS)© curriculum with an eye toward widespread dissemination to other U.S. communities, if deemed effective. Broadly, the investigators seek to determine the effect participation has on students: reductions in commercial sexual exploitation of children (CSEC) perpetration (the primary outcome); reductions in CSEC victimization, teen dating violence (TDV), and sexual violence victimization and perpetration; as well as increases in bystander intervention in CSEC situations compared to participants in the control condition (secondary outcomes). Process evaluation components include fidelity monitoring, post session surveys, and exit interviews. The methodology includes a community-based RCT in which youth (N=400-600) are randomly assigned to the treatment (RTS) or attention control condition (nutrition program).

This study is being done to learn how information from blood tests, medical records, and wearable devices that track sleep, activity, and heart rate can help predict how people recover after a concussion. The goal is to improve how doctors monitor recovery and give patients better information about what to expect after a head injury.

This randomized longitudinal study examines how interacting with an artificially intelligent (AI) companion affects psychological well-being, social experiences, and interpersonal attitudes and behaviors over time. A total of 1,200 U.S. adults will be randomly assigned to either interact with an AI companion (via the Replika app) for 10 weeks or continue life as usual. Participants will complete online surveys at baseline, throughout the 10-week study period, and at 1-, 3-, and 6-month follow-ups. The study will examine both potential benefits and risks of AI companionship, including effects on psychological well-being, social connection, and interpersonal attitudes and behaviors.

The purpose of this study is to assess the impact of artificial intelligence on proximal caries detection and subsequent treatment decisions of early learners and compare those with outcomes of experienced learners.

The purpose of this study is to investigate justice-involved Black/African American female adolescents' (JI BAFAs; N=35) self-reported outcomes: stress, posttraumatic stress disorder (PTSD), recidivism, etc., as well as their parents/caregivers' (P/Cs; N=35) stress and pre- and post- intervention results along with their views of an adapted intervention.

The overall goal of this project is to establish a novel design and control paradigm for modular, partial-assist powered orthoses (exoskeletons) to enhance voluntary lower-limb motion and manage pain in broad patient populations. Building upon a previous study period that addressed weakness from advanced age or muscle fatigue, this current period extends the technology to novel powered unloader orthoses designed to manage knee osteoarthritis (OA) pain. The investigators hypothesize that by providing 15-30% of biological joint torque, these motorized devices can reduce muscular contributions to painful loads on the joint's surfaces during activities of daily living (ADLs). The project aims to develop a task-agnostic, neural network-based controller and establish the feasibility of reducing knee pain and muscle effort in individuals with multi-compartment knee osteoarthritis.

The research team will perform a comparative-effectiveness sequential, multiple assignment, randomized trial in painful diabetic neuropathy (PDN) patients for 8 total months, divided into two 4-month stages. 600 participants 18+ with PDN will be enrolled in this study. The main goal is to compare the utility of three modalities (oral, topical, and behavioral) for initial PDN treatment, and to compare the utility of switching modalities versus continuing with the same modality for non-responders. Pain and discontinuation will be assessed weekly, whereas other outcomes will be assessed monthly for 8 months.

This study investigates the influence of sex hormones and exercise on age-related neuromuscular decline in females. Specifically, the research aims to evaluate how hormonal variations impact both age-associated neuromuscular decline and the subsequent adaptations to exercise and resistance training. Age-related declines in neuromuscular function are especially pronounced in females, potentially due to the sharp drop in estradiol after menopause. This project will compare postmenopausal females who have not taken hormonal therapy (HT) to age-matched females taking HT.

The goal of this observational study is to learn about the effects of antiplatelet drugs on patients over the age of 80 with atrial fibrillation. The main question it aims to answer is: -Is platelet reactivity effectively controlled in patients over the age of 80 diagnosed with atrial fibrillation following the Watchman procedure.

The goal of this study is to collect quantitative and qualitative data that can be used to optimize the HeartSteps mHealth intervention for physical activity. The current version of the intervention is intended to help patients with heart disease increase and maintain their physical activity long-term. To accomplish this goal, a 3-month pilot micro-randomized trial (MRT) will be conducted with 60 patients who are currently completing or have recently completed phase II cardiac rehabilitation (CR). The core of the study participation is the use of the HeartSteps intervention over the course of 3 months. This includes wearing the Fitbit Charge activity tracker during waking hours and using the HeartSteps intervention to support their efforts to be active. The HeartSteps intervention consists of two sets of intervention components: (1) components intended to improve participants' affective associations with physical activity, including activity suggestions designed to to trigger positive feelings and associate them with being active, and prompts to bring their awareness to intrinsically motivating aspects of being active; and (2) components that target reflective self-regulatory processes, including graphs for self-monitoring, prompts to plan activity, and weekly activity goals. How exactly, and how much, participants will use HeartSteps will not be prescribed since our goal is to understand naturalistic trajectory of engagement with the intervention.

This study experimentally investigates whether a reduction in ultra-processed (UP) food intake (1) causes aversive withdrawal symptoms in humans, (2) increases the motivational salience of UP food cues and, if so, (3) whether these factors undermine the ability to adhere to a low-UP diet. The following aims and hypotheses are tested: Aim 1: To investigate whether aversive physical, cognitive, and affective withdrawal symptoms emerge in response to reduced UP food intake compared to a high-UP diet, and whether this predicts failure to adhere to a low-UP diet. H1a: Reducing UP food intake will result in aversive physical, cognitive, and affective withdrawal symptoms, as indicated by 1) ecological momentary assessment (EMA) reports of aversive withdrawal symptoms, and 2) heart rate reactivity and subjective distress to an in-lab stressor. H1b: Aversive symptoms of UP food withdrawal will predict greater UP food intake and higher blood glucose levels when trying to adhere to a low UP diet. Aim 2: To investigate whether increased motivational salience of UP food cues emerges in response to reduced UP food intake, and whether this predicts failure to maintain a low-UP diet. H2a: Reducing UP food intake will result in increased motivational salience of UP food cues, as indicated by 1) EMA reports of UP food craving, 2) heart rate reactivity and subjective craving in a simulated fast-food restaurant, 3) heightened reinforcement value for UP food relative to other reinforcers, and 4) greater reward-related neural response to UP food cues. H2b: Increased motivational salience of UP food cues will predict greater UP food intake and higher blood glucose levels when trying to adhere to a low UP diet.

This research is studying changes in awareness and metabolism in the brain that may take place in various brain regions stimulated with ultrasound (low-intensity focused ultrasound pulsation or LIFUP) while undergoing magnetic resonance imaging (MRI)-based brain measurements.

The study team is conducting this project to learn more about how patients with eosinophilic esophagitis (EoE) like to use and receive educational materials about treatment options and treatment decision making. This study will assess the efficacy of a decision support intervention to make decisions about treatment and disease management for patients with EoE and will assess the feasibility and acceptability of the intervention to inform future R01-level studies. The study team hypothesize that deploying the intervention will be feasible, and it will demonstrate high acceptability among EoE patients. Additionally, that patients that use the intervention (vs general education about EoE) will report greater treatment knowledge, increased readiness to choose a therapy, adherence to therapy, and follow-up.

The researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have axial spondyloarthritis (axSpA). There are 3 main reasons the researchers are doing this study: 1) to test how easy it is for people with spondyloarthritis to use the RENEW program; 2) to assess whether people like the RENEW program and 3) to understand if it helps with symptom management and disease burden.

This is a pragmatic, open-label, multicenter, stepped-wedge, Type II hybrid effectiveness-implementation study. It is designed to evaluate both the comparative effectiveness and implementation feasibility of a biomarker-plus-clinical guidelines algorithm to reduce low-value brain computed tomography (CT) use in emergency department (ED) patients evaluated for suspected traumatic brain injury (TBI). The biomarkers are Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1), two brain-injury proteins cleared by the FDA to support brain CT imaging decisions after trauma. All six participating EDs will contribute baseline data for the first 6 months under usual care (clinical guidelines only). Beginning in month 7, two sites will transition to implementing the biomarker-guided algorithm. At month 13, two additional sites will implement the biomarker-guided approach, and the final two sites will transition at month 19. By the end of the 24-month rollout period, all sites will have implemented the biomarker-guided pathway.

This research is studying if a community-based, community health worker (CHW) led psychosocial intervention improves hemoglobin levels among Black/African American and/or Hispanic or Latino women with anemia compared to standard of care. The intervention group will demonstrate a greater mean increase in hemoglobin at follow up than the control group. The expected treatment difference effect is a between group difference of 1.0-point or greater in mean Hgb at follow up.

This study will assess the efficacy of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.

This study is being done to better understand how the study team can treat pain for people with cirrhosis and depression. Enrolled participants on this feasibility study will be randomized to Transcutaneous Electrical Acustimulation (TEA) or sham TEA.

This research is studying the use of low-intensity focused ultrasound (LIFU; a mild, noninvasive acoustic stimulation technique) in a small number of people to learn about its safety as a treatment for stuttering. LIFU is a small, safe sound signal that produces a gentle, pulsing flow of acoustic waves to help different parts of the brain communicate with each other. Researchers want to understand how the mild, non-invasive brain stimulation affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people who stutter.

The overall goal of this project is to model human joint biomechanics over continuously-varying locomotion to enable adaptive control of powered above-knee prostheses. The central hypothesis of this project is that variable joint impedance can be parameterized by a continuous model based on measurable quantities called phase and task variables. This project will use machine learning to identify variable impedance functions from able-bodied data including joint perturbation responses across the phase/task space to bias the solution toward biological values.

This pilot randomized controlled trial will evaluate the feasibility and preliminary effects of a home-based, technology-enabled hand telerehabilitation program for adults with chronic stroke. Participants will receive either remotely guided hand training or a standard home exercise program matched for duration and intensity. Outcomes will include measures of hand function, adherence, and feasibility to assess the potential of telerehabilitation for improving access to structured post-stroke hand rehabilitation.

Researchers are exploring how certain personal factors, such as symptoms, health history, and lifestyle, may help predict which treatments will work best for someone. The purpose of this study is to evaluate how well a study algorithm chooses the best treatments for a patient when considering their unique pain characteristics.

The purpose of this study is to evaluate whether a digital, incentive-based program, used in conjunction with traditional quitline (QL) services, can be beneficial to quitline callers who smoke menthol cigarettes. The services evaluated focus on coaching, support, and/or incentives for individuals who wish to quit smoking.