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2017 Is Banner Year for Drug Approvals by the Food and Drug Administration

In 2017, the US Food and Drug Administration (FDA) approved 46 novel drugs, a 21-year high,1, 2, 3 and an additional 29 previously approved drugs received newly approved indications. This record setting year was due, in part, to several new expedited review pathways at the FDA, including accelerated approval, priority review, and fast-track and breakthrough therapy, all of […]

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Actigraphy analysis methods and terms. Vertical lines represent the activity count in a 15-second epoch. Red markers at base of actigraphy bars represent epochs scored as awake by the software/algorithm. Light channel (yellow) removed from panels B and C in order to demonstrate activity patterns. (A) Hospitalized adult with long sleep bouts. Rest intervals (light blue background) are determined by the scorer, using decreased activity levels and light level changes, as periods where the subject is likely to be sleeping/trying to sleep. Sleep bouts within the rest interval are determined by the software's algorithm, which scores sleep or wake based on activity count thresholds in a particular epoch and multiple surrounding epochs; the sum total of these sleep bouts give the total duration of sleep within a particular interval. Please note the clear changes in activity level between daytime and nighttime, as well as the minimal amount of wrist activity during sleep for this individual. (B) Hospitalized adult with short sleep bouts. Here, sleep within the rest interval is characterized by multiple short sleep bouts (examples shown with arrows in this panel), suggesting substantial sleep fragmentation. (C) Acutely ill, hospitalized adult with Confusion Assessment Method–positive delirium. This individual was noted to become delirious overnight. Note the increased and prolonged activity during the night, as well as the lack of sleep. Daytime rest periods ≥30 minutes were designated as naptime rest intervals; naps were summed together with the nighttime sleep to determine the total sleep time for a 24-hour period. Gray area in this panel is time prior to the start of the device's recording.

Melatonin and Sleep in Preventing Hospitalized Delirium: A Randomized Clinical Trial

Studies suggest that melatonin may prevent delirium, a condition of acute brain dysfunction occurring in 20%-30% of hospitalized older adults that is associated with increased morbidity and mortality. We examined the effect of melatonin on delirium prevention in hospitalized older adults while measuring sleep parameters as a possible underlying mechanism. Methods This was a randomized […]

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Sudden Creatine Kinase Elevation When an Athlete Starts Boxing: Looking Deeper Prior to Knocking the Statin Out

A 55-year-old Caucasian man with a prior computed tomography calcium score in the 75th percentile for age, sex, and race at age 39 years, and on long-term high-intensity statin therapy presented with episodic myalgia. He reported 3 episodes within the past year of sudden severe quadriceps pain that self-resolved within 2 days. His activities included biking […]

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Bronchoscopy showing pill fragments (arrow) with intense inflammatory granulation response with bronchial stenosis.

Unusual Cause of Persistent Cough: ‘Pill Aspiration’

A 57-year-old woman with carcinoid syndrome was referred to the pulmonary clinic by her primary care physician (PCP) for persistent cough for the past 6 weeks. She was evaluated by her PCP approximately 6 weeks earlier for cough, which the patient thought started after she had aspirated one of her medications. Results from initial clinical […]

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Computed tomography scan demonstrating drug packets.

Ethico-Legal Challenges of Drug Packing—A Case Report

Body-packing, or the internal concealment of illicit drugs, has been described worldwide and is typically used to smuggle drugs across secure borders. Body-packers who swallow or insert packets of illicit drugs into body cavities are at risk for acute toxicity and gastrointestinal obstruction. We present a case of body-packing that exposed the challenging ethical and […]

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Effectiveness and Safety of Rivaroxaban Versus Warfarin in Frail Patients with Venous Thromboembolism (video)

Frailty predicts poorer outcomes in patients receiving anticoagulation. We assessed the effectiveness and safety of rivaroxaban vs warfarin in frail patients experiencing venous thromboembolism. Methods Using US MarketScan claims data from January 2012-December 2016, we identified frail patients (using the Johns Hopkins Claims-Based Frailty Indicator score) who had ≥1 primary hospitalization/emergency department visit diagnosis codes […]

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