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Fibrosis clinical trials

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NCT ID: NCT04183790 Completed - Cystic Fibrosis Clinical Trials

Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older

Start date: February 17, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF).

NCT ID: NCT04178096 Completed - Cirrhosis, Liver Clinical Trials

Using Data-Driven Implementation Strategies to Improve the Quality of Cirrhosis Care

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

This Veteran Affairs (VA) Quality Improvement project aims to understand which data-driven implementation strategies promote evidence based practices that improve high-quality care for Veterans with cirrhosis.

NCT ID: NCT04177251 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Cardiovascular Fibrosis in Idiopathic Pulmonary Fibrosis

CardioIPF
Start date: October 21, 2019
Phase:
Study type: Observational

Fibroproliferative diseases, including pulmonary, cardiac and vascular fibrosis share common pathogenetic mechanisms. Furthermore, cardiovascular comorbidities are frequently found in patients with IPF. However, the prevalence of cardiac and vascular fibrosis in patients with IPF have yet to be determined. Main Purpose of this study is to evaluate, with non-invasive methods (echocardiogram, endothelial function and pulse wave velocity) and blood biomarkers (galectins-3, osteopontin, periostin and pro-BNP), the presence of vascular fibrosis (vascular rigidity and endothelial function) and cardiac fibrosis (prevalence of HFpEF - Heart Failure with Preserved Ejection Fraction) in patients with idiopathic pulmonary fibrosis (IPF), compared to healthy controls.

NCT ID: NCT04176328 Completed - Cystic Fibrosis Clinical Trials

Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients

Start date: October 25, 2019
Phase: Phase 1
Study type: Interventional

Cystic Fibrosis (CF) is the most common autosomal recessive lethal disorders affecting 1:2.500 newborns among Caucasians. CF patients are peculiarly susceptible to infection and colonization of the respiratory tract with pathogens. In particular, Methicillin-resistant Staphylococcus aureus (MRSA) has become the third most prevalent bacterium in CF in the U.S. and has been increasing in other countries. Apart from the difficulty of treating the infection because of its antimicrobial resistances, MRSA is transmissible between individuals with and without CF. Chronic MRSA infection is associated with worse outcomes, and treatment/eradication is challenging. Antibiotic dosing and choices should be optimized to minimize further resistance and to maximize chances of successful therapy. Yet, MRSA has several mechanisms to escape clearance by the immune system and antibiotic killing. For these reasons, a better understanding of preventive measures and early therapy is of key importance. In consideration of all these assessments there is an emerging consensus that MRSA is an important pathogen in CF rather than simply a marker of severe disease. However, to date there are no guidelines or recommendations on the choice of antibiotics for MRSA in CF. Glycopeptides are an important class of antibiotics active against Gram-positive pathogens. These include teicoplanin and vancomycin, which are currently in widespread use and are active against MRSA. Teicoplanin is often preferred to vancomycin for intravenous treatment because of its better safety profile but its use in MRSA lung infection is limited by its limited lung penetration. Teicoplanin is mainly used for injection/infusion. Inhalation of anti-microbial drugs is a cornerstone in the treatment of patients with CF, since inhaled antibiotics decrease the rate of decline of lung function, improve the quality of life, and reduce the frequency of exacerbations and hospital admissions. It is expected that, using inhalation route, efficacy would be improved and risk of resistance reduced. At present, no antibiotic active against MRSA is available as an inhaled formulation. The objective of this phase I, first-in-man clinical study is to identify the dose providing, after single inhalation administration, a sputum Teicoplanin concentrations exceeding the drug concentration required to inhibit bacterial growth for at least 8 hours, while minimizing the development of resistance.

NCT ID: NCT04171583 Completed - Cystic Fibrosis Clinical Trials

Mucoid Staphylococcus Aureus in Cystic Fibrosis Airways

mucostaph
Start date: March 1, 2019
Phase:
Study type: Observational

Recently, the investigators described a new mucoid phenotype of Staphylococcus aureus cultured from the airways of cystic fibrosis (CF) patients.In this observational study, the investigators plan to determine the prevalence of mucoid S. aureus in respiratory specimens of CF patients and a possible impact of mucoid S. aureus on lung disease severity.

NCT ID: NCT04170114 Completed - Cystic Fibrosis Clinical Trials

Comparison of the Efficacy of Comprehensive Respiratory Physiotherapy in Children With Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The effect of comprehensive respiratory physiotherapy applications on respiratory function, functional capacity and peripheral muscle strength in children with cystic fibrosis and non-cystic fibrosis will be compared.

NCT ID: NCT04161313 Completed - Cystic Fibrosis Clinical Trials

Respiratory Function, Exercise Capacity and Peripheral Muscle Strength Among Patients With CF, PCD and Healthy Children

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

The aim of this study is to compare pulmonary function, respiratory muscle strength, exercise capacity and peripheral muscle strength of patients with CF, PCD and healthy childrens.

NCT ID: NCT04158986 Completed - Liver Cirrhosis Clinical Trials

Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis

NurseAID
Start date: December 1, 2019
Phase: N/A
Study type: Interventional

In a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis compared with standard follow-up will be investigated.

NCT ID: NCT04155515 Completed - Cirrhosis Clinical Trials

A Phase III Study to Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and RBV for HCV Type I Patients

Start date: June 13, 2019
Phase: Phase 3
Study type: Interventional

A Phase III, Multicenter, open-labeded study to Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and Ribavirin for 12 weeks of treatment in HCV Genotype I Infected Patients

NCT ID: NCT04153669 Completed - Clinical trials for Cystic Fibrosis in Children

Exercise With or Without Electrical Stimulation in Cystic Fibrosis (Part I): Effects on Physical Fitness

ECOMIRIN
Start date: January 15, 2019
Phase: N/A
Study type: Interventional

This study aims to assess the effects of programmed exercise with or without electrical stimulation in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis: A randomized controlled trial comparing two interventions with a control group.