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Fibrosis clinical trials

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NCT ID: NCT05012228 Recruiting - Renal Fibrosis, CKD Clinical Trials

Molecular Mechanisms of Fibrillin/LTBP Superfamily in Renal Fibrosis and Cardiorenal Syndrome

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

This project is to understand the LTBP4 expression in human renal fibrotic tissues. The investigators will exam major location of LTBP4 expression and check any similar or discrepancy in renal fibrosis with different etiologies.

NCT ID: NCT05011305 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis

NASH
Start date: August 18, 2021
Phase: Phase 2
Study type: Interventional

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

NCT ID: NCT04996303 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis With Acute Exacerbation

Efficacy of Steroid Pulse Therapy in Acute Exacerbation of Idiopathic Pulmonary Fibrosis (AE-IPF) Admitted in ER

Start date: July 27, 2021
Phase: N/A
Study type: Interventional

Idiopathic pulmonary fibrosis is the most severe form of interstitial lung disease. It is known that the prognosis is poor due to extensive inflammation and fibrosis of the lung parenchyma. In case of acute exacerbation, the prognosis becomes worse. In early studies, the 3-month mortality rate reached 50-80%, and in a recent study, the 1-month survival rate was 66%, and the 3-month survival rate was 41%. It is known that 20% of patients with IPF will experience acute exacerbations in their lifetime. The most commonly used treatment for such acute exacerbations is antibiotics and high-dose steroids, or steroid pulse therapy. However, its effectiveness is unclear, and the survival rate is still low. However, as there is no evident therapeutic agent other than steroids, it is included in the treatment guidelines, so conservative treatment is administered while steroids are administered to patients with acute exacerbation of idiopathic pulmonary fibrosis in most upper institutions. There is no precise treatment other than steroids for patients with idiopathic pulmonary fibrosis-acute exacerbation, but the side effects of steroid administration cannot be overlooked. Therefore, a study is needed to confirm whether steroid pulse therapy is necessary or not. 1. Inclusion criteria - Among patients with clinically or histologically confirmed idiopathic pulmonary fibrosis, patients who visited the emergency room with dyspnea symptoms - Patients within 1 month of exacerbation of respiratory symptoms - Patients with increased GGO or worsening of IPF on chest CT within the last 2 weeks - Patients who understand the purpose of the clinical study and voluntarily agree to participate in this clinical study - When it is determined that steroid administration is necessary under the judgment of the medical staff during the treatment process 2. Exclusion criteria - Patients who complain of dyspnea symptoms due to causes other than the respiratory system, such as fluid overload, congestive heart failure, pulmonary embolism, etc. - Patients whose respiratory symptoms have worsened for more than 1 month - Persons who cannot read consent forms (eg. illiterate, foreigners, etc.) 3. Study design Using an open-label RCT randomization method, the administration will be divided into Group 1 (high-dose followed by low-dose steroid administration) and Group 2 (high-dose/low-dose steroid administration after steroid pulse therapy). - Test group: Group 1 (high dose followed by low dose steroid administration) - Control group: Group 2 (high-dose/low-dose steroid administration after steroid pulse therapy) ▶ Steroid administration Protocol Group 1: Methylprednisolone 1 mg/kg 7 days → 0.5 mg/kg 7 days → 0.25 mg kg 7 days Group 2: Methylprednisolone 10 mg/Kg (500 mg ~ 1g) pulse 3 days -> Methylprednisolone 1 mg/kg 7 days → 0.5 mg/kg 7 days → 0.25 mg/kg 7 days Response evaluation 1. The level of inflammatory markers 2. Imaging improvement: chest x-ray or CT 3. Pulmonary function test: performed at the outpatient clinic before discharge or 12 weeks after the first visit for acute exacerbation

NCT ID: NCT04994301 Recruiting - Cystic Fibrosis Clinical Trials

Evaluation of Lung T1-MRI in Pediatric Cystic Fibrosis Patients

Start date: December 15, 2020
Phase:
Study type: Observational

In this observational study, the investigators evaluate the sensitivity of T1-MRI to identify lung perfusion changes in pediatric patients with CF (age = 6-11) before and after initiating FDA-approved Trikafta therapy. The investigators compare these Lung T1 MRI assessments (% Normal lung perfusion) to currently best-available assessments of lung function in CF patients (i.e., MBW (LCI( and Spirometry (FEV1 % Predicted).

NCT ID: NCT04986137 Recruiting - Acute Kidney Injury Clinical Trials

Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis

Start date: September 4, 2021
Phase:
Study type: Observational

The aim of this study is to evaluate: - The diagnostic performance of Fractional Excretion of Urea (FEUrea) for the differential diagnosis of acute kidney injury in patients with cirrhosis and ascites presenting to a tertiary care hospital. - The ability of Fractional Excretion of Urea to distinguish between 1. structural group of acute kidney injury (acute tubular necrosis) versus functional group of acute kidney injury (prerenal azotemia and hepatorenal syndrome), and 2. types of functional group (prerenal azotemia versus hepatorenal syndrome type 1).

NCT ID: NCT04971577 Recruiting - Alcohol Abuse Clinical Trials

Efficacy of Simvastatin in Alcoholic Liver Fibrosis

SIMFIB
Start date: February 22, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Evaluate the efficacy of simvastatin in reducing liver fibrosis in patients with advanced fibrosis due to alcohol

NCT ID: NCT04970225 Recruiting - Cystic Fibrosis Clinical Trials

Cystic Fibrosis Blood Neutrophils

MUCO-PNN
Start date: July 8, 2021
Phase: N/A
Study type: Interventional

The purpose of this prospective study is to analyze function and phenotype of blood neutrophils in cystic fibrosis patients and the impact of Pseudomonas aeruginosa chronic infection, treatment with CFTR modulators and acute exacerbation on blood neutrophils phenotype and function.

NCT ID: NCT04966234 Recruiting - Cystic Fibrosis Clinical Trials

A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection

cASPerCF
Start date: April 22, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study will provide: (1) new insights in the prevalence of Aspergillus infection in children and adolescents with CF aged 8-17 yrs; (2) an in silico modelled dose of posaconazole for children and adolescents with CF and Aspergillus infection aged 8-17 yrs; (3) an intensive sampling PK study to define the optimal dose in a limited number of children and adolescents with CF and Aspergillus infection aged 8-17 yrs; (4) a prospective clinical validation to reduce the residual variability and to allow investigation into PK-PD; and (5) an efficacy evaluation of this dosing regimen to treat Aspergillus infection in children and adolescents with CF to inform future primary efficacy trials.

NCT ID: NCT04965298 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole

TIPAL
Start date: June 16, 2021
Phase: Phase 3
Study type: Interventional

IPF is a progressive scarring lung condition causing coughing and breathlessness. IPF patients often have reflux disease meaning stomach acid may be breathed into the lungs, potentially damaging them. Medicines which stop stomach acid production, proton pump inhibitors (PPIs), can be used to reduce reflux symptoms including heartburn. Some researchers suggest PPIs also reduce IPF progression. This research aims to see if IPF progresses slower if treated with PPIs. Based on the results, we will be able to recommend whether or not IPF patients should take PPIs. This trial will involve 298 IPF patients from approximately 37 UK hospitals. At the beginning of the study, we will ask patients to start performing weekly breathing tests at home using equipment provided, and ask those with a cough to use a device to count the number of times they cough in 24hours. We will ask them to answer two questions rating their coughing and breathlessness, and complete questionnaires on their coughing, IPF, sleep habits and general condition. People will be given a PPI, called lansoprazole, or dummy tablets, twice per day for 12 months. They will be given a leaflet telling them what to do about reflux symptoms. At the end of the study, we will repeat these tests and analyse the results. We will record any side effects people may get. If people suffer side effects, they can reduce the dose. People taking medicines that interact with PPIs or have other serious medical conditions won't be able to participate. People receiving PPIs will only be able to participate if they can stop taking their medication without their heartburn returning.

NCT ID: NCT04956328 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Study of Obeticholic Acid(OCA) Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)

Start date: July 22, 2021
Phase: Phase 3
Study type: Interventional

Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion. Conventional therapy with obecholic acid will improve liver function of patients with PBC.