All Clinical Trials

This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result. Read Less

Alcohol use disorder (AUD) is a multifaceted, chronic relapsing disorder suffered by millions of men and women in the United States. AUD is associated with disrupted sleep continuity and architecture, which impact health-related quality of life, and contribute to relapse. However, many alcohol-sleep interactions and their underlying mechanisms remain unclear, especially those involving AUD and chronic sleep problems. Rapid eye movement (REM) sleep is altered long into abstinence, with excess duration and intensity of REM sleep, which is a predictor of relapse. Emotion deficits, including affective flattening and mesocorticolimbic hypo-responsiveness to emotional stimuli, are also consistent findings in AUD and predictors of relapse. Here, our investigators bring these two components together, building on an emerging literature showing that REM sleep is important for neural emotion regulation, calibrating emotions to promote next-day adaptive emotional functioning. Our investigators propose that the REM sleep-emotion pathway is dysfunctional in AUD, contributing to the deficits in emotion regulation in AUD shown by us and others, which could then lead to increased craving and relapse. Our investigators study male and female AUD patients compared to age- and gender-matched healthy controls, using 2 within-subject sleep conditions: uninterrupted sleep; selective REM sleep reduction, followed by functional neuroimaging with emotion reactivity and regulation tasks the following morning. Our investigators aim to determine specific effects of experimental REM sleep reduction on next-day neural emotional reactivity in AUD compared to healthy controls and compared to a night of uninterrupted sleep Read Less

There are data showing that a majority of pregnant women may not be accurately identified as high risk through screening and therefore, not receiving prophylactic low dose aspirin as recommended. This leads to missing many patients who would benefit from aspirin administration. Aspirin is an effective, affordable and safe intervention and its universal use in pregnancy has been proposed as the answer to help mitigate risk of significant morbidity from preeclampsia. However, adherence to aspirin in women at low risk compared to those deemed at high risk of preeclampsia has never been studied. One of the arguments against universal aspirin administration is the concern that universal receipt would change the compliance in those at high risk although there are no data to support this concern. To address the lack of data on differences in adherence, our goal in this proposal is to assess whether there is a difference in adherence to low dose aspirin (81 mg) in women at high risk of preeclampsia as indicated by USPSTF risk algorithm when compared to those women randomized to universal use. Read Less

This is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status. Read Less

This is a research study examining if hands-on therapy and prescribed exercise is an effective way to manage and reduce knee pain. It will also look at physical benefits of this treatment including balance, strength, and flexibility. Participation will include 2 assessment days and a 12-week treatment cycle. Assessments will be conducted during week 1 and after treatment. The treatment will vary based on the assigned group. This may include 12 in-person manual therapy sessions occurring once per week and or 12-weeks of at-home therapy occurring 5 times per week. The greatest risk of participation includes possible muscle/joint soreness, injury during at-home exercises, and loss of confidentiality. Read Less

The Building Resilience and Vital Equity (BRAVE) project seeks to partner with American Indian tribal communities in North Carolina to establish COVID-19 services and resources for American Indian communities. The goal of this study is to 1) understand the barriers and social implications of COVID19 testing and vaccination among American Indians by designing and implementing culturally sensitive survey tools and intervention materials; 2) Implement BRAVE outreach and testing interventions to increase testing in American Indian communities; 3) analyze data and share back with tribal communities to improve perceptions of COVID-19 testing in the AI community and decrease in vaccine hesitancy. Read Less

This retrospective, observational study will compare the results of a BioCartis' EGFR mutation test on the Idylla platform with test results from SoC pathology results from tissue biopsies in the same setting. A comparable rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies. Up to 150 samples will be tested and compared with existing results. Read Less

The main goal of this research is to determine the role of several brain regions in memory processes and cognitive functions. Participants will be remotely supervised via video chat while self-administering tDCS, a form of non-invasive brain stimulation. Before participating in the experiment, participants will be properly trained on use of the remote tDCS device and screened for eligibility. While using the tDCS device, participants will be engaging in tasks that assess different aspects of memory and executive functioning. By using remotely supervised tDCS while participants are completing these cognitive tasks, we will be able to make causal claims about the role of the targeted brain regions in different cognitive processes. Read Less

This is a Phase I multicenter, double-blind, single dose, dose-ranging study, in healthy men to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of Dimethandrolone Undecanoate (DMAU) administered as an intramuscular or subcutaneous injection. Read Less

This interventional clinical study will examine the safety and efficacy of a degenerate subdominant HER2 specific helper T cell epitope vaccine (H2NVAC) in patients with HER2-expressing ductal carcinoma in situ (DCIS). The ultimate goal of this vaccine is to prevent future invasive breast cancer among patients who are diagnosed with DCIS. However, the focus of this study is safety and efficacy. Read Less

Background: In the last several years, commercial pharmacogenetic (PGx) testing for the selection of psychotropic medications has become widespread as a means of implementing "precision medicine", with some insurers electing to cover the cost of testing. Mostly these efforts have focused on the decision of choosing a medication. Polypharmacy has become widespread and often the norm in patients with more severe of chronic illness. Objectives: This project is designed to evaluate the utility of PGx testing in reducing polypharmacy among Veterans with mental illness. Methods: The project is a randomized clinical trial in which 500 Veterans will be randomly assigned to have the results of the PGx battery available to clinical staff right after randomization (i.e., the intervention group) or after 3 months of treatment as usual (i.e., the delayed results group). The study will test the following primary hypotheses: Veterans with psychiatric illness and currently receiving an antidepressant and at least one additional psychotropic medication whose care is guided by the results of the PGx battery (the intervention group) will have a higher rate of reduction in polypharmacy than those in the delayed results group. Veterans whose care is guided by the results of the PGx battery (the intervention group) will have a higher rate of improvement in depressive symptoms (PHQ-9 score) than the delayed results group. Read Less

Previous research has shown that most parents would allow their child's leftover blood to be included in a de-identified biorepository using opt-out consent in an outpatient setting. In a pilot study to evaluate Pediatric Intensive Care Unit (PICU) parents' preferences and comprehension of a written opt-in consent to include their child's sample in a biorepository, the investigators showed 19% of parents did not agree to participate in the Biobank, more than the 8.7% reported in other settings. Parent comprehension varied. and the investigators also noted differential enrollment by sociodemographic factors. Critically ill children and their parents are vulnerable; seeking consent for non-therapeutic research in critical care requires special consideration. Therefore, the goal of this study is to evaluate whether the addition of a stakeholder influenced (parent, clinical research professionals) video aided consent will improve comprehension and rates of enrollment across diverse groups in this high intensity setting. Read Less