Active clinical trials for "Fibrosis"

Variceal bleeding is a major complication of cirrhosis, associated with a hospital mortality rate of 10%-20%. Surviving patients are at high risk for recurrent hemorrhage. For these reasons, management should be directed at its prevention. Endoscopic variceal band ligation (EBL) in combination with non-selective β-blocker (NSBB) therapy is the recommended first line therapy. Transjugular intrahepatic portosystemic stent-shunt (TIPS) is the most effective method to prevent rebleeding, however, it is burdened with increased hepatic encephalopathy and deterioration of liver function in patients with advanced cirrhosis. So TIPS placement forms an alternative if first line therapy fails. Hepatic venous pressure gradient (HVPG) is currently the best available method to evaluate the presence and severity of portal hypertension. Patients who experience a reduction in HVPG of ≥20% or to <12mmHg in response to drug therapy are defined as 'responders'. The lowest rebleeding rates are observed in patients on secondary prophylaxis who are HVPG responders. A recent meta-analysis has demonstrated that combination therapy is only marginally more effective than drug therapy. This suggests that pharmacological therapy is the cornerstone of combination therapy. Adding EBL may not be the optimal approach to improve the outcome of HVPG nonresponders and HVPG non-responders are a special high-risk population that may benefit from a more aggressive approach, such as an early decision for TIPS. It recently was shown that TIPS placement within 72 hours after acute bleeding not only prevented recurrent bleeding but also improved survival. These raise the question of whether ligation together with NSBB should remain the first choice for elective secondary prophylaxis. Therefore, the purpose of the study is to compare whether HVPG-guided therapy is superior to standard combination therapy for the prevention of variceal bleeding in patients with decompensated cirrhosis.

Despite the reduction in acute rejection episodes in renal transplant patients due to modern immunosuppression, proportionate improvements in long-term allograft survival have not been achieved. Virtually any disease or injury affecting renal allografts can culminate in irreversible injury of tubular epithelial cells and the development of interstitial fibrosis and tubular atrophy (IFTA). Renal allograft fibrosis drives chronic kidney disease (CKD) progression, predicts allograft failure and is associated with increased patient mortality. Other prognostic and/or actionable diagnoses described by the pathologic Banff scheme, such as inflammation, often co-exist and contribute to IFTA. Immune cell infiltration within allografts and within areas of IFTA (i-IFTA) can drive progressive kidney injury, fibrosis and worsened outcome. Pathology is the reference standard for IFTA; however, allograft biopsy has many well-known limitations and is not an ideal method for monitoring patients during trials of new therapies aimed at improving allograft survival. There is an urgent and unmet need for non-invasive assessment of renal allograft IFTA. Multiparametric MRI (mpMRI), including relaxometry [the spin-lock relaxation time T1ρ, a marker of interaction of water with macromolecules in tissues; the spin-lattice relaxation time T1, a marker of interstitial edema and collagen volume fraction)] and advanced diffusion [intravoxel incoherent motion diffusion-weighted imaging (IVIM-DWI), a marker of diffusion and perfusion] provides insight into renal structure and function. Validation of advanced MRI methods as markers of renal allograft IFTA would be of major clinical significance to enable early detection, assess the efficacy of novel anti-fibrotic agents, and provide longitudinal disease monitoring. The study team has established proof-of-concept in renal allografts with stable function and IFTA without confounding rejection or infection that mpMRI techniques are feasible for measuring fibrosis, especially using the combination of T1 and DWI. The study has established that urinary biomarkers for renal allograft fibrosis are also promising and have been validated against pathology in initial studies. In this proposal, the researchers will develop a short, non-contrast multiparametric MRI (mpMRI) protocol, consisting of advanced relaxometry (T1 mapping and T1ρ) and advanced diffusion weighted imaging (IVIM-DWI) to accurately detect and stage allograft fibrosis, taking into account confounding Banff variables of inflammation and tested against biopsy. The researchers will also assess the added value of urinary biomarkers of IFTA and if successful, this study will benefit a large population of patients with renal allograft fibrosis in the United States, enabling early diagnosis, optimized treatment planning, prognostication and longitudinal disease monitoring.

The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) transfusion in the treatment of liver cirrhosis. Liver function will be monitored by serum analysis. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at pre-transfusion, and 3 days to 2 years post-transfusion. Child-Pugh scores, Model for End-Stage Liver Disease scores and clinical symptoms will be assessed simultaneously.

A DDI study to assess the safety, tolerability and pharmacokinetics of both; doses of FDL176 with and without co-administration of FDL169 and doses of FDL169 with and without co-administration of FDL176.

Carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. A lot of studies have shown that the imbalance of flora and the progress of portal hypertension are mutually causal. Berberine can regulate the intestinal flora.In this study, we evaluated the effect of carvedilol and berberine on reducing portal vein pressure by observing the changes of endoscopy，endoscopic ultrasonography and intestinal flora.

This phase IIa trial studies long-term low-dose erlotinib hydrochloride treatment to assess its efficacy and safety to prevent development of hepatocellular carcinoma in patients with liver cirrhosis.

The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lung that were preserved and transported within the LUNGguard system, as well as retrospective standard of care patients

The goal of the clinical trial is to test whether a mental health program that is delivered through the Internet works well for healthy children and adolescents with siblings with cystic fibrosis (CF). The main questions it aims to answer are: Does the program improve the mental health and quality of life of healthy siblings? Does the program improve the relationship between healthy children and adolescents and their sibling with CF? Does the program help healthy siblings learn about CF? Participants will: Fill out an online survey asking questions about their family and mental health before the program Complete the online mental health program over five weeks Fill out a weekly question asking about their mood for 10 weeks Fill out an online survey asking questions about their family and mental health after the program Healthy children and adolescents with siblings with CF will be compared against themselves. Researchers will compare participants scores before starting the program with their scores during and after completing the program. Researchers hope to develop a program that improves mental health, quality of life, sibling relationships, and knowledge about CF.

The purpose of this study is to support the clinical validation of a new assay to measure the levels of ivacaftor, tezacaftor, and elexacaftor (the components of Trikafta) in the bloodstream in order to achieve greater understanding of the effectiveness of this medication in all people with cystic fibrosis. Blood will be drawn at 3.0, 4.5, and 6.0 hours after taking the medication in the morning.

Decompesated Cirrhosis is charecterised by decreased synthesis of both procoagulants and anticoagulants along with thrombocytopenia and a delicate balance exists bleeding and thrombosis in this condition. There is increase in Prothrombin Time (PT) in this condition, consequently guidelines recommend correction of International Normalised Ratio (INR) and platelete count by transfusion of Fresh Frozen Plasma (FFP) and platelet transfusion before invasive procedures to prevent bleeding complications. However PT and platelet count are not ideal tests to guide transfusion strategies as they do not take into account the relative deficiency of anticoagulant factors. Furthermore, cirrhotic patients have an excess of von Willebrand factors and Factor VIII which are prothrombotic. So FFP and platelet transfusions based on PT and platelet count can actually lead to a prothrombotic state. Viscoelastic assays like ROTEM measure the haemostatic process in real time by detecting the resistance to movement of an oscillating pin by the clotting blood. It has three componenets-EXTEM, which measures the extrinsic coagulation pathway, INTEM, which measures the intrinsic pathway and FIBTEM which measures fibrinogen. Two parameters of EXTEM indicate FFP and platelet requirement and should be able to guide transfusion therapy. The first is Clottting Time (CT), that is the latency time between the formation of the test and the clot formation as the tracing reaches 2 mm of amplitude and the second is Maximum Clot Formation (MCF), that is the greatest vertical amplitude of the tracing. While CT helps in guiding FFP transfusion, MCF guides platelet transfusion. Fibrinogen requirement is guided by MCF values of FIBTEM. The aim of this study will be to compare the transfusion requirement, efficacy and safety of ROTEM in guiding the use of FFP, Platelet and cryoprecipitate transfusion before invasive procedures in children with decompensated cirrhosis before invasive procedures. Project title:Rotational Thromboelastometry versus conventional haemostatic tests in children with Decompensated Cirrhosis undergoing invasive procedures: A Randomised Controlled Trial Student PI name: Dr Snigdha Verma