All Clinical Trials

The goal of this clinical trial is to identify any differences in elbow ulnar collateral ligament (UCL) relative thickness and joint space laxity in the dominant arm following an 8-week course of low intensity resistance exercises with blood flow restriction (BFR) exercises in healthy volunteers. The main questions it aims to answer are: 1. Do BFR exercises contribute to a change in the relative ligament thickness of the UCL, and changes in the ulnohumeral joint space? 2. Are there changes in arm strength following the 8-week strengthening protocol with/without BFR? Participants will: * Complete two BFR sessions a week for a total of eight weeks. * Complete an exercise session with both arms (dominant arm will receive BFR) at each study visit. * Have sonographs taken of the UCL at the first and last study visit. * Complete strength assessments at the first and last study visit. Read Less

This research aims to answer the question: does a group training program specifically for teens with chronic sickle cell disease (SCD) pain that teaches skills to strengthen the mind and body help improve everyday functioning and reduce pain symptoms? The program will be tailored to address challenges related to frequent or chronic sickle cell pain and may improve participants' physical and emotional health. The program, called I-STRONG for SCD (Integrative Strong Body and Mind Training for Sickle Cell Disease), may help improve everyday functioning and pain symptoms in teens with chronic pain related to SCD. The research team aims to determine how participants (teens and parents) respond to this program. Read Less

The goal of this clinical trial is to evaluate both the technical success and efficacy of using the LOBO™ device in patients undergoing embolization of Pulmonary Arteriovenous Malformations (PAVM). The main question\[s\] it aims to answer \[is/are\]: * What is the technical success rate, the number of LOBO™ devices needed for occlusion, and time to occlusion for each feeding artery during PAVM embolization using the LOBO™ device? * What is the short-term occlusion rate of the LOBO™ device for PAVM embolization (6 months post-embolization)? * What are the medium- and long-term occlusion rate of the LOBO™ device in PAVMs (12 months and 36 months post embolization)? Researchers will compare the percentage of LOBO™ embolized PAVMs that develop recanalization at 6, 12, and 36- month intervals compared to percentage of conventionally embolized PAVMs that develop recanalization at the same intervals. Participants will undergo the embolization procedure and be followed for 36 months after the procedure. There will be a total of 4 study visits: * Treatment visit * 6-Month Follow-up visit * 12-Month Follow-up visit * 36-Month Follow-up visit At each clinical follow-up visit participants will undergo imaging with a computed tomography angiography (CTA) of the chest. Read Less

The goal of this randomized clinical trial is to assess the impact of a video educational tool on patient decisional conflict at the time when making a decision about prenatal genetic testing. The control group will receive standard prenatal care. The secondary aims include assessing the impact of the video educational tool versus standard care on pregnant participants': perception of likelihood of having a baby affected by a genetic problem, intended plan for genetic testing, patient-provider communication, retention of prenatal genetics knowledge, and perception of genetic data privacy. Participants will be asked to: 1. Watch video education (if randomized to this group) and complete a baseline survey at their dating ultrasound regarding knowledge of prenatal genetics, prior experiences, and demographics 2. Complete a follow up survey after seeing their prenatal care provider regarding: decisional conflict scale with respect to prenatal genetic testing decision (primary outcome), perception of likelihood of having a baby affected by a genetic problem (secondary outcome) and the type of genetic testing chosen (secondary outcome). 3. Complete a second follow up survey six to ten weeks from the second survey to assess: Provider patient communication, retention of genetics knowledge, patient recollection of testing performed, and self-reported out of pocket cost related to genetic testing. Read Less

The purpose of this study is to determine if rapid drug desensitization (RDD) to Palynziq will improve drug tolerability and treatment persistence in adult patients on commercial Palynziq experiencing hypersensitivity reactions (HSRs) leading to treatment interruption or reduction of dose or dosing frequency. See Section 10.8 for full list of HSR preferred terms. Study details include: * Study duration: Up to 30 weeks (up to 6 weeks for Screening, then RDD, and 24 weeks of follow-up) * RDD duration: 1 day * Palynziq dosing/follow-up duration: 24 weeks * Palynziq dosing frequency: Individualized Read Less

The study will recruit 50 adults with stimulant use disorder currently in treatment and abstinent for at least 2 weeks. The study will also recruit up to 10 healthy controls (adults without StUD) for initial study configuration. The study will consist of five steps that are expected to be completed over two lab visits. Step 1: The 3T MRI scan will provide accurate prefrontal cortex anatomy for using neuronavigation for TMS. In addition, the study will use an analysis of resting fMRI connectivity to determine the location in the left DLPFC that has the maximum connectivity with the incentive-salience network. Step 2: The study will use the data collected at the MRI to select the individual TMS location. EEG will be used to collect TEPs in response to single pulse TMS at the left DLPFC. Participants will then be randomized to one of three conditions: A) TMS unsynchronized with EEG, B) TMS synchronized with EEG theta frequency trough, and C) TMS synchronized with EEG theta frequency peak. The stimulation will be applied with an intensity of up to 120% of the resting motor threshold (which is a safe and common practice; Rossi et al., 2021). The intensity can be decreased for individual participants. Step 3: Following randomization, the study will administer a pre-iTBS assessment. Step 4: The study will compare brain and behavioral responses before and after the iTBS session with TMS and EEG synchronization as assigned by their randomized group. Step 5: The study will administer a post-iTBS assessment. Read Less

The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on stress levels, with secondary outcomes of cognition, energy, and sleep, as compared to a placebo. Read Less

Primary Objective: 1. To determine objective response rate (ORR) according to RECIST v1.1 of pembrolizumab and high-dose pemetrexed in the treatment of patients with chordoma until disease progression. The OOR will be investigator assessed. Secondary Objectives: 1. To describe the adverse events associated with administering pembrolizumab and high-dose pemetrexed combination treatment. 2. To determine disease control rate based on imaging and overall survival. 3. To determine median PFS and PFS rates at 6, 9, 12, and 18 months. 4. To evaluate changes in volumetric tumor measurements based on imaging. 5. To determine the effects of combination treatment on quality of life, assessed by the EORTC-QLQ-C30 questionnaire. 6. To assess tumor evolution over time in patients with chordoma based on imaging, and molecular profiling. 7. To assess the pharmacodynamic effects of treatment in blood. Exploratory Objective: 1. To explore the relationship between molecular phenotype and patient response. Read Less

Mouth breathing, snoring and poor sleep can contribute to and worsen periodontitis (gum disease). The purpose of this study is to test whether the myTAP oral appliance with a mouth shield (OA+) can lessen periodontal symptoms in those with these conditions over a 12 week period. In addition to testing sleep respiration and quality, it will also evaluate periodontal pathogens and systemic stress in subjects treated with OA+. This split-mouth clinical trial will include adults with mild to moderate periodontist who snore and mouth breath. All will receive comprehensive periodontal care in addition to OA+ therapy. Read Less

This is a randomized trial designed to evaluate testicular outcomes after a single stage versus a two-stage surgical procedure to fix an undescended, one-sided testicle located in the abdomen. Also to determine and compare the costs, surgical complications and the health related quality of life for the two procedures. Testicular outcomes will be measured using a scrotal ultrasound 6-12 months after the procedure (after the second stage procedure for those randomized to a 2 stage surgery). Read Less

Over one-quarter of American adults engage in hazardous drinking (i.e., a pattern of alcohol consumption that increases risk for harmful consequences), which is the third leading cause of preventable death in the U.S. Rates of hazardous drinking are significantly higher among individuals with (vs. without) chronic pain. Moreover, 20% of individuals prescribed opioids endorse concurrent alcohol and opioid use, which may interfere with chronic pain treatment and lead to dangerous/potentially fatal health effects. No interventions to date have targeted either hazardous drinking or concurrent use of alcohol and opioids in the context of chronic pain. The current four-year R01 builds upon our past work by developing a brief, single-session, computer-based, personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse pain-alcohol-opioid interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding concurrent use of alcohol and prescription opioid medications. Specifically, we will develop an integrated PFI for hazardous drinkers with chronic pain who are prescribed opioids (PA-PFI). Our approach will follow a staged model consistent with NIH guidelines for developing and standardizing behavioral interventions. Phase IA activities will involve collecting qualitative and quantitative feedback from three iterative focus groups (N = 21) to refine intervention content and evaluate treatment acceptability and feasibility. Phase IB activities will include a proof-of-concept and highly rigorous randomized clinical trial designed to compare PA-PFI to control PFI (C-PFI) among a sample of 174 hazardous drinkers with chronic pain who are currently prescribed opioid medications. This study represents an important and pivotal step in the larger landscape of translating basic research to more efficacious strategies for reducing hazardous drinking among underserved populations with medical comorbidities. This intervention would be highly disseminable and relevant to millions of hazardous drinkers with chronic pain. Given the collective public health impact of chronic pain, hazardous drinking, and concurrent alcohol-prescription opioid use, we believe the current study will yield findings that enhance scientific knowledge, enhance our understanding of mechanisms in reciprocal pain-alcohol-opioid relations, and inform the development of novel treatments for hazardous drinkers with chronic pain that are adaptable and easily implemented across a variety of healthcare settings. Read Less

This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer. Read Less