E-Coaching: the DianaWeb study to prevent breast cancer recurrences.

INTRODUCTION: Breast cancer is the most common cancer in women worldwide, for which the survival rate is increasing over time. Growing evidence are showing that the effect of lifestyle could have the same weight of the effect of the usual clinical-pathological risk factors on survival rate. The DianaWeb study responds to the pressing request of patients diagnosed with breast cancer to know the most advanced point of scientific research on the prevention of recurrences, to have a virtual space to meet, where to receive advice and practical information for the daily management the lifestyle change. DianaWeb is a community-based participatory research, dedicated to breast cancer patients, aimed to monitor lifestyle, provide them tips to encourage sustainable lifestyle changes, and to analyze clinical outcomes. In order to achieve these aims, DianaWeb uses a specific interactive website (http://www.dianaweb.org/). METHODS: The web architecture has been designed essential and light, with a rigorous implantation that brings the figure of the woman to the center. In order to humanized the project the acronym used to identify the study was Diana (Diet and Androgens), a classical female name, who was illustrated as a female avatar, aimed to symbolize all women. The graphical interface was developed using seven pastel tones colors, which become a fundamental elements of the layout, such as frame, navigation menu, and separation interspaces. RESULTS: The project started in 2015, and in 4 days the web site was visited by more than 1000 people. A total of 2823 persons enrolled in the study, but 2182 did not send the full documentations, 61 persons abandoned the study, 641 timely answered to the questionnaires. CONCLUSIONS: The high number of participants' interaction within the web page, confirmed the high usability of the web page and the great interest of patients. Prevention of breast cancer recurrences with low cost technologies, easily available to everybody, is a priority for both public health and public finances.

Industrialization of a perfusion bioreactor: Prime example of a non-straightforward process.

Bioreactors are essential enabling technologies for the translation of advanced therapies medicinal products from the research field towards a successful clinical application. In order to speed up the translation and the spread of novel tissue engineering products into the clinical routine, tissue engineering bioreactors should evolve from laboratory prototypes towards industrialized products. In this work, we thus challenged the industrialization process of a novel technological platform, based on an established research prototype of perfusion bioreactor, following a GMP-driven approach. We describe how the combination of scientific background, intellectual property, start-up factory environment, wise industrial advice in the biomedical field, design, and regulatory consultancy allowed us to turn a previously validated prototype technology into an industrial product suitable for serial production with improved replicability and user-friendliness. The solutions implemented enhanced aesthetics, ergonomics, handling, and safety of the bioreactor, and they allowed compliance with the fundamental requirements in terms of traceability, reproducibility, efficiency, and safety of the manufacturing process of advanced therapies medicinal products. The result is an automated incubator-compatible device, housing 12 disposable independent perfusion chambers for seeding and culture of any perfusable tissue. We validated the cell seeding process of the industrialized bioreactor by means of the Design of Experiment approach, whilst the effectiveness of perfusion culture was evaluated in the context of bone tissue engineering.

A cost-effectiveness analysis of maternal CYP2D6 genetic testing to guide treatment for postpartum pain and avert infant adverse events.

Mothers with a CYP2D6 ultrarapid metabolizer phenotype may expose their infants to risk of adverse events when taking codeine while breastfeeding, by producing more of the active metabolite, morphine. Pharmacogenetic testing may be a valuable tool to identify such mothers, but testing can be costly. The objective of the study was to determine the incremental costs of genotyping to avert neonatal adverse events during maternal pharmacotherapy. A cost-effectiveness analysis, using a decision model, was performed with a hypothetical cohort of prenatal subjects. Parameter estimates, costs and ranges for sensitivity analyses were ascertained from the literature and expert opinion. Sensitivity analyses were conducted to assess the robustness of the results. Probabilistic sensitivity analysis revealed an incremental cost-effectiveness (ICER) of $10 433 (Canadian dollars) for genotyping compared to no genotyping per adverse event averted. Results were sensitive to hospital admission costs. The ICER was lower when evaluating only subjects having caesarean deliveries or those from ethnic populations known to have a high prevalence of ultra-rapid metabolizers. Although genotyping to guide pharmacotherapy was not cost saving, the cost to avert an infant adverse event may represent good value for money in specific populations. With a growing demand for personalized medicine, these findings are relevant for decision makers, clinicians and patients.

Fast and cost-effective fabrication of large-area plasmonic transparent biosensor array.

Surface enhanced Raman-based sensors are widely used for chemical and biological species analysis; but to date the high cost, long production time, hazardous, and toxic content as well as small sensing area and opacity are limiting their capabilities for widespread applications in the medical and environmental fields. We present a novel cost-effective method for fast laser-based fabrication of affordable large-area and transparent periodic arrays of ligand-free metallic nanoparticles, offering a maximum possibility for the adsorption/immobilization of molecules and labeling. Further, we demonstrate a remarkable detection limit in the picomolar range by means of Raman scattering, thus evidencing a superior signal-to-noise ratio compared to other sensor substrates. The high sensitivity performance along with a fast and cheap fabrication procedure of reusable large-area transparent plasmonic devices opens the route for direct, in situ multimodal optical analysis with broad applications in the biomedical/analytical fields.

Monitoring air pollution effects on children for supporting public health policy: the protocol of the prospective cohort MAPEC study.

INTRODUCTION: Genotoxic biomarkers have been studied largely in adult population, but few studies so far have investigated them in children exposed to air pollution. Children are a high-risk group as regards the health effects of air pollution and some studies suggest that early exposure during childhood can play an important role in the development of chronic diseases in adulthood. The objective of the project is to evaluate the associations between the concentration of urban air pollutants and biomarkers of early biological effect in children, and to propose a model for estimating the global risk of early biological effects due to air pollutants and other factors in children. METHODS AND ANALYSIS: Two biomarkers of early biological effects, DNA damage by the comet assay and the micronuclei (MN) test, will be investigated in oral mucosa cells of 6-8-year-old children. Concurrently, some toxic airborne pollutants (polycyclic aromatic hydrocarbon (PAH) and nitro-PAH) and in vitro air mutagenicity and toxicity in ultra-fine air particulates (PM0.5) will be evaluated. Furthermore, demographic and socioeconomic variables, other sources of exposures to air pollutants and lifestyle variables will be assessed by a structured questionnaire. The associations between sociodemographic, environmental and other exposure variables and biomarkers of early biological effect using univariate and multivariate models will be analysed. A tentative model for calculating the global absolute risk of having early biological effects caused by air pollution and other variables will be proposed. ETHICS AND DISSEMINATION: The project has been approved by the Ethics Committees of the local Health Authorities. The results will be communicated to local Public Health Agencies, for supporting educational programmes and health policy strategies. LIFE+2012 Environment Policy and Governance. LIFE12 ENV/IT/000614.

[Assessment of the genotoxic effects of gaseous emissions and percolates from three municipal landfills using plant bioassays]. / Valutazione dei rischi genotossici derivanti dalla produzione di biogas e percolati in tre discariche controllate mediante test su vegetali.

The biomonitoring of genotoxic effects in environmental complex mixtures using higher plants is very useful for hazard evaluation. In this study we evaluated the potential application of plant genotoxicity tests in monitoring mutagens in landfill environment. The clastogenic effects of gaseous emissions (biogas)from three municipal landfills were evaluated by in situ monitoring using the Tradescantia micronucleus assay. The cytotoxicity and genotoxicity of leachates were studied using the Allium cepa test. We found no significant differences in micronuclei frequency in pollen cells of Tradescantia. Leachate samples showed elevated toxicity that inhibited root tip development in Allium cepa. Genotoxicity of the leachates was evaluated in diluted samples only. We found a significant increase in chromosomal metaphase aberrations only in one of the samples analyzed. In conclusion, biogas was not shown to be a real hazard, whereas leachates were found to display elevated toxicity. It would be advisable to treat leachates before releasing them into the environment as they can cause ecological damages. Since plant bioassays are very useful for the in situ monitoring of environmental genotoxins they are important for the prevention of environmental pollution resulting from the disposal of solid waste.

Clinical and microbiological assessment of patients with a long-term diagnosis of human immunodeficiency virus infection and Candida oral colonization.

The objective of this study was to evaluate Candida oral colonization in human immunodeficiency virus (HIV)-infected patients undergoing long-term highly active antiretroviral therapy (ARV). The cross-sectional study included 331 HIV patients, diagnosed from 1983 to 2003. Oral swabs were performed, and Candida species were determined using ID 32C. Isolates were tested for antifungal susceptibility. Clinical and laboratory data were collected to identify the association with Candida colonization. In total, 161 Candida isolates were detected among 147 of the 331 patients (44%), independently of the time when HIV infection was diagnosed. Candida albicans strains represented 137 (85%) of the isolates, and were susceptible to all of the tested antifungal drugs. Among the non-C. albicans strains, six isolates were dose-dependently susceptible to fluconazole, nine to itraconazole, and seven to ketoconazole. The isolation of Candida was significantly higher in patients with virological failure (83/147; p 0.0002) and CD4(+) T-lymphocyte counts <200 cells/mm(3) (30/83; p 0.0003). Recovery of Candida in the oral cavity was independent of protease inhibitor (PI) usage (p 0.60). Colonized patients typically underwent salvage therapy (p 0.003), and had more episodes of opportunistic fungal infections (p 0.046) and malignancies (p 0.004).Oral Candida colonization in patients under ARV therapy was associated with the immunosupressed status of HIV-infected patients, i.e. low number of CD4(+) T-cells per cubic millimetre, failure of ARV therapy (salvage therapy), and higher number of opportunistic infections and malignancies. Despite the fact that PIs have in vitro antifungal activity, the use of this class of antiretroviral agent did not influence the presence of Candida in the oral cavity of AIDS patients.

Structural characterization and reliable biomechanical assessment of integrative cartilage repair.

Structural and functional characterization of integrative cartilage repair in controlled model systems can play a key role in the development of innovative strategies to improve the long-term outcome of many cartilage repair procedures. In this work, we first developed a method to reproducibly generate geometrically defined disk/ring cartilage composites and to remove outgrown fibrous layers which can encapsulate cartilaginous tissues during culture. We then used the model system to test the hypothesis that such fibrous layers lead to an overestimation of biomechanical parameters of integration at the disk/ring interface. Transmission electron microscopy images of the composites after 6 weeks of culture indicated that collagen fibrils in the fibrous tissue layer were well integrated into the collagen network of the cartilage disk and ring, whereas molecular bridging between opposing disk/ring cartilage surfaces was less pronounced and restricted to regions with narrow interfacial regions (< 2 microm). Stress-strain profiles generated from mechanical push-out tests for composites with the layers removed displayed a single and distinct peak, whereas profiles for composites with the layers left intact consisted of multiple superimposed peaks. As compared to composites with removed layers, composites with intact layers had significantly higher adhesive strengths (161+/-9 vs. 71+/-11 kPa) and adhesion energies (15.0+/-0.7 vs. 2.7+/-0.4 mJ/mm2). By combining structural and functional analyses, we demonstrated that the outgrowing tissue formed during in vitro culture of cartilaginous specimens should be eliminated in order to reliably quantify biomechanical parameters related to integrative cartilage repair.

The effect of long-term treatment with erdosteine on chronic obstructive pulmonary disease: the EQUALIFE Study.

Erdosteine is a new thiol compound with effects on bacterial adhesiveness as well as antioxidant and mucoactive properties. The EQUALIFE study, a fully randomized, double-blind, placebo-controlled, parallel-group, multicenter study, was designed to assets the effectiveness of long-term treatment with erdosteine in patients with moderate chronic obstructive pulmonary disease (COPD). One hundred and fifty-five patients received oral erdosteine, 300 mg b.i.d., or placebo for 8 months during the winter season to assess the effect of treatments on exacerbation rate, hospitalization, lung function and quality of life, assessed using the Short Form 36 and the St. George's Respiratory Questionnaire. A pharmacoeconomic analysis was also conducted to compare the two treatments. One hundred and twenty-four patients completed the study with erdosteine (n = 63) or placebo (n = 61). The group of COPD patients who received 8 months of continuous treatment with erdosteine had significantly fewer exacerbations and spent fewer days in the hospital than did the placebo group; furthermore, they had no loss of lung function. Patients in the erdosteine group also showed a significant improvement in health-related quality of life. The mean total COPD-related disease costs per patient were lower in the erdosteine group than in the placebo group over the study period. The results indicate that 8 months of treatment with erdosteine is effective in reducing exacerbation and hospitalization rates and in improving health status. The study suggests that erdosteine is likely to provide an important contribution to the therapy of patients with symptomatic COPD.