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Fibrosis clinical trials

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NCT ID: NCT03768089 Completed - Cystic Fibrosis Clinical Trials

Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis

Start date: March 20, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy subjects and in subjects with cystic fibrosis (CF).

NCT ID: NCT03760120 Completed - Cystic Fibrosis Clinical Trials

Short-term Effects of Physiotherapy on LCI

SPICy
Start date: November 21, 2016
Phase: N/A
Study type: Interventional

Although some studies have brought some evidences about the efficacy of positive expiratory pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly understood what is the contribution of this technique in modifying peripheral ventilation inhomogeneity, a typical feature of patients with Cystic Fibrosis (CF). The aim of this study is to investigate how PEP-MASK affects ventilation inhomogeneity in children and adolescents, with moderate to normal CF lung disease by the change in acinar airways (Sacin), lung clearance index (LCI) and conductive airways (Scond) indexes derived from nitrogen multiple-breath washout test (N2MBW).

NCT ID: NCT03759158 Completed - Liver Cirrhoses Clinical Trials

N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Contrast induced nephropathy has an incidence of 7-11 % in patients undergoing Contrast imaging for various conditions. The risk associated with the development of CIN are still under evaluation. Even with patients having normal kidney functions there is a risk of contrast induced nephropathy hence the need for markers which could predict injury. Cirrhosis of liver predisposes patient to Kidney abnormalities as these patients lower renal reserve and can have various conditions like Hepatorenal syndrome, Sepsis, ATN. Contrast imaging is vital for ruling out conditions like Hepatocellular Carcinoma in patients of cirrhosis of liver. Presently there is no study in cirrhosis of liver which studies the Effect of N-acetyl cysteine before and after contrast imaging in the prevention Of CIN. The incidence of CNI is cirrhosis is also an avenue which requires more studies and also there is a need for formulation of a Score to predict this CIN. Hence this study is being done to assess the incidence of CNI and the role of N-Acetyl cysteine in Preventing CNI.

NCT ID: NCT03757741 Completed - Atrial Fibrillation Clinical Trials

Inflammation, Fibrosis and Risk of Recurrence After Atrial Fibrillation Ablation

FIBRO-RISK
Start date: February 1, 2019
Phase:
Study type: Observational

FIBRO-RISK study aims to investigate the impact of inflammatory-mediated myocardial fibrosis on the risk of recurrence after successful ablation of atrial fibrillation. The level of systemic inflammation in the pre-ablation and immediate post-ablation period will be assessed on the basis of serum levels of inflammatory biomarkers (hs-CRP, matrix metalloproteases, interleukin-6), while the level of cardiac fibrosis will be determined based on MRI imaging associated with complex post-processing techniques for mapping myocardial fibrosis at the level of left atrium and left ventricle. At the same time, the amount of epicardial fat will serve as an indirect marker of localized inflammation and will be determined at different levels in the heart (surrounding left atrium, right atrium or the entire heart), while ventricular function will be assessed on the basis of serum levels of NT pro-BNP prior to the procedure. All these parameters will be investigated in patients with successful ablation of AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at 1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the following biomarkers will be determined: serum levels of inflammatory biomarkers and NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days. The primary endpoint of the study will be represented by the rate of AF recurrence at 1-year post ablation, documented by either ECG or Holter monitoring. The secondary endpoints of the study will be: - rate of re-hospitalization - rate of survival without relapse - rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)

NCT ID: NCT03754088 Completed - Cystic Fibrosis Clinical Trials

In Vitro Model of the Cystic Fibrosis Bronchial Epithelium Via iPS Technology

PaCyFIC
Start date: November 5, 2018
Phase:
Study type: Observational

In order to further enable physiopathology studies, the aim of this project is to validate an in vitro model of cystic fibrosis created using induced pluripotent stemcell (iPS) differentiated bronchial epithelium from cystic fibrosis (CF) patients homozygous for the p.Phe508del mutation of the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

NCT ID: NCT03753828 Completed - Clinical trials for Cystic Fibrosis Lung

Estimated Impact of Fungal Colonization in Cystic Fibrosis From Secondary Exploitation of MucoFong Database.

MucoFong2
Start date: July 13, 2017
Phase:
Study type: Observational

The main objective of the project "MucoFong" (19021906 national french program n which Vaincre La Mucoviscidose participated: N82006/ 351) was to determine the fungi present the respiratory tract of CF patients responsible for either colonization or authentic infectious diseases. The Mucofong data allowed the team to provide for the 1st time national French guidelines for the management of CF sputum mycological analysis (MucoMicrobes work group coordinated by Prof. Plésiat published in 2015 in the REMIC book). Nevertheless, the team has a comprehensive database that it still has to analyze beyond these initial results. The main goal today is to clarify the role of fungi in the lung function degradation of these patients by studying the overall risk and estimated impact of fungal colonization in our cohort.

NCT ID: NCT03748563 Completed - Liver Cirrhosis Clinical Trials

Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of EGV in Patients With Cirrhosis

Start date: January 7, 2021
Phase: N/A
Study type: Interventional

This is a diagnostic accuracy study. Eligible individuals will be enrolled and asked to undergo ds-MCE and EGD examinations. EGD is the reference standard against which ds-MCE is compared, and it will be performed within 48 hours after ds-MCE examination. The primary outcome is the sensitivity and specificity of ds-MCE in identifying the presence of esophagogastric (EGV) in patients with cirrhosis, using detection by EGD as the reference. The diagnostic accuracy of ds-MCE in detection of high-risk EV, high-risk EGV, EV, large EV, red signs of EV, GV, cardiofundal GV and PHG compared with the EGD will also be assessed. The incidence of PHE in small bowel under ds-MCE, the examination time of ds-MCE and EGD procedures, patient satisfaction assessment and safety evaluation will also be evaluated.

NCT ID: NCT03748199 Completed - Cystic Fibrosis Clinical Trials

Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF

Start date: November 8, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

"This is a randomised, double-blind, placebo-controlled multi-centre study to investigate safety and tolerability and to provide pharmacokinetic and pharmacodynamics information of orally inhaled multiple doses (80 mg, 160 mg or 320 mg) of the nebulised neutrophil elastase inhibitor POL6014 in patients with Cystic Fibrosis. The controlled inhalation will occur via the eFlow® nebuliser system (manufacturer: PARI Pharma GmbH, Germany)".

NCT ID: NCT03746483 Completed - Clinical trials for Cystic Fibrosis (CF)

OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

OPTION
Start date: January 10, 2019
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).

NCT ID: NCT03738332 Completed - Clinical trials for Head and Neck Cancer

Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study

Start date: February 25, 2019
Phase: N/A
Study type: Interventional

The purpose of this pilot clinical trial is to evaluate the feasibility of the use of low-level laser for head and neck cancer survivors with lymphedema.