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Lung Disease clinical trials

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NCT ID: NCT00076635 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF

Start date: November 2003
Phase: Phase 3
Study type: Interventional

Open-label therapy will be administered to up to 220 patients, following completion of either InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term safety of subcutaneous Interferon gamma-1b. The study duration will be 5 years.

NCT ID: NCT00075998 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

The INSPIRE Trial: A Study of Interferon Gamma-1b for Idiopathic Pulmonary Fibrosis (IPF)

Start date: December 2003
Phase: Phase 3
Study type: Interventional

- Purpose: A phase 3, randomized, double-blind, placebo-controlled trial to determine the efficacy and safety of 200 µg of recombinant Interferon gamma-1b administered by subcutaneous (SC) injection, compared with placebo, in patients with IPF - Enrollment: Approximately 800 patients will be enrolled from approximately 80 centers in North America and Europe - Randomization: 2:1 active-to-placebo ratio - Duration: at least 2 years active drug or placebo (rescue therapy will be permitted for patients who meet predefined criteria)

NCT ID: NCT00075179 Terminated - Cancer Clinical Trials

Natrecor in Pulmonary Hypertension

Start date: December 31, 2003
Phase: Phase 4
Study type: Interventional

The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is effective in lowering the pressure in your lungs. The primary objective of this study is to establish that Nesiritide (Natrecor) is effective in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the mean pulmonary arterial (PA) pressure. The secondary objectives will include: improvement in pulmonary vascular resistance (PVR), patient symptoms, exercise tolerance, frequency of toxicity, and surgeon's willingness to proceed with operation.

NCT ID: NCT00052052 Completed - Pulmonary Fibrosis Clinical Trials

An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Start date: September 2002
Phase: Phase 2
Study type: Interventional

Study GIPF-004 is an open-label, multicenter study that will enroll approximately 250 patients who complete Protocol GIPF-001. The purpose of this study is to assess the safety and efficacy of continued IFN-gamma 1b therapy in this well-defined cohort of patients for up to 48 weeks.

NCT ID: NCT00052039 Terminated - Pulmonary Fibrosis Clinical Trials

A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone

Start date: April 2002
Phase: Phase 3
Study type: Interventional

Study GIPF-003 is a Phase 3b study designed to define better therapeutic use of IFN-gamma 1b in patients wtih IPF. The study will be conducted primarily in Europe and will enroll 210 patients.

NCT ID: NCT00041574 Terminated - Sickle Cell Disease Clinical Trials

Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide

Start date: April 2002
Phase: Phase 2
Study type: Interventional

The purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient needs, patients with a variety of underlying diseases will be included. Safety of chronic therapy will be monitored by serial measurements of methemoglobin, platelet function assay and reported adverse events.

NCT ID: NCT00041548 Terminated - Hypoxemia Clinical Trials

Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation

Start date: May 2002
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects.

NCT ID: NCT00014963 Completed - Cancer Clinical Trials

Biomarkers of Benzene Exposure in Inner City Residents

Start date: n/a
Phase: N/A
Study type: Observational

This study compares air pollution exposures of residents in a South Baltimore community next to major industry with those in a comparison community with much less industry nearby. Parents and children as well as adults alone will be included. Air levels of 3 chemicals that have been found in increased amounts in the community as well as two urinary breakdown products of benzene will be measured. Participants will limit the amount of sorbate preserved foods they eat as this preservative interferes with one of the benzene breakdown products. Benzene air and urine exposure measurements will be compared in each community as well as between communities. By including children and parents we will gather exposure information on children who may be more sensitive that adults to these types of pollution. Lastly, by restricting the amount of food preserved with sorbates, we can decide if this improves the use of ttMA for people exposed to benzene from air pollution.

NCT ID: NCT00014950 Completed - Cystic Fibrosis Clinical Trials

Benefits and Risks of Newborn Screening for Cystic Fibrosis

Start date: n/a
Phase: N/A
Study type: Interventional

Although cystic fibrosis (CF) is the most common, life-threatening autosomal recessive genetic disorder of the white population, there are often delays in diagnosis and hence start of treatment. Advances of the past two decades have made CF screening feasible using routinely collected neonatal blood specimens and measuring an enzyme level followed by CF mutation DNA analysis. Our overall goal of the study is to see if early diagnosis of CF through neonatal screening will be medically beneficial without major risks. ''Medically beneficial'' refers to better nutrition and/or pulmonary status, whereas '' risks'' include laboratory errors, miscommunication or misunderstanding, and adverse psychosocial consequences. Specific aims include assessment of the benefits, risks, costs, quality of life, and cognitive function associated with CF neonatal screening and a better understanding of the epidemiology of CF. A comprehensive, randomized clinical trial emphasizing early diagnosis as the key variable has been underway since 1985. Nutritional status has been assessed using height and weight measurements and biochemical methods. The results have demonstrated significant benefits in the screened (early diagnosis) group. We are now focusing on the effect of early diagnosis of CF on pulmonary outcome. Pulmonary status is measured using chest radiographs, chest scans using high resolution computerized tomography, and pulmonary function tests. Other factors that we are looking at include risk factors for the acquisition of respiratory pathogens such as Pseudomonas aeruginosa, quality of life and cognitive function of children with CF who underwent early versus delayed diagnosis, as well as the cost effectiveness of screening and the costs of diagnosis and treatment of CF throughout childhood. If the questions underlying this study are answered favorably, it is likely that neonatal screening using a combination of enzyme level (immunoreactive trypsinogen) and DNA test will become the routine method for identifying new cases of CF not only in the State of Wisconsin, but throughout the country.

NCT ID: NCT00013949 Completed - Heart Disease Clinical Trials

Cardiovascular Vulnerability to Particulate Exposure

Start date: September 1998
Phase: N/A
Study type: Observational

This project is part of a program project directed toward assessing cardiac effects of particulate and other ambient air pollutants. In this project active elderly adults living in the communities of Boston and Steubenville have attended 12 weekly sessions including approximately 40 minutes of Holter monitoring, blood pressure, and oximetry evaluation before, during, and after outdoor exercise. To investigate the relation of air pollution to cardiac and pulmonary rehabilitation, a second portion of this study involves abstraction of blood pressure and symptom data and downloading of available repeated measures telemetry data in two populations. These populations include: 1) 200 outpatients attending 8 to 36 repeated weekly exercise training sessions in a major hospital cardiac rehabilitation unit.