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Discover 15,316 clinical trials near Massachusetts. Find research studies in your area.
Showing 10701-10720 of 15,316 trials
NCT03201159
The study drug (VLX103) is being developed for the treatment of Alcoholic Steatohepatitis and other liver diseases. Alcoholic Steatohepatitis is an inflammatory (associated with irritation, swelling and cell damage) disease that affects the liver. It is associated with heavy and chronic intake of alcohol and presence of fat in the liver. Signs and symptoms often include fever, yellowing of the skin, nausea and impairment of liver function. The main objective of this study is to evaluate the safety, pharmacodynamics (what the drug does to the body) and pharmacokinetics (how the drug is handled by the human body, like absorption and elimination) of increasing doses of VLX103 in subjects with moderate Alcoholic Steatohepatitis. In other words, we will evaluate how your body tolerates VLX103 at a specific dose and the effects that this VLX103 dose has on your liver and your body in general. The secondary objectives of this study are to evaluate if VLX103 has the potential to treat Alcoholic Steatohepatitis patients, to determine the maximum dose that can be tolerated, and to measure the levels of VLX103 in your blood at different time points during the study. VLX103 is an experimental drug. Experimental means that the drug has not been approved by the Food and Drug Administration (FDA) for the treatment of Alcoholic Steatohepatitis. The active ingredient in VLX103, pentamidine, is approved for treating parasitic (microorganisms) infections. Pentamidine is currently approved and marketed in about 20 countries, including the United States, for use by injection (administered by a syringe) and by inhalation (administered by a nebulizer) for other health conditions. However, VLX103 is the first oral form of pentamidine being developed, and is administered by mouth as an oral tablet.
NCT00623493
Objective: The ultimate goal of this project is to enhance the capacity of non-mental health clinicians working in an Emergency Departments (ED) to recognize and initiate further evaluation of children and adolescents at risk for suicide. Aim 1: To re-validate the Risk of Suicide Questionnaire (RSQ), a screening tool that assists non-psychiatric clinicians in rapidly detecting suicide risk in pediatric patients, in a pediatric ED mental health population in the Children s National Medical Center (CNMC) ED. Aim 2: To determine the utility of a suicide screening tool, a revised version of the Risk of Suicide Questionnaire, to detect suicide risk in pediatric patients presenting to the CNMC ED for non-mental health reasons. Study population: The study population includes all patients admitted to the CNMC Emergency Department, ages 10 to 21, during the data collection weeks of the study period. Both patients admitted for mental health and non-mental health reasons will be included in the study. Design: This will be a prospective instrument development /validation study. During a designated study week, all mental health patients and a random subset of non-mental health patients admitted to the CNMC ED will be approached after their triage assessment. Following informed consent and assent, a 17-item suicide assessment tool created for this research project (RSQ-Revised), as well as a brief background questionnaire will be administered. These questions will be validated against a gold standard suicide assessment questionnaire, which will be administered to the subjects directly after the RSQ-Revised. The study aims to develop a brief suicide screening tool to be used at triage for all patients entering the ED. Measures Measures include the proposed 17-item screening questionnaire and a gold standard assessment of suicidal ideation in adolescents, the Suicide Ideation Questionnaire (SIQ).