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Fibrosis clinical trials

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NCT ID: NCT03078127 Completed - Cystic Fibrosis Clinical Trials

Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis

REACT-CF
Start date: February 1, 2017
Phase: N/A
Study type: Interventional

This is a pilot study investigating the effectiveness and clinical efficacy of airway clearance therapy (ACT) in cystic fibrosis (CF). Enrolled subjects will undergo measurements of mucociliary clearance (MCC) and exhaled biomarkers at baseline and after 3 different forms of ACT: high frequency chest wall oscillatory vest, oscillatory positive expiratory pressure device, and whole-body vibration.

NCT ID: NCT03074149 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Investigating Idiopathic Pulmonary Fibrosis in Greece

INDULGEIPF
Start date: April 4, 2017
Phase:
Study type: Observational

To gain further insight on the characteristics, management, disease progression and the outcomes of patients with IPF, as diagnosed and treated under real-world, clinical practice conditions in Greece. More specifically, this registry will be used to: Provide a comprehensive clinical picture of IPF, Track access to health care and cost of caring for IPF patients over time, Examine the implementation of treatment guidelines used on patients diagnosed with IPF, according to the existing diagnosis guidelines, Characterization of patients on different treatments. To provide information regarding survival and mortality causes, IPF exacerbations as well as IPF patient co-morbidities including myocardial infarction, CNS infarction, other arterial thromboembolic events, deep vein thrombosis, hemorrhage, gastrointestinal perforation and pulmonary hypertension. Data regarding IPF patient hospitalization will be collected and evaluated with regards to potential respiratory causes, and there will be documentation of treatment patterns and economic aspects. Patients will be followed up for 2 years and information regarding IPF treatment changes since the last visit will be collected.

NCT ID: NCT03070522 Completed - Clinical trials for Cystic Fibrosis Pulmonary Exacerbation

Prednisone in Cystic Fibrosis Pulmonary Exacerbations

PIPE
Start date: May 1, 2017
Phase: Phase 3
Study type: Interventional

This will be a 5 year randomized, double blind, placebo controlled trial of 7 days of oral prednisone in cystic fibrosis (CF) patients receiving intravenous (IV) antibiotic treatment for a pulmonary exacerbation at the Hospital for Sick Children and other study sub-sites across Canada. The intervention will be oral prednisone 2 mg/kg/day (max 60 mg) divided twice daily for 7 days as an adjunctive therapy for pulmonary exacerbations in CF patients who have not recovered their baseline forced expiratory volume in 1 second (FEV1) after 7 days of IV antibiotic treatment. The primary outcome will be the proportion of subjects who achieve >90% of their baseline FEV1 % predicted at day 14 of IV antibiotic treatment for a pulmonary exacerbation in each treatment arm.

NCT ID: NCT03070353 Completed - Cirrhosis, Liver Clinical Trials

Dextran, a Plasma Expander, Offers New Hope for Patients With Decompensated Liver Cirrhosis and Acute Kidney Injury

Start date: July 1, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

A pilot study of Dextran-40 infusion in patients with decompensated cirrhosis presenting with AKI

NCT ID: NCT03069625 Completed - Cystic Fibrosis Clinical Trials

Sit-to-stand Test in Cystic Fibrosis Children and Adolescents

Start date: August 31, 2017
Phase: N/A
Study type: Interventional

Cystic fibrosis (CF) is a chronic hereditary respiratory disease. Exercise testing is part of CF patients regular assessment. Cardio-Pulmonary Exercise Testing (CPET) is currently considered as the gold standard to assess physical capacities. However, simple field tests are emerging. These tests are easier to perform especially in a population of CF children and adolescents. The 1minute Sit-To-Stand test have recently been evaluated in CF adults. This test correlates with maximal oxygen consumption during CPET. The investigators hypothesized that this test also correlates with 6-Minute Walking distance (during a 6-min Walk Test), quadriceps strength, respiratory muscles strength and health-related quality of life.

NCT ID: NCT03068312 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation

Start date: July 18, 2017
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation.

NCT ID: NCT03061331 Completed - Cystic Fibrosis Clinical Trials

Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation

Start date: January 31, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation.

NCT ID: NCT03056989 Completed - Cystic Fibrosis Clinical Trials

A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis

Start date: May 31, 2017
Phase: Phase 1
Study type: Interventional

Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.

NCT ID: NCT03056612 Completed - Clinical trials for Liver Cirrhosis With Acute Decompensation

Predicting Acute-on-Chronic Liver Failure in Cirrhosis (PREDICT) Study

PREDICT
Start date: March 31, 2017
Phase:
Study type: Observational

The aim of this study is to assess prospectively the critical period prior to the development of Acute-on-Chronic Liver Failure (ACLF) (1), to uncover mechanistic and pathophysiological processes associated with the development and clinical course of ACLF (2) and to identify the precipitating events of ACLF (3).

NCT ID: NCT03056326 Completed - Cystic Fibrosis Clinical Trials

A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects

CHF6333 FIH
Start date: November 2016
Phase: Phase 1
Study type: Interventional

Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. This study is designed to investigate the tolerability, safety and pharmacokinetics of inhaled CHF6333 DPI in healthy male subjects. The study will comprise two parts: Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333. Part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333