Annals of medicine
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Randomized Controlled Trial
Rationale and design of a double-blinded, randomized placebo-controlled trial of 40 Hz light neurostimulation therapy for depression (FELIX).
Major depressive disorder (MDD) is a debilitating condition that affects more than 300 million people worldwide. Current treatments are based on a trial-and-error approach, and reliable biomarkers are needed for more informed and personalized treatment solutions. One of the potential biomarkers, gamma-frequency (30-80 Hz) brainwaves, are hypothesized to originate from the excitatory-inhibitory interaction between the pyramidal cells and interneurons. The imbalance between this interaction is described as a crucial pathological mechanism in neuropsychiatric conditions, including MDD, and the modulation of this pathological interaction has been investigated as a potential target. Previous studies attempted to induce gamma activity in the brain using rhythmic light and sound stimuli (GENUS - Gamma Entrainment Using Sensory stimuli) that resulted in neuroprotective effects in Alzheimer's disease (AD) patients and animal models. Here, we investigate the antidepressant, cognitive, and electrophysiological effects of the novel light therapy approach using 40 Hz masked flickering light for patients diagnosed with MDD. ⋯ Sixty patients with a current diagnosis of a major depressive episode will be enrolled in a randomized, double-blinded, placebo-controlled trial. The active treatment group will receive 40 Hz masked flickering light stimulation while the control group will receive continuous light matched in color temperature and brightness. Patients in both groups will get daily light treatment in their own homes and will attend four follow-up visits to assess the symptoms of depression, including depression severity measured by Hamilton Depression Rating Scale (HAM-D17), cognitive function, quality of life and sleep, and electroencephalographic changes. The primary endpoint is the mean change from baseline to week 6 in depression severity (HAM-D6 subscale) between the groups.
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The therapeutic options for thrombocytopenia in non-severe aplastic anaemia (NSAA) are limited. Avatrombopag (AVA) is prescribed for thrombocytopenic diseases but not for NSAA. ⋯ AVA is effective and well-tolerated in NSAA patients who are refractory, relapsed, or intolerant to CsA/tacrolimus ± eltrombopag. Earlier treatment and relapsed/intolerant AA may show a better short-term response rate. More studies are needed to define the optimal dose and the long-term efficacy (NCT04728789).
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The notion of prediabetes, defined by the ADA as glycated hemoglobin A1c (HbA1c) of 5.7-6.4%, implies increased vascular inflammatory and immunologic processes and higher risk for developing diabetes mellitus and major cardiovascular events. We aimed to determine the risk factors associated with rapid progression of normal and prediabetes patients to type 2 diabetes mellitus (T2DM). ⋯ We suggest that perhaps a more aggressive preventative approach should be considered in patients with a family history of T2DM who have high BMI and year-to-year increase in HbA1c, whether they have normal hemoglobin A1c or they have prediabetes.KEY MESSAGESProgression to diabetes from normal or prediabetic hemoglobin A1c within four years is associated with baseline BMI.A steady rise in HbA1c during a four-year period is associated with age and family history of T2DM, whereas age and personal history of MACE are associated with a rapid rise in HbA1c.A more aggressive preventative approach should be considered in patients with a family history of T2DM who have high BMI and year-to-year increase in HbA1c.
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Background: The assessment of severity is crucial in the management of community-acquired pneumonia (CAP). It remains unknown whether updating cut-off values of severity scoring systems orchestrate improvement in predictive accuracy. Methods: 3,212 patients with CAP were recruited to two observational prospective cohort studies. ⋯ Key messagesUpdating cut-off values were performed better for predicting mortality. Bettered scoring systems orchestrated higher convergences. Bettered scoring systems demonstrated greater predictive accuracies for mortality.