Publications by authors named "Bruce S Schneider"

The U.S. Food and Drug Administration applies regulatory flexibility to balance benefits and risks to subjects in cell-therapy clinical trials.

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Article Synopsis
  • The study aimed to investigate the occurrence of hyperglycemia in patients taking quetiapine, an atypical antipsychotic medication.
  • Out of 46 reports of hyperglycemia linked to quetiapine, 34 involved new cases, while some patients had worsened existing diabetes; the age of affected individuals ranged from 5 to 76 years.
  • The findings suggest that quetiapine may unmask or lead to hyperglycemic conditions, with serious complications reported, including 21 cases of diabetic ketoacidosis and 11 fatalities identified by a retrospective survey.
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Study Objective: To explore the clinical characteristics of hyperglycemia in patients treated with risperidone.

Design: Pharmacovigilance survey of spontaneously reported adverse events in risperidone-treated patients, with reports of haloperidol-associated hyperglycemia used as a control.

Setting: Government-affiliated drug evaluation center.

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Objective: To provide insight into discussions at the Surgeon General's Listening Session, "Toward a National Action Plan on Overweight and Obesity," and to complement The Surgeon General's Call to Action to Prevent and Decrease Overweight and Obesity.

Research Methods And Procedures: On December 7 and 8, 2000, representatives from federal, state, academic, and private sectors attended the Surgeon General's Listening Session and were given an opportunity to recommend what to include in a national plan to address overweight and obesity. The public was invited to comment during a corresponding public comment period.

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