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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Randomized Controlled Trial
The prognosis of breast cancer patients with bone metastasis could be potentially estimated based on blood routine test and biochemical examination at admission.
Due to the poor and unpredictable prognosis of breast cancer (BC) patients with bone metastasis, it is necessary to find convenient and available prognostic predictors. This study aimed to recognize the clinical and prognostic factors related to clinical laboratory examination and to construct a prognostic nomogram for BC bone metastasis. ⋯ This study constructed a novel prognostic nomogram for BC patients with bone metastasis. It could serve as a potential tool of survival assessment to help individual treatment decision-making for clinicians.
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Randomized Controlled Trial
A digital health home intervention for people within the Alzheimer's disease continuum: results from the Ability-TelerehABILITation pilot randomized controlled trial.
This study tested the efficacy of digital-health home intervention for people within the Alzheimer's disease (AD)-continuum. ⋯ Our preliminary findings suggest that ABILITY is a promising eHealth intervention to improve at-home treatment adherence and to preserve cognitive and behavioral abilities.
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Randomized Controlled Trial
Effects of visual aid on state anxiety, fear and stress level in patients undergoing endoscopy: a randomized controlled trial.
The present study aimed to calculate the estimated size and confidence interval for the effects of adding visual aid to counselling on anxiety, stress and fear of patients undergoing upper gastrointestinal endoscopy. The secondary aim was to calculate confidence interval for endoscopy-related variables that predict which patients are likely to benefit from visual aids. ⋯ The increase in anxiety, acute stress and fear related to endoscopic procedures can be alleviated with psychological counselling coupled with visual aids before the procedure. Visual aid could lead to supplementary benefits in reducing anxiety scores.
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Randomized Controlled Trial Comparative Study
Emergency decompression for patients with ureteral stones and SIRS: a prospective randomized clinical study.
Patients with ureteral calculi and systemic inflammatory response syndrome (SIRS) often require emergency drainage, and percutaneous nephrostomy (PCN) and retrograde ureteral stent insertion (RUSI) are the most commonly used methods. Our study aimed to identify the best choice (PCN or RUSI) for these patients and to examine the risk factors for progression to urosepsis after decompression. ⋯ PCN and RUSI were effective methods of emergency decompression in patients with ureteral stone and SIRS. Patients with pyonephrosis and a higher PCT should be carefully treated to prevent the progression to urosepsis after decompression.Key messageIn this study, we evaluate the best choice (PCN or RUSI) for patients who have ureteral stones and SIRS and to examine the risk factors for progression to urosepsis after decompression. This study found that PCN and RUSI were effective methods of emergency decompression. Pyonephrosis and higher PCT were risk factors for patients to develop to urosepsis after decompression.