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Fibrosis clinical trials

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NCT ID: NCT06237335 Recruiting - Cystic Fibrosis Clinical Trials

A Phase 1 Study Evaluating Safety and Tolerability of RCT2100 in Healthy Participants

Start date: February 1, 2024
Phase: Phase 1
Study type: Interventional

This is the first-in-human study with RCT2100 and is designed to provide safety and tolerability data for future clinical studies.

NCT ID: NCT06230822 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Safety, Tolerability and Efficacy of VUM02 Injection in Treatment of Idiopathic Pulmonary Fibrosis (IPF)

DEVIF-I
Start date: February 2024
Phase: Phase 1
Study type: Interventional

This study is a single-arm, multiple-dose, dose-escalation, open-label multicenter clinical trial, aiming to evaluate the safety, tolerability, and preliminary efficacy of VUM02 Injection for treatment of idiopathic pulmonary fibrosis (IPF). VUM02 Injection (Human Umbilical Cord Tissue-derived Mesenchymal Stem Cells Injection, hUCT-MSC) is an allogeneic cell therapy product comprising culture-expanded Mesenchymal Stem Cells derived from the human umbilical cord tissue. The product is cryopreserved with the amount of 5 x 10^7 cells per 10 mL per bag (5 x 10^6 cells/mL). This study is a multiple-dose tolerability study following the "3+3" dose escalation principle and progressing from the low-dose group to the high-dose group sequentially. Three to six patients will be enrolled in each dose group and administered every 3 days for a total of 3 doses.

NCT ID: NCT06223893 Recruiting - Clinical trials for Decompensated Cirrhosis

CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis

CirrhoCare
Start date: November 24, 2023
Phase: N/A
Study type: Interventional

The CirrhoCare trial is a multi-centre, open label randomised controlled trial in patients with decompensated cirrhosis. The trial aims to investigate the clinical and cost-effectiveness of CirrhoCare digital home monitoring and management with current standard of care in these patients.

NCT ID: NCT06222905 Recruiting - Cystic Fibrosis Clinical Trials

Analysis of Remote Monitoring/Virtual Clinic Data in Adult Patients With Cystic Fibrosis (Project Breathe)

Start date: February 20, 2019
Phase:
Study type: Observational

The goal of this observational study is to learn about the impact of home monitoring in adults with cystic fibrosis. The main questions it aims to answer are: - how people with CF find using home monitoring equipment - to see if by using home monitoring data acute respiratory exacerbations (chest infections) can be detected earlier than standard care Participants will be provided with a range of home monitoring equipment - - hand held spirometer (lung function) - weighing scales - oximeter (blood oxygen levels) - activity and heart rate monitor to measure health at home several times a week. This information links to an app on a smartphone which the participant and clinicians can see.

NCT ID: NCT06221982 Recruiting - Cirrhosis Portal Clinical Trials

TIPS for PH Patients: an Observational, Cohort Study

Start date: January 1, 2021
Phase:
Study type: Observational

This is a single-center, prospective, observational study intended to include patients receiving TIPS for portal hypertension. Baseline data of enrolled patients were recorded, and samples of ascites, feces and urine were collected before surgery. Venous blood (superior mesenteric vein, hepatic vein, peripheral vein) from different parts of the entero-hepatic axis was retained during operation, and patients were followed up regularly for 2 years. The incidence of infection, hepatic encephalopathy, upper gastrointestinal hemorrhage and ascites in patients with portal hypertension who received TIPS intervention were observed within 3 months after operation. And the stent patency was observed within 2 years after surgery. To investigate the characteristics of microbial, protein and metabolic components on enterohepatic axis and their relationship with prognosis of patients with cirrhosis by detecting microbiome, proteome and metabolome.

NCT ID: NCT06216704 Recruiting - Cystic Fibrosis Clinical Trials

Skeletal Health and Bone Marrow Composition in Adolescents With Cystic Fibrosis

Start date: April 1, 2024
Phase:
Study type: Observational

The investigators will be evaluating bone marrow composition via magnetic resonance imaging in adolescents diagnosed with cystic fibrosis (CF) compared to healthy, matched controls. The investigators will also be assessing their bone mineral density via other imaging modalities, including dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT). This longitudinal project will focus on abnormalities in bone marrow composition, and specifically whether adolescents with diagnosed with CF exhibit increased bone marrow fat, its association with bone mineral density (BMD) and the underlying pathophysiology, including glycemic control, inflammation, and bone turnover markers.

NCT ID: NCT06216509 Recruiting - Cirrhosis Clinical Trials

Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

EUSPREM
Start date: January 10, 2023
Phase: N/A
Study type: Interventional

Portal hypertension (PHT) is the main consequence of advanced chronic liver diseases (ACLD) and is often associated with severe complications leading to increased morbidity and mortality. Currently, the gold standard for the evaluation of the severity of PHT is the hepatic venous-pressure gradient (HVPG). The disadvantage of using the HVPG, besides the availability of the technique only in referral centres, is in the case of patients with vascular liver disorders because the HVPG underestimates the severity of PHT. Recent studies have evaluated the feasibility of the pressure gradient measurement through endoscopic transgastric and transhepatic access using special kit with a 25-gauge FNA needle (Cook Medical, Winston-Salem, NC, USA) and a compact manometer (Cook Medical, Bloomington, Ind, USA) that has the disadvantage of high purchase cost, no tracing of pressure possible and has not yet been properly correlated with the gold standard HVPG measurement or PPG measurement thus limiting its use in current practice. The aim of the study is 1. to assess and compare the correlations in the porto-systemic gradient measurement between a) direct portal vein puncture during TIPS insertion, b) direct portal and hepatic pressure measurements using a 22 Gauge FNA needle during endoscopic ultrasound procedure and c) indirect portal vein pressure measurements using the interventional radiology based hepatic HVPG procedure in patients with cirrhosis submitted to TIPS procedure for complications of portal hypertension and 2. To evaluate and compare the porto-systemic gradient obtained by direct portal and hepatic pressure measurements using a 22 Gauge FNA needle during endoscopic ultrasound and indirect measurement through HVPG measuring in patients with presinusoidal hypertension and those with portal vein thrombosis.

NCT ID: NCT06215716 Recruiting - NASH With Fibrosis Clinical Trials

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Start date: December 1, 2023
Phase: Phase 3
Study type: Interventional

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3.

NCT ID: NCT06212635 Recruiting - Clinical trials for Inflammation in Decompensated Liver Cirrhosis

Hemostasis in Liver Cirrhosis and Hepatocellular Cancer

HELICS
Start date: December 2, 2022
Phase:
Study type: Observational

Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays.

NCT ID: NCT06206655 Recruiting - Liver Cirrhosis Clinical Trials

Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients

DALI
Start date: December 1, 2023
Phase:
Study type: Observational

Patients with liver cirrhosis (LC) often exhibit fatigue, poor oral intake, and abdominal discomfort, which are the symptoms that are also shown in subjects with adrenal insufficiency (AI). Controversy exists upon over-diagnosis of adrenal insufficiency in patients with LC, because decreased albumin and/or cortisol binding protein lower total cortisol levels while free cortisol increases/or is preserved. The investigators assumed that measuring salivary cortisol or direct free cortisol using mass-spectrometry would provide a more accurate level of cortisol in LC patients. 50 patients with LC will be recruited and undergo a rapid ACTH stimulation test and their blood/ saliva will be collected and analyzed. The difference between serum free cortisol and total cortisol, as well as between salivary cortisol and total cortisol will be investigated to find the optimal way to diagnose AI in LC patients.