All Clinical Trials

This observational study will examine newly activated cochlear implant users and determine whether their abilities to discern simple sounds change and relate to improved speech perception. Take-home computers and test-equipment will be sent home, and subjects will complete approximately 25 test sessions over the first 3 months of cochlea implant use. Then, subjects will be tested 3 more times in the laboratory until 1 year-post activation. The primary objective is to determine and quantify how sounds change and speech perception improves over the course of early cochlear implant use. Read Less

This is a single-center prospective study evaluating the efficacy of a prototype gastrostomy anchor dressing for use with button gastrostomy tubes. The anchor dressing has been previously evaluated for usability by parents, patients, and nurses. This study compares several outcomes related to complications from gastrostomy tube placement using a prospective cohort of patients and a retrospective analysis of complications associated with gastrostomy tubes. Prospective patients will initially be monitored until they have completed their last dressing change or for a maximum of 50 days. They will then complete their final survey. Their charts will be reviewed for up to one year from their initial gastrostomy placement. The study's primary objective is to determine if the novel gastrostomy tube anchor dressing reduces rates of gastrostomy tube dislodgement and ED/clinic visits for gastrostomy tube complications. Read Less

This study involves a Positron Emission Tomography (PET) scan using a new investigational radioactive tracer, \[18F\]-FZTA, to detect inflammation in the brain. The tracer will be tested in healthy younger adults and individuals with Multiple Sclerosis. Read Less

This study aims to evaluate the performance of biomarkers and their responsiveness to standard-of-care treatments (Vevye® or Xiidra®), in participants with dry eye disease (DED) compared to healthy volunteers (control participants). Read Less

Primary objective: to evaluate the non-inferiority in terms of improvement of hemoglobin (Hg) levels within 30 days postoperatively between two proposed treatments. Secondary objective: to evaluate the financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV), while demonstrating non-inferiority in the improvement of hemoglobin levels, reduction in transfusion requirements, and reduction of hospital/ICU stay length Read Less

This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs. Read Less

A novel dietary intervention combining a standardized IBD diet (IBD-AID) with supplementation from a pea protein plant-based oral nutrition supplement (ONS) (Kate Farms Peptide 1.5) to improve protein, calorie, and nutrient intake in adult patients experiencing a Crohn's disease flare starting new immunologic therapy. Additionally, this study will include objective measures of body composition to improve nutrition status assessment and provide a more sensitive measure of intervention efficacy compared to anthropometric measures of body weight or BMI. Read Less

The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI. Read Less

This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable. Read Less

ML-007C-MA-211 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered ML-007C-MA in inpatient adult participants aged 18 to 64 years with schizophrenia experiencing an acute exacerbation of psychosis. The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score. Read Less

In a multi-ethnic population, a genome-wide polygenic risk score (PRS) for systolic blood pressure (SBP), incorporating over one million common genetic variants, predicts blood pressure (BP) traits and the risk of adverse cardiovascular events beyond traditional risk factors. Delivering SBP PRS information to young and middle-aged adults with hypertension (HTN) and poor cardiovascular health (CVH) may enhance their motivation to adopt healthier lifestyles, improve blood pressure control, and ultimately reduce the risk of future cardiovascular disease (CVD). This randomized controlled trial will assess the impact of SBP PRS disclosure and theory-based genomic counseling on systolic blood pressure and health behaviors. A total of 300 adults aged 18-55 years will be enrolled and randomized to receive either routine clinical care or SBP PRS results with structured genomic counseling based on the Health Belief Model (HBM). Participants will be followed for 12 months. The primary outcome is change in 24-hour mean SBP from baseline to one year. Secondary outcomes include changes in physical activity, diet, medication adherence, smoking, lipid and glucose levels, and body composition. The study will also evaluate how behavior change is influenced by health beliefs, including perceived risk and self-efficacy. This study aims to advance the use of genomic tools in hypertension management and cardiovascular disease prevention. Read Less

Teens consume more added sugar than any other age group. Too much added sugar is associated with poor diet quality, obesity risk, and negative cardiometabolic outcomes. Behavioral interventions to improve dietary intake are needed, but are currently lacking for this age group. This study aims to test how feasible, acceptable, and effective a 12-week contextually-tailored health coaching program, called Sip \& Snack Better (SSB), is in reducing added sugar in teens, compared to a technology-only comparison. It will provide important information on how to improve dietary intake and reduce added sugar in teens. Additionally, measuring diet is very challenging in teens, so this study will also test the use of an objective biomarker (called the carbon isotope ratio (CIR)) as a measure of added sugar intake before, during, and after the 12-week study. Read Less