Sensorineural hearing loss (SNHL) is among the most prevalent chronic conditions in aging and has a profoundly negative effect on speech comprehension, leading to increased social isolation, reduced quality of life, and increased risk for the development of dementia in older adulthood. Typical audiological tests and interventions, which focus on measuring and restoring audibility, do not explain the full range of cognitive difficulties that adults with hearing loss experience in speech comprehension. For example, adults with SNHL have to work disproportionally harder to decode acoustically degraded speech. That additional effort is thought to diminish shared executive and attentional resources for higher-level language processes, impacting subsequent comprehension and memory, even when speech is completely intelligible. This phenomenon has been referred to as listening effort (LE). There is a growing understanding that these cognitive factors are a critical and often "hidden effect" of hearing loss. At the same time, the effects of LE on the neural mechanisms of language processing and memory in SNHL are currently not well understood. In order to develop evidence-based assessments and interventions to improve comprehension and memory in SNHL, it is critical that the cognitive and neural mechanisms of LE and its consequences for speech comprehension are elucidated. In this project, the investigators adopt a multi-method approach, combining methods from clinical audiology, psycholinguistics, and cognitive neuroscience to address this gap of knowledge. Specifically, the investigators adopt a novel and innovative method of co-registering pupillometry (a reliable physiological measure of LE) and language-related event-related brain potential (ERP) measures during real-time speech processing to characterize the effects of clear speech (i.e., a listener-oriented speaking style that is spontaneously adopted to improve intelligibility when speakers are aware of a perception difficulty on behalf of the listener) on high-level language processes (e.g., semantic retrieval, syntactic integration) and subsequent speech memory in older adults with SNHL. This innovative work addresses a time-sensitive gap in the literature regarding the identification of objective and reliable markers of specific neurocognitive processes impacted by speech clarity and LE in age-related SNHL.

Type: Interventional

Start Date: Sep 2023

open study

The purpose of this research is to evaluate the potential benefits of two Intervention programs in adults with TBI to improve well-being and other outcomes that are maintained over time.

Type: Interventional

Start Date: Sep 2023

open study

This study is investigating changes to the proteins in skeletal muscle that contribute to reduced muscle size and muscle function that occurs with aging.

Type: Interventional

Start Date: Nov 2017

open study

This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NST-6179 in subjects with intestinal failure-associated liver disease (IFALD) receiving parenteral nutrition (PN). The study will be conducted in 2 sequential parts. Up to 36 subjects diagnosed with IFALD will be enrolled in the study, of which up to 18 subjects will be enrolled in each of the 2 parts and randomized (2:1) to receive NST-6179 (N=12/part) or matched placebo (N=6/part). Subjects in Part A will receive once daily (QD) oral administration of 800 mg (32 mL solution) NST-6179 or placebo for 4 weeks. The NST-6179 dose for Part B is planned to be 1200 mg QD for 12 weeks. Actual dose, however, will be determined during the safety review meeting.

Type: Interventional

Start Date: Jan 2024

open study

Mental disorders are among the leading causes of disability and morbidity worldwide, including Brazil, where despite having a comprehensive network of publicly-funded, free, community-based mental health treatment, it is estimated that only 26% of people with psychiatric conditions successfully connect to community-based care. The study team hypothesizes that the successful adaptation and implementation of an evidence-based model of peer support to Brazilian culture, will contribute to enhanced levels of engagement, improved continuity of care, and improvements in quality of life and wellbeing among persons living with Serious Mental Illness (SMI) in Brazil. After this study, it will have established the feasibility, acceptability, safety and tolerability, of adapting a low-cost, culturally-responsive, evidence-based intervention to improve post-acute supports for people with SMI who access community mental health treatment.

Type: Observational

Start Date: Aug 2024

open study

The goal of this clinical trial is to learn about the effects of high blood glucose levels in the brain and assess if the changes seen in individuals with poorly control T2DM can be reversed with good glucose control. The main question[s] it aims to answer are: - To determine, whether abnormalities in brain glucose transport seen in individuals with uncontrolled diabetes, can be improved with better glucose control. - Assess which factors, (duration of diabetes mellitus (DM) and glycemic control) contribute to changes in glucose transport Participants will have: - A screening visit - placement of a continuous glucose monitor (CGM) 2 weeks before the first magnetic resonance spectroscopy (MRS) at week 0 - Additional visits/phone calls for intensification of diabetes management and nutrition visits - Second magnetic resonance spectroscopy (MRS) at week 12

Type: Interventional

Start Date: Jul 2024

open study

A prospective, non-blinded, randomized controlled trial studying the management of symptomatic ureteral stones. This study will compare upfront ureteroscopy vs observation and delayed intervention for patients presenting to the emergency department with a symptomatic ureteral stone.

Type: Interventional

Start Date: Aug 2023

open study

US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will not utilize clinical sites.

Type: Interventional

Start Date: Oct 2023

open study

The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT). Primary Objective To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors. Secondary Objectives: - To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors. - To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors .

Type: Observational

Start Date: Dec 2022

open study

This is a mechanistic, controlled, open-label, single-site study to evaluate the effects of RG-RV16 inoculation on airway mucosal gene expression and airway remodeling in 25 healthy controls (HC), in 25 allergic rhinitis subjects (AR) with cat dander allergy, and in 25 allergic asthmatic subjects (AA) with cat dander allergy. Three groups (HC, AR, and AA) will undergo screening to establish clinical history, will undergo pulmonary function testing (spirometry), and will have blood drawn for clinical characterization (IgE, , ImmunoCAP, CBC and differential), and for assessing the presence of existing neutralizing antibody against RV16. Only those who meet criteria will be permitted to continue into the interventional and run-out phases of the study.

Type: Interventional

Start Date: Apr 2023

open study

Parallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade D, Stages II-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.

Type: Interventional

Start Date: Feb 2022

open study

The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.

Type: Interventional

Start Date: Apr 2023

open study

The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material

Type: Observational

Start Date: Jan 2021

open study

The overall objective of this study is to determine if a reduced injection site protocol (5 injection sites) using an equivalent amount of Botox provides comparable relief of Urgency Urinary Incontinence (UUI) symptoms compared to the standard injection site protocol (15-20 injection sites). Our central hypothesis is that the 5-site injection protocol is non-inferior in terms of relief of UUI symptoms compared to the standard injection site protocol, measured by a non-inferior reduction in the number of UUI episodes per day.

Type: Interventional

Start Date: Feb 2021

open study

To evaluate whether an entire-body positron emission tomography (PET) scanner can be exploited to improve evaluation, monitoring and measurement of both peripheral and central demyelination in multiple sclerosis (MS) patients.

Type: Interventional

Start Date: Sep 2024

open study

Spinal muscular atrophy (SMA) is a neurogenetic disorder caused by a loss or mutation in the survival motor neuron 1 gene (SMN1) on chromosome 5q13, which leads to reduced SMN protein levels and a selective dysfunction of motor neurons. SMA is an autosomal recessive, early childhood disease with an incidence of 1:10,000 live births. SMA is the leading cause of infant mortality due to genetic diseases. The purpose of this registry is to assess the long term outcomes of patients with SMA in the context of advances in treatment options and also to characterize and assess long-term safety and effectiveness of OAV-101.

Type: Observational [Patient Registry]

Start Date: Sep 2018

open study

This is a phase IV, prospective, open label, randomized-controlled study that will compare radial access with state-of-the-art femoral access in patients without ST-segment elevation acute myocardial infarction undergoing cardiac catheterization. Subjects will be randomized 1:1 into 2 treatment groups: radial access and state-of-the-art femoral access. Randomization will be performed in blocks of 50 per site. Similarly, a second sub-randomization will be performed in the femoral access group into use of 18 vs 21 gauge needles, also in a 1:1 fashion.

Type: Interventional

Start Date: Nov 2019

open study

Patients seen who had autonomic and enteric profiling (Adrenergic, Cholinergic, Enteric Measures/Mapping=ACEM_ from 2012-2019 at the University of Louisville.

Type: Observational

Start Date: Oct 2012

open study

This study will help us learn more about how a mother's health during pregnancy may influence her child's growth and development later in life.

Type: Observational

Start Date: Mar 2017

open study

This study seeks to incorporate genetic testing into the postmortem examination of cases of sudden unexplained death.

Type: Observational

Start Date: Jun 2014

open study

The purpose of this registry is to gather information on patients with bicuspid aortic valve disease.

Type: Observational [Patient Registry]

Start Date: Apr 2010

open study

The purpose of the study is to: - Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from National Marrow Donor Program donors (NMDP) donors - Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis - Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients - Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors

Type: Interventional

Start Date: Feb 1997

open study

The goal of this clinical trial is to learn if dorsally applied kinesiology tape is an effective conservative treatment for symptoms of carpal tunnel syndrome and assess the potential performance effect of the tape color in first-person shooter esports games in esports gamers who exhibit symptoms that resemble carpal tunnel syndrome. The main questions it aims to answer are: Is dorsally applied kinesiology tape able to manage carpal tunnel syndrome-like symptoms in esports gamers? Does red kinesiology tape hinder or improve performance in first-person shooter esports games in esports gamers? Researchers will compare red kinesiology tape to skin tone kinesiology tape. Both will be applied on the dorsal aspect of the hand and wrist of the dominant upper extremity. Participants will visit the site 2 times to get kinesiology tape applied and complete a pre and post-test for pain and performance. Depending on randomization a participant will receive a random sequence of the study arm (ex: red then skin tone or skin tone then red tape)

Type: Interventional

Start Date: Jan 2025

open study

This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.

Type: Interventional

Start Date: Nov 2024

open study

The goal of this study is to improve how we teach self-control and communication skills to children and adolescents with challenging behaviors. Researchers aim to find ways to make behavior-change treatments more effective and long-lasting, even when the environment or reinforcement schedules change. The main questions this study will answer are: Can innovative techniques help children maintain learned skills, such as asking for attention or waiting for rewards, when faced with new people, places, or situations? How do cognitive and behavioral factors, like memory, timing, and decision-making, affect the success of treatments? Participants in this study will: Complete assessments to identify preferred activities and understand the causes of challenging behaviors. Learn communication skills to replace challenging behaviors, such as tantrums or crying, with more appropriate actions like asking for attention. Participate in activities designed to understand their individual responses to different types of rewards and delays.

Type: Interventional

Start Date: Nov 2024

open study