All Clinical Trials

To evaluate, in patients with suspected NASH referred for liver biopsy, the diagnostic performance of CT1 at discriminating those with NAS≥4 \& F≥2 from those without. Read Less

This is a Double-blinded randomized placebo-controlled trial based at Eastern Virginia Medical School. Subjects who are identified in clinic having menorrhagia or abnormal Uterine bleeding (AUB) due to uterine fibroids and meet inclusion criteria based on the ultrasound (US) or Magnetic Resonance Imaging (MRI), aged 18-45 undergoing laparoscopic or Robotic assisted myomectomies. A total of 50 women in each arm of the study with symptomatic fibroids. Patients will be randomized to receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline (intervention group) versus an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision. Read Less

The Investigators propose to test the hypothesis that GCSF enhances the clinical outcome of biliary atresia in a multi-institutional Phase 2 trial to prospectively evaluate the safety and efficacy of GCSF in each of the 2 groups of newly diagnosed BA patients: KBA (i.e., Kasai-operated) or NoK (i.e., patients who did not undergo Kasai surgery). Subjects who participate in the trial will be followed for 2 years. Read Less

The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with 510K FDA cleared, commercially available self-assembling peptide, AC5®Advanced Wound System, as compared to an advanced standard of care. Patient outcomes will be compared at the end of the study. Read Less

During the initial encounter, the nurses will complete program enrollment forms (consents and disclosures as approved by IRB), medical history, and risk assessment. If needed, the RN will facilitate a 4th generation rapid HIV test or draw HIV serology. A general review of systems, focused physical exam with emphasis on sexually transmitted infections and signs of seroconversion is provided, including identifying signs of genitourinary infection. The nurse will order labs per standing order and performs blood draw. Pre-test and Post-test counseling with HIV and STI testing is provided at this time. Upon receipt of a negative HIV rapid or serology test, PrEP-RN provides a 7-14 day supply of samples with a 30-day prescription of FTC/TDF (Truvada) or a 30-day prescription of FTC/TAF (Descovy) per standing order. At each follow-up visit, client's self-efficacy, attitudes/beliefs about PrEP, general health indicators, and social determinants of health, such as access to transportation and housing status, are recorded. Process evaluation will be performed to determine relationships of these variables and PrEP adherence, implementation (12 months), and continuation/dissemination (year 2) phases of the study. Read Less

Adolescent atraumatic anterior knee pain is a common yet cumbersome diagnosis that is currently managed with home exercises and physical therapy. The goal of this project is to present patients with an alternative treatment in the form of yoga available in an online video format. This new treatment, in the form of online yoga videos, may be more preferred for some patients and allow for higher compliance with home exercises aimed at treating anterior knee pain. Read Less

The purpose of this study to develop a well-characterized library of blood, biopsy tissue, and urine samples from transplant patients. Subjects without transplants will also be enrolled for comparison. Samples will be used to study the characteristics of patients undergoing transplantation that influence their response to transplant therapies and their reactions to drugs used in transplantation. This knowledge is important as it helps physicians design new drugs and tailor transplant therapies to the individual thereby reducing the side effects. In this study, people will be asked to donate blood, biopsy tissue and urine. Donation of these samples will not influence patients' treatments. These samples will be tested using a variety of biological tests to better understand how immunosuppressive drugs change the various components of the immune system. The tests will be for research only; no changes in an individual's treatment will be based on the results of tests performed in this study. If there is extra sample, the sample will be stored for use in other testing at a later date. The ultimate goal is find the right combination of medications for each individual patient while keeping their new organ working well. This study is a first step in that direction by perfecting tests used to characterize a patient's immune system Read Less

Purpose: The primary purpose of the proposed project is to investigate the efficacy of Tier 1 and Tier 2 interventions delivered through a Response to Intervention (RTI) framework for children with attention-deficit/hyperactivity disorder (ADHD). Further, for children who do not respond to initial Tier 2 strategies, the proposed study will assess which additional course of intervention is most effective: (1) enhanced Tier 2 strategies or (2) stimulant medication. The majority of youth with ADHD are in general education settings, whether classified as special education students or not. Thus, experimentally evaluating the efficacy of well-developed and evidence-based behavioral interventions within a problem-solving framework such as RTI would significantly inform practice within school-based behavioral intervention teams. Project Activities: This study will employ a sequential multiple assignment randomized trial design (SMART). Prior to the beginning of the academic year, students will be randomly assigned to one of two conditions: (1) Business as Usual in which children receive whatever sequence of academic supports and interventions their teachers, school, and parents would typically put into place throughout the entire academic year and (2) an RTI approach to begin with Tier 1 classroom-wide management strategies with opportunities to add Tier 2 strategies for youth who do not respond to the initial Tier 1 approach. Read Less

The Cedars-Sinai SHI Takotsubo Registry and Proteomic Study is an observational registry that will collect retrospective and prospective demographic, clinical, hemodynamic, laboratory and other diagnostic parameters, therapy and outcome data from individuals who meet the inclusion/exclusion criteria of Takotsubo Registry protocol. Subjects will also be invited to provide a blood sample utilizing a Mitra kit sent to their homes. Researchers from the Barbra Streisand Women's Heart Center will analyze Registry data to identify Takotsubo phenotypes, improve diagnostic capabilities, better predict recurrence rates, and develop targeted Takotsubo treatments. Read Less

The purpose of this study is to test the feasibility and efficacy of intervening with 2-year-old children with elevated temperamental Fear and/or Shyness or 3-year-old children with elevated anxiety and their parents, using a parent-child Cognitive Behavioral Therapy (CBT) protocol to reduce anxiety disorders and maintain reduced anxiety at one-year follow-up. Before the COVID-19 pandemic, study visits and treatment sessions were conducted in office. Now all visits and treatment sessions are conducted remotely. Read Less

This clinical study is conducted to develop a new test to identify prostate cancer patients at highest risk of radiotherapy-related complications, especially related to gastrolintestinal (GI) toxicities. This clinical study would allow monitoring of total tissue damage in blood samples as early as after the 2nd but before the 4th radiotherapy dose during week 1 of radiotherapy, which could help clinicians make treatment decisions. Detection of excessive tissue damage at this early time, well before symptoms occur, could allow doctors to tailor interventions which could include patient therapies that would reduce or prevent the problems that occur due to radiotherapy of their cancer. Read Less

This study is to evaluate the safety and tolerability of JAB-21822 monotherapy and combination therapy in adult participants with advanced solid tumors harboring KRAS G12C mutation. Read Less