All Clinical Trials

The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain. Secondary objectives are to assess the ability of LITUS to improve patients return to work time. Read Less

Sexual minority stressors (e.g., sexual minority identity-based discrimination) contribute to greater risk for and severity of depression, anxiety, substance use disorders and suicide among sexual minority Veterans. However, no brief, scalable, one-on-one interventions targeting sexual minority stressor-related distress are available in Veterans Affairs (VA) for sexual minority Veterans. The proposed research will examine the feasibility, acceptability, and preliminary effectiveness of a brief, 3-session expressive writing intervention to target distress related to sexual minority stressor exposure among sexual minority Veterans. The results of this work will advance knowledge about a promising brief and easy to implement intervention focused on reducing depressive and anxiety symptoms among sexual minority Veterans. This proposal aligns with VA's and CSR\&D's commitment to providing equitable services to sexual minority Veterans and the aim of reducing health disparities among underserved Veteran groups. Read Less

The intent of this study is to establish technical feasibility in a clinical population (PTSD, with or without mild TBI) of personalized TMS-fNIRS technology. Thereby demonstrating the utility of transcranial magnetic stimulation - functional near-infrared spectroscopy (TMS-fNIRS) technology as a direct measure of frontal brain activity, potentially replacing the indirect motor threshold procedure that may lead to improper dosing of TMS. Personalized TMS-fNIRS technology will guide therapy for depression, post-traumatic stress disorder (PTSD), and/or traumatic brain injury (TBI) Read Less

Sometimes, it is necessary to re-learn a previously learned movement behavior, for example, a bad posture during the golf drive or while playing the piano. Unlearning or relearning an intensively trained behavior is particularly important if the behavior is hampering recovery, for example, in chronic pain or after a stroke. With this pilot study, the brain mechanisms that control the change of pre-existing stable memories of a motor skill will be tested with electroencephalography (EEG). Non-invasive brain stimulation will be used to modulate these brain mechanisms and test if it is possible to change the pre-existing motor memory and the learning of a new motor skill. Read Less

This protocol will enroll patients with pancreatic adenocarcinoma and adenosquamous carcinoma (Cohort 1), gastrointestinal/pancreatic neuroendocrine neoplasms with Ki-67 \> 20% (Cohort 2) and neuroendocrine prostate carcinoma (Cohort 3)). Each cohort will have its own interim analysis after enrollment of 10 patients. Subjects will be given a one-month (28 day) supply of study drug (ESK981). Subjects will be instructed to take 4 capsules, with or without food, once per day for 5 consecutive calendar days, then take a drug holiday for 2 consecutive days before repeating the 5 days on-2 days off cycle in sets of 4 weeks or 28 calendar days. Subjects will be asked to keep a pill diary noting the date they take their study drug. Read Less

A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction. Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years. About 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval. Read Less

This study will deploy a scalable secondary prevention program that leverages existing foster youth transition services to improve mental health functioning and service use before and after exiting foster care. Our short-term objective is to remotely test a group intervention called Stronger Youth Networks and Coping (SYNC) that targets cognitive schemas influencing stress responses, including mental health help-seeking and service engagement, among foster youth with behavioral health risk. SYNC aims to increase youth capacity to appraise stress and regulate emotional responses, to flexibly select adaptive coping strategies, and to promote informal and formal help-seeking as an effective coping strategy. The proposed aims will establish whether the 10-module program engages the targeted proximal mechanisms with a signal of efficacy on clinically-relevant outcomes, and whether a fully-powered randomized control trial (RCT) of SYNC is feasible in the intended service context. Our first aim is to refine our SYNC curriculum and training materials, prior to testing SYNC in a remote single-arm trial with two cohorts of 8-10 Oregon foster youth aged 16-20 (N=26). Our second aim is to conduct a remote two-arm individually-randomized group treatment trial with Oregon foster youth aged 16-20 with indicated behavioral health risk (N=80) to examine: (a) intervention group change on proximal mechanisms of coping self-efficacy and help-seeking attitudes, compared to services-as-usual at post-intervention and 6-month follow-up: and (b) association between the mechanisms and targeted outcomes, including emotional regulation, coping behaviors, mental health service use, and symptoms of depression, anxiety, and PTSD. Our third aim is to refine and standardize the intervention and research protocol for an effectiveness trial, including confirming transferability with national stakeholders. Read Less

The aims of this project are: Aim 1: Determine the extent to which an environmental health literacy educational intervention designed for doulas improves their environmental health literacy of endocrine disrupting chemicals (EDCs) in personal care products. Hypothesis 1a. Doulas who participate in an environmental health literacy course will have a higher environmental health literacy score based on quantitative questionnaire evaluation post-course compared to pre-course. Hypothesis 1b. Doulas who participate in the environmental health literacy course will have a higher environmental health literacy scores post-course compared to doulas who do not take the environmental health literacy course. Aim 2: Determine the extent to which pregnant people counseled by doulas with training in environmental health literacy have higher environmental health literacy scores and lower usage of personal care products containing EDCs following doula counseling. Hypothesis 2a. Compared to pregnant people not counseled by doulas on EDCs in personal care products, pregnant individuals counseled by doulas on these EDCs will have improved scores in environmental health literacy. Hypothesis 2b. Compared to pregnant people not counseled by doulas on EDCs in personal care products, pregnant individuals receiving counseling will use fewer personal care products associated with containing EDCs based on a validated questionnaire. Aim 3: Determine whether concentrations of EDC biomarkers decreased after the intervention for the intervention group. Hypothesis 3: Urinary phthalate metabolite concentrations will be lower post-course compared to pre-course for the intervention group. Read Less

The goal of this NIH-sponsored study is to characterize three biomarkers derived from 129Xe gas exchange MRI and to understand how they change in response to interventions. Read Less

The purpose of this study is to determine whether a 16-week supervised, clinic-based circuit training intervention utilizing resistance and functional exercises and self-directed aerobic exercise will improve frailty and sarcopenic status and disease progression outcomes among pre-frail/frail metastatic prostate cancer patients receiving androgen deprivation therapy (ADT). The names of the study intervention involved in this study is: • Supervised circuit training (aerobic and resistance exercise regimen) Read Less

This study evaluates barriers to receiving care and risks associated with developing cancer among patients diagnosed with hepatobiliary cancer. Read Less

The aims of this study are to (1) identify the advance care planning deliberation process among 20 dyads of patients with advanced cancer and family caregivers and (2) conduct usability testing among 9 dyads to refine the content and design of the web-based resilience-building intervention. Read Less