Eriksson M, Andersen O, Runmarker B Long-term follow up of patients with clinically isolated syndromes, relapsing-remitting and secondary progressive multiple sclerosis. Mult Scler. 2003 Jun;9(3):260-74. Erratum in: Mult Scler. 2003 Dec;9(6):641.
Fang Y, Zhang S, Wu B, Liu M Hyperglycaemia in acute lacunar stroke: a Chinese hospital-based study. Diab Vasc Dis Res. 2013 May;10(3):216-21. doi: 10.1177/1479164112459663. Epub 2012 Oct 18.
Godoy DA, Di Napoli M, Rabinstein AA Treating hyperglycemia in neurocritical patients: benefits and perils. Neurocrit Care. 2010 Dec;13(3):425-38. doi: 10.1007/s12028-010-9404-8. Review.
Marrie RA, Horwitz R, Cutter G, Tyry T Cumulative impact of comorbidity on quality of life in MS. Acta Neurol Scand. 2012 Mar;125(3):180-6. doi: 10.1111/j.1600-0404.2011.01526.x. Epub 2011 May 26.
Nickerson M, Marrie RA The multiple sclerosis relapse experience: patient-reported outcomes from the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry. BMC Neurol. 2013 Sep 10;13:119. doi: 10.1186/1471-2377-13-119.
Rudick RA, Ransohoff RM Cytokine secretion by multiple sclerosis monocytes. Relationship to disease activity. Arch Neurol. 1992 Mar;49(3):265-70.
Sala F, Menna G, Bricolo A, Young W Role of glycemia in acute spinal cord injury. Data from a rat experimental model and clinical experience. Ann N Y Acad Sci. 1999;890:133-54.
Shoelson SE, Lee J, Goldfine AB Inflammation and insulin resistance. J Clin Invest. 2006 Jul;116(7):1793-801. Review. Erratum in: J Clin Invest. 2006 Aug;116(8):2308.
Southerland AM, Johnston KC Considering hyperglycemia and thrombolysis in the Stroke Hyperglycemia Insulin Network Effort (SHINE) trial. Ann N Y Acad Sci. 2012 Sep;1268:72-8. doi: 10.1111/j.1749-6632.2012.06731.x. Review.
Viardot A, Grey ST, Mackay F, Chisholm D Potential antiinflammatory role of insulin via the preferential polarization of effector T cells toward a T helper 2 phenotype. Endocrinology. 2007 Jan;148(1):346-53. Epub 2006 Sep 28.
Warabi Y Role of IL-1 and potential therapies in multiple sclerosis. Drug Discovery Today: Therapeutic Strategies 2007;4:19-24.
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.