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Fibrosis clinical trials

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NCT ID: NCT02423447 Completed - Cystic Fibrosis Clinical Trials

Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With CF

Start date: November 2013
Phase: N/A
Study type: Interventional

It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.

NCT ID: NCT02421120 Completed - Cystic Fibrosis Clinical Trials

Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients

Start date: September 2015
Phase: Phase 4
Study type: Interventional

There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Ceftolozane/Tazobactam is a newly approved broad spectrum intravenous antibiotic, which has potent in vitro activity against multidrug resistant Pseudomonas aeruginosa, the most common pathogen implicated in CF pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of ceftolozane/tazobactam in 20 adult CF patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the US. Patients will remain on standard of care IV antibiotics and receive 4-6 doses of ceftolozane/tazobactam 3 grams every 8 hours. Blood will be sampled after the final dose to determine concentrations and pharmacokinetics of ceftolozane and tazobactam. Safety and tolerability will be assessed throughout the 3 day study.

NCT ID: NCT02421094 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis

NASH-FX
Start date: September 2015
Phase: Phase 2
Study type: Interventional

A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis in Patients with NASH with Advanced Fibrosis

NCT ID: NCT02416375 Completed - Cystic Fibrosis Clinical Trials

Home Monitoring to Predict Exacerbation in Cystic Fibrosis

SmartCare
Start date: May 2015
Phase:
Study type: Observational

The study aims to establish if it is possible for people with Cystic Fibrosis to monitor a number of parameters on a daily basis at home which might predict respiratory infections before they have symptoms and which might also predict treatment failures before this is obvious with conventional measures.

NCT ID: NCT02415959 Completed - Clinical trials for Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis

Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Start date: March 2015
Phase: Phase 2
Study type: Interventional

The objective of this study is to assess the efficacy and safety of different doses of Creon Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant (DR/GR) in subjects with Pancreatic Exocrine Insufficiency (PEI) due to Cystis Fibrosis (CF).

NCT ID: NCT02412241 Completed - Lymphedema Clinical Trials

Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

Start date: June 2015
Phase: N/A
Study type: Interventional

This four-year, prospective, longitudinal study will evaluate and validate a patient-reported outcome measure, clinician-reported outcome measures, and imaging techniques in assessing characteristics, trajectory, and progression of lymphedema and fibrosis (LEF) in oral cavity and oropharyngeal cancer patients. This clinical trial studies patient-and-clinician-reported measures as well as standard imaging methods to see how accurate they are in identifying and evaluating lymphedema (swelling) or fibrosis (tough or tight tissue) in the head and neck region of patients receiving treatment for newly diagnosed stage II-IV oral cavity or oropharyngeal cancer. Lymphedema and fibrosis (LEF) can lead to physical symptoms, such as trouble swallowing and chewing, as well as psychological and emotional symptoms, such as negative body image and avoiding social interactions. Finding an accurate test to identify and evaluate LEF may allow doctors to treat LEF more quickly and control symptoms more effectively, and thus provide patients with a better quality of life.

NCT ID: NCT02412111 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor

Start date: June 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive.

NCT ID: NCT02408744 Completed - Clinical trials for Chronic Kidney Disease

Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease

Start date: September 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study was to evaluate the impact in safety and efficacy of a new formulation of prolonged-released Pirfenidone in the progression of renal damage in patients with Chronic kidney Disease (CKD).

NCT ID: NCT02407197 Completed - Clinical trials for Coronary Artery Disease

International T1 Multicentre CMR Outcome Study

T1-CMR
Start date: January 2011
Phase:
Study type: Observational [Patient Registry]

Myocardial fibrosis is the fundamental substrate for the development of heart failure. Cardiovascular magnetic resonance (CMR) allows non-invasive assessment of myocardial fibrosis based on late gadolinium enhancement (LGE) and T1 mapping. Patients: Prospective longitudinal observational multicenter study of consecutive patients with suspected or known non-ischemic cardiomyopathy. Imaging: Non-invasive measures of myocardial fibrosis: native T1, extracellular volume fraction (ECV) and LGE. Primary endpoints: all cause and cardiovascular mortality. Secondary endpoints: arrhythmic composite and HF composite endpoints.

NCT ID: NCT02400216 Completed - Cirrhosis Clinical Trials

Deciphering the Mechanisms Involved in Microbial Translocation Across the Spectrum of HCV Associated Liver Fibrosis

Start date: May 29, 2015
Phase:
Study type: Observational

Background: - Hepatitis C infection (HCV) is a leading cause of liver disease. Normal bacteria from the intestines may spread to the liver and blood during liver disease. This is called bacterial translocation (BT). Researchers think BT may cause liver disease to worsen. Objectives: - To study the mechanisms involved in BT in early and advanced liver disease. To find out whether BT causes liver disease to worsen. Eligibility: - People over age 18 with HCV and clinically stable liver disease. Design: - Participants will be screened with medical history and physical exam. They will have blood tests and imaging studies. - Participants will have 2 outpatient visits and a 3-day stay at the clinic. - At visit 1, participants will have urine and blood tests. They will have a magnetic resonance imaging (MRI) scan. A solution will be injected into a vein. The MRI scanner is a metal cylinder surrounded by a magnetic field. The participant will lie on a table that slides in and out of the cylinder. - At visit 2, a substance will be injected into a vein and swallowed. Participants will then have blood drawn 5 times over 90 minutes. - During the inpatient stay, serial blood tests will be drawn. - Participants will give 2 stool samples and have another MRI. - A needle will be inserted through the chest wall into a vein inside the liver, guided by ultrasound. The blood pressure inside this vein will be measured and blood will be drawn from it. About 1 inch of liver tissue will be removed. - A study investigator will call participants to discuss all test results.