Clinical trials

Enhancing Perinatal Population Health through Community Care Hubs (CARE) is designed to test system level, organizational level, and workforce level strategies that may activate individual, community health worker (CHW), CHW supervisor, and system level mechanisms to improve care coordination, timely connection to prenatal and postpartum services, and downstream clinical outcomes related to maternal morbidity and mortality.

AquOTic is an evidence-based, occupational therapy-led intervention designed to enhance water competency and swim safety skills in children on the autism spectrum. The 10-week program consists of weekly 60-minute group sessions, each including six children paired in a 1:1 ratio with an interventionist. Sessions follow a structured routine involving six rotating stations, targeting various swim and safety skills, with the flexibility for individualized support by the interventionist. Overall, this study has 3 major aims. The first aim evaluates the effectiveness of the AquOTic intervention in improving water competency and swim skills, while comparing outcomes between two implementation models: professional student interventionists (occupational and physical therapy students) and trained community-based interventionists. A total of 108 autistic children will be enrolled and randomly assigned to one of three groups: (1) AquOTic with professional student interventionists, (2) AquOTic with community interventionists, or (3) a control group receiving no AquOTic intervention. The second aim explores the mediators and moderators of the intervention outcomes to assess fidelity and efficacy. The third aim identifies the cost and resources associated with AquOTic. A cost analysis will be conducted to evaluate the resources required for implementation and to inform the development of a scalable, cost-effective drowning prevention strategy for autistic populations.

This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin. This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.

Family caregivers of people living with dementia are at high risk of poor health when caregiving for their loved one. Peer Support for Family Caregivers of Older Adults Living with Dementia (Pair 2 Care©) is a simple, nonjudgmental, flexible, and potentially scalable peer support program developed with and for family caregivers along with former (previous) caregivers, community leaders, and healthcare providers. Using the experiences of trained former caregivers as mentors to current caregiver mentees, Pair 2 Care© may lower caregiver depressive symptoms and promote health and well-being of current caregivers, their loved ones, and former caregivers while informing future Alzheimer's disease and Alzheimer's disease-related dementia caregiving policy.

This study aims to determine the ideal length of a spinal cord stimulation (SCS) trial period by analyzing daily pain scores, patient satisfaction, and when patients decide whether to proceed with permanent implantation. The primary goal is to identify the shortest trial duration that can reliably predict SCS success. A secondary goal is to compare SCS trial outcomes with patient-reported health measures (PROMIS domains) and recommendations from the SCS E-Health Tool to evaluate how well these tools predict treatment candidacy and outcomes.

The purpose of this clinical trial is to determine the best initial non-invasive respiratory support (NIRS) strategy for adults who present to the emergency department with acute hypoxemic respiratory failure, a condition in which blood oxygen levels are dangerously low and require urgent treatment. This study compares two commonly used non-invasive respiratory support strategies to evaluate their effectiveness and safety, based on important patient outcomes during hospitalization, including survival, the need for invasive mechanical ventilation, and the duration of respiratory support. Participants will be randomly assigned (with an equal chance) to receive one of the following treatments: * Non-Invasive Positive Pressure Ventilation (NIPPV): Oxygen delivered under pressure through a face mask. * High-Flow Nasal Oxygen (HFNO): Oxygen delivered at high-flow through a specially designed nasal cannula placed in the nostrils. Researchers will compare the two treatment strategies using a hierarchical assessment of major pulmonary outcomes, including: * Hospital survival * Days on mechanical ventilation * Duration of non-invasive respiratory support As part of the study, researchers will collect: * Blood and urine samples * Physiologic measurements (such as chest movement measured through sensors placed on the skin) * Information from participants' medical records

DIP : To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of immediate in-patient postpartum OGTT prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum OGTT (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by GDM. Follow up PP CARE: To engage with individuals with a history of GDM through a patient-centered mixed-methods survey and qualitative assessment to evaluate the barriers to and facilitators of Cardiovascular health (CVH) counseling and risk-reduction postpartum at the patient and healthcare system levels inclusive of Social determinants of health (SDOH) and structural factors, as well as patient preferences and perspectives on CVH and wellness interventions

The purpose of this study to assess the wear experience of people who have astigmatism when wearing a daily disposable contact lens for astigmatism over long days of wear.

The purpose of the study is to compare the hand-eye coordination and sports vision performance in participants while they are wearing their habitual contact lenses versus while wearing the dual-focus multifocal contact lenses.

The purpose of this study is to evaluate the impact of pre-procedure patient reminder systems on patient satisfaction, preparedness, and anxiety among patients undergoing urodynamics studies. The rate of successful procedure completion will be compared between a prospective intervention group and a historical control group to determine whether the intervention improves procedural success and healthcare delivery.

The REESE study is looking at information from past spine surgeries to learn how often screws placed at the top of a spinal fusion become loose over time. Researchers will review existing medical records and X-rays from adults who have already had thoracolumbar spinal fusion surgery. The study will also look at factors that may increase the risk of screw loosening and whether it leads to additional complications or surgeries. No new procedures, treatments, or patient visits are required because the study uses information that has already been collected during routine medical care.

This prospective, single-center interventional study will evaluate the effect of suzetrigine (Journavx), a selective NaV1.8 inhibitor, on postoperative opioid requirements in patients undergoing spine surgery. Participants receiving suzetrigine as part of standard perioperative care will be compared with matched historical controls treated with standard multimodal analgesia. The study aims to characterize the magnitude and variability of opioid-sparing effects during the immediate postoperative period, with primary assessment focused on inpatient opioid consumption during the first 48 hours after surgery. Secondary objectives include evaluation of postoperative pain scores, opioid-related adverse events, hospital length of stay, discharge disposition, post-discharge opioid prescribing patterns, and healthcare utilization. Findings from this study will provide real-world evidence regarding the potential role of suzetrigine in spine surgery and will inform the design and endpoint selection of a future multicenter randomized clinical trial.

To determine if wearing a novel treatment during a 15-month period will enhance emmetropization in 4-month-old infants who have demonstrated poor ocular accommodation (eye focusing).

The aims of this clinical trial will test whether or not the onset of nearsightedness is delayed in a group of children randomized to nightly drops in 0.05% atropine in both eyes, in comparison to children who receiving nightly placebo drops in both eyes. The primary outcome is the two-year cumulative incidence of nearsightedness. The second aim of this project will determine whether atropine is associated with slower eye growth in children receiving nightly drops of atropine versus placebo.

The goal of this study is to learn if one nutrition supplement formula works better than a different formula in adults with cystic fibrosis. The main question being addressed is: Will certain atypical versions of certain nutrients outperform typical versions of these nutrients? This will be determined by examining blood measures of nutrient levels and/or indications of nutrient function indicators pre- and post-intervention. Participants will take the supplements for 6 weeks with a blood draw before and after that time.

The goal of this clinical trial is to learn if, how, and for whom suvorexant (SUV) works to treat alcohol use disorder (AUD). The main questions it aims to answer are: * Is SUV effective for AUD? * Does SUV dampen stress reactivity? * Can the researchers develop a biomarker for SUV treatment response? Researchers will compare SUV to a placebo (a look-alike substance that contains no drug) to see if drug SUV works to treat AUD. Participants will: * Take 10mg capsules of SUV or a placebo orally each night before bedtime for 8-weeks. * Visit the laboratory before (baseline), 4-weeks (mid-point), and 8-weeks (end-point) after taking SUV or placebo that include the psychophysiological stress paradigm (electromyography; EMG). * Complete daily reports of medication adherence, side-effects, sleep, alcohol use, and mood will be collected via smartphones during the 8-week medication trial.

This study investigates the outcomes of a surgical procedure that is performed to increase bone support at a future implant site on the upper back jaw area. This procedure requires placing bone graft material and/or substitutes into the maxillary sinus. The average healing time for the graft is about 6 months. Then, the site will be ready for dental implant. The study will compare healing outcomes of two types of bone graft mixtures used on the same patient (right and left upper jaw regions). The outcomes will be evaluated through clinical examination but also by studying the quality of the tissue through tissue biopsies obtained from grafted sites.

The goal of this observational study is to study the molecular markers of stress in blood samples from people who are having periodontal surgery. The main question it aims to answer are: * How do the levels of inflammatory molecules in the blood change during a periodontal surgery? * How are the levels of inflammatory molecules in a person having surgery different from the levels in a person having a nonsurgical procedure? * Participants will be people who are having a periodontal surgery or a nonsurgical periodontal treatment as part of their dental care. Participants will be asked to let the investigator take blood samples from them before, during, and after the procedure is being done. The blood will later be analyzed for substances in the blood that are associated with inflammation.

Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Youth appear to be at greater risk for living on the streets or being homeless than adults and are more vulnerable to long term consequences of homelessness. Multiple social determinants of health (SDOH) are uniquely associated with homelessness, driving substance use and adverse mental health consequences. However, limited research has identified pragmatic interventions that have a long-term ameliorating impact on the complex, multi-symptomatic issues among these youth. This study overcomes prior gaps in research through testing a multi-component comprehensive prevention intervention targeting SDOH that may affect biopsychosocial health indicators and longer-term health outcomes. In partnership with a drop-in center for YEH, youth between the ages of 14 to 24 years, will be engaged and randomly assigned to conditions using a dismantling design so that essential intervention components can be efficiently identified. In particular, youth (N = 300) will be randomly assigned to a) Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU, n = 80), b) Strengths-Based Outreach and Advocacy + Services As Usual (SBOA + SAU, n = 80), c) MI/CRA + SBOA + SAU (n = 80) or d) SAU (n=60) through the drop-in center. In order to assess the longer-term prevention effects on substance use, mental health and other outcomes, all youth will be assessed at baseline and at 3, 6, 12, 18 and 24-months post-baseline. The primary goal of this study is to establish the impact of a comprehensive intervention embedded within a system that serves YEH, a community drop-in center, on youth's opioid misuse and disorder, other substance misuse and disorders, mental health diagnoses, and other targeted outcomes. This study will offer unique information on the physiological and psychological stress pathways underlying change for specific subgroups of youth along with cost estimates to inform future implementation efforts in drop-in centers around the country.

The purpose of this research study is to improve the effectiveness of a well-established therapy for suicidal thoughts and behaviors called Brief Cognitive Behavioral Therapy (BCBT) for Suicide Prevention.

Patients undergoing FIRM guided ablation of atrial fibrillation will undergo high resolution MRI imaging to determine correlation of underlying anatomic fibrotic regions with FIRM targeted sites for ablation.

The aim of this study is to develop a consensus on the curriculum for training cardiothoracic critical care by first evaluating the need for the field, based on a Delphi consensus among a panel of experts in this field.

This prospective, randomized, double-blind, two-arm clinical trial will evaluate whether applying 5% lidocaine ointment to endotracheal tubes before intubation reduces airway irritation compared with standard water-based lubricant in adult patients undergoing general anesthesia. The primary objective is to determine whether lidocaine ointment decreases the incidence of coughing or bucking during emergence and extubation. Secondary objectives include evaluating the incidence and severity of postoperative sore throat and hoarseness, as well as intraoperative opioid requirements. Additional demographic and procedural data will be collected to characterize the study population and adjust for potential confounders. The study hypothesis is that 5% lidocaine ointment will reduce emergence coughing and improve postoperative airway comfort without increasing adverse outcomes.

This study is testing whether taking vitamin C every day can help improve gut health and reduce inflammation in adults with obesity. Poor gut health-sometimes called "leaky gut"-can allow harmful substances from bacteria to enter the bloodstream, which may lead to inflammation and increase the risk of heart disease and liver problems. Participants will complete two study periods, each lasting two weeks, with a two-week break in between. In one period, they will take vitamin C; in the other, a placebo. During each period, researchers will collect blood, urine, and stool samples, ask participants to track their diet and activity, and perform a test to measure gut permeability. There are minimal risks, such as discomfort from blood draws or temporary stomach upset from a sugar drink. While participants may not directly benefit, their involvement will help researchers learn whether vitamin C is a safe and effective way to improve gut health in people with obesity.

The goal of this clinical trial is to learn how a partially self-supervised constraint-induced movement therapy (sCIMT) program in adults with arm and hand weakness will work after stroke. This study will look at whether the program can help people improve the use of their arm and hand after a stroke while requiring less time with a therapist. The main questions it aims to answer are: * Does the sCIMT program help people use their affected arm and hand better - after a stroke? * Do participants feel that the sCIMT program is useful, easy to follow, and a good fit for their recovery needs? * Does taking part in the sCIMT program improve participants' quality of life and daily well-being? Participants will: * Take part in a therapy program 5x/week for 2 weeks. The program is designed to help improve the use of the arm and hand affected by stroke. * Wear a mitt on the stronger hand during certain practice activities to encourage use of the weaker hand. * Complete surveys and tests before and after the program to measure arm and hand use, experiences with the program, and quality of life.