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Fibrosis clinical trials

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NCT ID: NCT05140837 Recruiting - Cirrhosis Clinical Trials

Early Diagnosis and Timely Treatment of Cirrhotic Patients With Minimal Hepatic Encephalopathy (CHESS-NCRCID 2106)

Start date: December 9, 2021
Phase:
Study type: Observational

Hepatic encephalopathy (HE) is a common complication of cirrhosis, which seriously damages the life quality of patients. As the disease progresses, 50-80% of patients with cirrhosis develop HE. Minimal hepatic encephalopathy (MHE) is a manifestation of HE, in which the patient usually has no obvious clinical symptoms and can only be detected by neuropsychological testing. Early identification and timely treatment are the keys to improve the prognosis of HE, and the diagnosis of MHE are the priority in the process of the disease intervention. Guidelines in many countries suggest that MHE does not recommend routine treatment. However, patients with cirrhosis usually have complex clinical complications, so whether timely treatment should be taken remains to be explored. The purpose of this study is to investigate the incidence of MHE in cirrhotic patients, and to establish a real-world cohort for further study on drug therapy and efficacy evaluation.

NCT ID: NCT05122741 Recruiting - Clinical trials for Myocardial Infarction

Modulation of Fibrosis-inducing Pathways in Acute Myocardial Infarction

BETA-MI
Start date: December 1, 2021
Phase:
Study type: Observational [Patient Registry]

This is a single-center, prospective, observational controlled cohort study designed to describe the role of WNT/B-catenin signaling and adenosine system after an acute myocardial infarction, correlating it with clinical markers of fibrosis/remodeling (primary objective). The modulation of the aforementioned molecular patterns will also be evaluated in light of the type of P2Y12 inhibitor implemented (ticagrelor or prasugrel) to identify variations in response (secondary objective).

NCT ID: NCT05122416 Recruiting - Spleen; Fibrosis Clinical Trials

Optimization of Spleen VCTE Examinations With FibroScan

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

This is an European, prospective, interventional, and multicenter clinical investigation which main objective is to develop a spleen examination dedicated to overweight or obese patients and assess its applicability. It will take place in 4 sites (1 site in the Netherlands, 2 sites in Spain and 1 site in Romania) to include a total of 500 patients (adults and children).

NCT ID: NCT05121870 Recruiting - Clinical trials for Decompensated Cirrhosis

Treatment With Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis

Start date: September 1, 2021
Phase: Phase 2
Study type: Interventional

Decompensated cirrhosis has a high overall mortality rate. There is a large unmet need for safe and alternative therapeutic potions. This clinical trial is to inspect the efficiency and safety of mesenchymal stem cells (MSCs) therapy for decompensated cirrhosis.

NCT ID: NCT05119972 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis (IPF)

Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Start date: October 21, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study was divided into two parts. The first part was a dose escalation study: a open label dose escalation design was used to evaluate the safety, tolerance and pharmacokinetic characteristics of ZSP1603 in IPF patients. The second part was a randomized double-blind placebo-controlled design was used to preliminatively investigate the efficacy and safety of ZSP1603 in the treatment of IPF at the target dose.

NCT ID: NCT05115942 Recruiting - Liver Fibrosis Clinical Trials

Hydronidone for the Treatment of Liver Fibrosis Associated With Chronic Viral Hepatitis B Phase 3 Trial.

Start date: December 30, 2021
Phase: Phase 3
Study type: Interventional

This study was a randomized, double-blind, placebo-controlled, entecavir basic treatment, multicentre clinical study. The main objective of this study was to confirm the efficacy and safety of hydronidone in the treatment of chronic hepatitis B liver fibrosis.

NCT ID: NCT05106972 Recruiting - Liver Cirrhosis Clinical Trials

Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

This study aims to evaluate the safety and clinical efficacy of umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis B cirrhosis.

NCT ID: NCT05104541 Recruiting - Obesity Clinical Trials

Impact of Weight Loss in Cirrhosis With Obesity and MAFLD

WELCOME
Start date: November 10, 2021
Phase: N/A
Study type: Interventional

Nutrition therapy is the cornerstone of medical therapy in patients with cirrhosis. 70% compensated patients with Chronic Liver Disease (CLD) are overweight or obese. Obesity in CLD augments decompensation, plausibly through increase in portal pressure. Moreover, the cardiometabolic risk factors are increased with increase in body weight, obesity also has an impact on the already compromised health-related quality of life of patients with CLD. Most feasible, safe, and widely used method of management of obesity is life-style modifications. Hypocaloric with normal to high protein diet along with moderate-intensity exercises have been practiced for weight reduction. These kinds of dietary changes reduce body weight and may bring about favourable changes in the body composition (reduce the body fat percentage but at the same time preserving the lean body mass). Weight loss in obese patients with CLD would in turn improve the clinical outcome, reduce the hepatic complications, moreover weight loss may also improve health related quality of life, and other prognostic markers of the disease like fibroscan along with improvement in the associated metabolic derangements in patients with CLD. There is no Indian data in this context. Thus, through this trial, investigator would be able to ascertain an appropriate lifestyle-related non- intervention regimen that helps in the management of obesity in patients with cirrhosis. Not only that the baseline information of these obese patients with CLD would give us an idea or the profile of the body composition in terms of muscularity, adiposity, sarcopenic obesity (if any), of these patients with CLD.

NCT ID: NCT05100823 Recruiting - Cystic Fibrosis Clinical Trials

Validation of Therapeutic Efficacy Targeting the Splicing Variants in Cystic Fibrosis and CFTR Pathologies

ONB-CFTR
Start date: March 30, 2022
Phase: N/A
Study type: Interventional

Cystic Fibrosis, an inherited autosomal recessive disease, arises from mutations in the CFTR gene. For intronic mutations affecting splicing events, oligonucleotides therapy has the potential to restore the production of the full length CFTR protein. Recent scientific research has demonstrated the potential of this approach to restore full length mRNA CFTR in in vitro human airway cells. The study aims to validate the therapeutic efficacy of oligonucleotide blockers (ONB) that target splicing defects associated to splicing variants in epithelia obtained from patients with Cystic Fibrosis and CFTR-related disorders.

NCT ID: NCT05099939 Recruiting - Cystic Fibrosis Clinical Trials

Identification of Dysglycemia With Continuous Glucose Monitoring to Assess Clinical Evolution in Cystic Fibrosis

ProspeC-F
Start date: November 25, 2021
Phase:
Study type: Observational [Patient Registry]

Cystic fibrosis (CF)-related diabetes (CFRD) is the most important emerging complication after pulmonary complications. This specific form of diabetes is associated with an increased morbidity and mortality. CFRD prevalence at the age of 10 is 10% and reaches 40 to 50% in adulthood, while a similar percentage is afflicted with milder dysglycemia also called pre-diabetes abnormalities. In order to identify patients at risk and to implement early therapeutic measures, an annual CFRD screening test is recommended for CF patients after 10 years of age. The standard 2-hour oral glucose tolerance test (OGTT) is the recommended screening test. However, this test is perceived by both patients and CF care teams as unpleasant while adding a significant burden and workload, resulting in screening rates lower than 50% in most centers. An ideal alternative test should be simpler, less invasive, more sensitive than an OGTT to establish risks for lung function and/or nutritional deterioration, and predict future CFRD risk. To date, compared to the OGTT, no alternative screening method has demonstrated its effectiveness. However, continuous glucose monitoring (CGM) is emerging as a possible alternative method. In patients living with CF, CGM is easy to use and can identify early dysglycemia, which in turn, can predict increased risk of accelerated decline of pulmonary function and/or weight, higher risk of pseudomonas colonization, and future risk of CFRD. However, these observations are based on studies of small sample size with very limited prospective data. Furthermore, many of the multiple CGM metrics that have been standardized are based on the risk of complications associated with Type 1 and Type 2 Diabetes. Thus, there is a need for prospective studies to identify the CGM metrics and the cut-off level that is relevant as a predictor of clinical deterioration and/or CFRD risk in CF. The identification of such CF-specific criteria would provide important information to target at-risk patients.