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Voshaar T.,Krankenhaus Bethanien Moers | Spinola M.,Chiesi Farmaceutici S.p.A. | Linnane P.,Chiesi Farmaceutici S.p.A. | Campanini A.,Chiesi Farmaceutici S.p.A. | And 5 more authors.
Journal of Aerosol Medicine and Pulmonary Drug Delivery | Year: 2014

Methods: This study investigated usability characteristics of NEXThaler® versus two other dry powder inhalers (DPIs; Diskus® and Turbuhaler®). Sixty-six adult patients with asthma (mean age 42.9±17.7 years) and with no previous experience of using a DPI were included in a randomized crossover comparison of the three devices. The main measures of usability were the number of steps failed for each device and the number of people who were able to use the device successfully (effectiveness), the time it took patients to set up the device and the time to read the instructions for use (IFU; efficiency), and patient preferences (satisfaction). Inhaler technique was evaluated after the IFU leaflet was read.Results: NEXThaler was found to be superior to the other two DPIs in terms of the number of device use failures (p<0.001), time to set up (p<0.001), and time to read IFU (p<0.001). Additionally, the proportion of participants who completed a successful inhalation without any errors at all was significantly higher for NEXThaler than for Diskus and Turbuhaler (p<0.001). Patients rated NEXThaler as the easiest to use and most preferred inhaler to own (p<0.001).Conclusions: NEXThaler displayed better usability compared with Diskus and Turbuhaler. The improved usability and higher satisfaction with the device may contribute to increased patient adherence to asthma treatment.Background: Inhaler mishandling is a common issue among patients suffering from asthma and is associated with poor clinical outcomes and greater consumption of health-care resources. Ease of use can improve inhaler technique and, possibly, patients' preference for their inhaler device, which in turn may lead to better adherence to therapy. © 2014 Mary Ann Liebert, Inc.

Lopez-Escamez J.A.,University of Granada | Lopez-Escamez J.A.,Hospital Of Poniente | Carey J.,University of Baltimore | Chung W.-H.,Sungkyunkwan University | And 7 more authors.
Journal of Vestibular Research: Equilibrium and Orientation | Year: 2015

This paper presents diagnostic criteria for Menière's disease jointly formulated by the Classification Committee of the Bárány Society, The Japan Society for Equilibrium Research, the European Academy of Otology and Neurotology (EAONO), the Equilibrium Committee of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) and the Korean Balance Society. The classification includes two categories: definite Menière's disease and probable Menière's disease. The diagnosis of definite Menière's disease is based on clinical criteria and requires the observation of an episodic vertigo syndrome associated with low- to medium-frequency sensorineural hearing loss and fluctuating aural symptoms (hearing, tinnitus and/or fullness) in the affected ear. Duration of vertigo episodes is limited to a period between 20 minutes and 12 hours. Probable Menière's disease is a broader concept defined by episodic vestibular symptoms (vertigo or dizziness) associated with fluctuating aural symptoms occurring in a period from 20 minutes to 24 hours. © 2015 - IOS Press and the authors. All rights reserved.

Larkin J.,Royal Marsden Hospital | Ascierto P.A.,Instituto Nazionale Tumori Fondazione G Pascale | Dreno B.,Hotel Dieu Place Alexis Ricordeau | Atkinson V.,Princess Alexandra Hospital | And 15 more authors.
New England Journal of Medicine | Year: 2014

Background The combined inhibition of BRAF and MEK is hypothesized to improve clinical outcomes in patients with melanoma by preventing or delaying the onset of resistance observed with BRAF inhibitors alone. This randomized phase 3 study evaluated the combination of the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib.Methods We randomly assigned 495 patients with previously untreated unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma to receive vemurafenib and cobimetinib (combination group) or vemurafenib and placebo (control group). The primary end point was investigator-assessed progression-free survival.Results The median progression-free survival was 9.9 months in the combination group and 6.2 months in the control group (hazard ratio for death or disease progression, 0.51; 95% confidence interval [CI], 0.39 to 0.68; P<0.001). The rate of complete or partial response in the combination group was 68%, as compared with 45% in the control group (P<0.001), including rates of complete response of 10% in the combination group and 4% in the control group. Progression-free survival as assessed by independent review was similar to investigator-assessed progression-free survival. Interim analyses of overall survival showed 9-month survival rates of 81% (95% CI, 75 to 87) in the combination group and 73% (95% CI, 65 to 80) in the control group. Vemurafenib and cobimetinib was associated with a nonsignificantly higher incidence of adverse events of grade 3 or higher, as compared with vemurafenib and placebo (65% vs. 59%), and there was no significant difference in the rate of study-drug discontinuation. The number of secondary cutaneous cancers decreased with the combination therapy. © 2014 Massachusetts Medical Society. All rights reserved.

Tripodi S.A.,University of Siena | Rocca B.J.,University of Siena | Mourmouras V.,University of Siena | Barbanti G.,Azienda Ospedaliera Universitaria Senese | And 2 more authors.
Archives of Pathology and Laboratory Medicine | Year: 2013

Glomus tumors are rare, mesenchymal neoplasms of adulthood, which occur in both the sexes with equal frequency. Most of these tumors are benign, but some cases with atypical/malignant behavior have been reported. They most often occur in the extremities, typically in the subungual region of the fingers, and rarely involve the internal organs. We report the case of a 63-year-old man who presented with hematuria. The cystoscopy showed a polypoid lesion of the anterior wall of the bladder, which was diagnosed on biopsy as a benign glomus tumor. To the best of our knowledge, this is the first case of benign glomus tumor of the bladder described in the literature. This report widens the spectrum of the differential diagnoses of bladder neoplasms.

Centro Of Riferimento Oncologico Instituto Nazionale Tumori Aviano and Azienda Ospedaliera Universitaria Senese | Date: 2012-08-01

The invention relates to a method for determining prognosis, predicting or monitoring response to therapy of patients affected by cutaneous melanoma through the evaluation of the methylation of different genomic DNA sequences, including the Long Interspersed Nucleotide Element-1 (LINE-1) repetitive DNA sequences and/or the concomitant methylation profile of specific groups of genes defined as methylation signature.

Centro Of Riferimento Oncologico Instituto Nazionale Tumori Aviano and Azienda Ospedaliera Universitaria Senese | Date: 2012-02-01

The invention relates to a method for determining prognosis, predicting or monitoring response to therapy of patients affected by melanoma through the evaluation of the methylation of different genomic DNA sequences, including the Long Interspersed Nucleotide Element-1 (LINE-1) repetitive DNA sequences and/or the concomitant methylation profile of specific groups of genes defined as methylation signature.

Mazzei M.A.,University of Siena | Guerrini S.,University of Siena | Squitieri N.C.,University of Siena | Imbriaco G.,University of Siena | And 5 more authors.
World Journal of Gastroenterology | Year: 2013

AIM: To validate the utility of magnetic resonance imaging (MRI) for the clinical management of acute ischemic colitis (IC). METHODS: This is a magnetic resonance (MR) prospective evaluation of 7 patients who were proved to have acute IC on the basis of clinical, endoscopic and computed tomography (CT) findings and who were imaged in our institution between February 2011 and July 2012. The mean age of the patients was 72.28 years. Abdominal CTs were obtained using a 64-detector row configuration for all patients with un-enhanced and contrast-enhanced scans, in the late arterial phase (start delay 45-50 s) and in the portal venous phase (start delay 70-80 s). The MR examinations were performed using a 1.5T superconducting magnet, using Fast Imaging Employing Steady State Acquisition and T2-weighted fast-recovery fast-spin echo sequences in axial and coronal plane. CT and MRI examinations were analysed for the presence of colonic abnormalities and associated findings. RESULTS: Segmental involvement was seen in 6 patients (85.71%), with a mean length of involvement of 412 mm (range 145.5-1000 mm). Wall thickness varied between 6 mm and 17.5 mm (mean 10.52 mm) upon CT examinations and from 5 to 15 mm (mean 8.8 mm) upon MR examinations. The MRI appearance of the colonic wall varied over the time: Type I appearance with a 3 layer sandwich sign was seen in 5 out of 12 examinations (41.66%), patients underwent MR within a mean of 36 h (ranging from 1 to 54 h) after the CT examination. Type II and III appearance with a 2 layer sign, was seen in 4 examinations (33.33%), patients underwent MR within a mean of 420.5 h (ranging from 121 to 720 h) after the CT examination. In the remaining three MRI examinations, performed within a mean of 410 h (ranging from 99.5 to 720 h) the colonic wall appeared normal. CONCLUSION: MRI, only using precontrast images, may be used as a substitute for invasive procedures in diagnosis and follow-up of acute IC. © 2013 Baishideng. All rights reserved.

Buki B.,Danube University Krems | Mandala M.,Azienda Ospedaliera Universitaria Senese | Nuti D.,Azienda Ospedaliera Universitaria Senese
Journal of Vestibular Research: Equilibrium and Orientation | Year: 2014

Atypical variants of benign paroxysmal positional vertigo (BPPV) are often encountered and frequently confusing. The authors present a hypothetical framework that accounts for all classical patterns of BPPV and several unusual variants such as BPPV without nystagmus, BPPV with downbeat nystagmus and BPPV with paradoxically direction-changing nystagmus. The authors introduce new concepts, such as "ipsicanal switch" and "horizontal short arm canalolithiasis" and suggest that their use may improve diagnosis and treatment in everyday clinical practice. The possible consequences of saccular otoconia detachment are reviewed according to the literature.

Bianciardi G.,University of Siena | Miracco C.,University of Siena | Lazzi S.,Azienda Ospedaliera Universitaria Senese | Luzi P.,University of Siena
Current Bioinformatics | Year: 2013

This paper investigates the use of computerized fractal analysis for objective characterization of the complexity of the epithelial-connective tissue interface in basal cell carcinoma and the ability of the technique to quantitatively discriminate among different diagnostic categories. Tumor boundaries were extracted by means of image analysis. The fractal dimension was calculated by using the box-counting method. The results showed that the shape of the boundaries between epithelium and stroma is significantly more complex in infiltrative high risk tumors than in circumscribed low risk ones (p<0.001), with 100% correct classifications. This study shows that the computerized fractal analysis of epithelial-connective tissue interface in basal cell carcinomas can provide an accurate, quantitative, inexpensive technique to help in tumor diagnosis. © 2013 Bentham Science Publishers.

Da Filicaia M.G.,Azienda Ospedaliera Universitaria Senese
Recenti Progressi in Medicina | Year: 2014

The management of patients with end-stage organ failure necessitates a considerable integration between palliative care and those who care the patient in different clinical settings: the general practitioner, who is - or should be - always involved and, in relation to the steps of care, the emergency department, the hospital units, and the intensive care unit. The staff involved should have skills and competences to plan with the patient or his/her family a shared schedule, which may result in the interruption of disproportionate treatments. All this leads to many concerns discussed in the document by the Società Italiana di Anestesia Analgesia Rianimazione e Terapia Intensiva (SIAARTI); the paper provides a useful guide to where, how, and when we care, inform, and communicate. In this editorial, the author discusses these three topics, setting them in the reality of the Italian health care system. The aim is to emphasize the aspects of space, time and organization of care, focusing on the communication challenges that influence the process of defining a "shared schedule" between the patients, their families, and the health care system.

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