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High alert

Lenneke Schrier, Rob Zuiker, Frans W H M Merkus, Erica S Klaassen, Zheng Guan, Bert Tuk, Joop M A van Gerven, Ronald van der Geest, Geert Jan Groeneveld
AIM: To evaluate the pharmacokinetics, pharmacodynamics, nasal tolerance and effects on sedation of a highly concentrated aqueous intranasal midazolam formulation (Nazolam) and to compare these to intravenous midazolam. METHODS: In this four-way crossover, double-blind, double-dummy, randomized, placebo-controlled study, 16 subjects received 2.5 mg Nazolam, 5.0 mg Nazolam, 2.5 mg intravenous midazolam or placebo on different occasions. Pharmacokinetics of midazolam and α-hydroxy-midazolam were characterized and related to outcome variables for sedation (Saccadic Peak Velocity, the Bond and Lader Visual Analogue Scale for sedation, the Simple Reaction Time Task and the Observer's Assessment of Alertness/Sedation)...
October 25, 2016: British Journal of Clinical Pharmacology
Stacy Cooper Bailey, Michael K Paasche-Orlow, William G Adams, Samantha A Brokenshire, Ryan P Hickson, Christine U Oramasionwu, Laura M Curtis, Mary J Kwasny, Michael S Wolf
BACKGROUND: Adverse drug events (ADEs) affect millions of patients annually and place a significant burden on the healthcare system. The Food and Drug Administration (FDA) has developed patient safety information for high-risk medications that pose serious public health concerns. However, there are currently few assurances that patients receive this information or are able to identify or respond correctly to ADEs. OBJECTIVE: To compare the effectiveness of the Electronic Medication Complete Communication (EMC(2)) Strategy to promote safe medication use and reporting of ADEs in comparison to usual care...
October 21, 2016: Contemporary Clinical Trials
Amir Zahir, Chesahna Kindred, Brunhilde Blömeke, Carsten Goebel, Anthony A Gaspari
BACKGROUND: Allergic contact dermatitis after exposure to p-phenylenediamine (PPD)-containing hair dye products is a common and important clinical problem. Because there is a high rate of cross-elicitation of allergic contact dermatitis to other important hair dye products (such as p-toluene diamine and other aminophenol hair dyes) in PPD-allergic patients, safer alternative dyes with excellent hair coloring options are needed. OBJECTIVE: This study aimed to study tolerance to Me-PPD in a PPD-allergic cohort...
October 21, 2016: Dermatitis
Zoubir Djerada, Françoise Daviet, Pierre-Michel Llorca, Alain Eschalier, Franck Saint-Marcoux, Danièle Bentué-Ferrer, Fréderic Libert
Clozapine is a prototypical atypical antipsychotic used to treat severe schizophrenia and for which a therapeutic drug monitoring (TDM) is quite commonly proposed. Clozapine is rapidly absorbed (maximum concentration reached within 1 to 4hours), and is extensively metabolized in the liver by CYP1A2 to an active metabolite (and to a lesser extent, to inactive metabolites via other enzymes). Its half-life is 8 to 16h. A therapeutic range has been proposed for clozapine as some studies have reported both a relationship between low plasmatic concentrations and resistance to treatment (threshold level is likely between 250 and 400μg/L), and a relationship between high plasmatic concentrations and an increase in the occurrence of toxicity (alert level=1000μg/L)...
August 24, 2016: Thérapie
David Picker, Maria Dans, Kevin Heard, Thomas Bailey, Yixin Chen, Chenyang Lu, Marin H Kollef
OBJECTIVE: To determine whether an Early Warning System could identify patients wishing to focus on palliative care measures. DESIGN: Prospective, randomized, pilot study. SETTING: Barnes-Jewish Hospital, Saint Louis, MO (January 15, 2015, to December 12, 2015). PATIENTS: A total of 206 patients; 89 intervention (43.2%) and 117 controls (56.8%). INTERVENTIONS: Palliative care in high-risk patients targeted by an Early Warning System...
October 20, 2016: Critical Care Medicine
Beata Powroźnik, Karolina Słoczyńska, Krzysztof Marciniec, Paweł Zajdel, Elżbieta Pękala
Purpose: Determination of the mutagenic potential of new biologically active compounds is of great concern for preliminary toxicity testing and drug development. Methods: The mutagenic and antimutagenic effects of some quinoline- and isoquinolinesulfonamide analogs of aripiprazole (1-8), which display potent antidepressant, anxiolytic, and antipsychotic properties, were evaluated using the Vibrio harveyi assay and OSIRIS Property Explorer software. Additionally, the Ames test was used as the reference. Results: In silico prediction showed that compounds 5 (N-(3-(4-(2,3- dichlorophenyl)piperazin-1-yl)propyl)quinoline-7-sulfonamide) and 6 (N-(4-(4-(2,3- Dichlorophenyl)piperazin-1-yl)butyl)quinoline-7-sulfonamide) trigger a mutagenic structural alert...
September 2016: Advanced Pharmaceutical Bulletin
Faisal R Jahangiri, Sami Al Eissa, Samir Sayegh, Fahad Al Helal, Shomoukh A Al-Sharif, Monerah M Annaim, Sheryar Muhammad, Tanweer Aziz
A 16-year-old male patient with Ehler-Danlos syndrome (EDS) and a back deformity since birth presented with severe kyphoscoliosis. The patient was neurologically intact but had respiratory and cardiac insufficiencies. A two-stage vertebral column resection (VCR) at T9-T10 with multiple level fusion with multimodality intraoperative neurophysiological monitoring (IONM) was planned.  During the first stage, pedicle screws were placed at multiple spinal levels above and below the VCR level. Upper and lower somatosensory evoked potentials (SSEP), transcranial electrical motor evoked potentials (TCeMEP), and electromyography were monitored continuously and showed no significant changes...
August 31, 2016: Curēus
Lin Huang, Lluis Capdevila
OBJECTIVE: This study analyzed the efficacy of aromatherapy in improving work performance and reducing workplace stress. SUBJECTS: The initial sample comprised 42 administrative university workers (Mage = 42.21 years, standard deviation = 7.12; 10 male). INTERVENTION: All sessions were performed in a university computer classroom. The participants were randomly assigned into an aromatherapy group (AG) and a control group (CG), and they were invited to participate in a specific session only once...
October 20, 2016: Journal of Alternative and Complementary Medicine: Research on Paradigm, Practice, and Policy
Merete L Hetland, Niels Steen Krogh, Kim Hørslev-Petersen, Berit Schiøttz-Christensen, Inge Juul Sørensen, Jensen Dorte Vendelbo
OBJECTIVES: Electronic platforms have been developed to help the clinician monitor disease activity in rheumatoid arthritis (RA) to support at treat-to-target strategy. We present an initiative to interactively improve disease control in patients with rheumatoid arthritis. METHODS: In patients who presented with one or more swollen joints AND moderate/high disease activity (i.e. either CDAI≥10.1 and/or DAS-28CRP>3.2, which is automatically calculated in the DANBIO registry), a red alert was shown, which activated a pop-up: "This patient has at least one swollen joint AND either CDAI≥ 10...
September 2016: Clinical and Experimental Rheumatology
Stephanie M Morris, Maria T Acosta, Shruti Garg, Jonathan Green, Susan Huson, Eric Legius, Kathryn N North, Jonathan M Payne, Ellen Plasschaert, Thomas W Frazier, Lauren A Weiss, Yi Zhang, David H Gutmann, John N Constantino
Importance: Recent reports have demonstrated a higher incidence of autism spectrum disorder (ASD) and substantially elevated autistic trait burden in individuals with neurofibromatosis type 1 (NF1). However, important discrepancies regarding the distribution of autistic traits, sex predominance, and association between ASD symptoms and attentional problems have emerged, and critical features of the ASD phenotype within NF1 have never been adequately explored. Establishing NF1 as a monogenic cause for ASD has important implications for affected patients and for future research focused on establishing convergent pathogenic mechanisms relevant to the potential treatment targets for ASD...
October 19, 2016: JAMA Psychiatry
Vishal Dey, Audrey Jones, Elaine M Spalding
INTRODUCTION: Telehealth technologies are being widely adopted across the globe for management of long-term conditions. There are limited data on its use, effectiveness and patient experience in end-stage renal disease. The aim of this pilot project was to explore patient acceptability of technology and evaluate its effect on clinical interventions and quality of life in patients undergoing peritoneal dialysis. METHODS: Peritoneal dialysis patients were provided with computer tablets (PODs)...
2016: SAGE Open Medicine
Matthew Grissinger
Risk-reduction strategies for high-alert medication lists.
October 2016: P & T: a Peer-reviewed Journal for Formulary Management
Chenchit Chayachinda, Thanapa Rekhawasin
This study aimed to investigate the prevalence and the predictors of the adverse reproductive outcomes in patients who had been hospitalised with pelvic inflammatory disease (PID). The retrospective cohort study was conducted by contacting all the patients admitted with PID or tubo-ovarian abscess (TOA) during January 2004 and December 2011. Those who were sexually active and aged 14-40 years were included. The exclusion criteria were no intention to conceive or undergoing hysterectomy, bilateral salpingo-oophorectomy, bilateral complete or partial salpingectomy...
October 18, 2016: Journal of Obstetrics and Gynaecology: the Journal of the Institute of Obstetrics and Gynaecology
Kendra Thomsen, Kim Zuber, Jane Davis, Greg Thomas
OBJECTIVE: Kidneys in a Box (KIB) was developed to identify the effect of a performance improvement CME (PI-CME) project on the management of patients with diabetes who are at risk for chronic kidney disease (CKD). The program provided nonnephrology practitioners with research-based interventions known to slow CKD progression. METHODS: PAs were given the KIB tool kit, which described the scope of CKD identified high-risk diagnoses such as diabetes, and listed six modifiable risk factors that have been shown to slow progression of diabetic kidney disease when implemented...
October 5, 2016: JAAPA: Official Journal of the American Academy of Physician Assistants
Pina Violano, Linda Roney, Kirsten Bechtel
BACKGROUND: Pedestrians distracted by digital devices or other activities are at a higher risk of injury as they cross streets. We sought to describe the incidence of pedestrians distracted by digital devices or other activities at two highly traveled urban intersections after the implementation of a pedestrian safety intervention at one of the intersections. METHODS: This was an observational field study of two urban intersections. Two investigators were stationed at each of the four corners of the intersection...
December 2015: Injury Epidemiology
Dominic Way, Hortense Blazsin, Ragnar Löfstedt, Frederic Bouder
This paper reviews the main tools for communicating benefit-risk medicines information to patients that are used, or could be used, by pharmaceutical regulators. One highly successful tool from the food safety sector (front-of-package traffic-light labelling) and the mental models approach (which provides a framework for developing new tools) are also reviewed as they show great promise for being usefully adapted to the pharmaceutical context. The evolution of benefit-risk medicines communication is first contextualised within the broader risk communication literature...
October 14, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Jana E Jones, Prabha Siddarth, Dace Almane, Suresh Gurbani, Bruce P Hermann, Rochelle Caplan
OBJECTIVE: This study identified items on the Child Behavior Checklist (CBCL) that predict those children and adolescents with epilepsy at highest risk for multiple psychiatric diagnoses. METHODS: Three hundred twenty-eight children, ages 5-18 years, and their parents participated in separate structured psychiatric interviews about the children, which yielded Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision (DSM-IV-TR) diagnoses...
October 14, 2016: Epilepsia
Myoung-Gyun Suh, Qi-Fan Yang, Ki Youl Yang, Xu Yi, Kerry J Vahala
Rapid characterization of optical and vibrational spectra with high resolution can identify species in cluttered environments and is important for assays and early alerts. Dual-comb spectroscopy has emerged as a powerful approach to acquire nearly instantaneous Raman and optical spectra with unprecedented resolution. Spectra are generated directly in the electrical domain and avoid bulky mechanical spectrometers. We demonstrate a miniature soliton-based dual-comb system that can potentially transfer the approach to a chip platform...
October 13, 2016: Science
Olivier Colin, Sylvie Favrelière, Alexandre Quillet, Jean-Philippe Neau, Jean-Luc Houeto, Claire Lafay-Chebassier, Marie-Christine Pérault-Pochat
Progressive multifocal leukoencephalopathy (PML) is an often fatal demyelinating disease of the central nervous system. As effective treatment is unavailable, identification of all drugs that could be associated with PML is essential. The objective of this study was to investigate the putative association of reports of PML and drugs. We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were reports of PML in the FPVD between January 2008 and December 2015. Noncases were all other reports during the same period...
October 13, 2016: Fundamental & Clinical Pharmacology
Luz A Padilla, Renee A Desmond, C Michael Brooks, John W Waterbor
A key outcome measure of cancer research training programs is the number of cancer-related peer-reviewed publications after training. Because program graduates do not routinely report their publications, staff must periodically conduct electronic literature searches on each graduate. The purpose of this study is to compare findings of an innovative computer-based automated search program versus repeated manual literature searches to identify post-training peer-reviewed publications. In late 2014, manual searches for publications by former R25 students identified 232 cancer-related articles published by 112 of 543 program graduates...
October 12, 2016: Journal of Cancer Education: the Official Journal of the American Association for Cancer Education
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