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Liver Diseases clinical trials

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NCT ID: NCT03692897 Recruiting - Hepatitis B Clinical Trials

An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection

Start date: October 11, 2018
Phase:
Study type: Observational

The TARGET-HBV study engages an observational research design to conduct a comprehensive review of outcomes for patients with CHB infection. The initial phase of the study that enrolled patients treated with tenofovir alafenamide (TAF) was successfully completed. The current protocol (Amendment 1) describes the second phase of the study that will engage research activities for patients being managed for CHB in usual clinical practice in the US and Canada. The study addresses important clinical questions regarding the management of CHB by collecting and analyzing data from patients at academic and community medical centers. TARGET-HBV creates a robust database of real-world data regarding the natural history, management, and health outcomes related to antiviral treatments used in clinical practice.

NCT ID: NCT03667157 Completed - Liver Diseases Clinical Trials

Liver Function After Intravenous Methylprednisolone Administration

Start date: January 1, 2012
Phase: Phase 4
Study type: Interventional

Graves' orbitopathy (GO) is a characterized by orbital soft tissue inflammation and oedema associated with glycosaminoglycan deposition and fibrosis. The most frequent cause is Graves' disease. The classification is comprised based on the severity of orbital changes ranging from mild, moderate-to-severe GO and sight-threatening GO, which includes dysthyroid optic neuropathy (DON). Intravenous methylprednisolone (IVMP) pulse therapy is the first-line treatment in the active-phase of moderate-to-severe GO and DON. This therapy is more effective and better tolerated than oral glucocorticoids (GCs). The current recommendation of the European Group of Graves' Orbitopathy (EUGOGO) is that cumulative doses of IVMP should not exceed 8.0g in each treatment course, and pulses should not be given on consecutive or alternate days, except in the case of DON. According to EUGOGO recommendations patients with moderate-to-severe GO are treated with IVMP cumulative dose 4.5g during a 12-week period (for the first 6 weeks 0.5g IVMP per week, for the next 6 weeks 0.25g IVMP per week). According to EUGOGO recommendations patients with DON should receive 3.0g IVMP (1.0g/day for 3 consecutive days) as the basic treatment. This limitation in doses are due to the necessity of the prevention of severe side effects that are rare but may be fatal. One of the most severe adverse events is acute liver injury (ALI), in some cases irreversible and/or fatal. The estimated morbidity and mortality of ALI was found to be 1-4 % and 0.01-0.3%, respectively. Since 2000, there were 5 reported fatal cases. Mechanisms causing an IVMP-induced ALI remains incompletely elucidated. There are some possible hypotheses that may explain the occurrence of ALI. Firstly, GCs can lead to reactivation of autoimmune hepatitis: an immune "rebound phenomenon" following GCs withdrawal. The second mechanism of ALI is reactivation of viral hepatitis. Finally, there is well known direct toxic effect of GCs on hepatocytes, probably dose-dependent. This study was performed to evaluate the influence of two different, routinely used schemes of therapy with IVMP in patients with moderate-to-severe GO (first scheme) and DON (second scheme) on biochemical liver parameters. Patients included into the study were treated according to EUGOGO recommendations with routine doses of IVMP and routine scheme of administration for moderate-to-severe GO and DON. No additional treatment was performed during the study protocol.

NCT ID: NCT03620916 Recruiting - Liver Cancer Clinical Trials

Comparison of Intrathecal and Intravenous Analgesia in Patients Undergoing Liver Resection

Start date: August 17, 2018
Phase: N/A
Study type: Interventional

The aim of this prospective, interventional, randomized trial is to compare the effectiveness of postoperative analgesia using single-dose intrathecal morphine and intravenous morphine in patients undergoing liver resection. The study is to include a total 36 patients randomized in a 1:1 ratio into two groups. The study will be single-blinded with respect to outcome assessors. Patients in the experimental group (n=18) will receive a single dose (0,4 mg) intrathecal morphine immediately before operation and patient-controlled analgesia (PCA) with morphine over first 24 postoperative hours and subcutaneous morphine (5 mg in case of numerical rating scale>4) over next two days in the postoperative period. Patients in the control group (n=18) will receive a single dose of intravenous morphine (0,15 mg/kg body mass) immediately after the operation and PCA with morphine over first 24 postoperative hours and subcutaneous morphine (5 mg in case of numerical rating scale>4) over next two days. Both groups will receive antiemetic prophylaxis with dexamethasone (4 mg) and ondansetron (4 mg) and standard baseline analgesia with paracetamol (1,0 g every 6 hours) and dexketoprofen (50 mg every 8 hours). Severity of pain at rest evaluated with numerical rating scale twice daily over 3 first postoperative days will be the primary outcome measure. Secondary outcome measures will include: severity of pain at coughing evaluated with numerical rating scale twice daily over 3 first postoperative days, total dose of morphine administered with PCA, time to patient mobilization, grade of sedation, intestinal motility, solid food intake tolerance, duration of hospitalization, and postoperative complications.

NCT ID: NCT03614039 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Effect of Probiotic and Smectite Gel on NAFLD

Start date: September 15, 2015
Phase: N/A
Study type: Interventional

Smectite is a natural silicate clay belonging to the dioctahedral smectite class and has the ability directly to absorb bacterial toxins, bacteria, viruses and bile salts. Diosmectite also has a protective effect against intestinal inflammation hence suppressing production of cytokines such as IL-8 and TNFα. Investigators suggested that all these pharmacological properties may be beneficial for the treatment of NAFLD. Based on preclinical data, in rats with MSG induced obesity supplementation of alive probiotics with smectite gel (Symbiter-Forte) due to his absorbent activity lead to significant reduction of chronic systemic inflammatory markers, lower total NAS (NAFLD activity score) score, with more pronounced reduction of lobular inflammation as compared to administration of probiotic alone. In respect to preclinical data, in this double-blind single center randomized clinical trial (RCT) the efficacy of alive probiotics supplementation with smectite gel (Symbiter-Forte) vs. placebo in type-2 diabetes patient with NAFLD detected on ultrasonography will be studied

NCT ID: NCT03600714 Completed - Liver Disease Clinical Trials

Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon

Start date: August 1, 2018
Phase: Phase 2
Study type: Interventional

Background: Infection with hepatitis D virus leads to a chronic liver disease with no effective treatment. Lonafarnib has improved hepatitis D virus levels in blood, but the medication still needs more research. Ritonavir makes other drugs more effective and is used with lonafarnib to make it more effective. Lambda interferon stimulates the body s response to viruses. Researchers want to see if combining these drugs fights hepatitis D and helps the liver. Objectives: To see if combining lonafarnib, ritonavir, and lambda interferon is safe and effective to treat chronic hepatitis D infection. Eligibility: Adults at least 18 years old with chronic hepatitis D infection Design: Participants will be screened with a physical exam, medical history, and blood and urine tests. Throughout the study, all participants will: - Follow rules for medicine, food, and contraception - Take hepatitis B medicine - Have weight checked - Have routine blood and urine tests - Give stool samples - Female participants will have pregnancy tests. Participants will have 3 visits before treatment. They will repeat screening tests and have a heart test and liver scan. Participants will have a 5-day inpatient stay. They will: - Baseline blood and urine tests - Have eye tests - Answer health questions - Have a liver sample taken and liver blood pressure measured. Participants will be sedated. - Have reproductive tests - Start the study drugs and have blood draws Over 24 weeks of treatment, participants will: -Take 2 study drugs by mouth every day and 1 as a weekly injection

NCT ID: NCT03598192 Completed - Liver Diseases Clinical Trials

The Effect and Safety of the Four Points Transversus Abdominis Plane Block

Start date: August 15, 2018
Phase: N/A
Study type: Interventional

The anterior abdominal wall from below the xiphoid to infraumbilical area is dominated by the sensory nerves which originate from the anterior rami of the thoracolumbar spinal nerves from T6-L1. The branches nerves from T7-T12 are between aponeurosis internal oblique and transversus abdominal muscle. They can be approached with the ultrasound guidance at subcostal and lateral abdominal wall position. The bilateral transversus abdominis plane (TAP) block has been demonstrated effectiveness and safety in postoperative analgesia to the under abdominal surgery. However, the effect of one to the upper abdominal surgery is unclear. The four points TAP block has been described the first in 2010. The effect of the four points TAP block in postoperative analgesia to the upper abdominal surgery has been reported in recent years. Besides, the effect of thoracic paravertebral block (PVB) in postoperative analgesia to liver resection was also reported. The both techniques have been performing in some studies. The effect and safety of the both techniques have been reported. However, the evidence level is still weak. The investigators need to find a technique, which has effectiveness as well as safety to replace the epidural analgesia, which was confirmed that had many complications, in postoperative analgesia to the hepatectomy. The investigators hypothesized that the four points TAP block under the ultrasound guidance has more effectiveness than the thoracic paravertebral block in postoperative analgesia to the hepatectomy.

NCT ID: NCT03596697 Completed - Hepatitis B Clinical Trials

A Study in Healthy Volunteers

Start date: July 9, 2019
Phase: Phase 1
Study type: Interventional

This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers. The second part of the study will be a single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF. The third part of the study will assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with TDF in stable HBV patients.

NCT ID: NCT03584646 Completed - Frailty Clinical Trials

Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation

PRIMER
Start date: February 28, 2018
Phase: N/A
Study type: Interventional

This is a single center, 2-arm, patient-randomized study evaluating the feasibility and potential efficacy of the PRIMER intervention in improving physical function and reducing frailty in adult Liver Transplant candidates. The intervention will consist of a patient-tailored prehabilitation program designed to reduce frailty, improve physical function and nutritional status, and optimize pre- and post-transplant outcomes.

NCT ID: NCT03563404 Completed - Liver Disease Clinical Trials

Portal Blood Flushes in the Peri-Reperfusion Stage of Liver Transplantation

Start date: June 29, 2015
Phase:
Study type: Observational

By showing that increased levels of acidotic metabolites and electrolytes in the systemic blood of patients who do not receive portal blood flush prior to reperfusion compared to patients who do receive portal blood flush, and that these increased levels correlate with cardiac depression as seen on TEE, the investigators hope to find a superior technique for liver reperfusion.

NCT ID: NCT03552367 Recruiting - Obesity Clinical Trials

Structured Exercise Prescription Program in Obese Children

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

This controlled clinical trial aims to compare the effects of a multicomponent program that includes structured personalized exercise prescription in children with obesity with a control group that will be enrolled in a multicomponent program without structured personalized exercise prescription. All children will be followed for a period of 6 months. The parameters that will be evaluated between groups are physical fitness, anthropometry, metabolic (glucose oral tolerance curve, lipids, HOMA-IR, ISI-MATSUDA), early cardiovascular damage, inflammatory biomarkers, anxiety and depression scores, and allelic variants related to physical fitness.