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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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Patients with elevated bilirubin treated with irinotecan have an increased risk of toxicity, and a dose reduction is recommended. Patients with elevated AST, creatinine or prior pelvic radiation do not appear to have increased sensitivity to irinotecan, but the data are not adequate to support a specific dosing recommendation.
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In this simple yet elegant, single-blind, placebo-controlled, crossover study, 12 patients with McArdles disease were given a sucrose, or artificially sweetened placebo load, prior to aerobic exercise to determine if this might improve exercise tolerance. Average age of the 7 men and 5 women was 37 years, and all had lifelong exercise intolerance, episodic muscle cramps, and myoglobinuria triggered by exercise.
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Hepatocellular carcinoma is one of the most common malignancies worldwide, and, for those with advanced disease, treatment responses have been dismal. The current report of a trial of gemcitabine and oxaliplatin offers some hope. Using 2 different schedules of these agents, this study found an approximate 20% objective response rate with stable disease occurring in an additional 50%.
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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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Visual hallucinations and delusions are common in patients with moderate to advanced Parkinsons disease (PD). Typically fleeting images of people, children, or animals are easily ignored; however, hallucinations often become more intense and frequent, with loss of insight.
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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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In August 1921, Franklin D. Roosevelt (1882-1945) was stricken with poliomyelitis, then also referred to as infantile paralysis. Afterward, he made a courageous, lifetime effort to overcome the ravages of the disease. In time, he helped create a foundation to help other polio victims, and he inspired, as well as directed, the March of Dimes program that eventually funded an effective polio vaccine.