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4. Safety assessment of Mpp75Aa1.1, a new ETX_MTX2 protein from Brevibacillus laterosporus that controls western corn rootworm.

Author

Cunxi Wang, Gregory J Bean, Chun Ju Chen, Colton R Kessenich, Jiexin Peng, Nicolo R Visconti, Jason S Milligan, Robert G Moore, Jianguo Tan, Thomas C Edrington, Bin Li, Kara S Giddings, David Bowen, Jinhua Luo, Todd Ciche, and William J Moar

Subjects
Medicine, Science
Abstract

The recently discovered insecticidal protein Mpp75Aa1.1 from Brevibacillus laterosporus is a member of the ETX_MTX family of beta-pore forming proteins (β-PFPs) expressed in genetically modified (GM) maize to control western corn rootworm (WCR; Diabrotica virgifera virgifera LeConte). In this manuscript, bioinformatic analysis establishes that although Mpp75Aa1.1 shares varying degrees of similarity to members of the ETX_MTX2 protein family, it is unlikely to have any allergenic, toxic, or otherwise adverse biological effects. The safety of Mpp75Aa1.1 is further supported by a weight of evidence approach including evaluation of the history of safe use (HOSU) of ETX_MTX2 proteins and Breviballus laterosporus. Comparisons between purified Mpp75Aa1.1 protein and a poly-histidine-tagged (His-tagged) variant of the Mpp75Aa1.1 protein demonstrate that both forms of the protein are heat labile at temperatures at or above 55°C, degraded by gastrointestinal proteases within 0.5 min, and have no adverse effects in acute mouse oral toxicity studies at a dose level of 1920 or 2120 mg/kg body weight. These results support the use of His-tagged proteins as suitable surrogates for assessing the safety of their non-tagged parent proteins. Taken together, we report that Mpp75Aa1.1 is the first ETX-MTX2 insecticidal protein from B. laterosporus and displays a similar safety profile as typical Cry proteins from Bacillus thuringiensis.

Published
2022
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6. Oral vs. IV paracetamol for pain control in patients with femur fracture in the emergency department: a practical randomized controlled trial

Author

Franceschi, Francesco, Saviano, Angela, Covino, Marcello, Candelli, Marcello, Ojetti, Veronica, Cicchinelli, S., Petrucci, M., Sardeo, F., Torelli, E., Nicolo, R., Forte, Enrica, Maccauro, Giulio, Franceschi F. (ORCID:0000-0001-6266-445X), Saviano A. (ORCID:0000-0002-2820-7180), Covino M. (ORCID:0000-0002-6709-2531), Candelli M. (ORCID:0000-0001-8443-7880), Ojetti V. (ORCID:0000-0002-8953-0707), Forte E., Maccauro G. (ORCID:0000-0002-7359-268X), Franceschi, Francesco, Saviano, Angela, Covino, Marcello, Candelli, Marcello, Ojetti, Veronica, Cicchinelli, S., Petrucci, M., Sardeo, F., Torelli, E., Nicolo, R., Forte, Enrica, Maccauro, Giulio, Franceschi F. (ORCID:0000-0001-6266-445X), Saviano A. (ORCID:0000-0002-2820-7180), Covino M. (ORCID:0000-0002-6709-2531), Candelli M. (ORCID:0000-0001-8443-7880), Ojetti V. (ORCID:0000-0002-8953-0707), Forte E., and Maccauro G. (ORCID:0000-0002-7359-268X)

Abstract

Femur fracture (FF) is a common reason for admission to the Emergency Department (ED) and pain is a frequent symptom. Effective and timely pain control is essential for these patients, however, the most appropriate analgesic therapy for quick pain relief in the ED setting is not well established. This is a single-center pragmatic randomized controlled study. We have enrolled 171 consecutive patients with FF and severe pain. They were randomized 1:5 to receive treatment with paracetamol 1000 mg orally (OR) or with paracetamol 1000 mg intravenously (IV). The effect on pain relief was measured with the Visual Analogue Scale for Pain (VAS) at baseline (T0), after 1 hour (T1), 2 hours (T2), and 4 hours (T4). The primary endpoint was the reduction of pain of 1 point of the VAS at T1. This target was reached by 75% of patients treated with paracetamol IV and 44% treated with paracetamol OR (p = 0.001). The secondary endpoint was the reduction of pain of at least 2 points of the VAS at T4, the need for rescue therapy, and the number of adverse events. At T4 the efficacy of paracetamol IV and OR resulted in 89.5% and 88.9%, respectively (p = 0.914). The 17.5% of patients treated with paracetamol IV vs. the 3.7% treated with paracetamol OR required rescue therapy (p = 0.082), with prevalence among women (p = 0.057). No adverse effects were reported. The treatment with paracetamol 1000 mg IV and OR resulted effective and safe for patients with FF waiting for surgery. IV administration was faster in reducing pain in the first 2 hours compared to oral administration but the latter required less rescue therapy. Interestingly, our study highlighted gender differences in pain relief opening the way for a gender-tailored therapy.

Published
2023

7. T.10.8 THE EFFECTS OF HIGH AMYLOSE PRODUCTS ON SYMPTOMS AND GUT MICROBIOTA COMPOSITION IN IRRITABLE BOWEL SYNDROME WITH PREDOMINANT CONSTIPATION (IBS-C)

Author

Altomare, A., primary, Di Rosa, C., additional, Putignani, L., additional, Emerenziani, S., additional, Nicolo, R., additional, De Arcangelis, E., additional, Crucilla, S., additional, Terrigno, V., additional, Conti, C., additional, Citterio, N., additional, Marconi, E., additional, De Gara, L., additional, Cicala, M., additional, and Guarino, M.P.L., additional

Published
2023
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9. Safety assessment of Mpp75Aa1.1, a new ETX_MTX2 protein from Brevibacillus laterosporus that controls western corn rootworm

Author

Wang, Cunxi, primary, Bean, Gregory J., additional, Chen, Chun Ju, additional, Kessenich, Colton R., additional, Peng, Jiexin, additional, Visconti, Nicolo R., additional, Milligan, Jason S., additional, Moore, Robert G., additional, Tan, Jianguo, additional, Edrington, Thomas C., additional, Li, Bin, additional, Giddings, Kara S., additional, Bowen, David, additional, Luo, Jinhua, additional, Ciche, Todd, additional, and Moar, William J., additional

Published
2022
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10. Safety assessment of insecticidal proteins: A case study utilizing His-tagged protein to determine the safety of Mpp75Aa1.1, a new ETX_MTX2 protein that controls western corn rootworm

Author

Cunxi Wang, Gregory J. Bean, Chun Ju Chen, Colton R. Kessenich, Jiexin Peng, Nicolo R. Visconti, Jason S. Milligan, Robert G. Moore, Jianguo Tan, Thomas C. Edrington, Bin Li, Kara S. Giddings, David Bowen, Jinhua Luo, Todd Ciche, and William J. Moar

Abstract

The recently discovered insecticidal protein Mpp75Aa1.1 from Brevibacillus laterosporus is one member of the ETX_MTX family of beta-pore forming proteins (β-PFPs) expressed in genetically modified (GM) maize to control western corn rootworm (WCR; Diabrotica virgifera virgifera LeConte). In this paper, bioinformatic analysis establishes that although Mpp75Aa1.1 shares varying degrees of similarity to members of the ETX_MTX2 protein family, it is unlikely to contribute to any allergenic, toxic, or otherwise adverse biological effects. The safety of Mpp75Aa1.1 is further supported by a weight of evidence including evaluation of history of safe use (HOSU) of ETX_MTX2 proteins. Assessments using either purified Mpp75Aa1.1 protein or a poly-histidine-tagged (His-tagged) variant of the Mpp75Aa1.1 protein demonstrate that both forms of the protein are heat labile at temperatures at or above 55 °C, degraded by gastrointestinal proteases within 0.5 min, and have no adverse effects in acute mouse oral toxicity studies at a dose level of 1920 or 2120 mg/kg body weight. Results also indicate that the domain-based protein characterization should be considered as part of the weight of evidence for the safe consumption of food or feed. Furthermore, these results support the use of His-tagged proteins as suitable surrogates for assessing the safety of their non-tagged parent proteins.

Published
2022
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13. Safety assessment of insecticidal proteins: A case study utilizing His-tagged protein to determine the safety of Mpp75Aa1.1, a new ETX_MTX2 protein that controls western corn rootworm

Author

Wang, Cunxi, primary, Bean, Gregory J., additional, Chen, Chun Ju, additional, Kessenich, Colton R., additional, Peng, Jiexin, additional, Visconti, Nicolo R., additional, Milligan, Jason S., additional, Moore, Robert G., additional, Tan, Jianguo, additional, Edrington, Thomas C., additional, Li, Bin, additional, Giddings, Kara S., additional, Bowen, David, additional, Luo, Jinhua, additional, Ciche, Todd, additional, and Moar, William J., additional

Published
2022
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15. Glass Ionomer Versus Self-adhesive Cement and the Clinical Performance of Zirconia Coping/Press-on Porcelain Crowns

Author

Torres, C. R. G. [UNESP], Avila, D. M. S. [UNESP], Goncalves, L. L. [UNESP], Meirelles, L. C. F. [UNESP], Mailart, M. C. [UNESP], Di Nicolo, R. [UNESP], Borges, A. B. [UNESP], and Universidade Estadual Paulista (UNESP)

Abstract

Made available in DSpace on 2022-04-28T17:22:39Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-07-01 Objective: This split-mouth clinical study investigated the effect of luting cement on the performance of veneered yttrium-stabilized tetragonal zirconia polycrystal (Y-TZP) zirconia crowns. Methods and Materials: A total of 60 crowns prepared with Y-TZP coping and press-on porcelain were made with a split-mouth design in 30 participants. The crowns were cemented either with glass ionomer cement (GIC) (Meron, Voco) or with self-adhesive resin cement (Bifix-SE, Voco). The restorations were assessed immediately after treatment and after 6, 12, 24, 36, and 48 months using the modified United States Public Health Service criteria. The parameters analyzed were retention, color stability, marginal discoloration, marginal adaptation, surface roughness, anatomic form, and secondary caries. The differences between the groups were analyzed by the Fisher exact test in each period of evaluation. The survival rate was analyzed with the Kaplan-Meier and logrank test (alpha=0.05). Results: After 48 months, 20 participants attended the recall. During the period of evaluation, 1 crown cemented with glass ionomer cement and 1 crown cemented with resin cement lost retention. Color match, marginal discoloration and adaptation, surface roughness, and anatomic form did not change in any of the periods evaluated, and no secondary caries was observed. No significant differences were found between the 2 luting cements for any of the clinical parameters analyzed, nor for the survival rates during the study. Conclusions: The type of cement did not influence the performance of the crowns after 48 months of clinical use. Both cements resulted in adequate retention rates, aesthetic and functional outcomes, and biological response. Sao Paulo State Univ UNESP, Inst Sci & Technol, Dept Restorat Dent, Sao Jose Dos Campos, SP, Brazil Sao Paulo State Univ UNESP, Inst Sci & Technol, Dept Restorat Dent, Sao Jose Dos Campos, SP, Brazil

Published
2021

18. Delayed intracranial hemorrhage after mild traumatic brain injury in patients on oral anticoagulants: Is the juice worth the squeeze?

Author

Covino, Marcello, Manno, Alberto, Della Pepa, Giuseppe Maria, Piccioni, Andrea, Tullo, Gianluca, Petrucci, Martina, Navarra, S., Sardeo, F., Torelli, E., Nicolo, R., Simeoni, B., Carbone, Luigi, Gaudino, Simona, Franceschi, Francesco, Covino M. (ORCID:0000-0002-6709-2531), Manno A., della Pepa G. M. (ORCID:0000-0001-8698-3359), Piccioni A., Tullo G., Petrucci M., Carbone L., Gaudino S. (ORCID:0000-0003-1681-4343), Franceschi F. (ORCID:0000-0001-6266-445X), Covino, Marcello, Manno, Alberto, Della Pepa, Giuseppe Maria, Piccioni, Andrea, Tullo, Gianluca, Petrucci, Martina, Navarra, S., Sardeo, F., Torelli, E., Nicolo, R., Simeoni, B., Carbone, Luigi, Gaudino, Simona, Franceschi, Francesco, Covino M. (ORCID:0000-0002-6709-2531), Manno A., della Pepa G. M. (ORCID:0000-0001-8698-3359), Piccioni A., Tullo G., Petrucci M., Carbone L., Gaudino S. (ORCID:0000-0003-1681-4343), and Franceschi F. (ORCID:0000-0001-6266-445X)

Abstract

OBJECTIVE: Mild Traumatic Brain Injury (MTBI) in anticoagulated patients is a common challenge for Emergency Department (ED) Physicians. Anticoagulation is considered a risk factor for developing delayed intracranial hemorrhage (ICH) after MTBI. The occurrence of this event in patients on Vitamin K Antagonists (VKA) or Direct Oral Anticoagulants (DOACs) remains unclear. Primary endpoint: to analyze the role of anticoagulants as risk factors for developing delayed ICH after MTBI and evaluate the indications to repeat a cranial computed tomography (CT) after a period of observation. Secondary endpoint: to assess the difference in the prevalence rate of delayed ICH in patients on VKA versus those on DOACs. PATIENTS AND METHODS: We evaluated all consecutive patients admitted to our ED for MTBI, which had a control CT for late ICH after a negative CT at admission. We used a propensity score match (PSM) on factors affecting the need for oral anticoagulation to adjust the comparison between anticoagulated vs. non-anticoagulated patients for the baseline clinical characteristics. RESULTS: Among 685 patients enrolled, 15 (2.2%) developed ICH at control CT. After PSM, the incidence of ICH, although slightly higher, was not statistically different in anticoagulated patients vs. non-anticoagulated (2.3% vs. 0.6%, p=0.371). Among the 111 patients on VKA, 5 (4.5%) had a late ICH, compared to 4 out of 99 (4.0%) on DOACs; the difference was not statistically significant (p=0.868). CONCLUSIONS: The risk of developing delayed ICH after MTBI in patients on anticoagulation therapy is low. After correction for baseline covariates, the risk does not appear higher compared to non-anticoagulated patients. Thus, a routine control CT scan seems advisable only for patients presenting a clinical deterioration. Larger, prospective trials are required to clarify the safety profile of DOACs vs. VKA in MTBI.

Published
2021

20. Assessment of neurological manifestations in hospitalized patients with COVID-19

Author

Luigetti, Marco, Iorio, Raffaele, Bentivoglio, Anna Rita, Tricoli, Luca, Riso, Vittorio, Marotta, Jessica, Piano, Carla, Primiano, Guido Alessandro, Zileri Del Verme, L., Lo Monaco, Maria Rita, Calabresi, Paolo, Abbate, V., Acampora, N., Addolorato, G., Agostini, F., Ainora, M. E., Akacha, K., Amato, E., Andreani, F., Andriollo, G., Annetta, Maria Giuseppina, Annicchiarico, B. E., Antonelli, Massimo, Antonucci, G., Anzellotti, G. M., Armuzzi, A., Baldi, F., Barattucci, I., Barillaro, C., Barone, F., Bellantone, R. D. A., Bellieni, A., Bello, G., Benicchi, A., Benvenuto, F., Berardini, L., Berloco, F., Bernabei, R., Bianchi, A., Biasucci, D. G., Biasucci, L. M., Bibbo, S., Bini, A., Bisanti, A., Biscetti, F., Bocci, M. G., Bonadia, N., Bongiovanni, F., Borghetti, A., Bosco, G., Bosello, Silvia Laura, Bove, V., Bramato, G., Brandi, V., Bruni, T., Bruno, C., Bruno, D., Bungaro, M. C., Buonomo, A., Burzo, L., Calabrese, A., Calvello, M. R., Cambieri, A., Cambise, C., Camma, G., Candelli, M., Canistro, G., Cantanale, A., Capalbo, G., Capaldi, L., Capone, E., Capristo, E., Carbone, L., Cardone, S., Carelli, S., Carfi, A., Carnicelli, A., Caruso, C., Casciaro, F. A., Catalano, L., Cauda, R., Cecchini, A. L., Cerrito, L., Cesarano, M., Chiarito, A., Cianci, Rossella, Cicchinelli, S., Ciccullo, A., Cicetti, M., Ciciarello, F., Cingolani, A., Cipriani, M. C., Consalvo, M. L., Coppola, G., Corbo, G. M., Corsello, A., Costante, F., Costanzi, M., Covino, M., Crupi, D., Cutuli, S. L., D'Addio, S., D'Alessandro, A., D'Alfonso, M. E., D'Angelo, E., D'Aversa, F., Damiano, F., De Berardinis, G. M., De Cunzo, T., De Gaetano, D. K., De Luca, G., De Matteis, G., De Pascale, G., De Santis, P., De Siena, M., De Vito, F., Del Gatto, V., Del Giacomo, P., Del Zompo, F., Dell'Anna, A. M., Della, P. D., Di Gialleonardo, L., Di Giambenedetto, S., Di Luca, R., Di Maurizio, L., Di Muro, M., Dusina, A., Eleuteri, D., Esperide, A., Fachechi, D., Faliero, D., Falsiroli, C., Fantoni, M., Fedele, A., Feliciani, D., Ferrante, C., Ferrone, G., Festa, R., Fiore, M. C., Flex, A., Forte, E., Franceschi, Francesco, Francesconi, A., Franza, L., Funaro, B., Fuorlo, M., Fusco, D., Gabrielli, M., Gaetani, E., Galletta, C., Gallo, A., Gambassi, G., Garcovich, M., Gasbarrini, A., Gasparrini, I., Gelli, S., Giampietro, A., Gigante, L., Giuliano, G., Giupponi, B., Gremese, E., Grieco, Domenico Luca, Guerrera, M., Guglielmi, V., Guidone, C., Gulli, A., Iaconelli, A., Iafrati, A., Ianiro, Gianluca, Iaquinta, A., Impagnatiello, M., Inchingolo, R., Intini, E., Iorio, R., Izzi, I. M., Jovanovic, T., Kadhim, C., La Macchia, R., La Milia, D. I., Landi, F., Landi, G., Landi, R., Landolfi, R., Leo, M., Leone, P. M., Levantesi, L., Liguori, A., Liperoti, R., Lizzio, M. M., Lo Monaco Maria, R., Locantore, P., Lombardi, F., Lombardi, G., Lopetuso, L., Loria, V., Losito, A. R., Lucia, M. B. P., Macagno, F., Macerola, N., Maggi, G., Maiuro, G., Mancarella, F., Mangiola, F., Manno, A., Marchesini, D., Maresca, G. M., Marrone, G., Martis, I., Martone, A. M., Marzetti, Emanuele, Mattana, C., Matteo, M. V., Maviglia, R., Mazzarella, A., Memoli, C., Miele, Luca, Migneco, A., Mignini, I., Milani, A., Milardi, D., Montalto, M., Montemurro, G., Monti, F., Montini, Luca, Morena, T. C., Morra, V., Morretta, C., Moschese, D., Murace, C. A., Murdolo, M., Murri, Rita, Napoli, M., Nardella, E., Natalello, G., Natalini, D., Navarra, S. M., Nesci, A., Nicoletti, A., Nicoletti, R., Nicoletti, T. F., Nicolo, R., Nicolotti, N., Nista, E. C., Nuzzo, E., Oggiano, M., Ojetti, V., Pagano, F. C., Paiano, G., Pais, C., Pallavicini, F., Palombo, A., Paolillo, F., Papa, Alfredo, Papanice, D., Papparella, L. G., Paratore, M., Parrinello, G., Pasciuto, G., Pasculli, P., Pecorini, G., Perniola, S., Pero, E., Petricca, L., Petrucci, M., Picarelli, C., Piccioni, A., Piccolo, A., Piervincenzi, E., Pignataro, G., Pignataro, R., Pintaudi, G., Pisapia, L., Pizzoferrato, M., Pizzolante, F., Pola, R., Policola, C., Pompili, M., Pontecorvi, F., Pontecorvi, V., Ponziani, F., Popolla, V., Porceddu, E., Porfidia, A., Porro, L. M., Potenza, A., Pozzana, F., Privitera, G., Pugliese, D., Pulcini, G., Racco, S., Raffaelli, F., Ramunno, V., Rapaccini, G. L., Richeldi, Luca, Rinninella, Emanuele, Rocchi, S., Romano, B., Romano, S., Rosa, F., Rossi, L., Rossi, R., Rossini, E., Rota, E., Rovedi, F., Rubino, C., Rumi, G., Russo, A., Sabia, L., Salerno, A., Salini, S., Salvatore, L., Samori, D., Sandroni, Claudio, Sanguinetti, M., Santarelli, L., Santini, P., Santolamazza, D., Santoliquido, A., Santopaolo, F., Santoro, M. C., Sardeo, F., Sarnari, C., Saviano, A., Saviano, L., Scaldaferri, Franco, Scarascia, R., Schepis, T., Schiavello, F., Scoppettuolo, G., Sedda, D., Sessa, F., Sestito, L., Settanni, C., Siciliano, M., Siciliano, V., Sicuranza, R., Simeoni, B., Simonetti, J., Smargiassi, A., Soave, P. M., Sonnino, C., Staiti, D., Stella, C., Stella, L., Stival, E., Taddei, E., Talerico, R., Tamburello, E., Tamburrini, E., Tanzarella, E. S., Tarascio, E., Tarli, C., Tersali, A., Tilli, P., Timpano, J., Torelli, E., Torrini, F., Tosato, M., Tosoni, A., Tricoli, L., Tritto, M., Tumbarello, M., Tummolo, A. M., Vallecoccia, M. S., Valletta, F., Varone, F., Vassalli, F., Ventura, G., Verardi, L., Vetrone, L., Vetrugno, G., Visconti, E., Visconti, F., Viviani, A., Zaccaria, R., Zaccone, C., Zelano, L., Zileri Dal Verme, L., Zuccala, G., Luigetti M. (ORCID:0000-0001-7539-505X), Iorio R. (ORCID:0000-0002-6270-0956), Bentivoglio A. R. (ORCID:0000-0002-9663-095X), Tricoli L., Riso V., Marotta J., Piano C., Primiano G., Lo Monaco M. R. (ORCID:0000-0002-1457-7981), Calabresi P. (ORCID:0000-0003-0326-5509), Annetta M. G. (ORCID:0000-0001-7574-1311), Antonelli M. (ORCID:0000-0003-3007-1670), Bosello S. (ORCID:0000-0002-4837-447X), Cianci R. (ORCID:0000-0001-5378-8442), Franceschi F. (ORCID:0000-0001-6266-445X), Grieco D. L. (ORCID:0000-0002-4557-6308), Ianiro G. (ORCID:0000-0002-8318-0515), Marzetti E. (ORCID:0000-0001-9567-6983), Miele L. (ORCID:0000-0003-3464-0068), Montini L. (ORCID:0000-0003-4602-5134), Murri R. (ORCID:0000-0003-4263-7854), Papa A. (ORCID:0000-0002-4186-7298), Richeldi L. (ORCID:0000-0001-8594-1448), Rinninella E. (ORCID:0000-0002-9165-2367), Sandroni C. (ORCID:0000-0002-8878-2611), Scaldaferri F. (ORCID:0000-0001-8334-7541), Luigetti, Marco, Iorio, Raffaele, Bentivoglio, Anna Rita, Tricoli, Luca, Riso, Vittorio, Marotta, Jessica, Piano, Carla, Primiano, Guido Alessandro, Zileri Del Verme, L., Lo Monaco, Maria Rita, Calabresi, Paolo, Abbate, V., Acampora, N., Addolorato, G., Agostini, F., Ainora, M. E., Akacha, K., Amato, E., Andreani, F., Andriollo, G., Annetta, Maria Giuseppina, Annicchiarico, B. E., Antonelli, Massimo, Antonucci, G., Anzellotti, G. M., Armuzzi, A., Baldi, F., Barattucci, I., Barillaro, C., Barone, F., Bellantone, R. D. A., Bellieni, A., Bello, G., Benicchi, A., Benvenuto, F., Berardini, L., Berloco, F., Bernabei, R., Bianchi, A., Biasucci, D. G., Biasucci, L. M., Bibbo, S., Bini, A., Bisanti, A., Biscetti, F., Bocci, M. G., Bonadia, N., Bongiovanni, F., Borghetti, A., Bosco, G., Bosello, Silvia Laura, Bove, V., Bramato, G., Brandi, V., Bruni, T., Bruno, C., Bruno, D., Bungaro, M. C., Buonomo, A., Burzo, L., Calabrese, A., Calvello, M. R., Cambieri, A., Cambise, C., Camma, G., Candelli, M., Canistro, G., Cantanale, A., Capalbo, G., Capaldi, L., Capone, E., Capristo, E., Carbone, L., Cardone, S., Carelli, S., Carfi, A., Carnicelli, A., Caruso, C., Casciaro, F. A., Catalano, L., Cauda, R., Cecchini, A. L., Cerrito, L., Cesarano, M., Chiarito, A., Cianci, Rossella, Cicchinelli, S., Ciccullo, A., Cicetti, M., Ciciarello, F., Cingolani, A., Cipriani, M. C., Consalvo, M. L., Coppola, G., Corbo, G. M., Corsello, A., Costante, F., Costanzi, M., Covino, M., Crupi, D., Cutuli, S. L., D'Addio, S., D'Alessandro, A., D'Alfonso, M. E., D'Angelo, E., D'Aversa, F., Damiano, F., De Berardinis, G. M., De Cunzo, T., De Gaetano, D. K., De Luca, G., De Matteis, G., De Pascale, G., De Santis, P., De Siena, M., De Vito, F., Del Gatto, V., Del Giacomo, P., Del Zompo, F., Dell'Anna, A. M., Della, P. D., Di Gialleonardo, L., Di Giambenedetto, S., Di Luca, R., Di Maurizio, L., Di Muro, M., Dusina, A., Eleuteri, D., Esperide, A., Fachechi, D., Faliero, D., Falsiroli, C., Fantoni, M., Fedele, A., Feliciani, D., Ferrante, C., Ferrone, G., Festa, R., Fiore, M. C., Flex, A., Forte, E., Franceschi, Francesco, Francesconi, A., Franza, L., Funaro, B., Fuorlo, M., Fusco, D., Gabrielli, M., Gaetani, E., Galletta, C., Gallo, A., Gambassi, G., Garcovich, M., Gasbarrini, A., Gasparrini, I., Gelli, S., Giampietro, A., Gigante, L., Giuliano, G., Giupponi, B., Gremese, E., Grieco, Domenico Luca, Guerrera, M., Guglielmi, V., Guidone, C., Gulli, A., Iaconelli, A., Iafrati, A., Ianiro, Gianluca, Iaquinta, A., Impagnatiello, M., Inchingolo, R., Intini, E., Iorio, R., Izzi, I. M., Jovanovic, T., Kadhim, C., La Macchia, R., La Milia, D. I., Landi, F., Landi, G., Landi, R., Landolfi, R., Leo, M., Leone, P. M., Levantesi, L., Liguori, A., Liperoti, R., Lizzio, M. M., Lo Monaco Maria, R., Locantore, P., Lombardi, F., Lombardi, G., Lopetuso, L., Loria, V., Losito, A. R., Lucia, M. B. P., Macagno, F., Macerola, N., Maggi, G., Maiuro, G., Mancarella, F., Mangiola, F., Manno, A., Marchesini, D., Maresca, G. M., Marrone, G., Martis, I., Martone, A. M., Marzetti, Emanuele, Mattana, C., Matteo, M. V., Maviglia, R., Mazzarella, A., Memoli, C., Miele, Luca, Migneco, A., Mignini, I., Milani, A., Milardi, D., Montalto, M., Montemurro, G., Monti, F., Montini, Luca, Morena, T. C., Morra, V., Morretta, C., Moschese, D., Murace, C. A., Murdolo, M., Murri, Rita, Napoli, M., Nardella, E., Natalello, G., Natalini, D., Navarra, S. M., Nesci, A., Nicoletti, A., Nicoletti, R., Nicoletti, T. F., Nicolo, R., Nicolotti, N., Nista, E. C., Nuzzo, E., Oggiano, M., Ojetti, V., Pagano, F. C., Paiano, G., Pais, C., Pallavicini, F., Palombo, A., Paolillo, F., Papa, Alfredo, Papanice, D., Papparella, L. G., Paratore, M., Parrinello, G., Pasciuto, G., Pasculli, P., Pecorini, G., Perniola, S., Pero, E., Petricca, L., Petrucci, M., Picarelli, C., Piccioni, A., Piccolo, A., Piervincenzi, E., Pignataro, G., Pignataro, R., Pintaudi, G., Pisapia, L., Pizzoferrato, M., Pizzolante, F., Pola, R., Policola, C., Pompili, M., Pontecorvi, F., Pontecorvi, V., Ponziani, F., Popolla, V., Porceddu, E., Porfidia, A., Porro, L. M., Potenza, A., Pozzana, F., Privitera, G., Pugliese, D., Pulcini, G., Racco, S., Raffaelli, F., Ramunno, V., Rapaccini, G. L., Richeldi, Luca, Rinninella, Emanuele, Rocchi, S., Romano, B., Romano, S., Rosa, F., Rossi, L., Rossi, R., Rossini, E., Rota, E., Rovedi, F., Rubino, C., Rumi, G., Russo, A., Sabia, L., Salerno, A., Salini, S., Salvatore, L., Samori, D., Sandroni, Claudio, Sanguinetti, M., Santarelli, L., Santini, P., Santolamazza, D., Santoliquido, A., Santopaolo, F., Santoro, M. C., Sardeo, F., Sarnari, C., Saviano, A., Saviano, L., Scaldaferri, Franco, Scarascia, R., Schepis, T., Schiavello, F., Scoppettuolo, G., Sedda, D., Sessa, F., Sestito, L., Settanni, C., Siciliano, M., Siciliano, V., Sicuranza, R., Simeoni, B., Simonetti, J., Smargiassi, A., Soave, P. M., Sonnino, C., Staiti, D., Stella, C., Stella, L., Stival, E., Taddei, E., Talerico, R., Tamburello, E., Tamburrini, E., Tanzarella, E. S., Tarascio, E., Tarli, C., Tersali, A., Tilli, P., Timpano, J., Torelli, E., Torrini, F., Tosato, M., Tosoni, A., Tricoli, L., Tritto, M., Tumbarello, M., Tummolo, A. M., Vallecoccia, M. S., Valletta, F., Varone, F., Vassalli, F., Ventura, G., Verardi, L., Vetrone, L., Vetrugno, G., Visconti, E., Visconti, F., Viviani, A., Zaccaria, R., Zaccone, C., Zelano, L., Zileri Dal Verme, L., Zuccala, G., Luigetti M. (ORCID:0000-0001-7539-505X), Iorio R. (ORCID:0000-0002-6270-0956), Bentivoglio A. R. (ORCID:0000-0002-9663-095X), Tricoli L., Riso V., Marotta J., Piano C., Primiano G., Lo Monaco M. R. (ORCID:0000-0002-1457-7981), Calabresi P. (ORCID:0000-0003-0326-5509), Annetta M. G. (ORCID:0000-0001-7574-1311), Antonelli M. (ORCID:0000-0003-3007-1670), Bosello S. (ORCID:0000-0002-4837-447X), Cianci R. (ORCID:0000-0001-5378-8442), Franceschi F. (ORCID:0000-0001-6266-445X), Grieco D. L. (ORCID:0000-0002-4557-6308), Ianiro G. (ORCID:0000-0002-8318-0515), Marzetti E. (ORCID:0000-0001-9567-6983), Miele L. (ORCID:0000-0003-3464-0068), Montini L. (ORCID:0000-0003-4602-5134), Murri R. (ORCID:0000-0003-4263-7854), Papa A. (ORCID:0000-0002-4186-7298), Richeldi L. (ORCID:0000-0001-8594-1448), Rinninella E. (ORCID:0000-0002-9165-2367), Sandroni C. (ORCID:0000-0002-8878-2611), and Scaldaferri F. (ORCID:0000-0001-8334-7541)

Abstract

Background and purpose: The objective of this study was to assess the neurological manifestations in a series of consecutive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive patients, comparing their frequency with a population hospitalized in the same period for flu/respiratory symptoms, finally not related to SARS-CoV-2. Methods: Patients with flu/respiratory symptoms admitted to Fondazione Policlinico Gemelli hospital from 14 March 2020 to 20 April 2020 were retrospectively enrolled. The frequency of neurological manifestations of patients with SARS-CoV-2 infection was compared with a control group. Results: In all, 213 patients were found to be positive for SARS-CoV-2, after reverse transcriptase polymerase chain reaction on nasal or throat swabs, whilst 218 patients were found to be negative and were used as a control group. Regarding central nervous system manifestations, in SARS-CoV-2-positive patients a higher frequency of headache, hyposmia and encephalopathy always related to systemic conditions (fever or hypoxia) was observed. Furthermore, muscular involvement was more frequent in SARS-CoV-2 infection. Conclusions: Patients with COVID-19 commonly have neurological manifestations but only hyposmia and muscle involvement seem more frequent compared with other flu diseases.

Published
2020

22. Concurrent evaluation of general, immune, and genetic toxicity endpoints as part of an integrated testing strategy

Author

Nicolo R. Visconti, Lynea Murphy, Melissa R. Schisler, Darrell R. Boverhof, Radhakrishna Sura, Lindsay K. Sosinski, and Matthew J. LeBaron

Subjects
medicine.medical_specialty, Hematology, Cyclophosphamide, Epidemiology, DNA damage, Health, Toxicology and Mutagenesis, Pharmacology, Biology, Comet assay, medicine.anatomical_structure, Immune system, Internal medicine, Immunology, Toxicity, Micronucleus test, medicine, Bone marrow, Genetics (clinical), medicine.drug
Abstract

Integrated testing strategies involve the assessment of multiple endpoints within a single toxicity study and represent an important approach for reducing animal use and streamlining testing. The present study evaluated the ability to combine general, immune, and genetic toxicity endpoints into a single study. Specifically, this study evaluated the impact of sheep red blood cell (SRBC) immunization, as part of the T-cell dependent antibody response (TDAR) assay, on organ weights, micronuclei (MN) formation (bone marrow and peripheral blood), and the Comet assay response in the liver of female F344/DuCrl rats treated with cyclophosphamide (CP) a known immunosuppressive chemical and genotoxicant. For the TDAR assay, treatment with CP resulted in a dose-dependent decrease in the antibody response with a suppression of greater than 95% at the high dose. Injection with SRBC had no impact on evaluated organ weights, histopathology, hematology, and clinical chemistry parameters. Analysis of MN formation in bone marrow and peripheral blood revealed a dose-dependent increase in response to CP treatment. Injection with SRBC had no impact on the level of MN in control animals and did not alter the dose response of CP. There was a slight increase in liver DNA damage in response to CP as measured by the Comet assay; however, injection with SRBCs did not alter this endpoint. Overall these data provide strong support for the concurrent assessment of general, immune, and genetic toxicology endpoints within a single study as part of an integrated testing strategy approach. Environ. Mol. Mutagen. 55:530–541, 2014. © 2014 Wiley Periodicals, Inc.

Published
2014
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23. Tiered application of the neutral red release and EpiOcular™ assays for evaluating the eye irritation potential of agrochemical formulations

Author

Lynn Kan, Raja S. Settivari, Sean C. Gehen, Edward W. Carney, Ricardo Acosta Amado, Marco Corvaro, Darrell R. Boverhof, and Nicolo R. Visconti

Subjects
0301 basic medicine, Neutral red, Agrochemical, Ocular irritation, 010501 environmental sciences, Pharmacology, Toxicology, Animal Testing Alternatives, Eye, 01 natural sciences, 03 medical and health sciences, chemistry.chemical_compound, Mice, Toxicity Tests, Medicine, Animals, Overall performance, Cells, Cultured, 0105 earth and related environmental sciences, Mice, Inbred BALB C, business.industry, Eye irritation, General Medicine, 3T3 Cells, 030104 developmental biology, chemistry, Neutral Red, Irritants, business, Agrochemicals
Abstract

Agrochemical formulations have been underrepresented in validation efforts for implementing alternative eye irritation approaches but represent a significant opportunity to reduce animal testing. This study assesses the utility of the neutral red release assay (NRR) and EpiOcular™ assay (EO) for predicting the eye irritation potential of 64 agrochemical formulations relative to Draize data. In the NRR, formulations with an NRR50 value ≤ 50 mg/mL were categorized as UN GHS Cat 1 and those >250 mg/mL were classified as UN GHS Non Classified (NC). The accuracy, sensitivity, and specificity were 78, 85 and 76% and 73, 85 and 61% for identifying UN GHS 1 and NC formulations, respectively. Specificity was poor for formulations with NRR50 > 50 to ≤250 mg/mL. The EO (ET-40 method) was explored to differentiate formulations that were UN GHS 1/2 and UN GHS NC. The EO resulted in accuracy, sensitivity, and specificity of 65%, 58% and 75% for identifying UN GHS NC formulations. To improve the overall performance, the assays were implemented using a tiered-approach where the NRR was run as a first-tier followed by the EO. The tiered-approach resulted in improved accuracy (75%) and balanced sensitivity (73%) and specificity (77%) for distinguishing between irritating and non-irritating agrochemical formulations.

Published
2016

24. Concurrent evaluation of general, immune, and genetic toxicity endpoints as part of an integrated testing strategy

Author

Melissa R, Schisler, Radhakrishna, Sura, Nicolo R, Visconti, Lindsay K, Sosinski, Lynea A, Murphy, Matthew J, LeBaron, and Darrell R, Boverhof

Subjects
Erythrocytes, Micronucleus Tests, Sheep, Dose-Response Relationship, Drug, T-Lymphocytes, Bone Marrow Cells, Organ Size, Rats, Inbred F344, Rats, Liver, Bone Marrow, Research Design, Antibody Formation, Toxicity Tests, Animals, Female, Comet Assay, Cyclophosphamide, DNA Damage, Mutagens
Abstract

Integrated testing strategies involve the assessment of multiple endpoints within a single toxicity study and represent an important approach for reducing animal use and streamlining testing. The present study evaluated the ability to combine general, immune, and genetic toxicity endpoints into a single study. Specifically, this study evaluated the impact of sheep red blood cell (SRBC) immunization, as part of the T-cell dependent antibody response (TDAR) assay, on organ weights, micronuclei (MN) formation (bone marrow and peripheral blood), and the Comet assay response in the liver of female F344/DuCrl rats treated with cyclophosphamide (CP) a known immunosuppressive chemical and genotoxicant. For the TDAR assay, treatment with CP resulted in a dose-dependent decrease in the antibody response with a suppression of greater than 95% at the high dose. Injection with SRBC had no impact on evaluated organ weights, histopathology, hematology, and clinical chemistry parameters. Analysis of MN formation in bone marrow and peripheral blood revealed a dose-dependent increase in response to CP treatment. Injection with SRBC had no impact on the level of MN in control animals and did not alter the dose response of CP. There was a slight increase in liver DNA damage in response to CP as measured by the Comet assay; however, injection with SRBCs did not alter this endpoint. Overall these data provide strong support for the concurrent assessment of general, immune, and genetic toxicology endpoints within a single study as part of an integrated testing strategy approach.

Published
2014

28. Influence of CVD diamond tips and Er:YAG laser irradiation on bonding of different adhesive systems to dentin.

Author

da Silva MA, Di Nicolo R, Barcellos DC, Batista GR, Pucci CR, Rocha Gomes Torres C, and Borges AB

Subjects
Animals, Bisphenol A-Glycidyl Methacrylate chemistry, Cattle, Composite Resins chemistry, Dental High-Speed Equipment, Dental Stress Analysis instrumentation, Microscopy, Electron, Scanning, Random Allocation, Resin Cements chemistry, Smear Layer, Stress, Mechanical, Surface Properties, Temperature, Tensile Strength, Time Factors, Ultrasonics instrumentation, Water chemistry, Dental Bonding, Dental Cavity Preparation instrumentation, Dentin ultrastructure, Dentin-Bonding Agents chemistry, Diamond chemistry, Lasers, Solid-State therapeutic use
Abstract

Aim: The aim of this study was to compare the microtensile bond strength of three adhesive systems, using different methods of dentin preparation., Materials and Methods: A hundred and eight bovine teeth were used. The dentin from buccal face was exposed and prepared with three different methods, divided in 3 groups: Group 1 (DT)- diamond tip on a high-speed handpiece; Group 2 (CVD)-CVD tip on a ultrasonic handpiece; Group 3 (LA)-Er: YAG laser. The teeth were divided into 3 subgroups, according adhesive systems used: Subgroup 1-Adper Single Bond Plus/3M ESPE (SB) total-etch adhesive; Subgroup 2-Adper Scotchbond SE/3M ESPE (AS) selfetching adhesive; Subgroup 3-Clearfil SE Bond/Kuraray (CS) selfetching adhesive. Blocks of composite (Filtek Z250-3M ESPE) 4 mm high were built up and specimens were stored in deionized water for 24 hours at 37°C. Serial mesiodistal and buccolingual cuts were made and stick-like specimens were obtained, with transversal section of 1.0 mm(2). The samples were submitted to microtensile test at 1 mm/min and load of 10 kg in a universal testing machine. Data (MPa) were subjected to ANOVA and Tukey's tests (p < 0.05)., Results and Conclusion: Surface treatment with Diamond or CVD tips associated with Clearfil SE Bond adhesive produced significantly lower bond strength values compared to other groups. Surface treatment with Er: YAG laser associated with Single Bond Plus or Clearfil SE Bond adhesives and surface treatment with CVD tip associated with Adper Scotchbond SE adhesive produced significantly lower bond strength values compared to surface treatment with diamond or CVD tips associated with Single Bond Plus or Adper Scotchbond SE adhesives., Clinical Significance: Interactions between laser and the CVD tip technologies and the different adhesive systems can produce a satisfactory bonding strength result, so that these associations may be beneficial and enhance the clinical outcomes.

Published
2013
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29. Description of six cases of child cauda equina leptomeningitis: an emerging disease.

Author

Dicuonzo F, Palma M, Tangari M, De Nicolo R, Maghenzani M, Andresciani S, Sesta M, and Aristide C

Subjects
Adrenal Cortex Hormones therapeutic use, Antiviral Agents therapeutic use, Cauda Equina immunology, Cauda Equina pathology, Child, Child, Preschool, Communicable Diseases, Emerging immunology, Communicable Diseases, Emerging pathology, Communicable Diseases, Emerging therapy, Diagnosis, Differential, Female, Guillain-Barre Syndrome pathology, Humans, Immunoglobulins, Intravenous therapeutic use, Magnetic Resonance Imaging, Male, Meningitis, Aseptic immunology, Meningitis, Aseptic pathology, Meningitis, Aseptic therapy, Meningitis, Aseptic virology, Peripheral Nervous System Diseases immunology, Peripheral Nervous System Diseases pathology, Peripheral Nervous System Diseases therapy, Plasmapheresis, Treatment Outcome, Cauda Equina virology, Communicable Diseases, Emerging virology, Meningitis, Aseptic complications, Peripheral Nervous System Diseases virology
Abstract

Child cauda equina leptomeningitis (CCEL) is a typical clinical example of aseptic meningitis with patterns of an emerging disease, and it affects children aged 2-9. Here we will describe six cases of CCEL. After the prodromes, all children underwent an acute phase with hypoasthenia of the lower limbs, hyporeflexia, staggering and ataxia with steppage. Only in one case there were generalized fits and coma of grade 1-2 too. All children underwent a spinal magnetic resonance imaging (MRI), proving pathologic enhancement of cauda equina and conus medullaris leptomeningitis. At the same time, MRI made possible the differential diagnosis between cauda equina leptomeningitis and isolated minor forms of Guillain-Barre syndrome involving the lower limbs. Three hypotheses will be formulated for understanding the pathogen mechanism(s) of CCEL. The first one is based on the presence of an immediate viral damage on the meninges, the second one, the more likely, contemplates the occurrence of an immunomediated mechanism in a host genetically prone to react in an abnormal way from an immune viewpoint. The third hyphotesis consists in a two-time damage: an early immediate damage from the virus, and a later immunomediated reaction.

Published
2008
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30. Histopathology of the pulp of primary molars with active and arrested dentinal caries.

Author

Di Nicolo R, Guedes-Pinto AC, and Carvalho YR

Subjects
Basophils pathology, Child, Child, Preschool, Dental Pulp Necrosis classification, Dental Pulp Necrosis pathology, Dental Pulp Necrosis therapy, Dentin, Secondary pathology, Female, Humans, Male, Odontoblasts pathology, Pulpitis classification, Pulpitis pathology, Pulpitis therapy, Statistics as Topic, Wound Healing, Dental Caries pathology, Dental Pulp pathology, Dentin pathology, Molar pathology, Tooth Remineralization, Tooth, Deciduous pathology
Abstract

The purpose of this study was to compare the histological appearance of the pulp of human primary molars with active and arrested lesions. The sample consisted of 36 primary molars (18 with active lesions and 18 with arrested lesions) extracted from 35 children between 5 to 9 years of age. The histological diagnosis was classified in normal pulp, transitional stage, partial pulpitis, total pulpitis and total necrosis, and then subdivided in three subgroups: treatable, untreatable and questionable. Results showed that normal pulp or transitional stage (treatable category) was diagnosed in 50% of teeth with arrested lesions, compared to 11.1% of teeth with active lesions. Partial pulpitis (questionable category) was present in 38.8% with arrested lesions compared to 22.2% with active lesions. Total pulpitis and total necrosis (untreatable category) was diagnosed in 11.2% with arrested lesions compared to 66.7% with active lesions. The observed frequencies of histological categories between both groups were statistically significant (P < 0.05). Histologically, pulp reaction under active and arrested lesions in primary molars revealed the formation of a basophilic calcio-traumatic line at the junction of the primary and reparative dentin, formation of reparative dentin and a regular odontoblastic layer in 60% of the cases. Results indicated that the type of lesion (active or arrested) is a good indicator of the histological status of the pulp.

Published
2000

32. [PREVENTION OF DEHISCENCE OF THE DUODENAL STUMP].

Author

NICOLO R

Subjects
Humans, Duodenal Ulcer, Duodenum, Gastrectomy, Postoperative Complications, Precancerous Conditions, Soft Tissue Neoplasms, Surgical Wound Dehiscence
Published
1964

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