View clinical trials related to Fibrosis.
Filter by:The purpose of this study is to assess safety and tolerability of once daily (QD) and twice daily (BID) dosing of ANG-3070 in subjects with idiopathic pulmonary fibrosis (IPF) who are treatment-naïve, refused therapy, or discontinued for any reason current standard of care with nintedanib or pirfenidone.
The COVID-induced fibrotic lung damage continues long after viral infection has subsided and is exhibited by severe respiratory pathology and concomitant symptoms. The long-lasting sequelae in patients who have recovered from severe COVID indicate that there is a 30% chance of developing a persistent respiratory system pathology and a 10% chance of developing a severe pathology. The symptoms of lung fibrosis include a severe disruption of respiration, reduction of exercise tolerance, and concomitant development of persistent fibrotic lung damage. This study intends to evaluate benefits of a combination of VL-P22 and VL-PX10 in Covid-19 patients exhibiting pulmonary fibrosis.
To date, no specific treatment options exist for liver diseases, and there is a large global effort to find drugs that will halt liver disease progression in these patients.Liver fibrosis staging is essential as a diagnostic/prognostic measure and there is an increasing demand for accurate non-invasive liver stiffness measurement tools. This research project proposes a novel MR-based quantitative Liver Deformation Biomarker (qLDB) approach for non-invasive liver fibrosis assessment by using a new technique called 4D-MRI. 4D-MRI allows to overcome the limitations of currently used techniques. Hence, 4D-MRI may help to identify a novel biomarker for non-invasive staging of liver fibrosis , and therefore improve the final diagnosis of patients suffering from liver diseases.
Non-alcoholic fatty liver disease is a major health problem worldwide. It includes simple steatosis and NASH which has inflammation in the liver, with or without fibrosis. Fat content, fibrosis, and inflammation are three important components to evaluate NASH. Liver biopsy is the current gold standard for the diagnosis of NASH. Liver biopsy; however, is invasive. The existing non-invasive methods still have significant limitations to assess NASH. It was reported that quantification of fatty acid composition is feasible for evaluation of metabolic disorders and inflammatory conditions. However, this measurement cannot be used to evaluate fibrosis. Liver fibrosis is characterized by excessive deposition of collagen-rich connective tissues in the liver, which can be quantified by macromolecular proton fraction (MPF), an MRI parameter reflecting the macromolecular level in tissues. Although it has the potential to directly quantify fibrotic tissue, the effect of inflammation on MPF measurement was not well studied. In summary, NASH assessment using non-invasive imaging methods remains challenging. Based on our previous work of MPF imaging with spin-lock (MPF-SL) and chemical-shift encoding-based water-fat imaging in spin-lock MRI, the investigators will develop a fast acquisition technology to collect data for simultaneous quantification of liver fat content, fatty acid composition, and fibrosis within a single breath-hold less than 14 seconds. Our method does not require extra hardware and does not need to inject a contrast agent. The investigators will evaluate the repeatability and reproducibility of the proposed method on volunteers. To evaluate its clinical value, the investigators will recruit 120 subjects (60 with simple steatosis and 60 with NASH) in this study. The investigators will use histology analysis as the gold standard and evaluate the diagnostic value of our proposed method for detecting NASH. This project will provide a non-invasive diagnostic technology for the assessment of NASH. The proposed MRI technology also has the potential to be applied for other clinical purposes.
The Visceral Adiposity Measurement and Observation Study
Pulmonary fibrosis (PF) results from a diverse group of health conditions and affects the lives of patients (including those who are post lung transplant), caregivers and family members. The Pulmonary Fibrosis Foundation Community Registry will offer an online portal where participants can self-enroll and directly contribute information about their experience with PF to be compiled into a longitudinal data set for use by researchers.
Rationale: Cystic fibrosis (CF) is an incurable genetic disease that affects the pulmonary system, digestive system, reproductive system and the sweat glands. 85 percent of patients with cystic fibrosis have pancreatic insufficiency, more than half of whom will develop CFRD. CFRD affects patients nutritional state and is associated with a decline in lung function and decreased longevity. Because early treatment with insulin can reverse some of this decline and mortality, CF patients are screened yearly for CFRD using an oral glucose tolerance test (OGTT). During an OGTT patients have to drink a solution of 75 grams of glucose in water and blood glucose levels are measured after 0 minutes and 120 minutes. Drinking the glucose solutions is experienced by patients as uncomfortable, as it causes nausea and sometimes even leads to vomiting. Therefore, some patients do not want to undergo the OGTT which results in patients getting diagnosed in a later stadium. Objective: To compare the performance of a glucose tolerance test ("AATT") with a commercially available beverage to the results of the conventional OGTT with respect to diagnosing IGT and CFRD in patients with CF. Study design: Randomized crossover trial Study population: Adult cystic fibrosis patients from the outpatient of CF-centre Amsterdam; 10 patients with CFRD who are not fully insulin dependent and 10 patients who have exocrine pancreatic insufficiency but no known CFRD. Intervention (if applicable): The groups will be undergoing both the oral glucose tolerance test with the standard glucose solution (OGTT), as the oral glucose tolerance test where the glucose solution is replaced by commercially available beverage (AATT). Main study parameters/endpoints: Serum glucose levels at 120 minutes after ingestion of either the standard glucose solution or the commercially available beverage. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients who have no known CFRD will be asked to undergo one additional glucose tolerance test, which involves a visit to the outpatient clinic, during which patients need to be fasting since 22:00 the evening before. CF patients already diagnosed with CFRD will be asked to visit the outpatient clinic two times. Patients who use short-acting insulin need to have stopped this as well from 23:59 the evening before the test. These patients may become hyperglycaemic, but since they are not fully insulin dependent there is no risk of keto-acidosis. During the test an I.V. cannula will be placed so blood samples can be taken at baseline, after 30 minutes, 60 minutes, 90 minutes and 120 minutes. There is a minor risk the I.V. cannula will lead to phlebitis. The overall risk for participation in the study is considered low given the fact that patients who are insulin dependent (i.e. also in need of long-acting insulin) are excluded, so the possibility on hyperglycaemia and ketosis seems remote. The commercially available beverage (AA-drink) used is already determined as a safe sports drink by the Food and Consumer Product Safety Authority (NVWA) in the EU.
Study the impact of differing meal contents on venous ammonia levels over time in patients with cirrhosis. Patients will be given specific meals and venous ammonia analyzed over time after those meals. The subjects will also provide stool for microbiome and serum, urine and plasma for metabolomics during this one-time study. Total duration=4 hours
The overall objective of this study is to evaluate the effectiveness and safety of cudetaxestat (BLD-0409) as compared to placebo with or without standard of care (nintedanib or pirfenidone) in subjects with idiopathic pulmonary fibrosis (IPF)
Background: During the hepatology evaluation, vibration-controlled transient elastography (VCTE) is often used as a clinical decision aid to target high-risk patients for liver biopsy. The enhanced liver fibrosis (ELF) test is expected to be approved in the US. We tested the hypothesis that making the ELF results available to the treating hepatologist will result in more appropriate and targeted use of liver biopsy in patients with elevated liver enzymes or fatty liver, and will result in more cases of advanced fibrosis/cirrhosis being diagnosed. Methods: During the hepatology evaluation for elevated liver enzymes or fatty liver at the University of Kansas Medical Center, the hepatologists (8 total) make a clinical decision on whether patients shall receive VCTE. At the end of the clinic visit, patients were enrolled and randomized to receiving an ELF test. Patients with liver biopsy within the last five years or decompensated cirrhosis were excluded. The primary outcome is the rate of a diagnosis of F3-4 fibrosis based on liver biopsy or clinical diagnosis of cirrhosis with the initiation of hepatocellular carcinoma surveillance. Four hundred fifty patients are to be enrolled over two years.