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How Do Drug Regulatory Bodies Deal With Potential Innovative Therapies?

Tutone M, Villa F, Addis A, Trotta F, Tafuri G.

Ther Innov Regul Sci. 2019 Jan 28:2168479018820889. doi: 10.1177/2168479018820889. [Epub ahead of print]


Time to recovery from obstetric fistula and determinants in Gondar university teaching and referral hospital, northwest Ethiopia.

Yismaw L, Alemu K, Addis A, Alene M.

BMC Womens Health. 2019 Jan 7;19(1):5. doi: 10.1186/s12905-018-0700-3.


Information needs on precision medicine: a survey of Italian health care professionals.

Addis A, Trotta F, Tafuri G, De Fiore L.

Ann Ist Super Sanita. 2018 Oct-Dec;54(4):316-323. doi: 10.4415/ANN_18_04_08.


Workshop on the Italian Pharmacovigilance System in the International Context: Critical Issues and Perspectives.

Sultana J, Moretti U, Addis A, Caduff P, Capuano A, Kant A, Laporte JR, Lindquist M, Raine J, Sartori D, Trifirò G, Tuccori M, Venegoni M, van Puijenbroek E, Leone R.

Drug Saf. 2018 Dec 18. doi: 10.1007/s40264-018-0768-6. [Epub ahead of print] No abstract available.


Early thrombosis prophylaxis with enoxaparin is not associated with hematoma expansion in patients with spontaneous intracerebral hemorrhage.

Ianosi B, Gaasch M, Rass V, Huber L, Hackl W, Kofler M, Schiefecker AJ, Addis A, Beer R, Rhomberg P, Pfausler B, Thomé C, Ammenwerth E, Helbok R.

Eur J Neurol. 2019 Feb;26(2):333-341. doi: 10.1111/ene.13830. Epub 2018 Dec 6.


Spinal anesthesia with a low dosage of local anesthetic for urgent cesarean delivery in a parturient with Klippel-Feil syndrome.

Santonastaso DP, de Chiara A, Addis A, Pini R, Agnoletti V.

J Clin Anesth. 2019 Feb;52:78-79. doi: 10.1016/j.jclinane.2018.09.013. Epub 2018 Sep 12. No abstract available.


Neonatal outcomes following new reimbursement limitations on palivizumab in Italy.

Belleudi V, Trotta F, Pinnarelli L, Davoli M, Addis A.

Arch Dis Child. 2018 Dec;103(12):1163-1167. doi: 10.1136/archdischild-2018-315349. Epub 2018 Sep 14.


[In the future, the medical-scientific library will be a laboratory and the information specialist will be a real researcher].

Addis A, Amato L.

Epidemiol Prev. 2018 May-Aug;42(3-4):261-262. doi: 10.19191/EP18.3-4.P261.078. Italian. No abstract available.


Studies on drug switchability showed heterogeneity in methodological approaches: a scoping review.

Belleudi V, Trotta F, Vecchi S, Amato L, Addis A, Davoli M.

J Clin Epidemiol. 2018 Sep;101:5-16. doi: 10.1016/j.jclinepi.2018.05.003. Epub 2018 May 16. Review.


[Biosimilars: Italian Medicines Agency takes position.]

Addis A.

Recenti Prog Med. 2018 Apr;109(4):214-215. doi: 10.1701/2896.29191. Italian.


Pattern of Use of Biosimilar and Originator Somatropin in Italy: A Population-Based Multiple Databases Study During the Years 2009-2014.

Marcianò I, Ingrasciotta Y, Giorgianni F, Ientile V, Chinellato A, Tari DU, Gini R, Cannavò S, Pastorello M, Scondotto S, Cananzi P, Traversa G, Trotta F, Belleudi V, Addis A, Trifirò G.

Front Endocrinol (Lausanne). 2018 Mar 13;9:95. doi: 10.3389/fendo.2018.00095. eCollection 2018.


[An epidemiology of research to avoid dissipation of resources of the Italian national health service].

Addis A, Davoli M.

Epidemiol Prev. 2018 Jan-Feb;42(1):96-97. doi: 10.19191/EP18.1.P096.027. Italian. No abstract available.


Population-based cohort study on comparative effectiveness and safety of biologics in inflammatory bowel disease.

Di Domenicantonio R, Trotta F, Cascini S, Agabiti N, Kohn A, Gasbarrini A, Davoli M, Addis A.

Clin Epidemiol. 2018 Feb 5;10:203-213. doi: 10.2147/CLEP.S150030. eCollection 2018.


[Real-world evidence.]

De Fiore L, Addis A.

Recenti Prog Med. 2017 Dec;108(12):497-499. doi: 10.1701/2829.28579. Italian.


[Switching from one drug therapy to another with the same therapeutic indication without harms.]

Belleudi V, Addis A.

Recenti Prog Med. 2017 Nov;108(11):451-453. doi: 10.1701/2812.28440. Italian.


[Big data versus randomized clinical trials? Nobody benefits from the contrast].

Addis A.

Epidemiol Prev. 2017 Sep-Dec;41(5-6):304-305. doi: 10.19191/EP17.5-6.P304.092. Italian. No abstract available.


Service user engagement in healthcare education as a mechanism for value based recruitment: An evaluation study.

Heaslip V, Scammell J, Mills A, Spriggs A, Addis A, Bond M, Latchford C, Warren A, Borwell J, Tee S.

Nurse Educ Today. 2018 Jan;60:107-113. doi: 10.1016/j.nedt.2017.09.021. Epub 2017 Oct 6.


Biologics combined with conventional systemic agents or phototherapy for the treatment of psoriasis: real-life data from PSONET registries.

Busard CI, Cohen AD, Wolf P, Gkalpakiotis S, Cazzaniga S, Stern RS, Hutten BA, Feldhamer I, Quehenberger F, Lichem R, Kojanova M, Adenubiova E, Addis A, Naldi L, Spuls PI.

J Eur Acad Dermatol Venereol. 2018 Feb;32(2):245-253. doi: 10.1111/jdv.14583. Epub 2017 Oct 17.


Late presentation of NMOSD as rapidly progressive leukoencephalopathy with atypical clinical and radiological findings.

Sechi E, Addis A, Batzu L, Mariotto S, Ferrari S, Conti M, Sechi G.

Mult Scler. 2018 Apr;24(5):685-688. doi: 10.1177/1352458517721661. Epub 2017 Aug 17.


Comparative efficacy and safety in ESA biosimilars vs. originators in adults with chronic kidney disease: a systematic review and meta-analysis.

Amato L, Addis A, Saulle R, Trotta F, Mitrova Z, Davoli M.

J Nephrol. 2018 Jun;31(3):321-332. doi: 10.1007/s40620-017-0419-5. Epub 2017 Jun 23. Review.


Ricerca clinica, tra presunti sprechi e governance dell’innovazione.

Perrone F, Addis A, Sinagra G, Bruzzi P.

Recenti Prog Med. 2017 May;108(5):207-210. doi: 10.1701/2695.27556. Italian. No abstract available.


Folic Acid for the Prevention of Neural Tube Defects.

Bortolus R, Parazzini F, Addis A.

JAMA Pediatr. 2017 Jul 1;171(7):709-710. doi: 10.1001/jamapediatrics.2017.0857. No abstract available.


The Italian reference sites of the European innovation partnership on active and healthy ageing: Progetto Mattone Internazionale as an enabling factor.

Illario M, De Luca V, Tramontano G, Menditto E, Iaccarino G, Bertorello L, Palummeri E, Romano V, Moda G, Maggio M, Barbolini M, Leonardini L, Addis A; Italian EIP-AHA Working Group.

Ann Ist Super Sanita. 2017 Jan-Mar;53(1):60-69. doi: 10.4415/ANN_17_01_12.


Comparative effectiveness and safety of erythropoiesis-stimulating agents (biosimilars vs originators) in clinical practice: a population-based cohort study in Italy.

Trotta F, Belleudi V, Fusco D, Amato L, Mecozzi A, Mayer F, Sansone M, Davoli M, Addis A.

BMJ Open. 2017 Mar 10;7(3):e011637. doi: 10.1136/bmjopen-2016-011637.


Osseointegration of Titanium Implants With Different Rough Surfaces: A Histologic and Histomorphometric Study in an Adult Minipig Model.

Fabbro MD, Taschieri S, Canciani E, Addis A, Musto F, Weinstein R, Dellavia C.

Implant Dent. 2017 Jun;26(3):357-366. doi: 10.1097/ID.0000000000000560.


[Equivalence, equity and evidence for the use of biosimilar drugs.]

Trotta F, Addis A.

Recenti Prog Med. 2017 Jan;108(1):11-13. doi: 10.1701/2624.26979. Italian.


Can systematic reviews contribute to regulatory decisions?

Barbui C, Addis A, Amato L, Traversa G, Garattini S.

Eur J Clin Pharmacol. 2017 Apr;73(4):507-509. doi: 10.1007/s00228-016-2194-y. Epub 2017 Jan 7. Review.


Inequalities in access to biological treatments for psoriasis: results from the Italian Psocare registry.

Naldi L, Cazzaniga S, Di Mercurio M, Grossi E, Addis A; Psocare study centres.

Br J Dermatol. 2017 May;176(5):1331-1338. doi: 10.1111/bjd.15234. Epub 2017 Apr 5.


[Biomedical research from philanthropy to scarcity.]

Addis A, De Fiore L, Traversa G.

Recenti Prog Med. 2016 Oct;107(10):507-509. doi: 10.1701/2454.25698. Italian.


Risk of serious infections, cutaneous bacterial infections, and granulomatous infections in patients with psoriasis treated with anti-tumor necrosis factor agents versus classic therapies: Prospective meta-analysis of Psonet registries.

Garcia-Doval I, Cohen AD, Cazzaniga S, Feldhamer I, Addis A, Carretero G, Ferrándiz C, Stern RS, Naldi L; Psonet Network.

J Am Acad Dermatol. 2017 Feb;76(2):299-308.e16. doi: 10.1016/j.jaad.2016.07.039. Epub 2016 Sep 29.


Percutaneous repair of the tricuspid valve using a novel cinching device: acute and chronic experience in a preclinical large animal model.

Taramasso M, Latib A, Denti P, Nietlispach F, Lynn K, Cesarovic N, Addis A, Emmert MY, Guidotti A, Vanermen H, Maisano F.

EuroIntervention. 2016 Sep 18;12(7):918-25. doi: 10.4244/EIJV12I7A150.


A Nutritional Approach to the Prevention of Cancer: from Assessment to Personalized Intervention.

Di Furia L, Rusciano MR, Leonardini L, Rossi P, Giammarchi C, Vittori E, Tilocca S, Russo FL, Montuori P, Triassi M, Nardone A, Giaimo MD, Migazzi M, Piffer S, Iaria A, Trapasso A, Firenze A, Cristaudo R, Revello M, Castiglion A, Zagonel V, Iaccarino G, Addis A, Natale L, Di Somma C, Colao A, Perra A, Giova K, Montuori N, Illario M.

Transl Med UniSa. 2016 Jan 31;13:33-41. eCollection 2015 Dec.


Longitudinally Extensive Spinal Cord Lesions Disclosing Occult Systemic Sarcoidosis.

Sechi E, Addis A, Piredda R, Rassu AL, Mameli G, Senes C, Sechi G.

JAMA Neurol. 2016 May 1;73(5):600-1. doi: 10.1001/jamaneurol.2016.0013. No abstract available.


Neuralgic amyotrophy mimicking Vernet syndrome.

Doneddu PE, Sechi E, Addis A, Fadda G, Fois C, Sechi G.

J Neurol Sci. 2016 Mar 15;362:230-1. doi: 10.1016/j.jns.2016.01.064. Epub 2016 Feb 2. No abstract available.


A Novel Cooling Device for Targeted Brain Temperature Control and Therapeutic Hypothermia: Feasibility Study in an Animal Model.

Giuliani E, Magnoni S, Fei M, Addis A, Zanasi R, Stocchetti N, Barbieri A.

Neurocrit Care. 2016 Dec;25(3):464-472.


[Governance of innovative cardiovascular devices: when evidence is not enough].

Addis A, Davoli M.

Recenti Prog Med. 2016 Jan;107(1):7-9. doi: 10.1701/2132.23096. Italian.


Transcatheter direct mitral annuloplasty with Cardioband: feasibility and efficacy trial in an acute preclinical model.

Taramasso M, Guidotti A, Cesarovic N, Denti P, Addis A, Candreva A, Nietlispach F, Fleischmann T, Emmert MY, Maisano F.

EuroIntervention. 2016 Dec 10;12(11):e1428-e1434. doi: 10.4244/EIJY15M11_06.


Teaching NeuroImages: Subacute encephalopathy in a young woman with THTR2 gene mutation.

Sechi E, Addis A, Fadda G, Minafra L, Bravatà V, Sechi G.

Neurology. 2015 Oct 6;85(14):e108-9. doi: 10.1212/WNL.0000000000002002. No abstract available.


[Considerations on what we can (and what we should not) ask to registries].

Addis A, Berti E, De Palma R, Fiori G, Papini D, Traversa G; Aziende Farmaceutiche partecipanti al gruppo di lavoro PRIER II.

Recenti Prog Med. 2015 Sep;106(9):444-54. doi: 10.1701/1996.21594. Italian.


[Considerations on limits and profits of registries].

Addis A, Costa E, De Palma R, Magrini N, Marata AM, Martelli L, Papini D, Traversa G; Aziende Farmaceutiche partecipanti ai lavori del PRIER II.

Recenti Prog Med. 2015 Sep;106(9):425-35. doi: 10.1701/1996.21590. Italian.


[PRIER II. The Emilia-Romagna Research and Innovation Programme].

Addis A, Papini D, Bassi MC, Grilli R.

Recenti Prog Med. 2015 Sep;106(9):409-15. doi: 10.1701/1996.21586. Italian.


Clinicopathologic features of folate-deficiency neuropathy.

Sechi G, Fois C, Addis A, Sechi E.

Neurology. 2015 Sep 22;85(12):1090-1. doi: 10.1212/01.wnl.0000471972.90236.b6. No abstract available.


First insights on the mitochondrial genetic variability of Lightiella magdalenina (Crustacea), the sole Mediterranean cephalocarid species.

Sanna D, Addis A, Scarpa F, Fabiano F, Carcupino M, Francalacci P.

J Biol Res (Thessalon). 2014 May 13;21(1):5. doi: 10.1186/2241-5793-21-5. eCollection 2014 Dec.


Pre-clinical In Vitro and In Vivo Models for Heart Valve Therapies.

Taramasso M, Emmert MY, Reser D, Guidotti A, Cesarovic N, Campagnol M, Addis A, Nietlispach F, Hoerstrup SP, Maisano F.

J Cardiovasc Transl Res. 2015 Jul;8(5):319-27. doi: 10.1007/s12265-015-9631-7. Epub 2015 May 13.


A translational "humanised" porcine model for transcatheter mitral valve interventions: the neo inferior vena cava approach.

Maisano F, Reser D, Pavicevic J, Guidotti A, Denti P, Taramasso M, Addis A, Cesarovic N, Emmert MY, Nietlispach F, Swain J, Falk V, Leon M.

EuroIntervention. 2015 May;11(1):92-5. doi: 10.4244/EIJY15M02_04.


XPO1/CRM1-selective inhibitors of nuclear export (SINE) reduce tumor spreading and improve overall survival in preclinical models of prostate cancer (PCa).

Gravina GL, Tortoreto M, Mancini A, Addis A, Di Cesare E, Lenzi A, Landesman Y, McCauley D, Kauffman M, Shacham S, Zaffaroni N, Festuccia C.

J Hematol Oncol. 2014 Oct 5;7:46. doi: 10.1186/1756-8722-7-46.


Meniscus maturation in the swine model: changes occurring along with anterior to posterior and medial to lateral aspect during growth.

Di Giancamillo A, Deponti D, Addis A, Domeneghini C, Peretti GM.

J Cell Mol Med. 2014 Oct;18(10):1964-74. doi: 10.1111/jcmm.12367. Epub 2014 Sep 12.


Integrated care pathways for airway diseases (AIRWAYS-ICPs).

European Innovation Partnership on Active and Healthy Ageing, Action Plan B3; Mechanisms of the Development of Allergy, WP 10; Global Alliance against Chronic Respiratory Diseases, Bousquet J, Addis A, Adcock I, Agache I, Agusti A, Alonso A, Annesi-Maesano I, Anto JM, Bachert C, Baena-Cagnani CE, Bai C, Baigenzhin A, Barbara C, Barnes PJ, Bateman ED, Beck L, Bedbrook A, Bel EH, Benezet O, Bennoor KS, Benson M, Bernabeu-Wittel M, Bewick M, Bindslev-Jensen C, Blain H, Blasi F, Bonini M, Bonini S, Boulet LP, Bourdin A, Bourret R, Bousquet PJ, Brightling CE, Briggs A, Brozek J, Buhl R, Bush A, Caimmi D, Calderon M, Calverley P, Camargos PA, Camuzat T, Canonica GW, Carlsen KH, Casale TB, Cazzola M, Cepeda Sarabia AM, Cesario A, Chen YZ, Chkhartishvili E, Chavannes NH, Chiron R, Chuchalin A, Chung KF, Cox L, Crooks G, Crooks MG, Cruz AA, Custovic A, Dahl R, Dahlen SE, De Blay F, Dedeu T, Deleanu D, Demoly P, Devillier P, Didier A, Dinh-Xuan AT, Djukanovic R, Dokic D, Douagui H, Dubakiene R, Eglin S, Elliot F, Emuzyte R, Fabbri L, Fink Wagner A, Fletcher M, Fokkens WJ, Fonseca J, Franco A, Frith P, Furber A, Gaga M, Garcés J, Garcia-Aymerich J, Gamkrelidze A, Gonzales-Diaz S, Gouzi F, Guzmán MA, Haahtela T, Harrison D, Hayot M, Heaney LG, Heinrich J, Hellings PW, Hooper J, Humbert M, Hyland M, Iaccarino G, Jakovenko D, Jardim JR, Jeandel C, Jenkins C, Johnston SL, Jonquet O, Joos G, Jung KS, Kalayci O, Karunanithi S, Keil T, Khaltaev N, Kolek V, Kowalski ML, Kull I, Kuna P, Kvedariene V, Le LT, Lodrup Carlsen KC, Louis R, MacNee W, Mair A, Majer I, Manning P, de Manuel Keenoy E, Masjedi MR, Melen E, Melo-Gomes E, Menzies-Gow A, Mercier G, Mercier J, Michel JP, Miculinic N, Mihaltan F, Milenkovic B, Molimard M, Momas I, Montilla-Santana A, Morais-Almeida M, Morgan M, N'Diaye M, Nafti S, Nekam K, Neou A, Nicod L, O'Hehir R, Ohta K, Paggiaro P, Palkonen S, Palmer S, Papadopoulos NG, Papi A, Passalacqua G, Pavord I, Pigearias B, Plavec D, Postma DS, Price D, Rabe KF, Radier Pontal F, Redon J, Rennard S, Roberts J, Robine JM, Roca J, Roche N, Rodenas F, Roggeri A, Rolland C, Rosado-Pinto J, Ryan D, Samolinski B, Sanchez-Borges M, Schünemann HJ, Sheikh A, Shields M, Siafakas N, Sibille Y, Similowski T, Small I, Sola-Morales O, Sooronbaev T, Stelmach R, Sterk PJ, Stiris T, Sud P, Tellier V, To T, Todo-Bom A, Triggiani M, Valenta R, Valero AL, Valiulis A, Valovirta E, Van Ganse E, Vandenplas O, Vasankari T, Vestbo J, Vezzani G, Viegi G, Visier L, Vogelmeier C, Vontetsianos T, Wagstaff R, Wahn U, Wallaert B, Whalley B, Wickman M, Williams DM, Wilson N, Yawn BP, Yiallouros PK, Yorgancioglu A, Yusuf OM, Zar HJ, Zhong N, Zidarn M, Zuberbier T.

Eur Respir J. 2014 Aug;44(2):304-23. doi: 10.1183/09031936.00014614. Epub 2014 Jun 12.


[Population ageing and health implication. Thinking time trends in Emilia-Romagna Region].

Mazzocchetti A, Caranci N, Addis A.

Recenti Prog Med. 2014 May;105(5):191-7. doi: 10.1701/1493.16453. Italian.


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