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Liver Diseases clinical trials

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NCT ID: NCT03734510 Recruiting - Clinical trials for Non Alcoholic Steatohepatitis

The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Non-alcoholic Fatty Liver Disease: A Randomized, Controlled Study

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

To study the effects of Hesperidin, flaxseed and both together on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 100 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.

NCT ID: NCT03726333 Not yet recruiting - Advanced Cancers Clinical Trials

Hepatic Impairment Study for Lorlatinib in Cancer Patients

Start date: January 11, 2019
Phase: Phase 1
Study type: Interventional

This is a phase 1 study in advanced cancer patients with varied hepatic fucntions to evaluate the potential effect of hepatic impairment on pharmacokinetics and safety of lorlatinib and provide dose recommendation for patients with hepatic impairment if possible.

NCT ID: NCT03723317 Completed - Liver Cirrhosis Clinical Trials

Associated Balance of Risk Score - Comprehensive Complication Index for the Prediction of Post-transplant Survival

Start date: January 15, 2018
Phase:
Study type: Observational

In recent years, several scoring systems have been developed aimed at predicting early post-LT graft function. However, many of them showed poor efficacy when long-term survivals were tested. Moreover, the necessity to find an easy-to-use score represents another obstacle, with several scores composed by numerous, difficult to find, variables. Recently, the pre-LT Balance of Risk (BAR) and the post-LT Comprehensive Complication Index (CCI) have been created, but their external validation and integration in this setting is lacking. This study aims at constructing an easy-to-use score system based on the combination of a small number of pre- and immediately post-liver transplant (LT) independent variables, in order to accurately predict long-term graft survival after LT.

NCT ID: NCT03721367 Recruiting - Urea Cycle Disorder Clinical Trials

Chronic Liver Disease in Urea Cycle Disorders

Start date: November 29, 2017
Phase:
Study type: Observational

This is a pilot, cross-sectional study to assess liver stiffness and markers of hepatic injury, function, and fibrosis in patients with urea cycle disorders. This study will be conducted at 3 UCDC sites: Baylor College of Medicine in Houston, Texas, University of California San Francisco (UCSF), San Francisco, California and Seattle Children's Hospital, Seattle,Washington

NCT ID: NCT03717792 Recruiting - Clinical trials for Vascular Disorder of Liver

Vascular Liver Disease Evaluation, Follow Up and Non-Invasive Diagnostics Program

VALID
Start date: January 1, 2010
Phase:
Study type: Observational

Background Vascular liver disorders (VALDI) are rare diseases, for which knowledge on risk factors, appropriate methods of diagnosis, effect of therapy and prognosis still need to be improved. Aim of the study This project aims to study risk factors, methods of detection, therapy and prognosis in order to elaborate and disseminate updated recommendations for the optimal management of patients with VALDI. Design of the study Data on patients will be collected from baseline (the date of diagnosis) up to 3 years. During this period, data on clinical condition, laboratory results, diagnostic tests, interventions and outcome will be collected anonymously using standardised review of medical charts by one special trained investigator. Only patients with VALDI are eligible to participate.

NCT ID: NCT03713242 Not yet recruiting - Hepatic Impairment Clinical Trials

A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment

Start date: November 12, 2018
Phase: Phase 1
Study type: Interventional

This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild, moderate, and severe hepatic impairment due to liver cirrhosis on the pharmacokinetics of ACT-541468.

NCT ID: NCT03706898 Recruiting - Hepatic Impairment Clinical Trials

Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs

Start date: October 1, 2018
Phase: Phase 1
Study type: Interventional

This is open label, phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child - Pugh Class А and B), as well as to assess the impact of food intake and drug-drug interactions in case of Co-administration with other antiviral drugs in healthy subjects.

NCT ID: NCT03704792 Not yet recruiting - Clinical trials for Chronic Liver Disease

Validation of the Second Generation of the Controlled Attenuation Parameter (CAP) Using the MRI-PDFF as Reference

Start date: October 2018
Phase: N/A
Study type: Interventional

Chronic liver diseases (CLDs) represent a major worldwide public health burden. Current, but probably undervalued, worldwide estimations show that 844 million people have CLDs, a lot more than other chronic diseases such as diabetes or cardiovascular diseases with 422 and 540 millions of people affected worldwide, respectively. As an example, in Europe, in 2013, 29 million people suffered from a chronic liver condition. CLD is most of the time an asymptomatic, progressive, and ultimately potentially fatal disease. With its complications such as decompensated cirrhosis and hepatocellular carcinoma it becomes one of the major causes of mortality worldwide, with 2 million deaths per year. Although CLD encompasses a number of liver diseases, globally, hepatitis B virus (HBV) and hepatitis C virus (HCV), as well as alcoholic liver disease (ALD) and non-alcoholic steatohepatitis (NASH), are the most important causes of liver disease. The diagnosis of liver lesions remains an important issue in patients with CLD. The prognosis and management of liver disease greatly depends on the amount of liver fibrosis. In early stages, it is the main factor predicting long-term outcome of these patients. The liver biopsy still represents the gold standard diagnostic tool for liver fibrosis assessment, although a wide spectrum of noninvasive tools has emerged and are now commonly used as a surrogate to the liver biopsy. It includes direct and indirect serum markers of liver fibrosis, but also several imaging-based methods, such as transient elastography (FibroScan®, Echosens, Paris, France), 2-dimensional shear wave elastography, acoustic radiation force impulse imaging or point shear wave elastography, and magnetic resonance elastography (MRE). Even if the liver fibrosis is the key pathological feature of progressive liver disease, the accumulation of excessive hepatic triglyceride, hepatic steatosis, is today recognised as an important factor in the pathogenesis of a number of CLD, not simply an "innocent bystander". The magnetic resonance imaging (MRI) techniques are particularly sensitive to steatosis and therefore show interesting diagnostic performances, especially the MRI using the proton density fat fraction (MRI-PDFF) which has shown at least equivalence in accuracy for quantifying hepatic steatosis with both 1H Magnetic Resonance Spectroscopy (MRS) and with histological grade, across several studies with various etiologies of chronic liver disease. Therefore, this technique is now part of the gold standard diagnostic tool to establish the grade of hepatic steatosis. More recently, Echosens has developed an ultrasonic controlled attenuation parameter (CAP) designed to quantify hepatic steatosis using a process based on vibration controlled transient elastography (VCTE™). Two studies, comparing CAP with liver biopsies in multi-etiology cases and in HCV patients have shown that there is a good correlation between steatosis assessed histologically and using CAP. In addition, in 2017, Han et al., showed FibroScan with CAP, MRI and MRE are highly accurate non-invasive diagnostic tools for quantifying hepatic steatosis and fibrosis. Therefore they could be used as clinical trials outcomes and in disease monitoring in clinical practice. Echosens is now working on improving the diagnostic accuracy of the CAP measurement performed with the FibroScan and also on decreasing the variability existing with the current CAP examination. In this context, this protocol is set-up to compare the diagnostic performances of the first generation of the CAP (CAP commercially available, CAPv1) and the second generation of the CAP (CAP improved, CAPv2) to the reference, the MRI-PDFF, in patients with chronic liver diseases, all etiologies combined.

NCT ID: NCT03701828 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Liver Health and Metabolic Function in People With Obesity

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

This project aims to determine the effect of significant weight loss on rates on hepatic fibrogenesis in people with obesity.

NCT ID: NCT03694431 Not yet recruiting - Cancer Clinical Trials

Comparative Trial of Home-Based Palliative Care

HomePal
Start date: January 2019
Phase: N/A
Study type: Interventional

Background: To effectively alleviate suffering and improve quality of life for patients with serious illness and their caregivers, palliative care (PC) services must be offered across multiple settings. Research is needed to determine how best to optimize home-based palliative care (HBPC) services to meet the needs of individuals with high symptom burden and functional limitations. Aim: The investigators will compare a standard HBPC model that includes routine home visits by a nurse and provider with a more efficient tech-supported HBPC model that promotes timely inter-professional team coordination via synchronous video consultation with the provider while the nurse is in the patient's home. The investigators hypothesize that tech-supported HBPC will be as effective as standard HBPC. Design: Cluster randomized trial. Registered nurses (n~130) will be randomly assigned to the tech-supported or standard HBPC model so that half of the patient-caregiver dyads will receive one of the two models. Setting/Participants: Kaiser Permanente (15 Southern California and Oregon sites). Patients (n=10,000) with any serious illness and a prognosis of 1-2 years and their caregivers (n=4,800) Methods: Patients and caregivers will receive standard PC services: comprehensive needs assessment and care planning, pain and symptom management, education/skills training, medication management, emotional/spiritual support; care coordination, referral to other services, and 24/7 phone assistance. Results: Primary patient outcomes: symptom improvement at 1 month and days spent at home in the last six months of life; caregiver outcome: perception of preparedness for caregiving. Conclusion: Should the more efficient tech-supported HBPC model achieves comparable improvements in outcomes that matter most to patients and caregivers, this would have a lasting impact on PC practice and policy.