View clinical trials related to Fibrosis.
Filter by:Crohn's disease (CD) is a chronic transmural inflammatory bowel disease. Prolonged episodes of inflammation can lead to intestinal fibrosis, leading to intestinal stenosis and obstruction. Inflammatory stenosis can be alleviated through anti-inflammatory treatment, while fibrotic stenosis requires endoscopic dilation or surgical treatment. Early detection of the presence and severity of intestinal fibrosis in CD is the key to treatment strategies. Currently, there are certain limitations in the non-invasive evaluation methods for intestinal fibrosis, and it is urgent to develop a new imaging method to achieve non-invasive diagnosis of the degree of fibrosis. Fibroblast activation protein (FAP) is a marker of intestinal fibrosis in CD. Based on the principle that fibroblast activation protein inhibitor (FAPI) can specifically bind to FAP, FAPI radioactive tracers can achieve targeted tracing and quantification of FAP in vivo. Therefore, 18F-FAPI positron emission tomography (PET) imaging technology has a good application prospect in the noninvasive diagnosis and evaluation of CD intestinal fibrosis. Based on the successful testing of 18F-FAPI PET imaging in the early stage of the project team to evaluate the nature of CD intestinal stenosis, this project intends to take patients with CD intestinal stenosis as the research object, and use postoperative histopathological analysis as a reference index to evaluate the role of 18F-FAPI combined with 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG) PET imaging in the qualitative diagnosis of CD intestinal wall fibrosis, as well as the differential diagnosis ability of inflammatory and fibrous stenosis in CD patients, and establish a diagnostic model and evaluation system. Achieving a noninvasive, stable, and objective diagnosis and evaluation of the degree of intestinal fibrosis in CD patients at the molecular level will provide imaging evidence for treatment decision-making, progress, and prognosis of CD patients, and also play an important support role in the development of anti fibrosis drugs, selection of suitable patients, and efficacy evaluation.
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.
In cystic fibrosis (CF) renal base excretion is impaired, due to mutations in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene, since CFTR function is crucial in regulation of the kidney's HCO3- excretion. The investigators suggest that challenged urine HCO3- excretion is a biomarker of CFTR function, which can be used to evaluate the extent of CFTR dysfunction and the possible correcting effects of CFTR modulating therapy. This study aims to evaluate changes in challenged urine HCO3- excretion in CF patients, who are currently in treatment with the triple CFTR modulator combination therapy, Elexacaftor/tezacaftor/ivacaftor (ETI), before, during, and after a short treatment pause.
The goal of this clinical trial is to learn about the potential effect of ENV-101 (taladegib) on the pharmacokinetics of nintedanib (an approved treatment for idiopathic pulmonary fibrosis) when the two compounds are dosed together in healthy subjects. Participants in this study will receive ENV-101 and/or nintedanib on various days throughout a 10-day period during which they will reside at the clinical trial site.
A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M Risk Allele
The exercise test provides prognostic information about clinical outcomes and quality of life to optimize care for cystic fibrosis patients (pwCF). The exercise test identifies the causes of exercise restriction, adverse exercise reactions, and exercise-related symptoms. The results help to determine and evaluate the impact of exercise programs at PWCF. Peak oxygen uptake (VO2peak) is a prognostic measure of maximum exercise capacity that usually worsens as CF lung disease progresses. The recommended gold standard exercise test at PWCF is a cardiopulmonary exercise test (CPET) performed on a loop ergometer to assess VO2peak and cardiopulmonary responses to exercise. the recommended incremental protocol, consisting of 1-minute phases, should reach VO2peak within 8-12 minutes. Trained operators perform cpets with complex and expensive laboratory equipment, and it is inaccessible and little used by many people internationally. Step tests are low-cost, portable, easily standardized and require minimal space to perform. The 3-Minute Step Test (3MST) is an externally paced test for the assessment of exercise tolerance set at 30 steps/minute for 3 minutes. In adults with CF, 3MST is useful for assessing oxygen desaturation and predicting future increased use of healthcare services. Limitations include the ceiling effect in less severe CF lung disease, and it is very difficult for some with more advanced lung disease. An incremental maximum A-STEP step test has been developed to assess exercise capacity in the CF lung disease December, without floor or ceiling effects, within clinical space constraints and the need for strict infection prevention. A-STEP is a new incremental maximum step test to assess exercise capacity in PWCF without floor or ceiling effects, as an alternative field test to CPET.
Hemorrhoidal disease (HD) is a common health problem, affecting up to 38,9% of adult population. HD is also a common finding in up to 36% of cirrhotic patients, as hemorrhoidal plexus is a possible site of portosystemic venous anastomosis. Cirrhotic patients represent a group often neglected in clinical trials so, little is known about the optimal treatment for HD these patients. The objective of this study is to prospectively evaluate the efficacy and safety of treatment of grade I, II and III internal HD with polidocanol foam in cirrhotic patients.
This is a 3-part, single-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy volunteers (Part A) and multiple-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy volunteers (Part B), and a Phase 1b open-label study in subjects with CF (Part C) to assess the safety, tolerability, PK, and preliminary efficacy of ABCI. Subjects will be evaluated for eligibility during Screening within 30 days prior to Day 1 (Randomization; Visit 3). In Parts A and B, eligible healthy volunteers may be enrolled in the study and randomly allocated to treatment with ABCI or placebo as described below. In Part C, eligible subjects with CF may be enrolled in the study and receive treatment with ABCI as described below. Approximately 72 healthy subjects total will be randomized to 9 cohorts (48 subjects in 6 cohorts in Part A, 24 subjects in 3 cohorts in Part B) and approximately 20 subjects with CF will receive the medium dose (2 sentinel subjects) or high dose (up to 18 subjects) of ABCI in Part C.
Cystic fibrosis (CF) is the most common severe autosomal recessive genetic disease in Caucasians. The CFTR (cystic fibrosis transmembrane regulator) gene, which encodes the chloride channel of the epithelial cell membrane, is responsible for the development of the disease. Respiratory physiotherapy, especially bronchial drainage is one of the basic elements of comprehensive management in patients with CF. Among the many procedures used in CF drainage physiotherapy, the most commonly include these using positive expiratory pressure (PEP) and oscillating positive expiratory pressure (OPEP). The aim of the study is to assess the efficacy of the usage of selected PEP and OPEP devices in bronchial drainage in cystic fibrosis patients during exacerbation of the disease.
Background: Non-Alcoholic Steatohepatitis (NASH) represents one of the stages of Non-Alcoholic Fatty Liver Disease (NAFLD) with a very high risk to evolve in cirrhosis and hepato-carcinoma. Currently, the only diagnostic method is a liver biopsy that remains the gold standard for characterizing liver histologic alterations and fibrosis stages. There is no specific treatment for NASH, in fact no drugs are currently licensed specifically for treating this disease. Aim: Our aim is to conduct a non-inferiority, randomized-controlled trial (RCT) comparing Roux-en-Y Gastric bypass (RYGB) with an intensive lifestyle modification plan (Very low-calorie diet, VLCD) for the reduction of advanced stages of fibrosis in subjects with obesity and NASH after 25% weight loss.