Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial.

BACKGROUND: Previous studies have investigated the protective effect of vitamin D serum levels, at diagnosis and during the follow-up period after treatment, on melanoma outcome. In the present study we assess whether vitamin D supplementation, in the follow-up period after diagnosis and surgical resection of the primary tumor, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and Vitamin D Receptor immunoreactivity in the primary tumor. METHODS/DESIGN: This study is a multicenter randomized double blind placebo- controlled phase III trial. Patients between the age of 18 and 80 years diagnosed and treated surgically for a melanoma stage IB-III are eligible for randomization in a 1:1 ratio to active treatment or placebo. The study drug is taken each month and consists of either 100,000 International Unit cholecalciferol or arachidis oleum raffinatum used as a placebo. The primary endpoint is relapse free survival. The secondary endpoints are 25 hydroxyvitamin D3 serum levels at diagnosis and at 6 month intervals, melanoma subtype, melanoma site and stage of melanoma at diagnosis according to the 2009 American Joint Committee on Cancer melanoma staging and classification. At randomization a bloodsample is taken for DNA analysis. The study is approved by the local Ethics Committees. DISCUSSION: If we can confirm our hypothesis that vitamin D supplementation after removal of the tumor has a protective effect on relapse of cutaneous malignant melanoma we may reduce the burden of CMM at several levels. Patients, diagnosed with melanoma may have a better clinical outcome and improved quality of life. There will be a decrease in health care costs related to treatment of metastatic disease and there will be a decrease in loss of professional years, which will markedly reduce the economic burden of the disease. TRIAL REGISTRATION: Clinical Trial.gov, NCT01748448 , 05/12/2012.

High prevalence of mental disorders in primary care.

OBJECTIVE: To determine the prevalence of common mental disorders in an adult primary care population. DESIGN: Cross-sectional survey in randomly selected subjects, using the PRIME-MD questionnaire. SETTING: Eighty-six general practices in Belgium. SUBJECTS: A total of 2316 randomly selected patients, aged 18 years or older and consulting their general practitioner for other than administrative reasons alone, with slightly more women (58.1%) than men (41.3%). MAIN OUTCOME RESULT: Prevalence rates of mental disorders most commonly seen in primary care practice (mood, anxiety, somatoform, eating and alcohol disorders). METHODS: To facilitate data collection and processing, the entire PRIME-MD questionnaire was programmed on a handheld computer. Patient answers and physician assessments were immediately electronically recorded during the interview. All investigators were trained on the use of the PRIME-MD. The recruitment period lasted 6 weeks: from 15 February to 25 March 1999, and patients were randomly selected for the interview based on a computerized procedure. RESULTS: Although only 5.4% of all patients consulted for a psychiatric reason, a threshold/subthreshold psychiatric disorder was detected in 42.5% of all patients. Most commonly detected disorders were mood disorders in 31.0% (major depressive disorder, 13.9% and dysthymia, 12.6%), anxiety disorders in 19.0% (generalized anxiety disorder, 10.3%), somatoform disorders in 18.0% and probable alcohol abuse/dependence in 10.1%. The results also showed the important rate of comorbidity between these disorders. CONCLUSION: The present study confirms the high prevalence of mental disorders in a general practice setting, and their frequent association. Prevalence rates of our study are even higher than those obtained in previously conducted trials. Our study also demonstrates the utility of the PRIME-MD as a screening tool for mental disorders in primary care. In addition the use of the handheld computer software version of the PRIME-MD allowed us to screen for mental disorders in patients who are unable to attend the GP office and are seen during 'home' visits.

[Recommendations for management of acute chest pain. Report of the Belgium Interdisciplinary Working Group on Acute Cardiology]. / Recommandations pour la prise en charge de douleurs thoraciques aiguës. Rapport du Groupe Interdisciplinaire Belge de Cardiologie Aiguë (BIWAC: Belgium Interdisciplinary Working group on Acute Cardiology).

The Belgium Interdisciplinary Working group on Acute Cardiology, including cardiologists, intensivists and urgentists was formed to provide consensus regarding the management of acute chest pain in the prehospital and the early hospital phase. General recommendations and critical pathways are proposed to improve the treatment of the patients with acute coronary syndromes.

[Recommendations for the management of acute chest pain. Report of the Belgian Interdisciplinary Group on Acute Cardiology]. / Recommandations pour la prise en charge de douleurs thoraciques aiguës. Rapport du Groupe Interdisciplinaire Belge de Cardiologie Aiguë.

The Belgium Interdisciplinary Working Group on Acute Cardiology (BIWAC), including cardiologists, intensivists and urgentists was formed to give consensus regarding the management of acute chest pain in the prehospital and the early hospital phases. General recommendations and critical pathways are proposed to improve the treatment of the patients with acute coronary syndromes.

Rapid detection of stressed Salmonella spp. in dairy and egg products using immunomagnetic separation and PCR.

The rapid detection of an average of 5.9 stressed Salmonella cells in 25 g of food product using immunomagnetic separation (IMS) and PCR is described. For pasteurised egg yolk, egg yolk powder, ice-cream, whole egg, egg white and cheeses made from pasteurised milk PCR was applied after 16 h of preenrichment in buffered peptone water (BPW) using IMS and alkaline lysis as sample preparation method. For whole egg and egg white the BPW was supplemented with iron. For milk powder, and raw milk cheeses, the 16-h preenrichment in BPW was followed by IMS and a 4-h enrichment in Rappaport-Vassiliadis broth. In the latter case, PCR was applied on the enrichment medium after centrifugation and alkaline lysis. For PCR the primers ST11 and ST15 (Aabo et al., 1993) producing a fragment of 429 bp were used. An internal PCR control, designed to be co-amplified with the target DNA using the same primers but producing a smaller fragment of 240 bp, was used.

AOAC validation of qualitative and quantitative methods for microbiology in foods. Association of Official Agricultural Chemists.

The purpose of AOAC International is promoting quality measurements and methods validation in the analytical sciences. The actual work of developing and testing methods is done by a network of AOAC members and volunteers. Validation of the methods is established by the AOAC Official Methods Program. The objective of this program is to provide analytical methods for which performance characteristics have been validated to the highest degree of confidence through an independent, multiple laboratory collaborative study. The performance characteristics for quantitative microbiological methods include repeatability, reproducibility and critical relative difference, while the characteristics for qualitative methods are sensitivity and specificity. The Official Methods Program is illustrated by a practical example of a collaborative study through which salmonella detection by motility enrichment on Modified Semi-solid Rappaport-Vassiliadis (MSRV) medium was adopted as an Official Method.

Acute and chronic effect of molsidomine extended release on exercise capacity in patients with stable angina, a double-blind cross-over clinical trial versus placebo.

A double-blind, placebo-controlled, cross-over study was performed in 50 patients with ischemic heart disease and stable angina to determine the duration of efficacy of 8 mg molsidomine in extended-release form. Exercise testing was performed at baseline and 2, 4, 6, 8, and 10 h after intake of either the medication or the placebo. Total duration of exercise (in minutes) and total work performance (workload x min) was significantly improved in the molsidomine retard group, not only compared with baseline but also with placebo for all time-points. ST segment depression at 60 W and at maximal exercise improved similarly until 10 h after molsidomine retard treatment. The rate-pressure product (heart rate x systolic blood pressure) showed significant improvement only at 60 W. No attenuation of the obtained effects was observed after 14 days of treatment. The number of anginal attacks and the consumption of sublingual nitroderivates were significantly reduced with molsidomine retard 8 mg as compared with placebo. Molsidomine retard 8 mg is effective until at least 10 h after oral (p.o.) intake. A dose schedule of molsidomine retard 8 mg twice daily definitely reduces anginal symptoms.

Salmonella detection in cocoa and chocolate by motility enrichment on modified semi-solic Rappaport-Vassiliadis medium: collaborative study.

A collaborative study was performed in 13 laboratories (including the authors' laboratories) to validate motility enrichment on modified semi-solid Rappaport-Vassiliadis (MSRV) medium for rapid detection of motile Salmonella in cocoa powder and chocolate. The MSRV method was compared with the AOAC standard culture method for detection of Salmonella in cocoa powder, milk chocolate, sweet chocolate, and dark chocolate. Chocolate samples were artificially inoculated with Salmonella at 2 levels of contamination. Cocoa powder was inoculated at 2 levels with naturally contaminated dust from cocoa beans. Uninoculated control samples were also included for each type of product. The sensitivity rate was 98.1% for the MSRV method and 94.9% for the AOAC culture method. The specificity rate was 100.0% for both methods. There was no significant difference in the proportion of samples positive by MSRV and the AOAC culture methods for any of the food types. The MSRV method has been adopted first action by AOAC INTERNATIONAL.

Collaborative study of the International Office of Cocoa, Chocolate and Sugar Confectionery on Salmonella detection from cocoa and chocolate processing environmental samples.

A comparative collaborative study was performed in 13 laboratories to evaluate the use of motility enrichment on Modified Semisolid Rappaport-Vassiliadis medium for rapid Salmonella detection from food-processing environmental samples. Artificially contaminated chocolate scrapings and naturally contaminated cocoa bean dust samples were used in the study. Pre-enrichment was performed in buffered peptone water with added casein and malachite green oxalate. Motility enrichment was compared with a conventional cultural procedure using Rappaport-Vassiliadis broth and selenite cystine broth as selective enrichment. The productivity of motility enrichment was 93.5% compared to a productivity of the cultural procedure of 92%. Statistical analysis showed that there was no significant difference between the two procedures. Modified Semisolid Rappaport-Vassiliadis medium is a sensitive and simple diagnostic tool for the microbiological safety evaluation of food-processing environments.

Collaborative study on the use of motility enrichment on modified semisolid Rappaport-Vassiliadis medium for the detection of Salmonella from foods.

A collaborative study was performed in 15 laboratories to evaluate the use of motility enrichment on modified semisolid Rappaport-Vassiliadis (MSRV) medium for rapid Salmonella detection in a variety of food products. The results of this procedure were compared with those obtained by the cultural procedure using Rappaport-Vassiliadis (RV) broth as selective enrichment and modified brilliant green agar for selective plating. The tests were performed with Salmonella reference samples (SRS) as well as with naturally contaminated food products. When SRS were used without added food the productivity of both MSRV and RV was 96%. When SRS were combined with reference samples containing competitive bacteria the productivity was 98% for MSRV and 95% for RV. In the tests with food samples the productivity of MSRV was 92% with SRS added to food and 96% with naturally contaminated samples, while the productivity of RV was 88% and 90%, respectively. Statistical analysis showed that there was no significant difference between the procedures.

Collaborative Study of the International Office of Cocoa, Chocolate, and Sugar Confectionery on the Use of Motility Enrichment for Salmonella Detection in Cocoa and Chocolate.

A comparative collaborative study was performed in 15 laboratories to validate the use of motility enrichment on Modified Semisolid Rappaport-Vassiliadis (MSRV) medium for Salmonella detection in cocoa and chocolate products. The use of MSRV was compared with a cultural procedure using Rappaport-Vassiliadis broth and selenite cystine broth as selective enrichments. Artificially contaminated milk chocolate samples as well as Salmonella reference capsules added to Salmonella-free cocoa and milk chocolate were used as test samples. Motility enrichment produced 347 positive test results compared to 320 for the cultural procedure. For samples containing a lactose positive Salmonella strain, motility enrichment was far more productive than the cultural procedure, while for the other samples no significant statistical difference in the productivity of both procedures was observed at the 5% level.

An HPLC-UV method for the direct evaluation of N-nitrosodiethanolamine in some cosmetic products and raw materials.

An HPLC-UV method for evaluating the possible contamination of cosmetic products and raw materials by N-nitrosodiethanolamine (NDELA) is described. The usual extraction process is eliminated and the risk introduced by various external factors is minimized. It is clearly shown that NDELA forms readily under certain conditions and that nitrite scavengers have an inhibitory effect on the formation of nitrosamines. Recommendations are made for improving the quality of cosmetic raw materials by testing them for nitrite and NDELA before use.

Improvements of the membrane filter method for DNA:rRNA hybridization.

We describe and recommend the following improvements of DNA:rRNA membrane filter hybridization methods. One of our aims was to avoid DNA release from filter discs during hybridization. 1. Our hybridization conditions are 2 SSC in aq. dest., with 20% formamide, 50 C, overnight for 16 hr. 2. Duplexing is over in 8-10 hr. 3. Formamide has to be very pure (O.D. less than or equal to 0.2/cm light path at 270 nm). 4. RNAase treatment: 250 mug/5 ml 2 SSC/filter at 37 C for 1 hr. 5. Our conditions for stepwise thermal denaturation are: 5 degrees C steps from 50 C to 90 C in 1.5 SSC in 20% formamide. 6. Single-stranded DNA, fixed on membrane filters, and stored in vacuo at 4C can be used reliably for hybridization for up to 20 months. 7. Concentrated DNA in 0.1 SSC, quick-frozen at -50 C and stored at -90 C for up to 2 years can be used for hybridization without much change. 8. A CsCl gradient purification step yields much purer DNA, but increases the release of DNA from filters by about 20%. Filters with 20% more DAN is a compensation. 9. rRNA can be stored for 20 months in SSC or 2 SSC at -12 C without changing the hybridization results.