Treatment Trials

20 Clinical Trials for Various Conditions

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COMPLETED
A Study to Evaluate Liver Stiffness With Shear Wave Elastography
Description

The purpose of the study is to assess the diagnostic accuracy of Endoscopic Ultrasound (EUS) shear wave elastography in liver fibrosis staging in both normal subjects and subjects with advanced liver fibrosis/cirrhosis

COMPLETED
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
Description

The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).

UNKNOWN
Endosonographic Shear Wave Elastography for Liver Stiffness
Description

This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy and safety of endosonographic real-time Elastography and shear wave Elastography with the current standards of care, i.e. liver biopsy and Vibration-controlled transient elastography (Fibroscan). Subjects who are referred for an endoscopic ultrasound (EUS) guided liver biopsy will be prospectively enrolled to undergo liver biopsy, Elastography and/or Vibration-controlled transient elastography.

Conditions
COMPLETED
Ultrasound Elastography Assessment of Spleen and Liver Stiffness Before and After Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure
Description

The primary purpose of this project is to determine if acute monitoring of shunt patency via ultrasound elastography measurements of splenic stiffness before and after TIPS placement results in reduced morbidity and mortality from shunt failure.

COMPLETED
Increased Liver Stiffness: A Study of Acoustic Radiation Force Impulse (ARFI) Elastography
Description

The goal of this study is to determine if ultrasound tools can be used to detect liver stiffness. Acoustic radiation force impulse (ARFI) elastography and backscatter will be used to see if they can detect liver stiffness in different populations of patients with liver disease. The study is measuring liver stiffness in pediatric patients aged 2-5 years. Patients either have had a Fontan cardiac surgery or have liver disease. Ultrasound scanning takes images of the liver and has much lower risks for patients. ARFI elastography and other tools can be used to measure liver stiffness.

Conditions
TERMINATED
Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness
Description

Pilot study examining changes in liver stiffness measured by ultrasound before and after TIPS creation

COMPLETED
Correlation of Ultrasound Based Measurements of Liver Stiffness and Steatosis With MRI
Description

The investigators will assess the ability of ultrasound (US) to measure liver stiffness (cirrhosis) and liver fat content (steatosis).

COMPLETED
Normal Liver Stiffness by MR Elastography
Description

Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR elastography to determine normal liver stiffness values.

Conditions
RECRUITING
Home Exercise And Resiliency Training (Heart) Club
Description

The purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in individuals with Fontan heart physiology, demonstrate that a telemedicine exercise program reduces socioeconomic and geographic barriers to access to exercise training, and to explore the impact of a structured exercise program on markers of Fontan-associated liver disease.

ACTIVE_NOT_RECRUITING
LITMUS Imaging Study
Description

The LITMUS Imaging Study is a prospectively recruited, observational study of patients with histologically characterised non-alcoholic fatty liver disease (NAFLD). It aims to evaluate the diagnostic performance of imaging biomarkers (ultrasound elastography and magnetic resonance biomarkers) against NAFLD histological scores in a cross-sectional analysis and the natural history of NAFLD in a longitudinal study.

UNKNOWN
Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
Description

This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (NASH). as well as the safety and tolerability of AXA1125. Subjects will take one of two different doses of AXA1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.

UNKNOWN
Non-invasive Methods and Surgical Risk Stratification in Cirrhotics Undergoing Elective Extrahepatic Surgery
Description

The ELASTO-SURGERY study aims to evaluate the prognostic role of portal hypertension evaluated by non-invasive methods in predicting post-operative morbidity (at 90 days) and mortality (at 365 days) in patients with advanced chronic liver disease undergoing elective extrahepatic surgery.

COMPLETED
Utilizing Non-Invasive Fibroscan® Technology to Identify Genetic Markers for Fatty Liver Progression
Description

Non-alcoholic fatty liver disease (NAFLD) is a common disorder, affecting \~30% of people in the general population and up to 96% of obese individuals. Variations in several genes have been found to be associated with fatty liver, but these associations only explain a small percentage of the risk, and further studies are needed. In many cases NAFLD does not cause serious side effects, but in some individuals it progresses to scarring or hardening of the liver, liver failure, and cancer. The purpose of this research study is to determine if individuals who carry certain genetic variations in a gene related to bile and choline metabolism have an increased risk of fatty liver progressing to fibrosis, or scarring of the liver. This study will also use a new, non-invasive method called the FibroScan® to measure liver fat and liver stiffness. The FibroScan® device is FDA approved for use to measure liver stiffness, but not for the liver fat measurement. However, the FibroScan® instrument is considered a non-significant risk device. Since its induction in Europe and worldwide in 2003, there have been no adverse effects reported with this device.

COMPLETED
Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis
Description

This is a study that will evaluate the utility of measuring liver and spleen stiffness before and after a meal by a non invasive ultrasound based technologies called Fibroscan (Transient elastography) and acoustic radio-frequency impulse (ARFI) in diagnosing or excluding cirrhosis in patients with chronic liver disease who will be getting a liver biopsy.

COMPLETED
Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Assessment of Spleen Stiffness Using VCTE by FibroScan.
Description

Hypothesis: The severity of portal hypertension in compensated advanced chronic liver disease (cACLD) can be assessed using vibration controlled transient elastography (VCTE) via the FibroScan® 502 Touch by measuring SS (splenic stiffness) Specific Aims: SS by VCTE will be measured in this single center clinical study comprising of 200 patients with cACLD (defined by LSM ≥10 kilopascals (kPa) according to the Baveno VI recommendations) who have not had a liver transplant and 100 subjects who are post-liver transplant. The association between baseline SS values will be examined in relation to the manifestations of portal hypertension such as esophageal or gastric varices. Specific Aim: To examine the relationship between SS and the presence of esophageal and gastric varices in patients with compensated advanced chronic liver disease (cACLD). Proposed Study Design: This is a cross sectional study that evaluates the relationship between SS by VCTE in patients with cACLD and manifestations of portal hypertension.

ENROLLING_BY_INVITATION
Optimal Measurement of Spleen Stiffness Among Veterans With Metabolic Dysfunction-Associated Steatotic Liver Disease
Description

A growing number of people are being diagnosed with fatty liver disease, also known as metabolic-dysfunction associated liver disease (MASLD). Fatty liver disease can unknowingly progress to serious liver disease and even permanent scarring (cirrhosis).The purpose of this research is to learn the best way to detect serious liver disease as early as possible in patients with fatty liver disease by measuring the stiffness of the spleen. Secondarily, the study hopes to understand how the stiffness of the spleen relates to the severity of liver disease.

COMPLETED
The Effect of Fontan Fenestration Closure on Hepatic Stiffness
Description

The overarching goal of this project is to discern how closure of Fontan fenestrations in patients with single ventricle heart disease will affect hepatic congestion, a major determinant of chronic liver disease. We will employ transient elastography (Fibroscan) to obtain liver stiffness measurements (LSM) before and after fenestration closure to study the impact of this intervention on hepatic congestion.

COMPLETED
Nonalcoholic Fatty Liver Disease and Atherosclerotic Risk in Children
Description

Nonalcoholic fatty liver disease is a serious health condition in overweight children which can lead to heart disease. This project will examine the links between liver health and cardiovascular risk factors in overweight and obese children, and will test the effect of a long-term after-school exercise program. Provision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic.

RECRUITING
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Description

Magnetic resonance elastography is a novel non-invasive MRI technique to obtain stiffness of soft tissues such as liver, heart, kidneys, etc. In this imaging technique a person is laid in an MR scanner and a paddle (plastic drum) is put on the area of interest to send sound vibration via a speaker placed outside the scan room which is connecting plastic drum via a plastic tube. These vibrations are scanned using MRI to estimate the stiffness of soft tissues such as liver, heart, kidneys, breast etc.

COMPLETED
Beyond Confounders: Addressing Source of Measurement Variability and Error in Shear Wave Elastography
Description

Chronic liver disease is a major problem in the general population and there is an unmet need to diagnose(and screen) for liver disease with using noninvasive, cost-effective and sensitive techniques.The investigators hypothesize that variation using ultrasound elastography for the estimation of stage of liver fibrosis and steatosis in patients with diffuse liver disease exists due to different methods of measurements, and/or different systems. The proposed investigation is a cross-sectional study using ultrasound elastography and fat quantification modalities. The investigators are planning to enroll 30 subjects 18 years old and older in whom diffuse liver disease is suspected, and who have undergone non-focal liver biopsy in the past 6 months or are scheduled to undergo biopsy within 3 months of enrollment, as part of their routine clinical care. The investigators will use 4 different ultrasound devices with their shear wave elastography and speed of sound functions. Specific aims; * Compare shear wave elastography(SWE) measurements from different ultrasound systems; using histopathology as reference standards. * Assess intra-operator and inter-operator reliability by measuring variability in elastography values by two operators on a single system. * Determine the effect of deviations from guidelines(less number of measurements and measurements during active breath)