1 Carmichael W. A world overview—One-hundred-twentyseven years of research on toxic cyanobacteria—Where do we go from here? Adv Exp Med Biol 2008;619:105-125 2. Petrus M, Culerrier R, Campistron M, Barre A, Rouge P. First case report of anaphylaxis to spirulin: identification of phycocyanin as responsible allergen. AL L ERGY (AllergyNet) 2010; 65 : 924-932N 3. Torokne A, Palovics A, and Bankine M. Allergenic (sensitization, skin and eye Irritation).Effects of freshwater Cyanobacteria—experimental evidence. Environ Toxicol 2001; 16: 512-516 4.Alster, A., Kaplan-Levy, R., Sukenik, A. & Zohary, T. Morphology and phylogeny of a non-toxic invasive Cylindrospermopsis raciborskii from a Mediterranean Lake. Hydrobiologia 2010; 639, 115-128. 5.Banker, R., Carmeli, S., Hadas, O., Teltsch, B., Porat, R. & Sukenik, A. Identification of cylindrospermopsin in Aphanizomenon ovalisporum (Cyanophyceae) isolated from Lake Kinneret, Israel. Journal of Phycology 1997; 33, 613-616. 6.Hadas, O., Pinkas, R., Malinsky-Rushansky, N., Nishri, A., Kaplan, A., Rimmer, A. & Sukenik, A. Appearance and establishment of diazotrophic cyanobacteria in Lake Kinneret, Israel. Freshwater Biology 2012; 57, 1214-1227. 7. Bernstein JA, Ghosh D, Levin LS, Zheng S, Carmichael W, Lummus Z, Bernstein IL. Cyanobacteria: an unrecognized ubiquitous sensitizing allergen? Allergy Asthma Proc. 2011;32:106-110 8.Törökné, A., Asztalos, M., Bánkiné, M., Bickel, H., Borbély, G., Carmeli, S., Codd, G.A., Fastner, J., Huang, Q., Humpage, A., Metcalf, J.S., Rábai, E., Sukenik, A., Surányi, G., Vasas, G. & Weiszfeiler, V. Interlaboratory comparison trial on cylindrospermopsin measurement. Analytical Biochemistry 2004; 332, 280-284. 9.Lawton, L.A., Edwards, C. & Codd, G.A. Extraction and high-performance liquid chromatographic method for the determination of microcystins in raw and treated waters. Analyst 1994; 119, 1525-1530
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.
