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Safety Aspects (safety + aspect)
Selected AbstractsBuchbesprechung: Functional Food , Safety Aspects by DFG, Senatskommission zur Beurteilung der gesundheitlichen UnbedenklichkeitCHEMIE IN UNSERER ZEIT (CHIUZ), Issue 3 2004Article first published online: 17 JUN 200 No abstract is available for this article. [source] Safety aspects for public access defibrillation using automated external defibrillators near high-voltage power linesACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 5 2004C. J. Schlimp Background:, Automated external defibrillators (AEDs) must combine easy operability and high-quality diagnosis even under unfavorable conditions. This study determined the influence of electromagnetic interference caused by high-voltage power lines with 16.7-Hz alternating current on the quality of AEDs' rhythm analysis. Methods:, Two AEDs frequently used in Austria were tested near high-voltage power lines (15 kV or 110 kV, alternating current with 16.7 Hz). The defibrillation electrodes were attached either to a proband with true sinus rhythm or to a resuscitation dummy with generated sinus rhythm, ventricular fibrillation, ventricular tachycardia or asystole. Results:, Electromagnetic interference was much more prominent in a human's than in a dummy's electrocardiogram and depended on the position of the electrodes and cables in relation to the power line. Near high-voltage power lines the AEDs showed a significant operational fault. One AED interpreted the interference as a motion artifact, even when underlying rhythms were clearly detectable. The other AED interpreted 16.7-Hz oscillation as ventricular fibrillation with consequent shock advice when no underlying rhythm was detected. Conclusion:, The tested AEDs neither filter nor recognize a technical interference of 16.7 Hz caused by 15-kV power lines above railway tracks or 110-kV overland power lines, as run by railway companies in Austria, Germany, Norway, Sweden and Switzerland. These failures in AEDs' algorithms for rhythm analysis may cause substantial harm to patients undergoing public access defibrillation. The proper function of AEDs needs to be reconsidered to guarantee patients' safety near high-voltage power lines. [source] Safety aspects of androgen treatment with 5,-dihydrotestosteroneANDROLOGIA, Issue 6 2007S. Sakhri Summary 5,-Dihydrotestosterone (DHT), the most powerful naturally occurring androgen, is commercially available since 1982 as a gel. In view of its considerably higher biopotency (three to six times) than of testosterone, side effects, particularly on the main target organ of androgens, the prostate, are anticipated. In fact, DHT appears to be a prostate-sparing androgen for two reasons. Unlike testosterone, it does not undergo any further amplification in biopotency through 5, reduction in the prostate. Secondly, it is likely to lead to less aromatisation of testosterone to oestradiol in the prostate, thus reducing local oestradiol concentrations. Oestrogens have been implicated in the aetiology of benign prostate hyperplasia and prostate cancer. However, aromatisation of testosterone has appeared to be essential for the maintenance of bone mineral density. Administration of DHT reduces circulating oestradiol levels, but the levels remain above the levels critical for the antiresorptive effect of oestrogens on bone. Effects of DHT on erythropoiesis and on lipids are very similar to those of testosterone. Safety concerns regarding androgen treatment with DHT are similar to those of treatment with testosterone, while the effects of DHT on the prostate are likely to be less biopotent. [source] Combination statin,fibrate therapy: safety aspectsDIABETES OBESITY & METABOLISM, Issue 2 2009R. Franssen Patients with type 2 diabetes or metabolic syndrome remain at high residual risk of cardiovascular events even after intensive statin therapy. While treatment guidelines recommend the addition of a fibrate to statin therapy in this setting, concerns about the potential for myopathy may limit the use of this combination in clinical practice. These concerns are certainly justified for gemfibrozil, which interferes with statin glucuronidation, leading to elevation in statin plasma concentrations and an increased risk of myotoxicity in combination with a range of commonly prescribed statins. However, the available evidence refutes suggestions that this is a class effect for fibrates. Fenofibrate does not adversely influence the metabolism or pharmacokinetics of any of the commonly prescribed statins. This in turn translates to a reduced potential for myotoxicity in combination with a statin. Data are awaited from the ongoing Action to Control Cardiovascular Risk in Diabetes (ACCORD) study to evaluate the efficacy and safety of fenofibrate plus simvastatin combination therapy in type 2 diabetes patients. [source] Predicting aggressive driving behavior: The role of macho personality, age, and power of carAGGRESSIVE BEHAVIOR, Issue 1 2002Barbara Krahé Abstract A study is presented that explored the role of macho personality, age, and power of car as predictors of aggressive driving behavior. A total of 154 male motorists completed two subscales of the Hypermasculinity Inventory as a measure of macho personality and self-reports of aggressive driving behavior based on the Driver Behaviour Questionnaire. They also provided information about their age, annual mileage, horsepower of their car, and features that had guided their choice of a car. A multiple regression analysis showed that each of the predictors was significantly related to aggressive driving: Younger motorists, those driving powerful cars, and those showing macho personality were significantly more likely to report driving aggression. Together, the three predictors accounted for 35.8% of the variance. In addition, macho men assigned greater importance to speed and sportiness of a car and less importance to safety aspects than nonmacho men. The findings are discussed with reference to individual and situational explanations of driving aggression. Aggr. Behav. 28:21,29, 2002. © 2002 Wiley-Liss, Inc. [source] Sodium Valproate in the Management of Painful Neuropathy in Type 2 Diabetes , a Randomized Placebo Controlled StudyJOURNAL OF THE PERIPHERAL NERVOUS SYSTEM, Issue 2 2003DK Kochar OBJECTIVE: To study the effectiveness and safety aspects of sodium valproate in the management of painful neuropathy in patients of type 2 diabetes mellitus. MATERIAL AND METHODS: A randomized double-blind placebo controlled trial of sodium valproate was done in type 2 diabetic patients to assess its efficacy and safety in the management of painful neuropathy. We screened 60 patients but eight patients could not complete the study; hence, the present study was done on 52 patients. Each patient was assessed by clinical examination, pain score by short form of the McGill pain questionnaire (SF-MPQ) and electrophysiological examination, which included motor and sensory nerve conduction velocity, amplitude and H-reflex initially and at the end of 1 month of treatment. RESULTS: Significant improvement was noticed in the pain score of patients receiving sodium valproate in comparison to patients receiving placebo at the end of 1 month (P < 0.05). The changes in electrophysiological data were not significant. The drug was well tolerated by all patients except one who developed a raised aspartate transaminase (AST)/alanine transaminase (ALT) level after 15 days of treatment. CONCLUSION: Sodium valproate is a well-tolerated drug and provides significant subjective improvement in painful diabetic neuropathy. These data provide a basis for future trials of longer duration in a larger group of patients. [source] Cronobacter (,Enterobacter sakazakii'): current status and future prospectsLETTERS IN APPLIED MICROBIOLOGY, Issue 2 2009J.W. Chenu Abstract The genus Cronobacter accommodates the 16 biogroups of the emerging opportunistic pathogen known formerly as Enterobacter sakazakii. Cronobacter spp. are occasional contaminants of milk powder and, consequently, powdered infant formula and represent a significant health risk to neonates. This review presents current knowledge of the food safety aspects of Cronobacter, particularly in infant formula milk powder. Sources of contamination, ecology, disease characteristics and risk management strategies are discussed. Future directions for research are indicated, with a particular focus on the management of this increasingly important bacterium in the production environment. [source] Probiotics: Immunomodulation and Evaluation of Safety and EfficacyNUTRITION REVIEWS, Issue 1 2006Janine Ezendam PhD The intake of probiotics has been associated with beneficial effects on the immune system, such as improved disease resistance and diminished risk of allergies. This review gives an overview of the immunomodulatory effects of probiotics investigated with in vitro assays, experimental animal models, and clinical trials, and explores possible mechanisms underlying the immunomodulatory effects. Immunomodulation, however, is not always beneficial and might induce detrimental effects; therefore, a scheme is proposed for benefit-risk assessment of immunomodulation by probiotics. Within this scheme, expert judgment based on data derived from a panel of in vitro assays, animal models, and clinical trials should lead to conclusions on efficacy and safety aspects of probiotics. [source] Public safety aspects of pyrethroid insecticides used in West Nile virus-carrying mosquito control,PEST MANAGEMENT SCIENCE (FORMERLY: PESTICIDE SCIENCE), Issue 7 2007Derek W Gammon Abstract West Nile virus is becoming increasingly prevalent in the USA, causing fever, encephalitis, meningitis and many fatalities. Spread of the disease is reduced by controlling the mosquito vectors by a variety of means, including the use of pyrethroid insecticides, which are currently under scrutiny for potential carcinogenic effects in humans. Pyrethrins and resmethrin, a pyrethroid, have been shown to cause tumours in rat and mouse models respectively. However, the tumours appear to be caused by liver enzyme induction and hypertrophy rather than genotoxicity, and the results are therefore unlikely to be applicable to humans. Nonetheless, for resmethrin, the US Environmental Protection Agency (EPA) has concluded that there is a likely risk of carcinogenicity in humans, requiring the manufacturers to provide more detailed data to prove that it can be used safely in vector control. Reproductive toxicity of resmethrin in the rat is also discussed. Copyright © 2007 Society of Chemical Industry [source] Some safety aspects on the design of sparger systems for the oxidation of organic liquidsPROCESS SAFETY PROGRESS, Issue 4 2006Manfred Weber Abstract This article summarizes all important parameters for a proper and safe design of the sparger system for large bubble columns, used for the oxidation of organic liquids with air or oxygen enriched air. As an example, this is done for the oxidation of cumene (isopropylbenzene), which is worldwide used in phenol processes. Based on data in the literature and newly measured flammability limits at 100° C and 5 barg, the potential hazards from uncontrolled gas reactions can be avoided, ultimately avoiding an explosion in the sparger system. For normal operation, a minimum flow of gas is necessary to ensure a uniform flow through all outlets, which are typically holes with a diameter of several millimeters. All holes should be directed towards the vessel bottom to self-drain the sparger. For start-up, a previous inerting of the sparger with nitrogen is preferable. Nevertheless, a certain amount of organic liquid may still be in the sparger system prior to start up. Therefore, the compressed air/oxygen should have a temperature below the Oxidation Initiation Temperature to avoid any initiation of a liquid phase oxidation within the sparger. In addition, the pressure in the sparger system should be high enough to keep the gas phase concentration of the organic liquid below the Lower Flammability Limit. © 2006 American Institute of Chemical Engineers Process Saf Prog, 2006 [source] Improving the Procedure for Detection of Intrahepatic Transplanted Islets by Magnetic Resonance ImagingAMERICAN JOURNAL OF TRANSPLANTATION, Issue 10 2009M. L. Malosio Islet transplantation is an effective therapy for restoring normoglycemia in type-1 diabetes, but long-term islet graft function is achieved only in a minority of cases. Noninvasive magnetic resonance imaging of pancreatic islets is an attractive option for "real-time" monitoring of graft evolution. So far, previous studies have been performed in the absence of a standardized labeling procedure and, besides a feasibility study in patients, the effectiveness and safety of various labeling approaches were tested only with high field magnets (4.7 T). In this study, we addressed: (a) standardization of a labeling procedure for human islets with clinically-approved contrast agent Endorem®, (b) safety aspects of labeling related to inflammation and (c) quality of imaging both at 7 T and 1.5 T. We have highlighted that the ratio of Endorem®/islet is crucial for reproducible labeling, with a ratio of 2.24 ug/IEQ, allowing successful in vivo imaging both with 1.5 T and 7.0 T magnets up to 143 days after intrahepatic transplant. With this standardized labeling procedure, labeled islets are neither inflamed nor more susceptible to inflammatory insults than unlabeled ones. This report represents an important contribution towards the development of a standardized and safe clinical protocol for the noninvasive imaging of transplanted islets in humans. [source] Current trends in paediatric regional anaesthesiaANAESTHESIA, Issue 2010H. Willschke Summary Regional anaesthesia is a cornerstone in paediatric anaesthesia today. Many paediatric anaesthetists include regional anaesthetic techniques in their daily clinical practice to provide superior and long-lasting analgesia without the risk of respiratory depression. The first part this article reviews new scientific findings in the field of paediatric regional anaesthesia. The second part focuses on safety aspects and on the impact of ultrasound on paediatric regional anaesthesia. [source] Environment and Food Safety in Agriculture: Are Labels Efficient?AUSTRALIAN ECONOMIC PAPERS, Issue 4 2000Lisette Ibanez In this article, we try to elicit whether an information on food safety is consistent with a more environmental-friendly agriculture. As the policy makers generally intervene to limit negative externalities in agriculture on the supply side, is a labelling policy an efficient way to reduce pollution levels in this sector? The intuitive reason of a food safety label rests on the fact that consumers seem to be more concerned with information on food safety aspects than on environmental ones. In a vertical differentiation model, we analyse the impacts of labels mentioning food safety and environmental aspects, on firms' profits, consumers' surplus and pollution levels. Given our main assumption that food safety and environmental consequences are directly linked, our principal results show that a labelling policy on food safety can be efficient from an environmental point of view, depending on the initial healthy products proportion in the market. Another result is based on the fact that a label policy can reduce consumer's surplus. [source] Engineering and biotechnological aspects for the manufacturing of high quality fried potato productsBIOTECHNOLOGY JOURNAL, Issue 4 2006Ernst H. Reimerdes Abstract Fried potato products have become very popular foods over the last decades. High quality standards have been established for these products by the food industry including uniform brown color and crispness. During frying, Maillard reactions takes place which contribute to color and taste development in these products. However, safety aspects are also influenced by these reactions, e.g., acrylamide formation. Maintaining high safety standards as well as the expected quality requires systematic research based on an integrated approach including all relevant variables, e.g., raw material properties, processing conditions and equipment concepts. Selected results of these investigations are presented and discussed, regarding influence of composition, e.g., precursor levels for Maillard reactions, treatment of raw materials and addition of reactants to frying fat. It has been demonstrated that a combined treatment of the potato sticks by coating of product surfaces and partial pre-drying can be successfully applied to produce well-browned French fries with lower acrylamide contents. Reductions up to 75% could be reached compared to samples without treatment. Furthermore, addition of a water/oil emulsion containing glutamine in the aqueous phase has been shown to influence Maillard reactions at the product surface, resulting in lower acrylamide contents at the same state of browning. [source] Nifedipine trials: effectiveness and safety aspectsBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 2005Herman P. van Geijn Nifedipine (Adalat) is marketed as an anti-hypertensive agent. Nifedipine inhibits voltage-dependent L-type calcium channels, which leads to vascular (and other) smooth muscle relaxation and negative inotropic and chronotropic effects on the heart. Vasodilation, followed by a baroreceptor-mediated increase in sympathetic tone then results in indirect cardiostimulation. Nifedipine was introduced as a tocolytic agent at a time when ,-agonists and magnesium sulphate dominated the arena for the prevention of preterm birth. The oral administration route, the availability of immediate and slow-release preparations, the low incidence of (mild) side effects, and its limited costs explain the attraction to this medication from the obstetric field and its rapid and widespread distribution. Currently, over 40 studies have been published on nifedipine's tocolytic effectiveness, including seven meta-analyses. The quality of the studies suffers particularly from performance bias because the majority of them failed to ensure adequate blinding to treatment both for providers and patients. Concerns about other methodological flaws include measurements, outcome assessment and attrition bias. In particular, the safety aspects of nifedipine for tocolysis have been underassessed. Conclusions from the meta-analyses, favouring the use of nifedipine as a tocolytic agent, are not supported by close examination of the data. The tocolytic effectiveness and ,safety' of nifedipine has been studied primarily in normal pregnancies. Based on its pharmacological properties, one should be cautious to administer nifedipine when the maternal cardiovascular condition is compromised, such as with intrauterine infection, twin pregnancy, maternal hypertension, cardiac disease, etc. Life-threatening pulmonary oedema and/or cardiac failure are definite risks and have been reported. Under such circumstances, the baroreceptor-mediated increase in sympathetic tone may not balance the cardiac-depressant activity of nifedipine. [source] Long-term safety aspects of systemic therapy with fumaric acid esters in severe psoriasisBRITISH JOURNAL OF DERMATOLOGY, Issue 2 2003J.J. Hoefnagel Summary Background Therapy with fumaric acid esters (FAE) has been shown to be safe and effective in patients with severe psoriasis in several clinical studies with limited follow-up periods. In view of the chronic character of psoriasis, long-term safety aspects are of major importance in determining the suitability of a drug during prolonged periods of treatment. Objectives To investigate adverse events of therapy with systemic FAE with follow-up periods of up to 14 years, in order to determine safety aspects of their long-term use in patients with severe psoriasis. Methods Current and/or past therapeutic use of FAE was reviewed in 66 patients with severe psoriasis. Results Forty-one of 66 patients had received FAE for at least 1 year, and 12 of these 41 patients had received FAE for between 10 and 14 years. Adverse events were reported in 73% of the patients. These were usually mild and mainly consisting of flushing (55%), diarrhoea (42%), nausea (14%), tiredness (14%) and stomach complaints (12%). A relative lymphocytopenia was observed in 76% of patients during therapy with FAE, resulting in a permanent discontinuation of therapy with FAE in four patients. A transient eosinophilia and moderate liver enzyme elevations were observed in 14% and 25% of patients, respectively. Conclusions The present study indicates that FAE can be considered as a safe long-term treatment in patients with severe psoriasis. [source] Efficacy of intravitreal bevacizumab (Avastin®) therapy for early and advanced neovascular age-related macular degenerationACTA OPHTHALMOLOGICA, Issue 6 2009Ilse Krebs Abstract. Purpose:, To evaluate the safety and efficacy of intravitreal bevacizumab therapy for early and advanced neovascular age-related macular degeneration (ARMD). Methods:, A consecutive series of eyes with neovascular ARMD treated with monthly intravitreal injections of bevacizumab (1.25 mg/0.05 ml) as long as there was evidence of activity on fluorescein angiography (FA) and optical coherence tomography (OCT) was included and observed for 6 months. For further analysis they were assigned to either an early (untreated/newly diagnosed) or an advanced (predominantly fibrotic/pre-treated) ARMD group. We examined distance visual acuity (VA) with Early Treatment Diabetic Retinopathy Study (ETDRS) charts and central retinal thickness with OCT, as well as lesion size and safety aspects. Results:, Forty-four patients (44 eyes) were enrolled (21 early lesions, 23 advanced lesions). Mean VA changed from 0.74 logMAR at baseline to 0.68 logMAR at month 6 (P = 0.01). Improvement in VA was statistically significant only in eyes with early lesions (n = 21) from month 1 (P = 0.015) up to month 6 (P = 0.03). The changes in central retinal thickness (CRT) (P < 0.001) and total lesion size (P < 0.001) were significant in both groups (early and advanced) at all time-points during follow-up. No significant ocular or systemic adverse effects were observed. Conclusion:, Intravitreal bevacizumab was tolerated well by our patients and we did not identify any apparent short-term safety concerns. We observed stabilization in VA overall, with significant improvement in the early lesion group. [source] Remifentanil for INSURE in preterm infants: a pilot study for evaluation of efficacy and safety aspectsACTA PAEDIATRICA, Issue 9 2009L Welzing Abstract Aim:, To evaluate intubating conditions, extubation times and outcome in preterm infants receiving remifentanil as induction agent for the INSURE procedure. Methods:, In twenty-one preterm infants of 29 to 32 weeks gestation and signs of respiratory distress, we utilized remifentanil as induction agent for the INSURE procedure. Following intubation and surfactant application, the infants were mechanically ventilated until respiratory drive was judged to be satisfactory for continuing CPAP therapy. Intubating conditions were classified by our own scoring system by rating limb movements, coughing and breathing. Heart rate, blood pressure and oxygen saturation were recorded during the entire INSURE procedure. Results:, Remifentanil provided excellent or good intubating conditions in all patients. We observed no serious side effects after remifentanil infusion, in particular, no thorax rigidity, clinically significant bradycardia or arterial hypotension. Average extubation time after surfactant administration was 16.9 min (1,45 min); none of the infants had to be reintubated. Following extubation, the infants required only 3.3 days (1,8 days) of CPAP therapy. None exhibited serious complications of prematurity like periventricular leucomalacia, intraventricular haemorrhage >I°, necrotizing enterocolitis or retinopathy. Conclusion:, In this pilot study, INSURE with remifentanil was associated with good intubating conditions and early extubation resulting in an excellent neonatal outcome. [source] | |||||||||||||||||||