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Background: The efficacy of antidepressant treatment is fair, but the efficacy is considerably lower in patients failing two or more trials underscoring the need for new treatment options. Our study evaluated the augmenting antidepressant effect of 8-weeks transcranial pulsed electromagnetic field (T-PEMF) therapy in patients with treatment-resistant depression., Methods: A multicenter 8-week single-arm cohort study conducted by the Danish University Antidepressant Group., Results: In total, 58 participants (20 men and 38 women) with a moderate to severe depression as part of a depressive disorder according to ICD-10 who fulfilled criteria for treatment resistance were included, with 19 participants being nonresponders to electroconvulsive therapy during the current depressive episode. Fifty-two participants completed the study period. Scores on the Hamilton Depression Scale 17-items version (HAM-D17) decreased significantly from baseline (mean = 20.6, SD 4.0) to endpoint (mean = 12.6, SD 7.1; N = 58). At endpoint, utilizing a Last Observation Carried Forward analysis, 49 and 28% of those participants with, respectively, a nonchronic current episode (≤2 years; N = 33) and a chronic current episode (>2 years; N = 25) were responders, that is, achieved a reduction of 50% or more on the HAM-D17 scale. At endpoint, respectively, 30 and 16% obtained remission, defined as HAM-D17 ≤ 7. On the Hamilton Scale 6-item version (HAM-D6), respectively, 51 and 16% obtained remission, defined as HAM-D6 ≤ 4., Conclusions: The findings indicate a potential beneficial role of T-PEMF therapy as an augmentation treatment to ongoing pharmacotherapy in treatment-resistant depression.

Introduction: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014., Methods: All ADR reports handled by the ADEM in 2014 were recorded anonymously and analysed descriptively., Results: A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome., Conclusion: The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad., Funding: none., Trial Registration: not relevant. .

We present a summary of the main findings of the latest report of the European Food Safety Authority and European Centre for Disease Prevention and Control on zoonoses, zoonotic agents and food-borne outbreaks in the European Union (EU), based on data from 2009. Zoonoses are prevalent and widely distributed across several countries in the EU. The most important highlight of this report was the continuous decrease of human salmonellosis since 2005, probably due to effective control programmes in livestock.

The objective of this study was to examine incidences of Campylobacter in broilers and humans, and to describe seasonal variation and long-term trends by comparing longitudinal surveillance data in six Northern European countries (Denmark, Finland, Iceland, Norway, Sweden and the Netherlands). Due to high degree of seasonality and autocorrelation, seasonally adjusted (de-seasonalized) and trend adjusted data (de-trended) were used for comparing incidences within and between the six countries. De-seasonalized time series were obtained by fitting the incidence time series to mean monthly temperature and then removing this effect from the data. Long-term trends were fitted to the de-seasonalized time series. The incidence of Campylobacter colonization in broiler flocks and incidence of campylobacteriosis in humans showed a concordant seasonality for all the countries. There was a strong association between the incidence in both broilers and humans in a given month and the mean temperature of the northern hemisphere in the same month, as well as the preceding month, as shown by the cross-correlations and the chosen Generalized Additive Model. Denmark and Sweden showed a steadily decreasing trend for Campylobacter in broilers and human campylobacteriosis in the period 2001-2007. In Iceland, there was a decreasing trend for campylobacteriosis in humans from 1999 to 2007, whilst the broiler trend for Campylobacter was stable from 2001 to 2004, then falling thereafter. In Norway, the human campylobacteriosis trend showed a steady increase throughout the period. On the other hand, the Norwegian broiler trend for Campylobacter showed a decrease from 2001 until 2004, but was thereafter stable. There was no significant decrease or increase in incidence for human campylobacteriosis in the Netherlands, and the trend for Campylobacter in broilers was close to stable. The seasonality seen in broiler and human closely follows the temperature, and was probably caused, at least partly, by temperature related factors.

Thermotolerant Campylobacter spp. have been the most common bacterial cause of human gastrointestinal disease in Denmark since 1999. In 2003, the Danish voluntary strategy to control Campylobacter was intensified. The focus was on biosecurity, allocation of meat from Campylobacter-negative broilers to the production of chilled products, and consumer information campaigns. From 2002 to 2007, the percentage of Campylobacter-positive broiler flocks at slaughter decreased from 43% to 27%. After processing, Campylobacter-positive samples of chilled broiler meat fell from 18% in 2004 to 8% in 2007. Furthermore, the number of registered human Campylobacter cases decreased by 12%; from 4379 cases in 2002 to 3865 cases in 2007. We believe that the observed decrease in the occurrence of Campylobacter in broilers and broiler meat and the coincidental fall in the number of registered human cases is, in part, a result of the implemented control strategy.

In recent years, several quantitative risk assessments for Campylobacter in broiler meat have been developed to support risk managers in controlling this pathogen. The models encompass some or all of the consecutive stages in the broiler meat production chain: primary production, industrial processing, consumer food preparation, and the dose-response relationship. The modelling approaches vary between the models, and this has supported the progress of risk assessment as a research discipline. The risk assessments are not only used to assess the human incidence of campylobacteriosis due to contaminated broiler meat, but more importantly for analyses of the effects of control measures at different stages in the broiler meat production chain. This review paper provides a comparative overview of models developed in the United Kingdom, Denmark, the Netherlands and Germany, and aims to identify differences and similarities of these existing models. Risk assessments developed for FAO/WHO and in New Zealand are also briefly discussed. Although the dynamics of the existing models may differ substantially, there are some similar conclusions shared between all models. The continuous introduction of Campylobacter in flocks implies that monitoring for Campylobacter at the farm up to one week before slaughter may result in flocks that are falsely tested negative: once Campylobacter is established at the farm, the within-flock prevalence increases dramatically within a week. Consequently, at the point of slaughter, the prevalence is most likely to be either very low (<5%) or very high (>95%). In evaluating control strategies, all models find a negligible effect of logistic slaughter, the separate processing of positive and negative flocks. Also, all risk assessments conclude that the most effective intervention measures aim at reducing the Campylobacter concentration, rather than reducing the prevalence. During the stage where the consumer handles the food, cross-contamination is generally considered to be more relevant than undercooking. An important finding, shared by all, is that the tails of the distributions describing the variability in Campylobacter concentrations between meat products and meals determine the risks, not the mean values of those distributions. Although a unified model for risk assessment of Campylobacter in the broiler meat production would be desirable in order to promote a European harmonized approach, it is neither feasible nor desirable to merge the different models into one generic risk assessment model. The purpose of such a generic model has yet to be defined at a European level and the large variety in practices between countries, especially related to consumer food preparation and consumption, complicates a unified approach.

In this study, seven Danish turkey flocks were investigated at the farm, on arrival to the slaughterhouse, and during and after slaughter. Flocks were selected based on their Campylobacter spp. status at the farm and three Campylobacter negative and four Campylobacter positive flocks were included in the study. At the slaughterhouse, 70-75 samples were collected at different points from the shackling station to packaging of the final meat cuttings. Samples included cloacal swabs, neckskin, liver, heart, meat and environmental samples. Detection of Campylobacter was carried out by conventional culture and by the EiaFoss system (Foss Electric, Hilleroed, Denmark) for detecting Campylobacter spp. in food, using Preston Broth as enrichment medium. The two methods were compared and sensitivities and specificities were calculated using the conventional culture as gold standard. The three negative flocks were consistently negative from the farm and all through processing. Among the samples from the positive flocks, the frequency of positive samples obtained at the slaughterhouse varied. The frequency of positive samples obtained from the four positive flocks varied and was found to be 4%, 49%, 87% and 96%, respectively. In 31 out of 424 samples, discrepancies were observed between results obtained by the EiaFoss system and the conventional culture technique. The sensitivity for the EiaFoss system was calculated to be 0.94 for meat and neckskin samples. A total of 161 strains were genotyped by pulsed-field gel electrophoresis (PFGE) in order to investigate possible changes in carriage of Campylobacter spp. strains during processing. In three flocks, only one PFGE type was encountered in samples collected at the farm level and, in one flock, two different types were observed. In two flocks, the strain from the farm was also isolated in samples collected at the slaughterhouse. Changes in carriage were observed in two flocks during processing, in particular post chilling.

A total of 117 Campylobacter jejuni isolates from Danish turkeys were tested for the presence of seven virulence and toxin genes by PCR. One hundred seventeen (100%) isolates were positive for flaA, cadF, and ceuE gene primers. One hundred three (88%) isolates were positive for cdt gene cluster PCR detection (cdt gene cluster-PCR), whereas 101 (86.3%), 102 (87.2%), and 110 (94%) isolates were positive for cdtA-, cdtB-, and cdtC-PCR, respectively. Only 39 (33.3%) isolates were positive for virB11. Of 117 isolates, 114 (97.4%) produced cytolethal distending toxin (CDT) in Vero cell assays, 105 (89.7%) in Colon 205 assays, and 109 (93.2%) in chicken embryo cell assays. The CDT titers were determined in Vero cell assays. Of 117 isolates, 50 (42.7%) produced a CDT titer of 1:100, 29 (24.8%) of 1:50, and 27 (23%) of 1:5 to 1:10; 8 (6.8%) produced a CDT titer at undiluted supernatants and 3 (2.6%) produced no toxin. Twenty-nine C. jejuni isolates that were PCR negative for one or more individual cdt toxin genes also produced low or no CDT toxin. The high prevalence of the seven virulence and toxin genes demonstrates that these putative pathogenic determinants are widespread among Campylobacter isolates from turkeys and calls for further investigation for the elimination of Campylobacter infection in industrial turkey production and in industrial food chains.

Aims: To use amplified fragment length polymorphism (AFLP) analysis to evaluate the genetic relatedness among 254 Campylobacter jejuni reference and field strains of diverse origin representing all defined 'Penner' serotypes for this species., Methods and Results: Field strains (n = 207) from human diarrhoea and diverse animal and environmental sources were collected mainly through a National surveillance programme in Denmark and serotyped by use of the established 'Penner' scheme. Genetic relationships among these isolates, and the archetypal serotype reference strains, were assessed by numerical analysis of AFLP profiles derived from genomic DNA. Extensive genetic diversity was seen among the strains examined; however, 43 groups of isolates were identified at the 92% similarity (S-) level. Thirteen groups contained isolates from a single host, possibly representing genotypes of 'low risk' to human health. The remaining 30 groups contained isolates from humans, chickens and associated food products, cattle, sheep, turkeys, ostriches and/or dogs. Strains assigned to serotypes 2, 6/7, 11 and 12 formed major clusters at the 77.6% S-level. Most other serotypes did not form homogeneous clusters., Conclusions: High-resolution genotyping applied to strains from a comprehensive range of sources provides evidence for multiple sources of sporadic C. jejuni infection. The results suggest that public health protection measures should be directed at all foods of animal origin., Significance and Impact of the Study: The genetic relatedness among all 'Penner' serotypes of C. jejuni is assessed by AFLP analysis. In addition, further evidence of epidemic and host-specific clones of C. jejuni is provided.

The prevalence of Salmonella serovars and their antimicrobial resistance patterns were investigated among Danish turkeys between 1995 and 2000, by sampling the flocks approximately 14 days before they were slaughtered. Within the flocks, the prevalence of salmonella varied from 7.1 per cent to 25 per cent, and 24 different serovars were detected. The five most prevalent, which accounted for 58.5 per cent of the isolates were Salmonella Heidelberg (16.2 per cent of the isolates), Salmonella Agona (15.8 per cent), Salmonella Derby (12.4 per cent), Salmonella Muenster (7.3 per cent) and Salmonella Anatum (6.8 per cent). In addition, a few rough isolates and isolates belonging to the antigenically incomplete formulae 6,7:-:- and 4,12:b:- were found. The level of antimicrobial resistance was low; the highest resistance was recorded to ampicillin (13.7 per cent) and streptomycin (9.0 per cent) followed by tetracycline (8.5 per cent), sulphonamides (7.7 per cent) and spectinomycin (4.7 per cent). Resistance to quinolones was very low: four isolates were resistant to nalidixic acid, and only one was resistant to enrofloxacin. No resistance was recorded to colistin, apramycin, ceftiofur, florfenicol, or amoxycillin with clavulanic acid. Only 24 isolates were resistant to two or more compounds in various combinations of up to six compounds; one Salmonella Havana isolate was resistant to six compounds. Six isolates were serovar Typhimurium, but none of them belonged to phage type DT104.

Aims: To determine the sensitivity and specificity of two automated enzyme immunoassays (EIA), EiaFoss and Minividas, and a conventional microbiological culture technique for detecting thermophilic Campylobacter spp. in turkey samples., Methods and Results: A total of 286 samples (faecal, meat, neckskin and environmental samples) were collected over a period of 4 months at a turkey slaughterhouse and meat-cutting plant in Denmark. Faecal and environmental samples were tested by the conventional culture method and by the two EIAs, whereas meat and neckskin samples were tested by the two EIAs only. Two enrichment broths were used, Campylobacter Enrichment Broth (CEB) and Preston Broth (PB). Verification of positive test results was carried out by conventional culture on selective solid media. The specificities of all methods were high. The sensitivities of the EIAs were higher than that of the conventional culture technique but varied depending on the type of sample and enrichment broth. For neckskin samples, the Minividas had a significantly higher sensitivity than the EiaFoss and using PB instead of CEB as the enrichment broth significantly improved the sensitivity for both EIAs., Conclusions: Both EIAs provided more accurate results than the conventional culture technique. Furthermore, neckskin samples enriched in PB resulted in more positive test results and Campylobacter growth than samples enriched in CEB., Significance and Impact of the Study: The Eiafoss and Minividas proved to be reliable methods for detecting Campylobacter spp. in various samples. However, the results emphasize the need for the development of specific enrichment protocols for specific samples.