All Clinical Trials

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156) Read Less

Pecan-enriched diets have been linked to improved cardiovascular health, including postprandial blood lipids and microvascular reactivity in older adults. This has led to recommendations to increase regular pecan consumption, however there is no consistent plasma measure of pecan intake. Traditionally, plasma tocopherols have been used, although they reach peak concentrations in plasma around 6-8 hours post pecan consumption, leading to high variability at 24 hours. Therefore, a more reliable biomarker of pecan consumption needs to be defined. The purpose of this study is to analyze the postprandial response of urolithins in human plasma after a pecan enriched meal and compare their appearance pattern to tocopherols. This single blind, randomized crossover trial is designed to provide two acute meal challenges for each participant (anticipated n=30, BMI 18.5 - 24.9, age 18-30y) with a washout period of \~14 days between each challenge. The intervention meal contains 68g of pecans and the control shake contains whipped cream instead of pecans, and the order of each meal will be randomly assigned. Blood draws will be collected at fasting (0-h) and every 2 hours until 8 hours postprandial, then at 12-, 24-, and 48h after the meal. The levels of urolithins and tocopherols will be quantified through liquid chromatography tandem mass spectrometry. To our knowledge, this is the first time urolithins will be tracked in plasma up to 48h post meal. This study will be used to establish of a new and more consistent dietary biomarker for pecans. Read Less

This study will examine whether continuous glucose monitoring in patients hospitalized in the immediate postpartum period is more effective than traditional point of care glucose testing in identifying patients with hypoglycemia. Read Less

This study is testing the usefulness of two types of Brain Health \& Wellness classes for Veterans with a history of concussion to improve mental health. Read Less

This study will critically examine the feasibility, safety and efficacy of HBOT during inpatient rehabilitation (IPR) after acute ischemic stroke measured by non-disruption of 3 hours of daily therapy, frequency of neurological deterioration or complications (seizure, hemorrhage, brain edema), and functional communication, activities of daily living (ADLs) and mobility. Read Less

There are no guidelines or prospective studies defining the optimal surgical treatment for gliomas of older patients (≥70 years) or those with limited functioning performance at presentation (KPS ≤70). Therefore, the decision between resection and biopsy is varied, amongst neurosurgeons internationally and at times even within an instiutition. This study aims to compare the effects of maximal tumor resection versus tissue biopsy on survival, functional, neurological, and quality of life outcomes in these patient subgroups. Furthermore, it evaluates which modality would maximize the potential to undergo adjuvant treatment. This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be treated with resection or biopsy at a 3:1 ratio. Primary endpoints are: 1) overall survival (OS) and 2) proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy. Secondary endpoints are 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months and 6 months after surgery 2) progression-free survival (PFS); 3) quality of life at 6 weeks, 3 months and 6 months after surgery and 4) frequency and severity of Serious Adverse Events (SAEs). Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. Read Less

There is no consensus on the optimal treatment of patients with high-grade glioma, especially when patients have limited functioning performance at presentation (KPS ≤70). Therefore, there are varied practice patterns around pursuing biopsy, resection, or palliation (best supportive care). This study aims to characterize the impact of palliative care versus biopsy versus resection on survival and quality of life in these patients. Also, it will aim to determine if there is a subset of patients that benefit the most from resection or biopsy, for which outcome, and how they could be identified preoperatively. This study is an international, multicenter, prospective, 3-arm cohort study of observational nature. Consecutive HGG patients will be treated with palliative care, biopsy, or resection at a 1:3:3 ratio. Primary endpoints are: 1) overall survival, and 2) quality of life at 6 weeks, 3 months and 6 months after initial presentation based on the EQ-5D, EORTC QLQ C30 and EORTC BN 20 questionnaires. Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. Read Less

This observational study characterizes the relationship between amniotic fluid lactate and uterine electromyography during labor in healthy individuals at term planning a vaginal birth. Additional comparison measures and outcomes measures will be collected and analyzed as exploratory measures. Read Less

Rapidly evolving virtual reality (VR) and augmented reality (AR) technologies are being incorporated by many large-scale industries, and the medical field is no exception. One area that has gained significant attention in recent years is virtual rehabilitation which allows physical therapists to leverage state-of-the-art immersive virtual environments to uniquely address functional deficits in patients who are unresponsive to conventional treatment techniques. Advanced VR and AR technologies are now available in commercially available small-scale, mobile head-mounted displays which can be readily used in outpatient clinic settings and possibly at home. The aim of this study is to determine whether advanced VR- and AR-based physical therapy improves functional status and reduces self-reported symptoms in individuals experiencing vestibular disorders secondary to mild traumatic brain injury (mTBI). Study participants will be randomized into treatment groups: 1) conventional therapy, 2) therapy performed using a large-scale VR system (the Computer Assisted Rehabilitation Environment or CAREN), 3) therapy performed using a mobile AR. Upon completion of treatment, groups will be compared to determine functional outcome improvements with respect to static and dynamic balance as well as reduction of vestibular symptoms. Read Less

The goal of this randomized control trial is to clinical trial is to evaluate Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationships. The overall goal of the MWB program is to reduce incidence of sexually transmitted infections (STI) and unplanned pregnancy and promote healthy, consensual, and violence-free relationships among youth. The primary research question we aim to answer through this study is: Among youth ages 15-19, does the Many Ways of Being program reduce unprotected sex (through consistent and correct use of condoms and contraceptives) compared to the a career readiness program, which does not include sexual health components? As part of the study, participants will be asked to: * Attend approximately 14 hours and 40 minutes of programming completed over 4-8 weeks * Complete baseline, post-intervention, and 9-month follow-up surveys * For select participants who received the MWB program, participate in an optional focus group discussion The local evaluation will focus on the impact of the entire MWB intervention, as compared to a similar-length control program focused on career readiness. Read Less

The goal of this study is to evaluate the impact of SafeSpace Sexual Health App, an innovative sexual health promotion program focused on reducing sexual risk factors and promoting sexual and reproductive health and wellbeing among young people assigned female or intersex at birth, particularly Black and/or Latine youth, LGBTQ+ youth, youth in states with high teen birth rates and youth who live in rural communities. This study utilizes a two-arm randomized control trial design to measure impacts of receiving the SafeSpace Sexual Health program compared to receiving a similar-length control app program, SafeSpace General Health that focuses on general health. The investigators will ask participants to: * Keep the SafeSpace app downloaded to their device and visit the app regularly over the course of 10 weeks. * Provide contact information. * Receive and open app push notifications for 10 weeks (up to 3 per week). * Complete 3 online surveys over a year: baseline, short-term follow-up (10 weeks after baseline), and long-term follow up (9 months after short-term follow-up). * Receive occasional text messages from the study team. Read Less

The present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents. Read Less