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An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is SERIOUS and should be reported when the patient outcome is the following.
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IRBs often struggle with decisions regarding the reporting of adverse events and unanticipated problems, and the recent increases in IRBs workloads do not help the situation, experts say.
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In the year 2000, Health Care Financing Administration (now known as the Centers for Medicare & Medicaid Services) issued its National Coverage Determination (NCD) extending Medicare coverage to routine costs of qualifying trials, as well as those items and services made necessary to diagnose or treat complications arising from clinical trial participation.
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Munger and colleagues reviewed a database of 187,563 women enrolled in the Nurses Health Study, which longitudinally surveyed participants aged 25-55. There were 173 women with probable or definite multiple sclerosis (MS). Vitamin D intake was determined through the study questionnaire and 4 1-week diet records.
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The possible association of migraine and stroke remains an active area of controversy in clinical neurology. Since migraines predominantly affect young people and the medications used can cause vasoconstriction, assessing the full vascular risk profile of migraine is important from a diagnostic and therapeutic point of view. To date, the literature is incomplete.
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New guidelines for the treatment of bacterial rhinosinusitis were published in the January supplement of Otolaryngology-Head and Neck Surgery by the Sinus and Allergy Health Partnership.
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The concept that epilepsy arises from an imbalance between excitatory and inhibitory influences in epileptogenic tissue has become fundamental to further investigations of the pathophysiology of this disorder. The primary observation motivating the study of Eid and colleagues is that glutamate levels are elevated in patients with mesial temporal sclerosis (MTS), perhaps the most common cause of medication-resistant epilepsy.
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Martin and ONeill called attention to and commented upon a revised classification of higher-level gait disorders (HLGD) proposed by Liston and associates.
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Shared pathophysiologic mechanisms for migraine, neuropathic pain, and epilepsy underscore the notion that antiepileptic drugs (AED) should be standard treatment for the former. Five new AEDs and their use in these nonepileptic painful disorders are summarized.
