47 Clinical Trials for Various Conditions
To investigate the potential efficacy of dupilumab in the treatment of moderate to severe chronic hepatic pruritus.
To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with the hepatic impairment and matched healthy subjects.
The purpose of this study is to understand mechanisms associated with the development of coma during hepatic failure. As of today, those mechanisms are not understood and it is difficult to intervene and prevent coma development which is often associated with mortality. Understanding the mechanism involved, may allow us to prevent coma and develop new therapies to treat this disease.
The purpose of this study is to compare the effectiveness of three different treatments for hepatic encephalopathy.
The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients undergoing EUS-guided liver biopsy at Methodist Dallas Medical Center (MDMC).
The study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more than 24 hours due to acute deterioration of liver function.
The purpose of this study is to determine if patients with congestive heart failure, diabetes or secondary cardiovascular diseases, who access HealthMedia's online tailored behavior change programs on the electronic health record patient portal have better clinical and behavioral change outcomes.
This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.
Current treatment of chronic liver disease relies upon removing the primary insult to the liver (e.g., alcohol) or treating the underlying viral infection (HBV, HCV, etc.). However, in the case of hepatitis C, a significant number of individuals will not clear the virus with current approved standard antiviral therapy, leaving them no options to manage their hepatic fibrosis, which can progress to cirrhosis and ultimately hepatocellular carcinoma (HCC). Fuzheng Huayu has been used in numerous studies in China and has been found to have a satisfactory prophylaxis effect on the chronic liver injury and formed liver fibrosis in rats and humans. In addition, it enhances the degradation of liver fibrosis and protects hepatocytes from injury and death, manifesting as decreasing of ALT and AST, and enhancement of albumin level. In addition, preliminary studies indicate that the Fuzheng Huayu has a good safety and tolerability profile with promising efficacy. The number of patients failing Interferon based therapy (i.e. not achieving SVR) is increasing. There are no approved standard of care treatment options for this population nor for patients who are intolerant or unwilling to receive Interferon; thus they are at higher risk for the progression of fibrosis. Moreover, there are no approved therapies to treat hepatic fibrosis, but basic research is exploring the pathophysiological mechanisms. Fuzheng Huayu is easy to administer, with a good safety and efficacy profile against fibrosis. Therefore, the investigators propose to further study the safety and efficacy profile of Fuzheng Huayu in a randomized, placebo-controlled, double blind study in Chronic Hepatitis C patients with hepatic fibrosis who have failed prior anti-HCV therapy or are intolerant or refuse Interferon based therapy. The primary objective of this study is to establish the safety and efficacy of Fuzheng Huayu treatment in chronic hepatitis C subjects who have failed prior anti-HCV therapy or cannot receive or refused Interferon based therapy in improving liver fibrosis.
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.
This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.
A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and failures in the presence of liver cirrhosis (Acute-on-Chronic Liver Failure, ACLF) and accumulation of fluid in the abdominal cavity (ascites)
This is a cross sectional study that evaluates the relationship between LSM (liver stiffness measurement) by Liver Incytes in patients with cACLD (compensated advanced chronic liver disease) and manifestations of portal hypertension.
Randomized pilot trial of patients (n=30) undergoing Total Pancreatectomy and Islet AutoTransplant (TPIAT). Patients with islet harvest of greater than 5000 islet equivalents/kg body weight will be randomized to receive a portion of their islets into an omental pouch. For outcomes related to islet function, a group of normal volunteers (n=15) will be studied as a comparator group.
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.
The high prevalence of chronic illnesses is a serious public health problem in the U.S., and more than 70 million adults age ≥50 have at least one chronic illness. Management of chronic conditions requires long-term use of complex treatment plans and can cause unintended consequences, such as increased risk of medication errors. Patient portals (PPs), a federally supported health information technology (IT), can be especially helpful for patients with chronic illnesses. Patients can now access their own health records and directly communicate with care providers through PPs. Prior findings suggest a great potential for using PPs to improve care quality, and the federal government funds healthcare organizations to implement this tool nationwide. Despite the potential benefits, the overall PP adoption rate in the U.S. is low. A lack of PP use among older adults has been addressed as a particular concern. When only older adults who use the Internet are considered, however, their proportion of PP use is similar to other age groups. A few studies also reported that older adults are receptive to PPs. In general, older adults need additional support for learning to use PPs, as they tend to be less familiar with technology. Currently, most older adults receive little or no PP support from their providers. This is an important gap in the nation's health IT initiative because without appropriate support, older adults will not be able to use this robust health tool, missing an important opportunity to improve their health outcomes. In an effort to fill this gap, the investigators developed and tested an older adult friendly Theory-based Patient portal eLearning Program (T-PeP) to support older adults in using PPs for their care. In the proposed feasibility study, the investigators plan to (Aim 1) optimize and implement a vendor-agnostic T-PeP and conduct formative and process evaluations; and (Aim 2) assess the preliminary impact of T-PeP on PP use and selected outcomes (PP knowledge, self-efficacy for PP use and health decision making, health communication, and medication reconciliation). If successful, this study could directly affect quality of care provided to older adults and the success of the national health IT initiative. Findings from this study will also provide hospitals, vendors, and policymakers with in-depth information on older adults' current PP usage patterns and other challenges in using various types of PPs at the national level.
This is a double-blind, multicenter study involving patients with chronic HCV infection who had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response (SVR) following anti-HCV therapy; but still have fibrosis and/or incomplete cirrhosis on liver biopsy to see if treatment with IDN-6556 is better than placebo in reversing or stopping the progression of the damage to the new liver caused by HCV.
TriVox Health is an online system designed to make it easy for healthcare providers to monitor patients' disease symptoms and functioning over time and in between in-person visits (http://www.youtube.com/watch?v=VR1vcbx0Ef4). Using combined quality improvement and randomized clinical trial methods, we will evaluate the impact of TriVox on the health outcomes, patient/family experience of care, and healthcare utilization for children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD), asthma, autism, depression, and epilepsy.
The objectives of this study are: * To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic decompensation events * To evaluate the relationship between liver Biopsy and clinical outcome and show that the MBT has a better predictive ability of clinical outcome than liver biopsy. * To evaluate the ability of the MBT to predict each of the individual liver related complications.
The purpose of this study is to evaluate whether the use of polyethylene glycol is superior and more safe in treating hepatic encephalopathy compared to lactulose and also to determine if treatment with polyethylene glycol will reduce the duration of hospital stay.
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
The aim of this diagnostic study is to evaluate the efficacy of ARFI imaging (a specific type of ultrasound) in assessing the pressure of the portal vein (the major vein passing through the liver) and the amount of liver fibrosis in patients with chronic liver disease.
HepQuant tests are new liver tests that are being developed to accurately measure liver function with sensitivity and specificity while being safe and non-invasive. The primary goal of this study is to define the intra-individual reproducibility of the HepQuant tests, that is, to see if a person is given the tests several times that the test results are essentially the same each time. Subjects for this study will include healthy controls and patients with chronic liver diseases. The chronic liver diseases will include hepatitis C virus (HCV) infection and a serious form of fatty liver disease, known as non-alcoholic steatohepatitis (NASH). The HCV and NASH patients will include men and women, and those with early stage and late stage liver disease as defined by the amount of fibrosis observed in their liver biopsies. Once a subject has been enrolled in the study they will be given the HepQuant tests on three separate days within the span of one month. The hypothesis of this study is that HepQuant tests will reproducibly report liver function in healthy controls and patients with all stages of chronic HCV and NASH liver disease and that liver function will decrease as the amount of liver fibrosis increases in the chronic liver disease patients.
This study will be conducted in Hepatitis C positive patients to determine whether the pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction in future clinical studies.
This study is being done to find out if the laxative polyethylene glycol (also known as GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). In this study, the investigators will evaluate if polyethylene glycol (GoLYTELY®) is more effective than lactulose on neurocognition (memory and thinking skills) and determine if it decreases the hospital stay.
Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will determine if patients have MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a washout period with no treatment. At this time patients are re-tested and then begin another three month period switching to the opposite treatment of first 3 months.Final cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.
An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic hepatic impairment compared. Additionally, the healthy adult volunteers will participate in a randomized, open-label, crossover study in which they will receive Sporanox® to compare the safety and pharmacokinetics of HPβCD when administered in DIC075V compared to Sporanox®.
Evaluate on how well the ELAD system works in treating people with liver failure.