Clinical trials

The purpose of this interventional study is to identify which combination of remote monitoring devices (e.g. home spirometry, pulse oximetry, scale, ePROs) is the most feasible (as defined by adherence, retention, and data completeness) and acceptable when used for the detection of clinically significant Interstitial Lung Disease events.

The goal of this clinical trial is to learn whether a pain-management program called a Transitional Pain Service can help prevent long-term pain and reduce opioid needs after surgery in adult surgical patients who may be at higher risk for developing persistent pain. The main questions this trial aims to answer are: 1) Does the Transitional Pain Service help high-risk surgical patients manage pain better after surgery? 2) Can a computer tool (an algorithm) improve screening of patients for long-lasting pain after surgery? The investigators will compare patients who continue with their usual care to patients who receive support from the Transitional Pain Service to see if the program leads to better pain control and lower opioid use. Participants will share information about their pain levels and the pain-relief treatments they are using before and after surgery so researchers can better understand how the program affects recovery. Patients assigned to the Transitional Pain Service will also be offered additional coordinated support before and after their surgery to help optimize their pain control and overall recovery.

In Kenya, HIV incidence among adolescent girls and young women (AGYW) ages 15-24 years is 1-2 per 100 person-years and approximately 30% of AGYW have had at least one sexually transmitted infection (STI). Kisumu and Migori counties in Western Kenya have some of the highest HIV/STI incidence in the country. Food insecurity (FI) and poverty are also highly prevalent in Western Kenya. FI and poverty are important drivers of vulnerability to HIV and STIs among AGYW. Poverty alleviation interventions have the potential to reduce STIs and HIV risk among AGYW but, to date, these interventions have reported mixed findings on HIV/STI outcomes, have been primarily targeted at the individual level, and none have focused on agriculture or FI. Therefore, there remains a critical need to develop sustainable, multi-level, economic and FI interventions that improve AGYW STI/HIV prevention outcomes. Our team has successfully developed a household-level agricultural intervention in Western Kenya called Shamba Maisha ("farm life" in Kiswahili; SM) to reduce household FI. In our prior pilot study with AGYW, the investigators found that SM was feasible, acceptable, and associated with less FI and improved mental health. In this proposal, the investigators will build upon our promising SM work by examining the effectiveness and implementation of our SM intervention, including provision of a water pump and agricultural implements for use at home, training in agriculture delivered at school-based demonstration farms, and adolescent-caregiver relationship strengthening training. The investigators plan to conduct this school- and home-based cluster randomized trial with 800 AGYW and their primary caregivers recruited from schools in Kisumu and Migori counties. The investigators will randomize 20 schools in Kisumu and Migori in a 1:1 ratio to intervention or control conditions and follow AGYW-caregiver dyads for 18 months with surveys and STI/pregnancy testing to assess intervention impacts. The study has the following aims: Aim 1. Determine the impact of SM on adolescent HIV prevention and sexual and reproductive health outcomes (primary outcome is gonorrhea and/or chlamydia incidence). Aim 2. Assess the effect of SM on intermediate outcomes theorized from our published conceptual framework to be on the causal pathway, including household food security and wealth, and adolescent and caregiver factors including mental health and aspects of the caregiver-AGYW relationship dyad (e.g., communication). Aim 3. Identify critical implementation facilitators and barriers influencing SM effectiveness and delivery and conduct a programmatic cost assessment. The investigators will also evaluate the extent to which SM can have "spillover" nutritional benefits for a larger population of adolescents who had access to demonstration farms at intervention schools but did not receive other aspects of the intervention. The ultimate goal is to provide an innovative household-level intervention to halt the cycle of FI, and poor HIV-related outcomes among vulnerable populations including AGYW, consistent with the "Ending the HIV Epidemic".

The goal of this clinical trial is to learn if a wearable ultrasound device, called ATTN201, is safe and easy to use. The study is for adults ages 65 and older who have mild cognitive impairment (MCI) and a buildup of a protein called amyloid in the brain. Amyloid buildup is an early sign of Alzheimer's disease. The ATTN201 device sends low-intensity sound waves to a deep area of the brain that helps control sleep. The aim is to boost deep-sleep brain waves. These brain waves may help the brain clear away waste, including amyloid. The main questions it aims to answer are: 1. What, if any, issues do participants have when using the ATTN201 device? 2. Can participants complete the full study schedule? Researchers will compare focused ultrasound to unfocused ultrasound. Unfocused ultrasound is a look-alike treatment. It feels and sounds the same but is not aimed at the brain target. The comparison will show if the focused treatment changes sleep brain waves, blood markers of Alzheimer's disease, or memory and thinking. Participants will: * Visit the study site for memory and thinking tests, blood draws, a health check, and MRI scans of the brain * Record their sleep at home for at least 5 days with a sleep diary, a watch-like sensor, and a headband that measures brain waves * Be assigned by chance to focused or unfocused ultrasound * Take part in 10 nap sessions over 2 weeks while wearing the device, at the study site or at home * Return for a final visit to repeat the first tests, and may return for an optional visit 3 months later

The goal of this pilot clinical trial is to explore the feasibility and acceptability of implementing an intervention for caregivers in our health care system. The intervention is intended to provide information and consultation to caregivers of youth ages 12-26 years old who are at risk of self-harm (i.e., suicidal behaviors and/or nonsuicidal self-injury). The intervention is based on principles of Dialectical Behavior Therapy, an evidence-based intervention for youth who engage in suicidal behaviors and nonsuicidal self-injury. Acceptability will be assessed through questionnaires and qualitative feedback. Feasibility will be assessed by tracking the amount of clinician resources needed and how long it takes to identify caregivers who want to participate. A group of caregivers who have lived experience of having a child at risk for self-harm will form an advisory board. The board will review the study methods and data; their advice will guide next steps.

The goal of this clinical trial is to evaluate whether a narrative medicine (NM) curriculum can enhance self-expression, reflection, and resilience in adolescents and young adults with anorexia nervosa. The main questions it aims to answer are: * Does participation in an NM curriculum improve self-expression and reflection in individuals with anorexia nervosa? * Does engaging in creative writing and group discussion promote resilience and emotional processing in this population? Participants will be 16-25 years old, medically stable for outpatient eating disorder therapy, and actively engaged in treatment. Those with active suicidal ideation, recent non-suicidal self-injury, or a co-occurring personality disorder will not be eligible. Participants will: * Attend six weekly workshops focused on themes such as self-definition, kindness, resilience, and possibility * Engage in close reading of visual or written texts * Complete creative writing exercises in response to prompts * Participate in group discussions and sharing An optional capstone reading event will provide a supportive space for participants to share their work with peers, loved ones, and providers, fostering connection and community. This study aims to explore the role of narrative medicine in eating disorder treatment and assess its potential benefits for psychological well-being and self-expression.

Many pregnant people don't get the dental care they need, even though it's safe and important. The CHEER Study offers free dental check-ups, cleanings, and supplies to help participants take care of their teeth and gums during pregnancy. The purpose of this research study is to compare two types of noninvasive oral health interventions to evaluate their effectiveness. We want to learn if one method is more effective in supporting oral health and improving pregnancy outcomes. There are two aims of this study: Aim 1: To evaluate whether a structured oral health intervention reduces periodontal inflammation during pregnancy and postpartum in pregnant people with indicators of periodontal disease. Aim 2: To assess whether a structured oral health intervention is associated with changes in oral health behaviors or birth outcomes in pregnant people with periodontal disease.

The PLUM Study is a randomized, double-blinded, 2-arm, parallel-group, placebo-controlled trial is designed to compare the efficacy of letrozole versus placebo on leiomyoma-related symptoms and quality of life as well as leiomyoma and uterine size.

This Hybrid Type 1 cluster randomized trial will test the Peer-led Dynamic Choice HIV Prevention (DCP) intervention compared to standard of care.

This is a multi-site study of the pharmacodynamic effects and efficacy of metformin in children and young adults with recurrent or progressive Posterior Fossa Group A (PFA) ependymoma.

This is a prospective, single-blinded, single-arm, open-label Phase II trial of trans-arterial radiation segmentectomy using Yttrium-90 glass microspheres (TheraSphere®) for Hepatocellular Carcinoma (HCC) participants with unresectable Barcelona clinic liver cancer (BCLC) stage A disease.

People living with human immunodeficiency virus (PLWH) have an estimated 1.6-6.0 times increased risk of developing oropharyngeal cancer (OPC) compared with individuals in the general population. 70% of OPCs are caused by human papillomavirus (HPV), and PLWH also have an increased prevalence of oral HPV infection. Disparities by race/ethnicity also include a later stage of diagnosis and less frequent cancer-directed treatment for members of ethnic minority groups. There is little known regarding the racial/ethnic differences in oral HPV infection, persistence of oral HPV infection, or progression of oral HPV infection to OPC among PLWH. This is an observational, prospective cohort study to investigate the feasibility of alternative sample collection methods for HPV testing among PLWH.

Whereas the available evidence mostly supports chronic sleep disruption as a risk factor for incident AF, less is known about the near-term risk of a discrete atrial fibrillation (AF) episode following a night of disrupted or poor-quality sleep. This prospective, randomized, case-crossover study aims to examine the acute effects of sleep disruption on clinically relevant cardiac ectopy pertinent to AF.

Atherosclerotic cardiovascular disease remains the leading cause of death for adults in the United States. The cardiovascular impact of milk consumption remains a matter of long-standing scientific debate. Current guidelines for Americans recommend three daily servings of fat-free or low-fat (1%) dairy over full-fat options due to concerns that saturated fat may increase cardiovascular risk. Yet, the literature does not consistently support non-fat dairy as superior to high-fat dairy for reducing cardiometabolic risk. Identifying the comparative health benefits of non-fat versus high-fat dairy milk would be immediately applicable to patients who seek cardiovascular care. In this randomized, case-crossover trial, the investigators seek to efficiently assess the association between high-fat versus non-fat dairy milk consumption and insulin resistance. Utilizing the Eureka Platform, participants will be randomized to limit their liquid milk consumption to whole milk followed by skim milk (or vice versa), measuring the effect of milk fat content on glycemic index and lipid profile.

Per the 2021 National Survey on Drug Use and Health administered by the U.S. Department of Health and Human Services, 85% of all American adults consume alcohol. Atrial fibrillation (AF) is the most common arrhythmia, affecting more than 10 million individuals in U.S., comprising 4.5% of the adult population. Although alcohol abstinence clearly reduces AF in heavy drinkers, observational data comparing the health effects of limited consumption versus abstention are conflicting. The Mediterranean diet is one of the few that has demonstrated clear cardiovascular benefits in a randomized study-this diet allows for the consumption of red wine (or high polyphenol/ low alcohol alcohol), generally not more than one drink in 24 hours, with meals, avoiding spirits and binge drinking. The effect of the "Mediterranean drinking pattern" on AF risk compared to alcohol abstinence remains unknown. This single center, randomized, controlled trial aims to compare the effects of a digital health intervention to encourage durable alcohol abstinence versus allowing guideline-adherent moderate alcohol consumption on AF severity. The knowledge gained from this study may be used to determine optimal thresholds for alcohol use among AF patients.

VIBRANT-AF seeks to: * Identify clinically relevant predictors of effectiveness and complications of AF ablation procedures in a prospective, US-based, multi-center, real-world longitudinal study * Assess changes in modifiable lifestyle-related exposures influence the effectiveness of AF ablation * Determine incidence and predictors of complications of AF ablation procedures Participants will connect with the Eureka Research Platform and answer a series of surveys and activities over a one-year period. They will be asked about lifestyle habits, recurrence of AFib, hospitalizations, and general feelings and emotions.

This phase II trial tests the safety and effectiveness of glofitamab given in combination with pirtobrutinib in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Obinutuzumab may also reduce the risk of immune-related conditions from treatment. Pirtobrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the protein that signals cancer cells to multiply. Giving glofitamab in combination with pirtobrutinib may be safe, tolerable and/or effective in treating patients with relapsed or refractory mantle cell lymphoma.

This phase Ib/II trial studies the side effects, best dose, and effectiveness of enfortumab vedotin (EV) in combination with pembrolizumab and radiation therapy for treating patients with muscle invasive bladder cancer. Standard of care treatment for muscle invasive bladder cancer is chemotherapy, to shrink the tumor before the main treatment is given (neoadjuvant), followed by surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). In cases where patients are not candidates for the standard of care approach or prefer a bladder sparing option, tri-modality therapy with transurethral resection of bladder tumor (TURBT) followed by combined chemotherapy and radiation therapy is used. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Giving enfortumab vedotin with pembrolizumab and radiation therapy may work better in treating patients with muscle invasive bladder cancer.

A randomized, open-label behavioral study designed to evaluate the feasibility, acceptability, and early impact of a large language model (LLM)-based artificial intelligence (AI) tool to support patient understanding following an initial oncology consultation.

The goal of this observational study is to learn about the long-term effects of GLP-1RAs (Ozempic, Wegovy, Rybelsus, Mounjaro, or Zepbound) in adolescents and young adults aged 12-21 who will start taking this drug for weight management. The main question it aims to answer is: How does starting GLP-1RAs impact eating behaviors and mental health symptoms? Participants starting to take GLP-1RAs as part of their medical care for weight management will answer online survey questions about their experience taking the drug for 1 year.

The goal of this clinical trial is to learn if the oral medication upadacitinib can safely and effectively treat acute severe ulcerative colitis (ASUC) in adults who are hospitalized. It will also evaluate whether upadacitinib can be used without corticosteroids during initial treatment. The main questions it aims to answer are: 1. Does upadacitinib reduce treatment failure by Day 14 (defined as need for colectomy or rescue therapy)? 2. What side effects and safety events occur when using upadacitinib in hospitalized patients with ASUC? Researchers will compare outcomes in participants receiving upadacitinib to a historical group of similar patients previously treated with standard therapies, including intravenous corticosteroids and infliximab, to determine if upadacitinib improves outcomes. Participants will: 1. Take oral upadacitinib once daily during hospitalization. 2. Undergo routine clinical monitoring, including blood tests and symptom assessments. 3. Be followed after discharge with clinic visits or phone calls for up to 12 months to assess outcomes such as need for additional treatment, surgery, and safety events

The goal of this observational study is to learn if a ketone ester can improve the content of the gut microbiome. The main questions it aims to answer are: * Does a ketone ester reduce age-related signatures in the gut microbiome? * What changes occur in the gut microbiome after consuming a ketone ester? Participants will: * Take a ketone ester every day for seven (7) days * Collect and ship stool samples within seven (7) days before, during, and within seven (7) days after the study period * Measure their ketone levels with a urine strip every day after having the drink * Answer questions about their typical diet on a normal day * Record their symptoms, if any arise

This study is being done to collect patient generated health data to predict the risk of patients needing emergency department visits or hospitalization before, during. and after receiving radiation therapy.

This project investigates safety, tolerability, and efficacy signals of accelerated continuous theta burst stimulation (cTBS), a form of inhibitory repetitive transcranial magnetic stimulation (rTMS), for patients with Tourette Syndrome and chronic tic disorders (CTD). It integrates resting-state functional MRI (fMRI) to assess changes in brain circuits and neurophysiology. CTD are neurodevelopmental disorders marked by motor and/or vocal tics, associated with dysfunction in cortico-striato-thalamo-cortical (CSTC) networks, particularly the supplementary motor area (SMA), primary motor cortex (M1), and connected regions. While low-frequency rTMS has shown preliminary benefits in pediatric populations, circuit-targeted approaches remain relatively unexplored in children, adolescents and adults, leaving no consensus about optimal applications. Participants will be randomized to receive 50 sessions of 1800 pulses of cTBS rTMS over two weeks, with five sessions/day targeting the SMA or M1. Assessments will include the Yale Global Tic Severity Scale (YGTSS) and MRI. Aim 1 Determine if cTBS to the M1 can reduce CTD symptoms and normalize abnormal network connectivity within the Somato-Cognitive Action Network (SCAN). Aim 2 Determine if cTBS to the SMA can reduce symptoms of CTD and normalize abnormal network connectivity within the Action Mode Network (AMN).

This study is being done to see which of two common grafting techniques-mixing two different grafting materials or layering two grafting materials-works better to augment bone volume next to your dental implant(s). We want to know which technique results in better bone augmentation.