All Clinical Trials

The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids. Read Less

The main purpose of the study is to evaluate the safety and tolerability of HRO761 and identify the recommended dose(s), i.e., the optimal safe and active dose of HRO761 alone or in combination with pembrolizumab or irinotecan that can be given to patients who have cancers with specific molecular alterations called MSIhi (Microsatellite Instability-high) or dMMR (Mismatch Repair Deficient) that might work best to treat these specific cancer types and to understand how well HRO761 is able to treat those cancers. Read Less

This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum. Read Less

Patients between 4-21 years of age with at least one wart or molluscum lesion are eligible to participate in this study. The duration of the study is a minimum of 4 weeks with the maximum duration of monthly treatments for one year, depending on lesion clearance. The number of lesions will be chosen by the dermatologist. Patients who opt to participate will receive non-thermal, or cold, atmospheric plasma to treat all lesions selected. Safety profile as well as changes in size, pain and appearance will be measured. Photographs and dermatologist impressions will be used to measure treatment response. Read Less

This is a clinical trial using CPI-0209 in combination with Carboplatin chemotherapy followed by CPI-0209 maintenance in patients with platinum sensitive, recurrent ovarian cancer. Read Less

This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD. Read Less

A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System. Read Less

This study will assess how different types of training and support influence the way that school staff understand, and respond to, the mental and behavioral health needs of middle school students. Researchers will work with middle schools using a developed screening system (called the Early Identification System; EIS) and compare how staff and student outcomes change when schools receive two different types of training and support: 1) standard onboarding/training versus 2) participating in professional learning communities and coaching. Read Less

The goal of this study is to characterize the immune response, both innate and adaptive, as well as locally and systemic, to intradermal (ID) vaccination in healthy individuals. The intervention involves intradermal administration of an FDA-approved intramuscular seasonal influenza vaccine, using an FDA-approved device MicronJet. Investigators will measure antibody titers, cell subtypes, and multi-omic profiles, by collecting skin and peripheral blood at baseline and at several time points after vaccination. The primary objective is to identify baseline correlates of immune response in the skin and peripheral blood to the seasonal influenza vaccine. The investigators secondary goals are to describe the inflammatory response in the skin over time. Read Less

Primary Objective • Assess the safety and tolerability of low-dose lenalidomide administered by continuous subcutaneous (SC) infusion (STAR-LLD) in combination with dexamethasone and a proteasome inhibitor (PI). Secondary Objectives * • To establish the pharmacokinetic (PK) profile of STAR-LLD at a defined infusion rate targeting steady-state blood concentrations. * • Evaluate changes in efficacy indicators including objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR). Exploratory Objective * To assess the impact of STAR-LLD on patient reported symptoms and outcomes. Primary Endpoints * The grade, frequency, and relationship of treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESIs): (gastrointestinal \[GI\] toxicity, fatigue, hematologic toxicity, rash (non-infusion site). * The observation of dose-limiting toxicities (DLTs) of STAR-LLD during Cycle 1. Secondary Endpoints •• Blood concentrations of lenalidomide at on Day 1 and at steady state. * Changes in biomarkers during treatment. * Rate of complete response, very good partial response (VGPR), partial response (PR), stable disease (SD), and progressive disease. * Determination of ORR, PFS, and DOR Read Less

The goal of this clinical trial is to develop non-invasive brain stimulation targets for the treatment of apathy, or motivation problems, in Parkinson Disease. The main questions the study aims to answer are: 1. Does transcranial magnetic stimulation change effort task performance in Parkinson's Disease patients? 2. Is there a link between brain signals and apathy? Participants will * complete questionnaires and assessments * perform an effort task * have their brain activity recorded (EEG) * receive non-invasive brain stimulation (TMS) Researchers will compare two stimulation locations (experimental site and control site) to see if TMS of the experimental site has an effect on apathy. Participants will receive stimulation of both sites (during separate visits). Read Less

This study is a placebo-controlled randomized trial comparing the effects of hemp-derived cannabidiol (CBD) with and without Delta-9-tetrahydrocannabinol (THC), relative to placebo, on reducing cannabis use and cannabis use disorder (CUD) symptoms in adult treatment seeking cannabis concentrate users with CUD. Participants enroll in the study for 8 weeks (with telehealth follow-ups at 12 and 16 weeks) and are randomized to either full spectrum CBD, broad spectrum CBD, or placebo. Participants are also engaged in five weeks of psychotherapy treatment for CUD. Blood is collected to quantify investigational drug exposure and cannabis use. Participants also complete self-report measures of medical history, sleep quality, subjective cognitive function, physical activity, psychological functioning, substance use, and acute drug effects. Read Less