All Clinical Trials

Social, emotional, and behavioral (SEB) problems occur frequently among elementary school students, dramatically impede student outcomes, and have been exacerbated by the COVID-19 pandemic. Evidence based practices exist to address student SEB needs, prevent problems, and ensure academic success. However, the implementation of these programs in schools is frequently incomplete, uneven, and occurs with insufficient fidelity to ensure positive effects for students due to significant implementation barriers across multiple levels. The purpose of this Impact Trial is to test the effectiveness of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy in school-wide implementation of a Tier 1 evidence-based practice (EBP) - Positive Behavioral Interventions and Supports (PBIS). Read Less

The goal of this YH42946-101 is to evaluate the safety, Tolerability, Pharmacokinetics and anti-tumor activity of YH42946 in patients with locally advanced of metastatic solid tumors with HER2 aberration and EGFR exon 20 insertions. Read Less

This is a phase 2 study, single-arm study of adjuvant combination therapy with Sacituzumab Govitecan and Nivolumab in patients with muscle-invasive urothelial carcinoma of the bladder, ureter, or upper tract, who are high risk for cancer recurrence post curative-intent surgery based on surgical pathology. Read Less

To compare the effects of IV iron versus placebo (saline) injection on arterial oxygen saturation, submaximal exercise responses, and 2-mile treadmill time-trial performance during acute exposure to hypobaric hypoxia (430 mmHg, simulating \~4800m) assessed 1 and 14 days after treatment. Primary Hypothesis 1: IV iron treatment will improve arterial oxygen saturation at rest and during exercise in acute hypobaric hypoxia and this effect will persist for 2 weeks Primary Hypothesis 2) IV iron treatment will improve 2-mile treadmill time trial performance in acute hypobaric hypoxia and this effect will persist for 2 weeks Read Less

The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can manage symptoms in patients with autism spectrum disorder (ASD). Additionally, this study also uses magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to track brain state changes during taVNS treatment in ASD. Investigators will recruit up to 16 participants with ASD. Read Less

Facial fullness is often regarded as a characteristic feature of a youthful face. Chronic reduction of collagen, elastin, and glycosaminoglycans contribute to the facial volume loss that characterizes the aging face. Volume restoration by replacing or augmenting soft tissue is critical to successful facial rejuvenation. NOA VOLUME is a crosslinked Hyaluronic Acid (HA) gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of improving mid-face volume deficit. The purpose of this study is to assess safety and effectiveness of NOA VOLUME in adult participants seeking improvement of mid-face volume compared to JUVÉDERM VOLUMA XC (VOLUMA XC). NOA VOLUME is an investigational device being developed for the improvement of mid-face volume. There will be 2 cohorts in this study. In Cohort 1, participants will receive either NOA VOLUME or VOLUMA XC with a fixed follow-up period. In Cohort 2, participants will receive either NOA VOLUME or VOLUMA XC with a variable follow-up period. Around 231 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 15 sites in the United States. Participants will receive either NOA VOLUME or VOLUMA XC as subcutaneous and/or supraperiosteal plane injections in the cheek on Day 1. Participants will receive optional touch-up treatment at Day 31 and optional repeat treatment at Month 18 for Cohort 1 and at Month 12, 15, or 18 for Cohort 2 and will be followed up for up to 22 months. Read Less

This study is being done to assess the feasibility and safety of a time-restricted 12-hour enteral feeding protocol (experimental group) in comparison to a standard-of-care, 24-hour enteral feeding protocol (control group) in critically ill patients. Investigators hope to gain knowledge about how these feeding schedules affect feeding tolerance, blood sugar control, and other factors affecting critically ill adult patients. * Investigators expect that the 12-hour feeding protocol will be tolerated similarly to the 24-hour feeding protocol and will not result in a greater number of adverse events related to feeding. * Investigators expect that the proportion of participants in both groups receiving at least 75% of their estimated nutrition needs will be similar. Read Less

The goal of this clinical trial is to evaluate if a digital group intervention (named IMAGINE) can prevent depression in perinatal populations. The main questions it aims to answer are: Does IMAGINE engage cognitive behavioral therapy targets? Does IMAGINE lead to lower depression scores? Is IMAGINE acceptable, appropriate, usable and feasible? Participants will be randomized to either participate in an IMAGINE group for 12 weeks or receive standard of care. Participants will respond to questionnaires at enrollment and study visits at 12 and 24 weeks after enrollment. Read Less

This is a two-site randomized clinical trial aiming to test whether a modified investigational bariatric surgical procedure can improve gastroesophageal reflux disease (GERD) after sleeve gastrectomy. Read Less

The purpose of this study is to evaluate the effectiveness and implementation considerations of a video aid to improve communication and patient-centered outcomes in older injured adults Read Less

The ALPCO Calprotectin CLIA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. The goal of the study is to generate data to support positive and negative predictive value of the ALPCO Calprotectin assay in patients with signs and symptoms of IBS or IBD. Read Less

The purpose of this study is to evaluate whether the entry technique surgeons use to get inside the uterus to perform fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome has an effect on the rates of chorioamniotic membrane separation. Read Less