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Rolla S.,University of Turin | Ria F.,Catholic University Sacro Cuore | Occhipinti S.,University of Turin | Di Sante G.,Catholic University Sacro Cuore | And 8 more authors.
Journal of Immunology | Year: 2010

Rat (r)Erbb2 transgenic BALB-neuT mice genetically predestined to develop multiple invasive carcinomas allow an assessment of the potential of a vaccine against the stages of cancer progression. Because of rErbb2 expression in the thymus and its overexpression in the mammary gland, CD8+ T cell clones reacting at high avidity with dominant rErbb2 epitopes are deleted in these mice. In BALB-neuT mice with diffuse and invasive in situ lesions and almost palpable carcinomas, a temporary regulatory T cells depletion combined with anti-rErbb2 vaccine markedly enhanced the anti-rErbb2 Ab response and allowed the expansion of latent pools of low-avidity CD8+ T cells bearing TCRs repertoire reacting with the rErbb2 dominant peptide. This combination of a higher Ab response and activation of a low-avidity cytotoxic response persistently blocked tumor progression at stages in which the vaccine alone was ineffective. However, when diffuse and invasive microscopic cancers become almost palpable, this combination was no longer able to secure a significant extension of mice survival. Copyright © 2010 by The American Association of Immunologists, Inc.


Papini E.,Regina Apostolorum Hospital | Rago T.,University of Pisa | Gambelunghe G.,University of Perugia | Valcavi R.,Thyroid Disease Center | And 7 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2014

Background: The aim of the present trial on ultrasound (US)-guided laser ablation therapy (LAT) of solid thyroid nodules is to assess long-term clinical efficacy, side effects, and predictability of outcomes in different centers operating with the same procedure.Patients: Two hundred consecutive patients were randomly assigned to a single LAT session (group 1,101 cases) or to follow-up (group 2, 99 cases) at four thyroid referral centers. Entry criteria were: solid thyroid nodule with volume of 6-17 mL, repeat benign cytological findings, normal thyroid function, no autoimmunity, and no thyroid gland treatment.Methods: Group 1: LAT was performed in a single session with two optical fibers, a 1064nm Nd-YAG laser source, and an output power of 3 W. Volume and local symptom changes were evaluated 1, 6,12,24, and 36 months after LAT. Side effects and tolerability of treatment were registered. Group 2: Follow-up with no treatment.Results: One patient was lost to follow-up in each group. Group 1: Volume decrease after LAT was -49 ± 22%, -59 ± 22%, -60 ± 24%, and -57 ± 25% at 6, 12, 24, and 36 months, respectively (P <.001 vs baseline). LAT resulted in a nodule reduction of >50% in 67.3% of cases (P <.001). Local symptoms decreased from 38 to 8% of cases (P =.002) and cosmetic signs from 72 to 16% of cases (P =.001). Baseline size, presence of goiter (P =.55), or US findings (fluid component ≤ 20% [P =.84], halo [P =.46], vascularization [P =.98], and calcifications [P =.06]) were not predictive factors of a volume decrease > 50%. The procedure was well tolerated in most (92%) cases. No changes in thyroid function or autoimmunity were observed. In group 2, nodule volume increased at 36 months (25 ± 42%; P =.04). The efficacy and tolerability of the procedure were similar in different centers.Conclusions: A single LAT treatment of solid nodules results in significant and persistent volume reduction and local symptom improvement, in the absence of thyroid function changes. Copyright © 2014 by the Endocrine Society.


Pelone F.,Catholic University Sacro Cuore | Kringos D.S.,University of Amsterdam | Kringos D.S.,NIVEL Netherlands Institute for Health Services Research | Spreeuwenberg P.,NIVEL Netherlands Institute for Health Services Research | And 2 more authors.
International Journal for Quality in Health Care | Year: 2013

Objective: To measure the relative efficiency of primary care (PC) in turning their structures into services delivery and turning their services delivery into quality outcomes. Design: Cross-sectional study based on the dataset of the Primary Healthcare Activity Monitor for Europe project. Two Data Envelopment Analysis models were run to compare the relative technical efficiency. A sensitivity analysis of the resulting efficiency scores was performed. Setting: PC systems in 22 European countries in 2009/2010. Main Outcome Measures: Model 1 included data on PC governance, workforce development and economic conditions as inputs and access, coordination, continuity and comprehensiveness of care as outputs. Model 2 included the previous process dimensions as inputs and quality indicators as outputs. Results: There is relatively reasonable efficiency in all countries at delivering as many as possible PC processes at a given level of PC structure. It is particularly important to invest in economic conditions to achieve an efficient structure-process balance. Only five countries have fully efficient PC systems in turning their services delivery into high quality outcomes, using a similar combination of access, continuity and comprehensiveness, although they differ on the adoption of coordination of services. There is a large variation in efficiency levels obtained by countries with inefficient PC in turning their services delivery into quality outcomes. Conclusions: Maximizing the individual functions of PC without taking into account the coherence within the health-care system is not sufficient from a policymaker's point of view when aiming to achieve efficiency. © The Author 2013. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.


Petruzzi M.,University of Bari | Lucchese A.,The Second University of Naples | Lajolo C.,Catholic University Sacro Cuore | Campus G.,University of Sassari | And 2 more authors.
Dermatology | Year: 2013

Background: Treatment of oral lichen planus (OLP) is a major challenge for clinicians and patients. There is limited scientific evidence about topical treatment with retinoids. We conducted a literature review of data on the effectiveness and safety of topical retinoids in OLP patients. Materials and Methods: We searched the MEDLINE, Embase and Cochrane databases for articles on topical retinoids treatment on OLP patients (searches from 1970 to February 2012). Results: Sixteen studies (280 OLP patients topically treated with different classes of retinoids) met the inclusion criteria. Isotretinoin was the most frequently employed retinoid in the treatment of OLP. The clinical and/or histopathological efficacy of retinoids was recorded in the majority of the selected studies. A transient and moderate burning sensation was the most frequently reported side effect. Conclusions: Topical retinoids appear as an alternative choice in OLP treatment. Whether keratotic OLP better responds to topical retinoids than erosive OLP is still an open question that deserves further comparative and controlled clinical trials. The benefits and harms of using topical retinoids in people with OLP require thorough evaluation in properly designed controlled studies. © 2013 S. Karger AG, Basel.


Mussini C.,University of Modena and Reggio Emilia | Cossarizza A.,University of Modena and Reggio Emilia | Sabin C.,University College London | Babiker A.,Medical Research Council Clinical Trials Unit | And 6 more authors.
AIDS | Year: 2011

Objective: Treatment guidelines recommend initiation of therapy for individuals experiencing rapid CD4 cell decline. It is not known, however, whether the rate of CD4 cell decline before combination antiretroviral therapy (cART) is related to immunological response following cART. Methods: We estimated precART and postcART CD4 cell slopes by mixed models and categorized patients into two groups according to whether estimated precART slopes were above or below the 75th percentile. We compared immunological responses of the two groups through both mixed models and survival techniques. Models were stratified by CD4 cell at baseline, adjusted for HIV RNA, age, sex, HIV transmission group, year of seroconversion, initiation during primary infection, hepatitis C virus and hepatitis B virus serostatus, and cART class. Results: Of 2038 eligible patients, 1531 and 507 experienced median (interquartile range) precART CD4 cell slope of -105 (-471 to -61) and -42 (-62 to +80) cells/μl, respectively, over 2 years. After adjusting for potential confounders, individuals with shallower decline experienced a slower rate of CD4 cell recovery following cART initiation of +9.5 [95% confidence interval (CI) +6.6 to +12.2] compared to +13.9 (+13.0 to +14.8) cells/μl per month among those with steeper precART decline (P < 0.001). After stratifying by the baseline CD4 cell count, the adjusted relative hazard of an increase from baseline of more than 50 cells/μl was 0.70 (95% CI 0.62-0.79) for those with a shallower vs. steeper precART decline. Conclusion: Findings highlight the existence of a subgroup of individuals with shallower precART CD4 cell decline who experience poorer CD4 cell increases after cART; new studies in this group may provide information to optimize responses to therapy. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Babiloni C.,University of Foggia | Vecchio F.,Hospital San Giovanni Calibita | Infarinato F.,IRCCS San Raffaele Pisana | Buffo P.,University of Rome La Sapienza | And 7 more authors.
Cortex | Year: 2011

Here we describe a methodological approach for the simultaneous electroencephalographic (EEG) recording in musicians playing in ensemble. Four professional saxophonists wore pre-wired EEG caps (30 electrodes placed according to an augmented 10-20 system; cephalic reference and ground). Each cap was connected to a single multi-channel amplifier box [Brain Explorer (BE), EB-Neuro©]. The four boxes converged to a single workstation equipped with a software (GALILEO NT, EB-Neuro©) allowing the simultaneous recording of sounds, digital trigger, and EEG-electrooculographic (EOG)-electromyographic (EMG) data, and providing a separate output file for each individual. Noteworthy, the subjects were electrically decoupled to satisfy international safety guidelines. The quality of the EEG data was confirmed by the rate of artifact-free EEG epochs (about 80%) and by EEG spectral features. During the resting state, dominant EEG power density values were observed at alpha band (8-12Hz) in posterior cortex. The quality of EMG can be used to identify " on" and " off" states of the musicians' motor performance, thus potentially allowing the investigation of the relationships between EEG dynamics and different characteristics of the specific performance. During the music performance, alpha power density values decreased in amplitude in several cortical regions, whereas power density values enhanced within narrow high-frequency bands. In conclusion, the present methodological approach appeared to be suitable for simultaneous EEG recordings in musicians playing in ensemble. © 2011 Elsevier Srl.


Vicenti I.,University of Siena | Rosi A.,University of Siena | Saladini F.,University of Siena | Meini G.,University of Siena | And 8 more authors.
Journal of Antimicrobial Chemotherapy | Year: 2012

Objectives: To assess the prevalence of hepatitis C virus (HCV) NS3/4A protease inhibitor (PI) resistance mutations in HCV genotype 1-infected PI-naive individuals in Italy. Patients and methods: One hundred and twelve patients infected with HCV genotype 1a or 1b (based on Versant HCV Genotype 2.0 or 5'UTR/core sequencing) and never treated with any HCV PI were evaluated. The whole NS3 region was analysed by population sequencing and mutations related to resistance to linear and macrocyclic PIs were recorded. Results: Forty-six HCV-monoinfected and 66 HCV/HIV-coinfected subjects were studied. Complete NS3 sequence information was obtained for 109 (97.3%) samples: 67 subtype 1a and 42 subtype 1b. Subtype assignment by NS3 sequencing was concordant in 100.0% and 83.9% of cases with the original 5'UTR sequencing and Versant result, respectively. At least one mutation related to PI resistance was detected in 21 (19.3%) isolates. However, 11 of these had only Q80K, expected to confer resistance to one investigational macrocyclic compound, and were detected only in subtype 1a. Boceprevir and telaprevir resistance-related mutations were detected in 10 (9.2%) isolates and included V36L, T54S and V55A. Only one isolate harboured two mutations (V36L and T54S). There was no association between HCV PI resistance and HIV coinfection or exposure to HIV PIs. Conclusions: A minority of untreated HCV genotype 1 patients in Italy harbour a virus population carrying HCV PI resistance-related mutations. The clinical implications of this finding warrant further analysis. © The Author 2012. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved.


Rizza S.,University of Rome Tor Vergata | Muniyappa R.,U.S. National Institutes of Health | Iantorno M.,U.S. National Institutes of Health | Kim J.-A.,University of Alabama at Birmingham | And 7 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2011

Context: Hesperidin, a citrus flavonoid, and its metabolite hesperetin may have vascular actions relevant to their health benefits. Molecularandphysiological mechanisms of hesperetin actions are unknown. Objective: We tested whether hesperetin stimulates production of nitric oxide (NO) from vascular endothelium and evaluated endothelial function in subjects with metabolic syndrome on oral hesperidin therapy. Design, Setting, and Interventions: Cellular mechanisms of action of hesperetin were evaluated in bovine aortic endothelial cells (BAEC) in primary culture. A randomized, placebo-controlled, double-blind, crossover trial examined whether oral hesperidin administration (500 mg once daily for 3 wk) improves endothelial function in individuals with metabolic syndrome (n = 24). Main Outcome Measure: We measured the difference in brachial artery flow-mediated dilation between placebo and hesperidin treatment periods. Results: Treatment of BAEC with hesperetin acutely stimulated phosphorylation of Src, Akt, AMP kinase, and endothelial NO synthase to produce NO; this required generation of H2O2. Increased adhesion of monocytes to BAEC and expression of vascular cell adhesion molecule-1 in response to TNF-α treatment was reduced by pretreatment with hesperetin. In the clinical study, when compared with placebo, hesperidin treatment increased flow-mediated dilation (10.26±1.19 vs. 7.78± 0.76%; P = 0.02) and reduced concentrations of circulating inflammatory biomarkers (high-sensitivity C-reactive protein, serum amyloid A protein, soluble E-selectin). Conclusions: Novel mechanisms for hesperetin action in endothelial cells inform effects of oral hesperidin treatment to improve endothelial dysfunction and reduce circulating markers of inflammation in our exploratory clinical trial. Hesperetin has vasculoprotective actions that may explain beneficial cardiovascular effects of citrus consumption. Copyright © 2011 by The Endocrine Society.


Savastano M.C.,Catholic University Sacro Cuore | Minnella A.M.,Catholic University Sacro Cuore | Tamburrino A.,University of Cassino and Southern Lazio | Giovinco G.,University of Cassino and Southern Lazio | And 2 more authors.
Investigative Ophthalmology and Visual Science | Year: 2014

Purpose. We evaluated layer-by-layer retinal thickness in spectral-domain optical coherence tomography (SD-OCT), determined by automated segmentation analysis (ASA) software in healthy and early age-related maculopathy (ARM) eyes. Methods. There were 57 eyes (specifically, 19 healthy eyes under 60 years old, 19 healthy eyes over 60, and 19 ARM eyes) recruited into this cross-sectional study. The mean ages were 36.78 (SD, ± 13.82), 69.89 (SD, ± 6.14), and 66.10 (SD, ±8.67) years, respectively, in the three study groups. The SD-OCT scans were transferred into a dedicated software program that performed automated segmentation of different retinal layers. Results. Automated layer segmentation showed clear boundaries between the following layers: retinal nerve fiber layer (RNFL), ganglion cell layer plus inner plexiform layer (GCL+IPL), inner nuclear layer plus outer plexiform layer (INL+OPL), outer nuclear layer (ONL), and RPE complex. The thickness of the RNFL, ONL, and RPE layers did not show a statistically significant change across the three groups by ANOVA (P 1/4 0.10, P 1/4 0.09, P 1/4 0.15, respectively). The thickness of GCL+IPL and INL+OPL was significantly different across the groups (P < 0.01), being reduced in the ARM eyes compared to healthy eyes, under and over 60 years old.Conclusions. The early morphologic involvement of the GCL+IPL and INL+OPL layers in ARM eyes, as revealed by the ASA, could be related to early anatomic changes described in the inner retina of ARM eyes. This finding may represent a morphologic correlation to the deficits in postreceptoral retinal function in ARM eyes. © 2014 The Association for Research in Vision and Ophthalmology, Inc.


Moscato U.,Catholic University Sacro Cuore | Poscia A.,Catholic University Sacro Cuore | Gargaruti R.,Catholic University Sacro Cuore | Capelli G.,University of Cassino and Southern Lazio | Cavaliere F.,Catholic University Sacro Cuore
BMC Pulmonary Medicine | Year: 2014

Background: In a previous study, exhaled carbon monoxide (eCO) has been assessed in healthy non-smokers with a photo acoustic spectrometer Brüel&Kjær 1312. Unexpectedly, values were higher than those reported in literature, which were mostly obtained with electrochemical analysers. This study was aimed to compare eCO values obtained with Brüel&Kjær 1312 and PiCO + Smokerlyzer, a largely utilized electrochemical analyser. Methods: Thirty-four healthy subjects, 15 non-smokers and 19 smokers, underwent eCO assessment with Brüel&Kjær 1312 and PiCO + Smokerlyzer during a prolonged expiration (15 seconds). Brüel&Kjær 1312 assessed CO concentration 7 and 12 seconds after the beginning of expiration and displayed the mean value. PiCO + Smokerlyzer was utilized according to the manufacturer's recommendations. In vitro, the two devices were tested with standard concentrations of CO in nitrogen (5, 9.9, 20, and 50 ppm), and the time needed by PiCO + Smokerlyzer readings to stabilize was assessed at different gas flows. Results: Both Brüel&Kjær 1312 and PiCO + Smokerlyzer presented very good internal consistency. The values provided were strictly correlated, but at low test concentrations, the Brüel&Kjær 1312 readings were greater than the PiCO + Smokerlyzer, and vice versa. PiCO + Smokerlyzer overestimated the CO standard concentrations at 5 and 9.9 ppm by 20%, while Brüel&Kjær 1312 measures were correct. PiCO + Smokerlyzer readings stabilized in 12 seconds during in vitro tests and in 15 seconds during in vivo measurements, suggesting that the values displayed corresponded to the initial phase of expiration. Conclusions: Differences between Brüel&Kjær 1312 and PiCO + Smokerlyzer may be explained because Brüel&Kjær 1312 measured CO levels in the middle and at the end of expiration while PiCO + Smokerlyzer assessed them in the initial part of expiration. © 2014 Moscato et al.

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