22 results on '"De Luca, Stefano"'
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2. A hybrid traffic flow model for traffic management with human-driven and connected vehicles
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Storani, Facundo, Di Pace, Roberta, and de Luca, Stefano
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This paper proposes a hybrid traffic flow model able to support the implementation of traffic management strategies in the presence of human-driven and connected vehicles. The model is based on the combination of two models: an aggregate model (the cell transmission model) and a disaggregate model (the cellular automata model). The model was tested considering three main layouts, namely a ring-shaped arc, a signalised link, and a grid network with four origins and four destinations, and then calibrated on real data. The model was also applied in the presence of connected vehicles. Our results point out the model’s local consistency in terms of wave propagation and its suitability with respect to the benchmark models as well as in the presence of connected vehicles.
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- 2022
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3. Artificial intelligence for target prostate biopsy outcomes prediction the potential application of fuzzy logic
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Checcucci, Enrico, Rosati, Samanta, De Cillis, Sabrina, Vagni, Marica, Giordano, Noemi, Piana, Alberto, Granato, Stefano, Amparore, Daniele, De Luca, Stefano, Fiori, Cristian, Balestra, Gabriella, and Porpiglia, Francesco
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Background: In current precision prostate cancer (PCa) surgery era the identification of the best patients candidate for prostate biopsy still remains an open issue. The aim of this study was to evaluate if the prostate target biopsy (TB) outcomes could be predicted by using artificial intelligence approach based on a set of clinical pre-biopsy. Methods: Pre-biopsy characteristics in terms of PSA, PSA density, digital rectal examination (DRE), previous prostate biopsies, number of suspicious lesions at mp-MRI, lesion volume, lesion location, and Pi-Rads score were extracted from our prospectively maintained TB database from March 2014 to December 2019. Our approach is based on Fuzzy logic and associative rules mining, with the aim to predict TB outcomes. Results: A total of 1448 patients were included. Using the Frequent-Pattern growth algorithm we extracted 875 rules and used to build the fuzzy classifier. 963 subjects were classified whereas for the remaining 484 subjects were not classified since no rules matched with their input variables. Analyzing the classified subjects we obtained a specificity of 59.2% and sensitivity of 90.8% with a negative and the positive predictive values of 81.3% and 76.6%, respectively. In particular, focusing on ISUP ≥ 3 PCa, our model is able to correctly predict the biopsy outcomes in 98.1% of the cases. Conclusions: In this study we demonstrated that the possibility to look at several pre-biopsy variables simultaneously with artificial intelligence algorithms can improve the prediction of TB outcomes, outclassing the performance of PSA, its derivates and MRI alone.
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- 2022
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4. Development of a novel nomogram to identify the candidate to extended pelvic lymph node dissection in patients who underwent mpMRI and target biopsy only
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Fiori, Cristian, Checcucci, Enrico, Stura, Ilaria, Amparore, Daniele, De Cillis, Sabrina, Piana, Alberto, Granato, Stefano, Volpi, Gabriele, Sica, Michele, Piramide, Federico, Verri, Paolo, Manfredi, Matteo, De Luca, Stefano, Autorino, Riccardo, Migliaretti, Giuseppe, and Porpiglia, Francesco
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Background: Nowadays a tool able to predict the risk of lymph-node invasion (LNI) in patients underwent target biopsy (TB) only before radical prostatectomy (RP) is still lacking. Our aim is to develop a model based on mp-MRI and target biopsy (TB) alone able to predict the risk of LNI. Methods: We retrospectively extracted data of patients with preoperative positive mp-MRI and TB only who underwent RARP with ePLND from April 2014 to March 2020. A logistic regression model was performed to evaluate the impact of pre- and intra-operative factors on the risk of LNI. Model discrimination was assessed using an area under (AUC) the ROC curve. A nomogram, and its calibration plot, to predict the risk of LNI were generated based on the logistic model. A validation of the model was done using a similar cohort. Results: 461 patients were included, of which 52 (11.27) had LNI. After logistic regression analysis and multivariable model DRE, PI-RADS, seminal vesicle invasion, PSA and worst GS at I and II target lesions were significant predictors of LNI. The AUC was 0.74 [0.67–0.81] 95% CI. The calibration plot shows that our model is very close to the ideal one which is in the 95% CI. After the creation of a visual nomogram, the cut-off to discriminate between the risk or not of LNI was set with Youden index at 60 points that correspond to a risk of LNI of 7%. The model applied on a similar cohort shown a LH+ of 2.58 [2.17–2.98] 95% CI. Conclusions: Our nomogram for patients undergoing MRI-TB only takes into account clinical stage, SVI at MRI, biopsy Gleason pattern and PSA and it is able to identify patients with risk of LNI when a score higher than 7% is achieved.
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- 2022
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5. Accounting for attitudes and perceptions influencing users’ willingness to purchase Electric Vehicles through a Hybrid Choice Modeling approach based on Analytic Hierarchy Process
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de Luca, Stefano, Pace, Roberta Di, and Bruno, Francesca
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Depending on the context, several factors may affect users’ choices. In this paper, the main focus refers to modeling users’ willingness to purchase a new/innovative technology. This is a crucial task in order to increase the attractiveness of strategies that may be employed to achieve sustainable transportation. In particular this paper aims to investigate the different attributes/determinants that may influence the decision on choosing an Electric Vehicle. As a matter of fact, psychological factors, may play a significant role which should be modeled. Indeed, it is widely recognized that traditional approaches used to interpret and model users’ choice behavior may lead to neglect the numerous non-quantitative factors that may affect users’ behaviors. In particular, the role of attitudes and perception towards EVs advantages/barriers were investigated through the specification of a Hybrid Choice Model where the utility function was specified in accordance with the consolidated Random utility modeling but an alternative approach, based on the Analytic Hierarchy Process, was adopted for attitudes and perceptions representation. The purposes of the paper rely on (i) the survey data collection, (ii) data analysis, (iii) purchase behavior modeling. In particular, the main contribution of the paper is in the preliminary investigation of the combination between HCM and AHP method.
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- 2020
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6. A monastery in Magdala (Taricheae)?
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De Luca, Stefano and Leibner, Uzi
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Ancient Magdala is located at the foot of the E slopes of Mt. Arbel, on the shore of the Sea of Galilee (map ref. 7477/2478) (fig. 1). The Aramaic name Magdala or Migdal Nunayya (“The tower of the fish”), mentioned in Rabbinic sources of the Roman period, is preserved in the name of the Arab village of “el-Mejdel” that stood on the site until 1948. The identification is also confirmed by ancient sources that indicate Magdala was located on the main road a few kilometers from Tiberias. In 1877, Charles Wilson suggested identifying this site also with the toponym Tαριχέα (Taricheae, “factories/vats for salting fish”), which is mentioned only in Greek and Latin sources (Cassius Longinus in Cic., Ad Fam. 12.11; Plin., NH5.71-72; Strab. 16.2.45, Josephus [see below], and Suet., Tit. 4.3), although they do not mention the name Magdala. It becomes evident from these sources that the town was located on the shore near Tiberias; Josephus’s explicit note, placing it 30 stadia (c.5.4 km) from Tiberias, exactly fits the site of el-Mejdel. Although some scholars raised alternative identifications, it has become widely accepted that the names Magdala and Taricheae are synonymous and that they should be identified with the Arab village of el-Mejdel.1
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- 2019
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7. DOES INSPIRATORY CAPACITY (IC) CHANGE AFTER BRONCHODILATOR IN PATIENTS WITH NON REVERSIBLE AIRWAY OBSTRUCTION?
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De Luca, Stefano and Massei, V
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Respiration -- Measurement -- Physiological aspects ,Airway obstruction (Medicine) -- Physiological aspects -- Measurement ,Health ,Physiological aspects ,Measurement - Abstract
Purpose: The presence of non reversible airway obstruction is usually assessed as change in forced expiratory volumes (FEV1 and/or FVC). Recently IC has been proposed as a new index to [...]
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- 1999
8. Estimating an Injury Crash Rate Prediction Model based on severity levels evaluation: the case study of single-vehicle run-off-road crashes on rural context
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Russo, Francesca, Di Pace, Roberta, Dell’Acqua, Gianluca, and de Luca, Stefano
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In general in case of crash situations the quality of collected data is very limited and several information are usually unreliable. Thus it is recognised that a significant effort is required in order to improve the quality of the crash prediction models moreover a crucial role is played by the identification of the factors influencing the crashes occurrence and the levels of severity estimation. In this paper two injury crash rate prediction models related to single-vehicle run-off-road crashes type are calibrated and in particular significant attributes estimated are identified not only with roadway geometric characteristics and surface conditions, but also with gender/number-of-drivers. To this aim a survey of injury crashes on two-lane rural roads collected in the Southern Italy was considered and analysed. Finally before the calibration step, a preliminary analysis of the data was provided through the estimation of the levels of severity by multinomial logit; in fact by this model only segments with highest values of severity are identified and involved in the calibration procedure.
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- 2017
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9. Scheduled Synchronisation based on a mesoscopic flow model with speed dispersion
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Pace, Roberta Di, Cantarella, Giulio E., de Luca, Stefano, and Gangi, Massimo Di
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This paper proposes a method for netwok signal setting design, based on enhacements of an existing coordination method aiming: 1) to extend the existing approach in order to address the Traffic Control through Scheduled Synchronisation (i.e ‘one step’ optimisation of stage matrix, green timings, and node offsets ); 2) to extend the considered Mesoscopic Traffic Flow model (TRAFFMED) to the vehicle platoon speed dispersion; 3) to build up a solution method suitable for both off-line and on-line applications. The proposed optimisation method is an application of the Simulated Annealing meta-heuristic. Some numerical applications are proposed, specifically analysing ‘two step’ optimisation (synchronisation), and‘one step’ optimisation (scheduled synchronisation), for off-line (pre-timed strategy) and on-line applications (on-line computation strategy). A grid network was considered as case study and the effectiveness of the proposed strategies were evaluated by comparing the obtained results with those computed through commercial (benchmark) and in-house codes.
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- 2017
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10. Reply to Anwar R. Padhani, Ivo G. Schoots, Jelle O. Barentsz. Fast Magnetic Resonance Imaging as a Viable Method for Directing the Prostate Cancer Diagnostic Pathway. Eur Urol Oncol 2021;4:863–5
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Russo, Filippo, Mazzetti, Simone, Regge, Daniele, Ambrosini, Ilaria, Giannini, Valentina, Manfredi, Matteo, De Luca, Stefano, Bollito, Enrico, and Porpiglia, Francesco
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- 2021
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11. A probable case of gigantism/acromegaly in skeletal remains from the Jewish necropolis of “Ronda Sur” (Lucena, Ćordoba, Spain; VIII–XII centuries CE)
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Viciano, Joan, De Luca, Stefano, López-Lázaro, Sandra, Botella, Daniel, and Diéguez-Ramírez, Juan Pablo
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Pituitary gigantism is a rare endocrine disorder caused by hypersecretion of growth hormone during growing period. Individuals with this disorder have an enormous growth in height and associated degenerative changes. The continued hypersecretion of growth hormone during adulthood leads to acromegaly, a condition related to the disproportionate bone growth of the skull, hands and feet. The skeletal remains studied belong to a young adult male from the Jewish necropolis of “Ronda Sur” in Lucena (Ćordoba, Spain, VIII–XII centuries CE). The individual shows a very large and thick neurocranium, pronounced supraorbital ridges, an extremely prominent occipital protuberance, and an extremely large and massive mandible. Additional pathologies include enlargement of the vertebral bodies with degenerative changes, thickened ribs, and a slight increased length of the diaphysis with an increased cortical bone thickness of lower limbs. Comparative metric analysis of the mandible with other individuals from the same population and a contemporary Mediterranean population shows a trend toward acromegalic morphology. This case is an important contribution in paleopathological literature because it is a rare condition that has not been widely documented in ancient skeletal remains.
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- 2015
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12. Age estimation in Egyptian children by measurements of carpals and epiphyses of the ulna and radius
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El-Bakary, Amal A., Attalla, Sohayla M., Hammad, Shaza M., El-Ashry, Rasha A., De Luca, Stefano, Ferrante, Luigi, and Cameriere, Roberto
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One of the most frequently used area for age estimation, in children and adolescents, is hand–wrist. This retrospective study of 257 Egyptian children and adolescents (142 boys and 115 girls), aged 4–18 years, used the ratio between the total area of carpal bones and epiphyses of the ulna and radius (Bo) and carpals (Ca) as age indicators. Age calculated, using a formula reported earlier for an Italian sample, resulted in a standard error of estimate of 1.96 years. The new regression model for the Egyptian population, describing age as a linear function of gender (g) and the ratio between carpal bones area and carpal area (Bo/Ca), yielded the following equation: Age=−0.998+18.708 (Bo/Ca)+1.724g (Bo/Ca). This model explained 71% of total variance. The median of the absolute values of residuals (observed−predicted age) was −1.67 years, with a standard error of estimate of 1.85 years. It can be concluded that the Cameriere׳s method is not completely suitable for the Egyptian sample and a new modified formula was proposed.
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- 2014
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13. Modelling the Propensity in Adhering to a Carsharing System: A Behavioral Approach
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de Luca, Stefano and Di Pace, Roberta
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In this paper carsharing behavior was investigated with regard to a different and little investigated aspect of users’ behavior: modeling the propensity in adhering to a carsharing system. The propensity was modeled within the random utility framework through starting from a stated preferences survey. The main focus was on the investigation and estimation of a set of attributes able to interpret and measure the propensity. In particular, together with socio-economic and activity related attributes, the satisfaction variable (expected maximum utility) was tested in order to interpret the interest towards carsharing in light of the level of service supplied by the other transport modes and of the users’ socio-economic and activity-based characteristics. The satisfaction variable was specifically calibrated on actual mode choice behavior starting from revealed preferences data.
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- 2014
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14. Greening the transportation sector: a methodology for assessing sustainable mobility policies within a sustainable energy action plan
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Cartenì, Armando and de Luca, Stefano
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The reducing use of fossil fuels and greenhouse gas emissions is one of the main aims of urban planning. These objectives directly involve urban activities which are responsible for 80% of energy consumption and CO
2 emissions and indirectly the transport sector which contributes in the range of 20%–40% in terms of consumption of fossil fuels and emissions of greenhouse gases and particulate matter. In this context, the simulation, the evaluation and the implementation of sustainable mobility policies are a crucial challenge for decision makers and analysts. At this aim, the paper proposes an integrated modelling framework which, following a bottom-up approach, combines a transportation simulation model (demand, supply and supply-demand interaction) with traffic fuel consumption and vehicle emission models. The aim was twofold: 1) specify and implement a modelling framework characterised by a level of detail not usual in literature and able to estimate fuel consumptions and greenhouse gas emissions with respect to any transportation scenario; 2) investigate the effects of different transport policies by applying the system of models. The proposed methodology was implemented to the urban context of Salerno municipality (Southern Italy), within the development of the sustainable energy action plan.- Published
- 2014
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15. Two Variables Algorithms for Solving the Stochastic Equilibrium Assignment with Variable Demand: Performance Analysis and Effects of Path Choice Models
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Cantarella, Giulio Erberto, de Luca, Stefano, Di Gangi, Massimo, and Di Pace, Roberta
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In this paper a general fixed-point approach dealing with multi-user (stochastic) equilibrium assignment with variable demand is proposed. The main focus is on (i) the implementation and comparison of different algorithm solutions based on successive averages methods calculated on one (arc flows, arc costs) and on two variables (arc flows and path satisfaction; arc costs and demand flows); (ii) the effects of algorithm efficiency on different path choice models and/or travel demand choice models.
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- 2013
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16. Modelling Passenger Departure Airport Choice: Implicit vs. Explicit Approaches
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de Luca, Stefano and Di Pace, Roberta
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In this paper different airport choice modelling solutions are investigated. The focus is on the gain which is obtainable by taking explicitly into account an increasing number of those choice dimensions that characterize a generic air trip: departure airport choice dimension only; departure airport and carrier dimensions; airport, carrier and departure time windows dimensions. At this aim a set of random utility discrete choice models were estimated. They cope with a choice-set constituted by airports of different type that compete with one another on medium/short haul trips at a European scale (Naples, Rome Fiumicino and Rome Ciampino). Closed form and heteroscedastic models were investigated and compared. Cross comparison was carried out for each choice dimension; longitudinal comparison was carried out to compare models in terms of airport choice prediction capability.
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- 2012
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17. Su alcuni graffiti cristiani scoperti nella cappella bizantina delle Beatitudini a Tabgha
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De Luca, Stefano and Ilardi, Karen
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This article focuses on some Greek graffiti discovered on the Northern wall of the byzantine Chapel of Beatitudes at Tabgha used in the late antiquity to commemorate the Sermon of the Mount (Mt 5:1-12).During the ancient restoration of the monument, the palimpsests were covered by a layer of liquid whitewash. As a result, during the 1935 archaeological excavations carried out by B. Bagatti, they were not visible.The Christian character of the inscription is undoubtable, as testified by the abbreviation of the invocation Kyrie Christe, and by the considerable number of crosses also engraved in the plaster by ancient pilgrims. Due to the poor state of preservation, the authors offer some interpretations for the other recognizable letters - apparently in capital Greek - on the base of the published epigraphic repertoires for the Near East.These findings add new elements for the interpretation of the place as the sanctuary mentioned by Egeria in her Travel Diaryand for the identification of the venerated grotto inside the precinct.Based on the location of the graffiti, the authors recognize in the quadrangular annex (mt. 3,20 × 3,20) opened in the northern side of the chapel and connected with it, the cave (speculaor spelunca) mentioned by the late Forth Century A.D. pilgrim.This locus seems to match adequately the liturgical needs of the numerous travellers who visited the Western coast of the Sea of Galilee.Original sketches and photos, new maps and sections contribute to illustrating the monument for which the Custody of the Holy Land started a project of restoration.
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- 2010
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18. La città ellenistico-romana di Magdala/Taricheae. Gli scavi del Magdala Project 2007 e 2008: relazione preliminare e prospettive di indagine
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De Luca, Stefano
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This Preliminary Report presents the most valuable achievements and results of the 2007 and 2008 Archaeological Campaigns carried out by the SBF-Magdala Project’s Team in the site of Migdal/Taricheae, on the West coast of the Sea of Galilee. Among the major discoveries of the two seasons of excavations, here illustrated by 42 inedited maps and plans and 140 pictures, are: in the Western Area (H1-3), new residential quarters along a well preserved paved decumanus(USM 5); five plastered and stepped pools (C3, D1, D3, E11, E22) belonging to the thermal bath complex which has been completely excavated, as well as many different water installations and devices (E2-7, E12-13, E21-22a-23-26, C14, D8, E5) to supply or discharge the publicae thermaeor to collect, drain, heating, mix, clean or pressurize water for the balnea. This work also concerns a new portion of the paved cardo maximus(V2); some residential buildings (Area I) located next to the urbic aqueduct on arcationes; a castellum aque(A1, A2-3-5); a newly discovered plastered basin, probably equipped with a water wheel device – the noria– (M31); a first-order conduit covered by basaltic slabs (E5-20); a calidarium/ tepidariumwith the pilaestacks for the upper floor – the suspensurae– of an hypocaustum, and arranged with clay box-flue tiles – the tubuli – inside the walls (E18-19); a possible praefurniumwith remains of a testudo alvei(E30); an aquariumdecorated by polychrome sectilia (E27-28). Of great interest is the discovery of a built-in quay (USM 317-USM 328) in the Eastern branch of the quadriporticus (F). This city’s harbour includes: a plastered basin (USM 317-318- 376), an Hasmonean tower with casematte(E32-33-35), built of ashlars stones with dressed margins (USM 328); a limestone masonry staircase; stone ramps – slipways – to haulage the ships (USM 331); and six intact basaltic mooring stones in situ. The above listed remains have been related with other ruins located farther to the East, which were recorded and described in the 1960s as part of the ancient port of Magdala/Taricheae. Written and Archaeological sources, briefly presented in the Summary, enable the outline of the history of the site from the 2nd century BCE to the 4th century CE and from the 4th/5th century CE – with the settlement of a monastic compound after the earthquake of 363 CE – to 1948. In order to contribute to the actual debate on the “Historical Jesus”, in the Conclusions are offered some considerations and remarks regarding the city extension, its urban character, the time of its foundation, its economical profile in the Roman period, the Jewish or Pagan ethosof its inhabitants and the stratigraphical evidences of destruction and abandonment related to the First Jewish War (66-67 CE) described by Flavius Josephus.
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- 2009
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19. Changes in Bone Mineral Density, Lean Body Mass and Fat Content as Measured by Dual Energy X-Ray Absorptiometry in Patients With Prostate Cancer Without Apparent Bone Metastases Given Androgen Deprivation Therapy
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BERRUTI, ALFREDO, DOGLIOTTI, LUIGI, TERRONE, CARLO, CERUTTI, STEFANIA, ISAIA, GIANCARLO, TARABUZZI, ROBERTO, REIMONDO, GIUSEPPE, MARI, MAURO, ARDISSONE, PAOLA, DE LUCA, STEFANO, FASOLIS, GIUSEPPE, FONTANA, DARIO, ROCCA ROSSETTI, SALVATORE, and ANGELI, ALBERTO
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We characterize the consequences of androgen deprivation therapy on body composition in elderly men.
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- 2002
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20. Diagnostic Accuracy of Single-plane Biparametric and Multiparametric Magnetic Resonance Imaging in Prostate Cancer: A Randomized Noninferiority Trial in Biopsy-naïve Men
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Russo, Filippo, Mazzetti, Simone, Regge, Daniele, Ambrosini, Ilaria, Giannini, Valentina, Manfredi, Matteo, De Luca, Stefano, Bollito, Enrico, and Porpiglia, Francesco
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Urological guidelines recommend multiparametric magnetic resonance imaging (mpMRI) in men with a suspicion of prostate cancer (PCa). The resulting increase in MRI demand might place health care systems under substantial stress.
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- 2021
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21. One Year Follow-up of Steroid-Free Immunosuppression Plus Everolimus in Isolated Pancreas Transplantation
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di Francesco, Fabrizio, Cautero, Nicola, Vincenzi, Paolo, Nicolini, Daniele, De Luca, Stefano, Vecchi, Andrea, Garelli, Paolo, Martorelli, Giacomo, Gentili, Marco, Risaliti, Andrea, and Boemi, Massimo
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- 2008
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22. Salvage Treatment with Lenalidomide and Dexamethasone In Patients with Relapsed Refractory Mantle Cell Lymphoma: Clinical Results and Modifications of Angiogenic Biomarkers
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Zaja, Francesco, De Luca, Stefano, Vitolo, Umberto, Orsucci, Lorella, Levis, Alessandro, Salvi, Flavia, Rusconi, Chiara, Ravelli, Erika, Tucci, Alessandra, Bottelli, Chiara, Balzarotti, Monica, Santoro, Armando, Brusamolino, Ercole, Bonfichi, Maurizio, Di Rocco, Alice, Stelitano, Caterina, Baldini, Luca, Pileri, Stefano A., Volpetti, Stefano, Saccona, Fabio, Ciccone, Gianni, Ferranti, Antonella, Catacchio, Ivana, Ria, Roberto, Vacca, Angelo, and Fanin, Renato
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Previous in vivo and in vitro studies have highlighted the activity of Lenalidomide (Len) in patients with relapsed or refractory mantle cell lymphoma (MCL), achieving a 53% overall response rate (ORR), which included 20% complete responses (CR) (Habermann et al. Br J Haematol. 2009) and the possible synergistic anti-proliferative effect of Dexamethasone (Dex).On this basis we performed a prospective, multicenter, phase II study, to evaluate safety and efficacy of Len Dex combination for adult patients with MCL.Patients had to have ≥1 prior treatment regimen, and were either not eligible for, or had relapsed after, more intensive treatments including stem cell transplantation (SCT). During the induction phase (month 1 to 3), patients received Len 25 mg/day on days 1 to 21 and Dex 40 mg/day on days 1, 8, 15, 22 of a 28-day cycle (Len Dex). Enoxaparin 4000 U/day was administered as anti-thrombotic prophylaxis. Patients who achieved a partial response (PR) or stable disease (SD) at the end of the induction phase continued to the consolidation phase, which consisted of treatment with Len Dex until disease progression or unacceptable toxicity, for a maximum of 12 months. Patients with a CR at the end of the induction phase, or those who achieved a CR during consolidation, received an additional 3 courses of Len Dex. The primary objective was to evaluate the ORR and CRR. Response data were correlated with the modification of angiogenic biomarkers by analyzing immunohistochemistry macrophage infiltration and the bone marrow (BM) microvessel counts, and by measuring plasma levels of VEGF, bFGF and HGF before and after therapy.Between July 2008 and July 2009, 33 patients were enrolled on this study. Patients' median age is 68 years (range 51–80); 30 have the classic histology while 3 patients have the blastoid variant; 10 patients previously received two lines of therapy, 10 patients had three lines and 13 patients had >3 prior lines (median 3; range 1–7). Twelve patients previously underwent an autologous SCT and 8 received prior therapy with Bortezomib. The number of patients who responded to induction phase was: OR= 22 (67%) including 5 CR (15%), SD= 1 (3%), no response (NR) or progression (PD)= 10 (30%); OR in patients previously treated with Bortezomib or an autologous SCT was 50% each. At present, 13 patients completed the therapeutic program, 15 discontinued therapy prematurely (14 NR or PD, 1 poor compliance) and 5 remain on therapy. The final response status at the end of the therapeutic program is: OR= 18 patients (55%) including 8 CR (24%), NR/PD= 15 (45%). After a median follow-up of 6 months (range 3–13 months) from the end of therapy, none of the CR patients had subsequent progression while 2 PR patients had progression 7 and 10 months after the end of therapy. The macrophage counts increased significantly in the BM after the first three months of therapy (P < 0.01; r2=0,8927). This was parallel to a significant increase in the microvessel counts (P < 0.05, r2= 0,1547). The within-group comparisons showed that both counts were always significantly correlated (P < 0.001). Regarding angiogenic plasma biomarkers, preliminary data of bFGF, VEGF and HGF concentrations showed a trend, albeit not significant, to decrease after the first three cycles of therapy. Most common Grade 3–4 adverse events were hematologic and included neutropenia (48%), thrombocytopenia (18%) and anemia (6%). Other events included 4 patients (12%) with Grade 3–4 neutropenic fever and 3 patients (9%) with Grade 3 bacterial pneumonia. Grade 3–4 hypotension and dyspnea developed in 1 and 3 patients respectively; no patient developed thrombo-embolic or neuropathic complications.Results from this study confirm the high therapeutic activity of Len in association with Dex in patients with relapsed and refractory MCL with a favourable safety profile. The significant increase of the macrophage infiltration in the BM seems to be a possible immunomodulatory effect of Len. Perhaps, the increase in microvessel counts may be induced by the activated macrophages and be an example of “indirect angiogenesis”. On the other hand, angiogenic plasma biomarkers tend to be lower, suggesting only a limited effect of Len on the neovascularization.Off Label Use: Lenalidomide in Mantle Cell Lymphoma. Vitolo:Celgene: Membership on an entity's Board of Directors or advisory committees.
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- 2010
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