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Quinto di Treviso, Italy

Rienzi L.,GENERA Centres for Reproductive Medicine | Bariani F.,Italian National Transplant Center | Dalla Zorza M.,Centro Trasfusionale | Romano S.,GENERA Centres for Reproductive Medicine | And 4 more authors.
Reproductive BioMedicine Online | Year: 2015

Traceability of cells during IVF is a fundamental aspect of treatment, and involves witnessing protocols. Failure mode and effects analysis (FMEA) is a method of identifying real or potential breakdowns in processes, and allows strategies to mitigate risks to be developed. To examine the risks associated with witnessing protocols, an FMEA was carried out in a busy IVF centre, before and after implementation of an electronic witnessing system (EWS). A multidisciplinary team was formed and moderated by human factors specialists. Possible causes of failures, and their potential effects, were identified and risk priority number (RPN) for each failure calculated. A second FMEA analysis was carried out after implementation of an EWS. The IVF team identified seven main process phases, 19 associated process steps and 32 possible failure modes. The highest RPN was 30, confirming the relatively low risk that mismatches may occur in IVF when a manual witnessing system is used. The introduction of the EWS allowed a reduction in the moderate-risk failure mode by two-thirds (highest RPN = 10). In our experience, FMEA is effective in supporting multidisciplinary IVF groups to understand the witnessing process, identifying critical steps and planning changes in practice to enable safety to be enhanced. © 2015 Reproductive Healthcare Ltd.

Sanna S.,CNR Institute of Neurogenetics and Neuropharmacology | Pitzalis M.,University of Sassari | Zoledziewska M.,University of Sassari | Zara I.,Research and Development in Sardinia CRS4 | And 41 more authors.
Nature Genetics | Year: 2010

A genome-wide association scan of 6.6 million genotyped or imputed variants in 882 Sardinian individuals with multiple sclerosis (cases) and 872 controls suggested association of CBLB gene variants with disease, which was confirmed in 1,775 cases and 2,005 controls (rs9657904, overall P = 1.60 × 10 -10, OR = 1.40). CBLB encodes a negative regulator of adaptive immune responses, and mice lacking the ortholog are prone to experimental autoimmune encephalomyelitis, the animal model of multiple sclerosis. © 2010 Nature America, Inc. All rights reserved.

Grossi E.,Centro Diagnostico Italiano | Podda G.M.,University of Milan | Pugliano M.,University of Milan | Gabba S.,Centro Diagnostico Italiano | And 5 more authors.
Pharmacogenomics | Year: 2014

Background: In recent years, pharmacogenetic algorithms were developed for estimating the appropriate dose of vitamin K antagonists. Aim: To evaluate the performance of new generation artificial neural networks (ANNs) to predict the warfarin maintenance dose. Methods: Demographic, clinical and genetic data (CYP2C9 and VKORC1 polymorphisms) from 377 patients treated with warfarin were used. The final prediction model was based on 23 variables selected by TWIST® system within a bipartite division of the data set (training and testing) protocol. Results: The ANN algorithm reached high accuracy, with an average absolute error of 5.7 mg of the warfarin maintenance dose. In the subset of patients requiring ≤21 mg and 21-49 mg (45 and 51% of the cohort, respectively) the absolute error was 3.86 mg and 5.45 with a high percentage of subjects being correctly identified (71 and 73%, respectively). Conclusion: ANN appears to be a promising tool for vitamin K antagonist maintenance dose prediction. © 2014 Future Medicine Ltd.

Zappacosta B.,University Cattolica Del ore | Persichilli S.,University Cattolica Del ore | Iacoviello L.,University Cattolica Del ore | Di Castelnuovo A.,University Cattolica Del ore | And 5 more authors.
Nutrition, Metabolism and Cardiovascular Diseases | Year: 2013

Background and aims: The relevance of folate, other B-vitamins and homocysteine (Hcy) for the occurrence or prevention of several diseases has induced growing interest. Unfortunately, little evidence is available regarding B-vitamin concentrations in Italy.This study evaluated in a region of middle-southern Italy, folate, vitamin B12 and Hcy concentrations and the prevalence of their ideal blood levels. The main determinants of B-vitamins and Hcy were also considered. Methods and results: Male and female blood donors (n=240), aged 18-66 years and living in Molise region (Italy), were enrolled in the study. They completed a brief questionnaire concerning fruit and vegetables intake, physical activity and smoking; serum and red blood cell (RBC) folate and serum vitamin B12 were measured by an immunoassay on an automated analyzer. Total Hcy was measured by high performance liquid chromatography (HPLC).Geometric means of serum folate, RBC folate and serum vitamin B12 were 10.8nmoll-1, 426.0nmoll-1 and 245.0pmoll-1, respectively. Only 22.5%, 24.2% and 16.3% of blood donors showed an adequate level of serum folate, RBC folate or serum vitamin B12 respectively. When a cut-off of RBC folate ≥906nmoll-1 was used no women of childbearing age had adequate levels. A geometric mean of 14.0μmoll-1 was found for total Hcy, with an ideal concentration in 12.1% of subjects. Folate concentration was higher in women and non-smokers and in subjects with higher consumption of fruit and vegetable. Conclusion: This study shows a low-moderate B-vitamins status in middle-southern Italy, associated with an inadequate fruit and vegetable consumption. A public health strategy should be undertaken to encourage a B-vitamin-rich diet with the addition of vitamin supplements or vitamin fortified foods in population subgroups with special needs. © 2011 Elsevier B.V.

Fucile C.,University of Genoa | Marenco S.,Gastroenterology Unit | Bazzica M.,Gastroenterology Unit | Zuccoli M.L.,University of Genoa | And 10 more authors.
Medical Oncology | Year: 2015

Pharmacokinetics and dose-finding studies on sorafenib were conducted on heterogeneous groups of patients with solid tumors. Portal hypertension, gut motility impairment and altered bile enterohepatic circulation may explain different sorafenib toxicological profile in cirrhotic patients. This study evaluated sorafenib plasma concentration in a homogeneous group of cirrhotic patients with hepatocellular carcinoma (HCC). Sorafenib concentrations were determined by liquid chromatography in 12 consecutive patients. Data have been evaluated by the generalized estimating equations method (p value statistical level was set at α = 0.05). (1) There were not significant differences between sorafenib concentrations in patients who tolerate the full dose versus patients with reduced dose due to toxicity; (2) the average sorafenib concentrations measured 3 h after the morning dosing were lower than those measured 12 h after the evening dosing (p = 0.005); (3) sorafenib concentrations decrease overtime (p < 10−4); (4) it has been found an association between the development of severe adverse reactions and sorafenib concentrations (p < 10−5). The relationship between dose and concentration of sorafenib in HCC patients is poor and not clinically predictable, confirming the variability both in the maximum tolerated dose and in plasma concentrations. Several factors may influence the pharmacokinetics in patients with liver disease. This may explain the inter-patient variability of concentrations and the lack of differences in concentration at different dosages. It could be interesting to extend the series of HCC patients to enhance information on the kinetics of the drug; furthermore, to establish a threshold of plasma sorafenib concentrations to predict severe adverse reactions would be clinically useful. © 2014, Springer Science+Business Media New York.

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