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Fibrosis clinical trials

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NCT ID: NCT00753987 Completed - Cystic Fibrosis Clinical Trials

Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis

Start date: March 2006
Phase: Phase 1
Study type: Interventional

The objective of the study is to determine whether or not inhalation of hypertonic saline will be tolerated by infants with cystic fibrosis and the effect of inhalation on their lung function.

NCT ID: NCT00751647 Completed - Cystic Fibrosis Clinical Trials

Cystic Fibrosis Core Strengthening and Respiratory Exercise Program

CSREP
Start date: December 2008
Phase: Phase 2
Study type: Interventional

The purpose of this project is to determine the short-term effects of a customized Core Strengthening and Respiratory Exercise Program (CSREP) on children with cystic fibrosis (CF) between the ages of 10 and 21 who are receiving outpatient care at Children's Hospitals and Clinics of Minnesota. The CSREP, which will be provided by a physical therapist and a physical therapist assistant, consists of specific breathing techniques and core strengthening exercises, designed to improve rib cage mobility, pulmonary function, aerobic capacity, posture, and core strength. Currently the CF population at Children's receives physical therapy on an inpatient basis only. The overall goal of this program is to prove the viability of an outpatient exercise program for this population. Specific aims include: - To customize a CSREP protocol per each patient - To measure patient outcomes at baseline and six months - To develop a satisfaction tool in order to measure patient experience and satisfaction

NCT ID: NCT00750932 Completed - Cystic Fibrosis Clinical Trials

Biodistribution of Neutrophile Proteases in the Sputum of Patients Affected by Cystic Fibrosis

Pro-Muco
Start date: January 2008
Phase: N/A
Study type: Observational

The purpose of the proposed project is to characterize the neutrophile proteases which participate in the chronic inflammatory phenomenon associated with the cystic fibrosis and which are responsible for the degradation of the lung tissue. The respiratory failure which results from it is one of main causes of the fatal evolution of this pathology but the anti-inflammatory therapies based on the use of antiproteases targeting specifically the soluble elastase did not end, until now, in the hoped results. The identification of the other noxious targets is a crucial element to give new orientations to the anti-inflammatory strategies based on the administration of antiproteases which remain a promising way.

NCT ID: NCT00744939 Completed - Renal Insufficiency Clinical Trials

Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist

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

Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist injection. Subjects will be screened within 48 hours of previously scheduled MRI, those meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post MRI with visits occuring at 1yr and 2 yr timepoints, in addition follow-up phone calls conducted at 1, 3, 6 and 18 months to assess for skin changes suggestive of NSF.

NCT ID: NCT00743483 Completed - Cystic Fibrosis Clinical Trials

Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency

Start date: August 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and pancreatic insufficiency following treatment with BSSL

NCT ID: NCT00742092 Completed - Cystic Fibrosis Clinical Trials

Miglustat in Cystic Fibrosis

Start date: August 2008
Phase: Phase 2
Study type: Interventional

Single Center, Double-Blind, Randomized, Placebo-Controlled, Two-Period/Two-Treatment Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del Mutation

NCT ID: NCT00737100 Completed - Cystic Fibrosis Clinical Trials

Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis

Start date: September 2008
Phase: Phase 2
Study type: Interventional

This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations

NCT ID: NCT00736840 Completed - Clinical trials for Chronic Liver Disease

BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

MBT
Start date: August 2008
Phase: Phase 3
Study type: Interventional

This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.

NCT ID: NCT00730509 Completed - Cystic Fibrosis Clinical Trials

Effects of 5-Methyltetrahydrofolate and Vitamin B12 Supplemetation on Red Cell Membrane in Children With Cystic Fibrosis

Start date: April 2004
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether 5 - methyltetrahydrofolate and vitamin B12 supplementation can ameliorate cell plasma membrane features in pediatric patients with cystic fibrosis

NCT ID: NCT00727285 Completed - Cystic Fibrosis Clinical Trials

Cystic Fibrosis (CF) Leukocyte Genes as Biomarkers for Novel Therapies

Start date: February 2008
Phase: N/A
Study type: Observational

Presently, effectiveness of treatments for CF lung disease is judged by improvement in lung function (FEV1). However, in CF patients, FEV1 can range from severely decreased to normal, and improvements may occur slowly. Thus, clinical trials require many patients over prolonged periods to evaluate medications. As the pace of drug development accelerates, it is no longer possible to test all of the promising candidate therapies using conventional study designs. A sensitive technique for assessing lung inflammation has been developed which uses the expression of genes located in circulating blood cells. Mononuclear cells pass repeatedly through the blood vessels of the lung, and are exposed to many of the inflammatory products that are present in the airways. Over the past 4 years the investigators have identified a small group of candidate genes that are unregulated or downregulated in response to antibiotic treatment. The investigators now propose to prospectively test this method of quantifying lung inflammation in a large group of CF patients undergoing treatment of pulmonary exacerbations. Blood will be sampled before and after antibiotic treatment for a pulmonary exacerbation, and the relative change in gene expression will be compared to improvement in FEV1 and other clinical responses, to determine the utility of this method for use in studies. If successful, this technique could allow for a rapid and noninvasive method to gauge immediate effects by new treatments, and assist caregivers in determining optimal treatment strategies for the individual.