Dearborn DG Pulmonary hemorrhage in infants and children. Curr Opin Pediatr. 1997 Jun;9(3):219-24. Review.
Dearborn DG Pulmonary Hemosiderosis (pulmonary hemorrhage), in Nelson's Textbook of Pediatrics, 16th edition. Editors: R Behrman, R Kleigman, H Jenson, p 1295-1297, 2000.
Etzel, R A., and Dearborn, D.G. Pulmonary hemorrhage among infants with exposure to toxigenic molds: An update. In: Bioaerosols, Fungi, and Mycotoxins:Health effect, Assessment, Prevention and Control, Ed. E. Johanning, Boyd Printing Co., Inc., Albany, NY, 1999, pp 70-83.
Montaña E, Etzel RA, Allan T, Horgan TE, Dearborn DG Environmental risk factors associated with pediatric idiopathic pulmonary hemorrhage and hemosiderosis in a Cleveland community. Pediatrics. 1997 Jan;99(1):E5.
Vesper SJ, Dearborn DG, Elidemir O, Haugland RA Quantification of siderophore and hemolysin from Stachybotrys chartarum strains, including a strain isolated from the lung of a child with pulmonary hemorrhage and hemosiderosis. Appl Environ Microbiol. 2000 Jun;66(6):2678-81.
Yike I, Allan T, Sorenson WG, Dearborn DG Highly sensitive protein translation assay for trichothecene toxicity in airborne particulates: comparison with cytotoxicity assays. Appl Environ Microbiol. 1999 Jan;65(1):88-94.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
