View clinical trials related to Fibrosis.
Filter by:Direct-acting antiviral agents (DAAs) targeting HCV have revolutionized the treatment of HCV. The efficacy of DAA-based therapy can depend on patient-related factors such as treatment experience, cirrhosis, but also on viral genotype. The high prevalence of genotype 3, which is considered difficult to cure, remains a challenge because many oral DAAs are less effective for this genotype, particularly subtype 3b than for others. Current guidance generally recommends sofosbuvir (SOF)/velpatasvir (VEL) ± ribavirin (RBV), glecaprevir/pibrentasvir and SOF/VEL/voxilaprevir (VOX) as first-line therapy for genotype 3, and an interferon-based regimen - SOF plus pegylated interferon and ribavirin is still recommended as an alternative treatment option. These recommendations are based on clinical data generated in regions where genotype 3a predominates. Our recent study indicated that sofosbuvir plus ribavirin for 24 weeks in subjects with HCV genotype 3 infection resulted in high rates of SVR. However, the SVR12 rate among subjects with genotype 3b was lower than that observed in subjects with genotype 3a infection, particularly among treatment-experienced subjects with cirrhosis. Our study aimed to investigate the efficacy and safety of SOF/VEL plus RBV for 12 weeks or SOF/VEL/VOX for 12 weeks in DAAs treatment naïve HCV subjects with GT3b, compensated cirrhosis in China.
Prediction of hepatic encephalopathy after insertion of a transjugular intrahepatic portosystemic stent shunt (post-TIPS HE) are critical for patient selection prior to TIPS insertion, and a currently unmet, clinically highly relevant need. In this prospective multicenter observational cohort study, the investigators aim to evaluate the ability of Stroop EncephalApp and the simplified Animal Naming Test (S-ANT1) in comparison to the goldstandard PHES to predict the occurence of post-TIPS HE in patients with decompensated liver cirrhosis. Moreover, secondary aims of this study include the detection of potential blood based biomarkers for prediction of post-TIPS HE and the predictive value of frailty and quality of life/sleep prior to TIPS insertion.
This is a randomized, open-label, parallel-dosing, multi-center study to evaluate the safety and efficacy of rencofilstat as evidenced by assessing changes in the HepQuant Shunt Disease Severity Index Score (DSI), safety labs, and clinical events in adult NASH subjects with compensated Fibrosis stage F 2/3. Antifibrotic biomarker activity will be evaluated on an exploratory basis.
This research aims to develop an optimal physiotherapy intervention for people with arthrofibrosis (stiffness due to scar tissue) after total knee replacement (TKR). We will develop an optimal intervention by conducting: 1. A review of the evidence to identify what components could be included in the intervention, how effective they are and what outcomes have been measured by the research. 2. Interviews with patients with arthrofibrosis to understand the impact it has on their life and what outcomes are important to them and interviews with healthcare professionals (HCPs) to understand their experiences of treating patients with arthrofibrosis. 3. A Delphi study with a larger group of HCPs and patients to reach a consensus on what the optimal intervention should include. This involves a series of anonymous voting on a range of items that have been generated by the group and the results of the evidence review. 4. A workshop with patients, HCPs and health-care commissioners to finalise the intervention. During the workshop we will present our findings and work in small groups to agree the intervention
This is a phase 1b/2 study of a single dose of intravenous (IV) bacteriophage in males and non-pregnant females, at least 18 years old, diagnosed with Cystic Fibrosis (CF). This clinical trial is designed to assess the safety and microbiological activity of bacteriophage product WRAIR-PAM-CF1, directed at Pseudomonas aeruginosa in clinically stable CF individuals chronically colonized with P. aeruginosa. WRAIR-PAM-CF1 is a 4 component anti-pseudomonal bacteriophage mixture containing between 4 x 10^7 and 4 x 10^9 Plaque Forming Units (PFU) of bacteriophage. Enrollment will occur at up to 20 clinical sites in the United States. In stage 1, two eligible subjects will be assigned to each of the three dosing arms receiving a single dosage of the IV bacteriophage therapy (4 x 10^7 PFU, 4 x 10^8 PFU, and 4 x 10^9 PFU; total of 6 sentinel subjects), followed by 30 ± 7 days observation period. If no SAEs (related to the study product) are identified during the 96 hours after bacteriophage administration for all Sentinel Subjects in Stage 1, the study will proceed to Stage 2. In Stage 2a, 32 subjects will be enrolled into one of 4 arms (placebo IV, 4 x 10^7 PFU, 4 x 10^8 PFU, and 4 x 10^9 PFU) in a 1:1:1:1 allocation. An interim analysis will be performed after all subjects have completed follow up visit 7 on Day 30 to select the IV bacteriophage dose with the most favorable safety and microbiological activity profile. During Stage 2b, subjects will be randomized into the bacteriophage (dose selected based on Interim Analysis following Stage 2a) or placebo arm. The final sample size is expected to be up to 72 subjects total with up to 25 subjects in the placebo arm and up to 25 subjects in the Stage 2b bacteriophage dose.
Fibrosing interstitial lung diseases or pulmonary fibrosis represent a heterogeneous group of progressive pulmonary pathologies, responsible for a significant morbi-mortality. They are defined by an infiltration of the pulmonary interstitium associating in a variable way an inflammatory component (deposit of inflammatory cells) and a fibrosing component (deposit of collagen). Idiopathic pulmonary fibrosis (IPF) is the most common and most severe pulmonary fibrosis. Other pulmonary fibroses are mainly represented by non-specific interstitial lung disease, pulmonary fibroses associated with connectivites, hypersensitivity pneumonitis, certain pneumoconiosis (occupational diseases) and sarcoidosis. The process of fibrosis is responsible for a loss of elasticity of the lung, leading to a decrease in lung volumes associated with an alteration of gas exchange. In these diseases, the clinician must be able to rely on reliable means to assess the severity of the disease based mainly on the measurement of lung volumes and gas exchange, at diagnosis and in the follow-up of the patient, in order to propose the most appropriate management. Lung volumes are assessed by respiratory function tests. Forced vital capacity is the reference volume value used. Impaired gas exchange is assessed at rest by measuring carbon monoxide diffusion capacity, arterial oxygen saturation and arterial blood gases. The functional capacity to exercise is also a very important evaluation criterion in terms of prognosis and in the follow-up of the patient. It is assessed by means of ergocycle tests which mainly determine the maximal oxygen consumption. These are relatively complex tests that require special equipment and are not routinely performed. Simpler field tests have been developed to assess functional capacity during exercise, the most widely used and validated being the 6-minute Walk Test (TM6). Other field tests to assess functional capacity to exercise have been developed, such as the 30-second, 1-minute, and 3-minute chair lift tests, stepper tests, and step and stair tests. Among them, the 1-minute chair lift test (TLC1) is the best evaluated. It consists of sitting down and getting up from a chair as many times as possible in 1 minute. The criteria measured are mainly the number of lifts and desaturation. Thus, the fundamental advantage of the TLC1 over the TM6 is the exemption from temporal and spatial constraints since it takes only a few minutes and can be performed in a medical office. While TLC1 seems to be the most suitable, there are still a few pitfalls in substituting TLC1 for TM6 during diffuse interstitial lung disease. First, there is only one study reporting the results of TLC1 in a healthy population. It provides a chart of results according to age. Unfortunately, only the number of lifts is reported without any data on heart rate, SaO2 or sensation of dyspnea. In respiratory pathologies, TLC1 has been studied mainly in patients with chronic obstructive pulmonary disease (COPD) and little in PID. Unlike TM6, TLC1 is reproducible and has no learning effect in this population. Interestingly, one study found that peak desaturation and peak oxygen consumption occurred during the recovery phase some seconds after the end of the test. Studies on TLC1 during SID do not allow us to conclude that this test can substitute for TM6. However, investigators may note certain limitations, in particular the small number of patients studied and the retrospective nature of the 2 largest of them. Above all, it seems that the use of TLC1 could be optimized by taking into account the recovery phase in the evaluation of desaturation. The hypothesis of our study is that the TLC1 taking into account the recovery phase can replace the TM6 in the management of fibrosing PID for prognostic evaluation, patient follow-up and indication of oxygen therapy. It is more accessible and its use by all practitioners in face-to-face or telemedicine would allow a better management of these patients. Finally, the investigators hypothesize that the TLC1 will result in lower costs in the management of these patients.
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
Patients with cirrhosis patients have a high incidence of sepsis which can trigger decompensation and may result in prolonged hospital stay and increased mortality. About 30%-50% admissions of patients with cirrhosis have sepsis at presentation and about 15% patients admitted to hospital develop sepsis during the hospital stay . After infection develops, the patient may develop acute kidney injury (AKI), shock, encephalopathy or disseminated intravascular coagulation (DIC) further decreasing the chances of survival. In fact, sepsis in patients with cirrhosis is associated with 15% in-hospital mortality, approximately double that of patients without sepsis. So, sepsis is directly responsible for 30-50% of deaths in cirrhosis . Therefore, it is critical to manage sepsis early and appropriately in cirrhosis to reduce the complications and mortality. Early administration of fluids, source control and empirical antibiotics along with vasopressors if refractory shock are essential components of treatment in all patients with sepsis. Currently, the most accepted strategy for early sepsis management is a combination of early goal directed therapy (EGDT) and physiological parameters, such as urine output, lactate clearance, and administration of antibiotics, within 1 hour of presentation . The use of central venous pressure assessment is fallacious for gauging adequacy of fluid resuscitation in cirrhosis, and the difficulty of performing echocardiographic assessments in the setting of ascites and cirrhotic cardiomyopathy is also well described .
This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.
Point-of-care echocardiography (POC-Echo) is used to determine left ventricular systolic and diastolic dysfunction (LVDD), inferior vena cava (IVC) dynamics and volume status in cirrhosis and Acute-on-chronic liver failure ACLF accurately. We will assess IVC dynamics, LV systolic function [LV ejection fraction (EF) & cardiac output (CO)], and diastolic dysfunction (E/e', e' and E/A ratio) and urinary biomarkers (cystatin C and NGAL) in patients with cirrhosis and ACLF with hepatorenal syndrome-acute kidney injury (HRS-AKI).