All Clinical Trials

Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine is effective in reversing AMD but has a short duration of action, and patient commonly experience recurrence of AMD after initial control with physostigmine. Recent case reports and small observational studies suggest that rivastigmine, which has a longer duration of action than physostigmine, might be useful in the treatment of AMD. In order to investigate the effectiveness of rivastigmine in preventing recurrence of AMD after initial control with physostigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine after initial control of AMD with physostigmine will experience less recurrence of antimuscarinic delirium than those treated with placebo. Read Less

This study aims to evaluate the effectiveness of a mobile application in improving postoperative rehabilitation outcomes among patients undergoing orthopedic surgery. Read Less

The goal of this single-arm feasibility study is to evaluate the feasibility and acceptability of an 8-week mindful self-compassion intervention and associated data-collection plan among transgender and nonbinary young adults. Participants will be asked to: * Complete weekly 2.5-hour virtual classes for 8 weeks and a 4-hour virtual retreat * Practice specific activities in between classes for 20-30 minutes a day * Answer survey questions before starting the intervention, half-way through the intervention, after the intervention, and 3-months after the intervention ends. Read Less

SAFE HV is an observational, prospective, multi-center, non-randomized study evaluating real-world clinical experience of centers where a single procedural physician schedules eight or more left atrial appendage occlusion (LAAO) device implant procedures in a single calendar day. Read Less

This is a Phase 1 study to determine the safety and efficacy of allogeneic neonatal mesenchymal stromal cells (nMSCs) for the treatment of Dilated Cardiomyopathy. The purpose of the study is to help doctors and scientists learn if allogeneic neonatal mesenchymal stromal cells (nMSCs) infusions are a safe and effective way to improve cardiac function and left ventricular ejection fraction. Read Less

Recognition of speech sounds is accomplished through the use of adjacent sounds in time, in what is termed acoustic context. The frequency and temporal properties of these contextual sounds play a large role in recognition of human speech. Historically, most research on both speech perception and sound perception in general examine sounds out-of-context, or presented individually. Further, these studies have been conducted independently of each other with little connection across labs, across sounds, etc. These approaches slow the progress in understanding how listeners with hearing difficulties use context to recognize speech and how their hearing aids and/or cochlear implants might be modified to improve their perception. This research has three main goals. First, the investigators predict that performance in speech sound recognition experiments will be related when testing the same speech frequencies or the same moments in time, but that performance will not be related in further comparisons across speech frequencies or at different moments in time. Second, the investigators predict that adding background noise will make this contextual speech perception more difficult, and that these difficulties will be more severe for listeners with hearing loss. Third, the investigators predict that cochlear implant users will also use surrounding sounds in their speech recognition, but with key differences than healthy-hearing listeners owing to the sound processing done by their implants. In tandem with these goals, the investigators will use computer models to simulate how neurons respond to speech sounds individually and when surrounded by other sounds. Read Less

Firearm injuries are the leading cause of death for American youth. Strikingly, firearm suicide among adolescents is growing faster than other groups. Lethal means counseling is standard of care, however, infrequently occurs despite pediatricians recognizing the importance. Lack of time, topic discomfort, and inadequate resources for families are commonly reported barriers to counseling. By addressing these factors, we can improve counseling with the ultimate goal of increasing safe storage and reducing firearm injuries in youth. Children admitted in acute mental health crises while awaiting psychiatric hospital placement are a population at greater risk of suicide. We plan to implement a pilot intervention to offer secure storage counseling and storage device distribution to families of behavioral health patients who indicate firearm ownership on initial screening. The goal of this project is to evaluate the feasibility and acceptability of firearm secure storage counseling and device provision in the inpatient setting. Read Less

Strategies for creating and maintaining reciprocal partnerships between teachers and parents are considered essential elements of developmentally appropriate practice in early childhood education (ECE). Particularly for children who are high-risk for behavioral, developmental, or mental health problems, effective partnerships between family and preschool are essential for promoting optimal classroom participation and learning outcomes. The current study is an uncontrolled (pre-post) feasibility trial of Family-School Partnership Intervention (FPSI). FSPI was developed using stakeholder input, is delivered by existing preschool staff, and aims to promote development and reduce barriers to learning among children with pre-clinical social-communication delays. FSPI integrates evidence-based practices (EBPs) from education (7 EBPs; National Association for the Education of Young Children) with clinical interventions for toddlers with autism spectrum disorder (ASD) (12 EBPs at the educator-parent level and 8 EBPs at the parent-child level; Naturalistic Developmental Behavioral Interventions). Data will be collected across 10 ECE programs. At each participating ECE program, research procedures will be completed during a single school year. Selected ECE programs will include public school, Head Start, and private preschool programs. Participants include 20 non-teaching support staff (1-2 per program; e.g., director, principal, education-coordinator), 30 lead teachers (2-4 per program), and 60 children with social-communication deficits (two per teacher). Data collection will focus on feasibility data (enrollment, attendance, attrition, data completion), observational measures of implementation fidelity (at the educator-parent and parent-child level), and mixed methods to evaluate educator and parent acceptability and satisfaction and identify implementation drivers/barriers. This research will prepare a large, multi-site hybrid trial to evaluate the effectiveness of FSPI for promoting social-communication skills and kindergarten readiness, in addition to factors that mediate the relation between FSPI delivery and fidelity (implementation drivers/barriers). Read Less

This is a randomized, double-blind, placebo-controlled, two-arm phase 2 study of etrasimod plus corticosteroids versus placebo plus corticosteroids for the treatment of IMDC CTCAE v5.0 grade ≥ 2 due to ICI therapy alone (α-PD-(L)1 monotherapy or combined with another ICI, such as α-CTLA-4 or α-LAG-3) or ICI plus an oral tyrosine kinase inhibitor that in the opinion of the treating physician requires treatment with corticosteroid-based immunosuppression and does not require immediate secondary immune suppression, such as vedolizumab or infliximab (or equivalent). IMDC is one of the most common Immune Related Adverse Events (irAEs) from treatment with ICI. Current guidelines recommend steroid treatment for IMDC CTCAE grade ≥ 2, which requires temporary or permanent cessation of ICI therapy. Corticosteroids may interfere with the anti-tumor activity of ICIs and are therefore not co-administered. Strategies are needed to both reduce the dose and duration of corticosteroids needed for IMDC treatment and minimize the duration off ICI therapy before re-administering ICI (for those patients in whom it is deemed safe to rechallenge). Read Less

The prevalence of gout has been steadily increasing over several decades and is correlated with the rising burden of obesity, chronic cardiac and renal disease; all conditions overrepresented in the Southeastern U.S. - particularly in African Americans. Through a novel post-emergency department visit intervention, we aim to improve the care patients with gout receive, both during acute exacerbations and long-term. A secondary goal of the project is to concurrently enhance participation of minorities in biomedical research in the Deep South. Read Less

To provide a comprehensive yoga therapy (CYT) program to patients with ovarian, fallopian tube, or primary peritoneal cancer who are scheduled to receive chemotherapy and then undergo surgery. Researchers want to learn about the effects of the program on patients' quality of life and other outcomes described below. Read Less

The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System. Read Less