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Fibrosis clinical trials

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NCT ID: NCT01537965 Completed - Liver Fibrosis Clinical Trials

Evaluation of Innovative Ultrasonic Techniques for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Viral Hepatitis B or C

FIBRECHO
Start date: January 2012
Phase: N/A
Study type: Interventional

The non-invasive assessment of liver fibrosis in chronic viral hepatitis B and C is now entering clinical practice. It is based on blood tests, especially FibroMetre® and Fibrotest® and on elastography with the Fibroscan®. Despite the overall satisfactory diagnostic performance for all of these tests (AUROC ranging from 0.80 to 0.90 depending on the study) for the discrimination of F≤1 versus F≥2, the positive and negative predictive values , however, are far from be perfect in a given patient. With these technique, failures are also possible and the measures do not meet quality standards that increase the risk of misclassification. It would be particularly useful to have new generation techniques with a better diagnostic performance. In this project, in response to the problems presented above, we propose to evaluate the diagnostic performance of five innovative ultrasonic techniques for the non-invasive diagnosis of fibrosis.

NCT ID: NCT01537614 Completed - Cystic Fibrosis Clinical Trials

Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis

COLI-VLM
Start date: October 2011
Phase: Phase 1
Study type: Interventional

Pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2M UI colimycin either as an aerosol or after IV injection, the administration being separated by 5 to 10 days intervals

NCT ID: NCT01532427 Completed - Liver Cirrhosis Clinical Trials

ALFApump System Post Marketing Surveillance Registry

2011-AAR-004
Start date: June 2012
Phase:
Study type: Observational [Patient Registry]

This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.

NCT ID: NCT01531673 Completed - Cystic Fibrosis Clinical Trials

Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation

Start date: February 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in participants with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del-CFTR mutation.

NCT ID: NCT01529853 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)

Start date: January 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objective: To assess in adult patients with Idiopathic Pulmonary Fibrosis (IPF) the safety and tolerability of ascending doses of SAR156597 administered subcutaneously (SC) once weekly over a 6-week period. Secondary Objectives: To assess in adult patients with IPF: - The pharmacodynamic effects of SAR156597, as measured on pulmonary function tests (PFTs), pulse oximetry and patient reported outcome and peripheral blood biomarkers. - The trough plasma concentrations of SAR156597 - The potential immunogenicity of SAR156597.

NCT ID: NCT01524562 Completed - Fibrosis Clinical Trials

HIV Accelerated Liver Disease in Uganda

Start date: December 20, 2011
Phase:
Study type: Observational

Background: - Liver disease is a leading cause of death in people who have the human immunodeficiency virus (HIV). It especially affects those who have both HIV and hepatitis B or C viruses. Most research on HIV-related liver disease has been conducted in North America and Europe. However, HIV-related liver disease in Uganda and other African nations may involve other diseases that are not common in the West, and may not involve hepatitis B or C. Researchers want to study HIV-related liver disease in Uganda to learn more about the differences between Western and African trends of this disease. Objectives: - To study HIV-related liver disease in rural Uganda. Eligibility: - Individuals at least 18 years of age who were tested for possible liver disease. Some participants will have HIV infection; others will be uninfected. - All participants will be from rural areas of Uganda. Design: - Participants will have at least two study visits. - Participants will have a physical exam and medical history. They will complete a questionnaire about health and quality of life. Blood, urine, and stool samples will be collected. Participants will also have a liver scan to check for liver scarring, and an ultrasound to take images of the liver. - Participants who may have liver disease will visit a local hospital for more tests. A liver biopsy will be performed to collect liver tissue samples.

NCT ID: NCT01521338 Completed - Cystic Fibrosis Clinical Trials

G551D Observational Study- Expanded to Additional Genotypes and Extended for Long Therm Follow up (GOAL-e2)

GOAL- e2
Start date: January 2014
Phase:
Study type: Observational

The goal of this research study is to collect blood and urine samples from people who have either the R117H type of CF or the non-G551D gating type of CF to be kept for future research.We will also use some of the collected blood to measure the number of neutrophils.

NCT ID: NCT01519661 Completed - Clinical trials for Pulmonary Infections

Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis

Start date: January 2012
Phase: Phase 4
Study type: Interventional

This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.

NCT ID: NCT01515007 Completed - Clinical trials for Non Cystic Fibrosis Bronchiectasis

Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)

Start date: March 31, 2014
Phase: Phase 3
Study type: Interventional

This study (ARD-3150-1201, ORBIT-3) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.

NCT ID: NCT01510860 Completed - Clinical trials for Primary Biliary Cirrhosis

Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis

Start date: November 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).