Kauhanen P, Kovanen PT, Reunala T, Lassila R Effects of skin mast cells on bleeding time and coagulation activation at the site of platelet plug formation. Thromb Haemost. 1998 Apr;79(4):843-7.
Lindstedt KA, Kovanen PT Mast cells in vulnerable coronary plaques: potential mechanisms linking mast cell activation to plaque erosion and rupture. Curr Opin Lipidol. 2004 Oct;15(5):567-73. Review.
Szczeklik A, Dropinski J, Góra PF Serum immunoglobulin E and sudden cardiac arrest during myocardial infarction. Coron Artery Dis. 1993 Nov;4(11):1029-32.
Szczeklik A, Jawien J Possible role of IgE in acute-phase response. Allergy. 1997 Nov;52(11):1149-50.
Szczeklik A, Milner PC, Birch J, Watkins J, Martin JF Prolonged bleeding time, reduced platelet aggregation, altered PAF-acether sensitivity and increased platelet mass are a trait of asthma and hay fever. Thromb Haemost. 1986 Dec 15;56(3):283-7.
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.
