Plos One
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Randomized Controlled Trial Multicenter Study
Design and initial results of a multi-phase randomized trial of ceftriaxone in amyotrophic lateral sclerosis.
Ceftriaxone increases expression of the astrocytic glutamate transporter, EAAT2, which might protect from glutamate-mediated excitotoxicity. A trial using a novel three stage nonstop design, incorporating Phases I-III, tested ceftriaxone in ALS. Stage 1 determined the cerebrospinal fluid pharmacokinetics of ceftriaxone in subjects with ALS. Stage 2 evaluated safety and tolerability for 20-weeks. Analysis of the pharmacokinetics, tolerability, and safety was used to determine the ceftriaxone dosage for Stage 3 efficacy testing. ⋯ The goals of Stages 1 and 2 of the ceftriaxone trial were successfully achieved. Based on the pre-specified decision rules, the DSMB recommended the use of ceftriaxone 4 g/d (divided BID) for Stage 3, which recently closed.
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Randomized Controlled Trial Multicenter Study
Analysis of serum inflammatory mediators identifies unique dynamic networks associated with death and spontaneous survival in pediatric acute liver failure.
Tools to predict death or spontaneous survival are necessary to inform liver transplantation (LTx) decisions in pediatric acute liver failure (PALF), but such tools are not available. Recent data suggest that immune/inflammatory dysregulation occurs in the setting of acute liver failure. We hypothesized that specific, dynamic, and measurable patterns of immune/inflammatory dysregulation will correlate with outcomes in PALF. ⋯ The application of DBN analysis of inflammatory mediators in this small patient sample appears to differentiate survivors from non-survivors in PALF. Patterns associated with LTx pre-transplant were more like those seen in spontaneous survivors than in those who died. DBN-based analyses might lead to a better prediction of outcome in PALF, and could also have more general utility in other complex diseases with an inflammatory etiology.
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Randomized Controlled Trial
Use of a computerized C-reactive protein (CRP) based sepsis evaluation in very low birth weight (VLBW) infants: a five-year experience.
Serial C-reactive protein (CRP) values may be useful for decision-making regarding duration of antibiotics in neonates. However, established standard of practice for its use in preterm very low birth weight (<1500 g, VLBW) infants are lacking. ⋯ CDS/CRP-guided antibiotic use is safe and effective in culture-negative VLBW infants. CRP results are not affected by low WBC indices.
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Randomized Controlled Trial
Speak fast, use jargon, and don't repeat yourself: a randomized trial assessing the effectiveness of online videos to supplement emergency department discharge instructions.
Emergency department discharge instructions are variably understood by patients, and in the setting of emergency department crowding, innovations are needed to counteract shortened interaction times with the physician. We evaluated the effect of viewing an online video of diagnosis-specific discharge instructions on patient comprehension and recall of instructions. ⋯ In this single-center trial, patients who viewed an online video of their discharge instructions scored higher on their understanding of key concepts around their diagnosis and subsequent care. Those who viewed the videos found them to be a helpful addition to standard care.
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Randomized Controlled Trial
"Best practice" skills lab training vs. a "see one, do one" approach in undergraduate medical education: an RCT on students' long-term ability to perform procedural clinical skills.
Benefits of skills lab training are widely accepted, but there is sparse research on its long-term effectiveness. We therefore conducted a prospective, randomised controlled-trial to investigate whether in a simulated setting students trained according to a "best practice" model (BPSL) perform two skills of different complexity (nasogastral tube insertion, NGT; intravenous cannulation, IVC) better than students trained with a traditional "see one, do one" teaching approach (TRAD), at follow-up of 3 or 6 months. ⋯ This study shows that within a simulated setting BPSL is significantly more effective than TRAD for skills of different complexity assessed immediately after training and at follow-up. The advantages of BPSL training are seen especially in long-term retention.