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Fibrosis clinical trials

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NCT ID: NCT02937012 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders

Start date: October 2016
Phase: Phase 3
Study type: Interventional

The primary biliary cholangitis (PBC), formerly known as primary biliary cirrhosis, treatment is based in the use of ursodeoxycholic acid (UDCA) at a daily dose of 13 to 15 mg/kg, without other treatment options. Patients with good or complete response to UDCA have more liver transplant-free survival and delay histologic progression compared to patients with partial or no response. Nowadays there is an estimated partial response to UDCA in approximately 30 to 50% of patients with PBC. There is a need for new second line management strategies for patients without a biochemical response to UDCA. The addition of bezafibrate to the treatment of PBC patients with partial biochemical response to UDCA, will increase the biochemical response and improve the long term prognosis? And if so, which are the efficacy and security of bezafibrate in PBC patients without biochemical response?

NCT ID: NCT02931812 Recruiting - Cirrhosis Clinical Trials

Feeding Behavior and Taste Sensitivity Before and After Liver or Renal Transplantation

GREFFE
Start date: May 2014
Phase:
Study type: Observational

This study evaluates the influence of the taste sensitivity, of food preferences and of the reward system on the energetic balance before and after liver transplantation in cirrhotic patients and after kidney transplantation in renal failure patients

NCT ID: NCT02926261 Recruiting - Malnutrition Clinical Trials

Methods for Nutritional Assessment in Cirrhosis

Start date: December 2016
Phase:
Study type: Observational

Nutritional status in patients with cirrhosis has been shown to have a direct influence on the prognosis of these patients, it is related to higher mortality and it has been linked to the developement and perpetuation of certain complications such as hepatic encephalopathy, ascites and spontaneous bacterial peritonitis. Despite the importance of nutritional status in this patients, most of the methods for its assessment are still not completely reliable or not easily accessible; therefore, evaluating nutritional status in the daily clinical practice is still a complex task.

NCT ID: NCT02923336 Recruiting - Liver Cirrhosis Clinical Trials

Evaluation of Gastrointestinal Transit Pre and Pos Treatment With Non Selective Betablocker in a Population of Cirrhotics

Start date: May 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the influence of non betablockers in gastrointestinal motility (transit time) in patients with liver cirrhosis.

NCT ID: NCT02916290 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Start date: January 2016
Phase: Phase 3
Study type: Interventional

Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA (13—15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation. However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver fibrosis might jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for liver fibrosis and cirrhosis. Both lab research and some clinical studies suggest that Fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind of etiology. Here the investigators start a random, open and parallel clinical research to explore the effect of Fuzhenghuayu combined with UDCA in the PBC treatment.

NCT ID: NCT02850692 Recruiting - Cystic Fibrosis Clinical Trials

Portal Hypertension and Systemic Endothelial Function

ENDOTH-MUCO
Start date: April 18, 2016
Phase: N/A
Study type: Interventional

Cystic fibrosis can affect organs other than the lungs. Liver disease affects about 30% of patients: its main manifestation is the development of portal hypertension (PHT). The pathophysiology of this comorbidity is still poorly understood. It was previously considered secondary to the formation of biliary cirrhosis but another hypothesis would be that of a primitive pathology of venous vessels may cause the gradual emergence of portal hypertension without cirrhosis. Evidence indiscutly suggest that cystic fibrosis is associated with a specific endothelial dysfunction, especially as the CFTR (Cystic Fibrosis Transmembrane conductance Regulator) protein is expressed on the surface of endothelial cells. The investigators hypothesize that liver disease related to PHT−associated cystic fibrosis is associated with systemic endothelial dysfunction. The aim is: To demonstrate a systemic endothelial dysfunction in patients with cystic fibrosis when associated with PHT. To study the correlations between measures of systemic endothelial function and serum markers of endothelial dysfunction and between measures of liver stiffness and systemic endothelial function.

NCT ID: NCT02823366 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid

Start date: January 2016
Phase: Phase 3
Study type: Interventional

Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Both lab research and some clinical studies suggest that fenofibrate could improve cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a random, open and parallel clinical research to explore the effect of fenofibrate in the PBC treatment.

NCT ID: NCT02805699 Recruiting - Clinical trials for Combined Pulmonary Fibrosis and Emphysema

A Clinical Evaluation of Baofeikang Granule in Combined Pulmonary Fibrosis and Emphysema Treatment

Start date: June 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to confirm the efficacy and safety of BaofeiKang Granule in the treatment of Combined Pulmonary Fibrosis and Emphysema patients.

NCT ID: NCT02802839 Recruiting - Cystic Fibrosis Clinical Trials

Virtual Reality for the Reduction of Pain During Venipuncture in Children With CF

VRAP
Start date: June 2016
Phase: N/A
Study type: Interventional

Children with Cystic fibrosis (CF) have to undergo several needle-related procedures during outpatient visits or hospital stay. It is common for children with CF to display distress and behavioural problems during invasive procedures. Children with chronic diseases have a lower threshold of pain compared to non-chronic patients. Effective management of needle distress in children with CF is critical. Although pharmacological and non pharmacological methods are used during needle -related procedures to lower painful stimuli nearly all patients with CF experience anxiety. Distraction has been shown to be an effective technique that directs children's attention away from noxious stimuli. The application of Virtual Reality (VR) in the medical field has been shown to be successful already 15 years ago. VR has found its use during the medication of burns and in patients undergoing cancer treatments whereas so far few studies have been published to assess its efficacy in reducing needle related pain and distress in children and none in children with CF. Objectives To assess the efficacy of VR in reducing pain and distress during venipuncture in children with CF compared to routine care. Project description Randomized controlled parallel trial with a 1 to 1 allocation ratio. The use of VR compared to standard care during venipuncture in children with CF (age 6-18 years) attending the outpatient clinic of the CF Centre of Florence will be compared over the period of 1 year. Patients randomly assigned to arm A will use VR during the procedure, those patients assigned to arm B will receive routine care. Anticipated output Determination of the efficacy of VR in lowering pain and distress during venipuncture.

NCT ID: NCT02790879 Recruiting - Cystic Fibrosis Clinical Trials

Transition From Pediatric to Adult Cystic Fibrosis Care Center

SAFETIM RNM
Start date: October 2015
Phase: N/A
Study type: Observational [Patient Registry]

The main objective of register-SAFETIM is to assess the impact of the transition from pediatric to adult cystic fibrosis care center on changes in lung function and nutritional status of patients. This is a multicenter, observational, longitudinal, with analysis of the French national registry data of patients with cystic fibrosis. Our study will assess the clinical features of adolescent patients with cystic fibrosis during the transition from pediatric care to adult care. It will explore factors associated with the impact of the transition on the clinical course of adolescent patients (respiratory and nutritional functions).