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153. Identifying and managing CAR T-cell–mediated toxicities: on behalf of an Italian CAR-T multidisciplinary team

Author

Martino, Massimo, Macheda, Sebastiano, Aguglia, Umberto, Arcudi, Luciano, Pucci, Giulia, Martino, Bruno, Altomonte, Maria, Rossetti, Antonio Maria, Cusumano, Giuseppa, Russo, Letteria, Imbalzano, Lucrezia, Stelitano, Caterina, Alati, Caterina, Germano’, Jessyca, Labate, Demetrio, Amalfi, Vincenzo, Florenzano, Maria Teresa, Morabito, Antonella, Borzumati, Vittoria, Dattola, Vincenzo, Gattuso, Caterina, Moschella, Antonio, Quattrone, Domenico, Curmaci, Francesco, Franzutti, Claudio, Scappatura, Giuseppe, Rao, Carmelo Massimiliano, Loddo, Viviana, Pontari, Antonella, Pellicano’, Maria, Surace, Rosangela, Sanguedolce, Cristina, Naso, Virginia, Ferreri, Anna, Irrera, Giuseppe, Console, Giuseppe, Moscato, Tiziana, Loteta, Barbara, Canale, Filippo Antonio, Trimarchi, Alfonso, Monteleone, Renza, Al Sayyad, Said, Cirrone, Frank, and Bruno, Benedetto

Abstract

ABSTRACTIntroductionChimeric antigen receptor (CAR)-T-cell therapy is a new treatment for patients with hematologic malignancies in which other therapies have failed.Areas coveredThe review provides an overview for recognizing and managing the most acute toxicities related to CAR-T cells.Expert opinionThe development of immune-mediated toxicities is a common challenge of CAR-T therapy. The mechanism that determines this toxicity is still unclear, although an unfavorable tumor microenvironment and a pro-inflammatory state put patients at risk. The monitoring, diagnosis, and treatment of post-CAR-T toxicities must be determined and based on international guidelines and internal clinical practice. It is urgent to identify biomarkers that can identify patients at greater risk of developing complications. The adoption of consistent grading criteria is necessary to improve toxicity management strategies continually. The first-line therapy consists of supportive care and treatment with tocilizumab or corticosteroids. An early start of cytokine blockade therapies could mitigate toxicity. The plan will include cytokine release prophylaxis, a risk-adapted treatment, prevention of on-target/off-tumor effect, and a switch on/off CAR-T approach.

Published
2022
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157. Establishment and characterization of induced pluripotent stem cells (iPSCs) from central nervous system lupus erythematosus

Author

De Angelis, Maria Teresa, primary, Santamaria, Gianluca, additional, Parrotta, Elvira Immacolata, additional, Scalise, Stefania, additional, Lo Conte, Michela, additional, Gasparini, Sara, additional, Ferlazzo, Edoardo, additional, Aguglia, Umberto, additional, Ciampi, Clara, additional, Sgura, Antonella, additional, and Cuda, Giovanni, additional

Published
2019
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160. Kufs disease due to mutation ofCLN6: clinical, pathological and molecular genetic features

Author

Berkovic, Samuel F, primary, Oliver, Karen L, additional, Canafoglia, Laura, additional, Krieger, Penina, additional, Damiano, John A, additional, Hildebrand, Michael S, additional, Morbin, Michela, additional, Vears, Danya F, additional, Sofia, Vito, additional, Giuliano, Loretta, additional, Garavaglia, Barbara, additional, Simonati, Alessandro, additional, Santorelli, Filippo M, additional, Gambardella, Antonio, additional, Labate, Angelo, additional, Belcastro, Vincenzo, additional, Castellotti, Barbara, additional, Ozkara, Cigdem, additional, Zeman, Adam, additional, Rankin, Julia, additional, Mole, Sara E, additional, Aguglia, Umberto, additional, Farrell, Michael, additional, Rajagopalan, Sulekha, additional, McDougall, Alan, additional, Brammah, Susan, additional, Andermann, Frederick, additional, Andermann, Eva, additional, Dahl, Hans-Henrik M, additional, Franceschetti, Silvana, additional, and Carpenter, Stirling, additional

Published
2018
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167. Variable course of Unverricht-Lundborg disease

Author

Canafoglia, Laura, Ferlazzo, Edoardo, Michelucci, Roberto, Striano, Pasquale, Magaudda, Adriana, Gambardella, Antonio, Pasini, Elena, Belcastro, Vincenzo, Riguzzi, Patrizia, Fanella, Martina, Granata, Tiziana, Beccaria, Francesca, Trentini, Claudia, Bianchi, Amedeo, Aguglia, Umberto, Panzica, Ferruccio, and Franceschetti, Silvana

Subjects
Adult, Male, Analysis of Variance, Adolescent, Valproic Acid, Somatosensory, Electroencephalography, Middle Aged, Prognosis, Age of Onset, Anticonvulsants, Cathepsin B, Evoked Potentials, Somatosensory, Female, Humans, Italy, Phenytoin, Retrospective Studies, Unverricht-Lundborg Syndrome, Young Adult, Neurology (clinical), Evoked Potentials
Published
2017

169. Autologous hematopoietic stem cell transplantation in multiple sclerosis: A phase II trial

Author

Mancardi, Giovanni L., Sormani, Maria P., Gualandi, Francesca, Saiz, Albert, Carreras, Eric, Merelli, Elisa, Donelli, Amedea, Di Bartolomeo, Paolo, Rottoli, Maria R., Rambaldi, Alessandro, Amato, Maria P., Massacesi, Luca, Di Gioia, Massimo, Vuolo, Luisa, Currò, Daniela, Roccatagliata, Luca, Filippi, Massimo, Aguglia, Umberto, Iacopino, Pasquale, Farge, Dominique, Saccardi, Riccardo, ASTIMS Haemato Neurological Collaborative Group, on behalf of the Autoimmune Disease Working Party of the European Group for Blood, Marrow Transplantation, ASTIMS Haemato Neurological Collaborative Group on behalf of the Autoimmune Disease Working Party ADWP of the European Group for Blood, Marrow Transplantation EBMT, LUGARESI, ALESSANDRA, Mancardi, Gl, Sormani, Mp, Gualandi, F, Saiz, A, Carreras, E, Merelli, E, Donelli, A, Lugaresi, A, Di Bartolomeo, P, Rottoli, Mr, Rambaldi, A, Amato, Mp, Massacesi, L, Di Gioia, M, Vuolo, L, Currà, D, Roccatagliata, L, Filippi, Massimo, Aguglia, U, Iacopino, P, Farge, D, Saccardi, R., Mancardi, Giovanni L., Sormani, Maria P., Gualandi, Francesca, Saiz, Albert, Carreras, Eric, Merelli, Elisa, Donelli, Amedea, Lugaresi, Alessandra, Di Bartolomeo, Paolo, Rottoli, Maria R., Rambaldi, Alessandro, Amato, Maria P., Massacesi, Luca, Di Gioia, Massimo, Vuolo, Luisa, Currò, Daniela, Roccatagliata, Luca, Aguglia, Umberto, Iacopino, Pasquale, Farge, Dominique, Saccardi, Riccardo, ASTIMS Haemato-Neurological Collaborative Group, on behalf of the Autoimmune Disease Working Party (ADWP) of the European Group for Blood and Marrow Transplantation (EBMT)., and ASTIMS Haemato-Neurological Collaborative Group on behalf of the Autoimmune Disease Working Party ADWP of the European Group for Blood and Marrow Transplantation EBMT

Subjects
Oncology, Adult, Male, medicine.medical_specialty, Transplantation Conditioning, medicine.medical_treatment, Antineoplastic Agents, Gadolinium, Hematopoietic stem cell transplantation, Filgrastim, Transplantation, Autologous, Antineoplastic Agent, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, medicine, Clinical endpoint, Humans, Carmustine, Mitoxantrone, Expanded Disability Status Scale, business.industry, Hematopoietic Stem Cell Transplantation, Immunosuppression, Middle Aged, Multiple Sclerosis, Chronic Progressive, Image Enhancement, Magnetic Resonance Imaging, Transplantation, Autologou, Transplantation, Treatment Outcome, Immunology, Female, Neurology (clinical), business, Human, medicine.drug
Abstract

Objective: To assess in multiple sclerosis (MS) the effect of intense immunosuppression followed by autologous hematopoietic stem cells transplantation (AHSCT) vs mitoxantrone (MTX) on disease activity measured by MRI. Methods: We conducted a multicenter, phase II, randomized trial including patients with secondary progressive or relapsing-remitting MS, with a documented increase in the last year on the Expanded Disability Status Scale, in spite of conventional therapy, and presence of one or more gadolinium-enhancing (Gd+) areas. Patients were randomized to receive intense immunosuppression (mobilization with cyclophosphamide and filgrastim, conditioning with carmustine, cytosine-arabinoside, etoposide, melphalan, and anti-thymocyte globulin) followed by AHSCT or MTX 20 mg every month for 6 months. The primary endpoint was the cumulative number of new T2 lesions in the 4 years following randomization. Secondary endpoints were the cumulative number of Gd+ lesions, relapse rate, and disability progression. Safety and tolerability were also assessed. Twenty-one patients were randomized and 17 had postbaseline evaluable MRI scans. Results: AHSCT reduced by 79% the number of new T2 lesions as compared to MTX (rate ratio 0.21, p = 0.00016). It also reduced Gd+ lesions as well as the annualized relapse rate. No difference was found in the progression of disability. Conclusion: Intense immunosuppression followed by AHSCT is significantly superior to MTX in reducing MRI activity in severe cases of MS. These results strongly support further phase III studies with primary clinical endpoints. The study was registered as EUDRACT No. 2007-000064-24.

Published
2015

170. Administration of subcutaneous interferon beta 1a in the evening: data from RELIEF study.

Author

Patti, Francesco, Zimatore, Giovanni Bosco, Brescia Morra, Vincenzo, Aguglia, Umberto, Bossio, Roberto Bruno, Marziolo, Roberto, Valentino, Paola, Chisari, Clara Grazia, Capacchione, Antonio, and Zappia, Mario

Subjects
INTERFERONS, MULTIPLE sclerosis
Abstract

Background: Subcutaneous recombinant interferon-beta 1a (IFN-β1a SC) is indicated for treatment of relapsing multiple sclerosis (RMS); however, it is associated with development of flu-like syndrome (FLS) in 75% of patients. No recommendations are available on whether evening or morning administration could induce better or worse FLS. Objective: Primary objective was to investigate whether morning administration of IFN-β1a 44 µg (Rebif) would affect the severity of FLS versus evening administration, in patients with RMS. Secondary objectives were to investigate whether timing of administration could lead to a better quality of life. Methods: Multicenter, open-label, 12-week, randomized, controlled, parallel-group, phase 4 study. Results: Of 217 patients screened at 29 Italian sites, 200 were included in the study. Among these, 104 patients were randomized to IFN-β1a SC administration in the morning and 96 in the evening. Morning administration resulted in higher FLS scores, as measured by the Multiple Sclerosis Treatment Concern Questionnaire, at week 4 (p = 0.0083) and week 8 (p = 0.0079); however, the difference was no longer significant at the end of 12 weeks. Conclusion: IFN-β1a evening injections in the first 8 weeks of treatment led to an improvement in FLS; when continuing therapy, time of administration could be decided according to patient's lifestyle and preference. [ABSTRACT FROM AUTHOR]

Published
2020
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171. Management of epilepsy in brain tumors.

Author

Maschio, Marta, Aguglia, Umberto, Avanzini, Giuliano, Banfi, Paola, Buttinelli, Carla, Capovilla, Giuseppe, Casazza, Marina Maria Luisa, Colicchio, Gabriella, Coppola, Antonietta, Costa, Cinzia, Dainese, Filippo, Daniele, Ornella, De Simone, Roberto, Eoli, Marica, Gasparini, Sara, Giallonardo, Anna Teresa, La Neve, Angela, Maialetti, Andrea, Mecarelli, Oriano, and Melis, Marta

Subjects
*EPILEPSY, *BRAIN tumors, *VALPROIC acid, *DISABILITIES, *ANTINEOPLASTIC agents, *ANTICONVULSANTS, *LAMOTRIGINE, *TREATMENT of epilepsy, *DISEASE complications
Abstract

Epilepsy in brain tumors (BTE) may require medical attention for a variety of unique concerns: epileptic seizures, possible serious adverse effects of antineoplastic and antiepileptic drugs (AEDs), physical disability, and/or neurocognitive disturbances correlated to tumor site. Guidelines for the management of tumor-related epilepsies are lacking. Treatment is not standardized, and overall management might differ according to different specialists. The aim of this document was to provide directives on the procedures to be adopted for a correct diagnostic-therapeutic path of the patient with BTE, evaluating indications, risks, and benefits. A board comprising neurologists, epileptologists, neurophysiologists, neuroradiologists, neurosurgeons, neuro-oncologists, neuropsychologists, and patients' representatives was formed. The board converted diagnostic and therapeutic problems into seventeen questions. A literature search was performed in September-October 2017, and a total of 7827 unique records were retrieved, of which 148 constituted the core literature. There is no evidence that histological type or localization of the brain tumor affects the response to an AED. The board recommended to avoid enzyme-inducing antiepileptic drugs because of their interference with antitumoral drugs and consider as first-choice newer generation drugs (among them, levetiracetam, lamotrigine, and topiramate). Valproic acid should also be considered. Both short-term and long-term prophylaxes are not recommended in primary and metastatic brain tumors. Management of seizures in patients with BTE should be multidisciplinary. The panel evidenced conflicting or lacking data regarding the role of EEG, the choice of therapeutic strategy, and timing to withdraw AEDs and recommended high-quality long-term studies to standardize BTE care. [ABSTRACT FROM AUTHOR]

Published
2019
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172. Diagnostic Biomarkers of Epilepsy

Author

Sueri, Chiara, primary, Gasparini, Sara, additional, Balestrini, Simona, additional, Labate, Angelo, additional, Gambardella, Antonio, additional, Russo, Emilio, additional, Leo, Antonio, additional, Casarotto, Silvia, additional, Pittau, Francesca, additional, Trimboli, Michele, additional, Cianci, Vittoria, additional, Ascoli, Michele, additional, Cavalli, Salvatore M., additional, Ferrigno, Giulia, additional, Aguglia, Umberto, additional, and Ferlazzo, Edoardo, additional

Published
2018
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175. Epileptogenic role of occult temporal encephalomeningocele

Author

Gasparini, Sara, primary, Ferlazzo, Edoardo, additional, Pustorino, Giuseppe, additional, Ascoli, Michele, additional, Cianci, Vittoria, additional, Sueri, Chiara, additional, Calabrò, Silvio, additional, Campello, Mauro, additional, Africa, Emilio, additional, Gangemi, Antonio, additional, Versace, Paolo, additional, and Aguglia, Umberto, additional

Published
2018
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181. Epilepsy and sleep disorders improve in adolescents and adults with Angelman syndrome: A multicenter study on 46 patients

Author

Sueri, Chiara, primary, Ferlazzo, Edoardo, additional, Elia, Maurizio, additional, Bonanni, Paolo, additional, Randazzo, Giovanna, additional, Gasparini, Sara, additional, D'Agostino, Tiziana, additional, Sapone, Antonino R., additional, Ascoli, Michele, additional, Bellavia, Marina A., additional, Cianci, Vittoria, additional, Gambardella, Antonio, additional, Labate, Angelo, additional, and Aguglia, Umberto, additional

Published
2017
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182. Relevance of clinical context in the diagnostic-therapeutic approach to status epilepticus

Author

Aguglia, Umberto, Sueri, Chiara, Gasparini, Sara, Beghi, Ettore, Labate, Angelo, Gambardella, Antonio, Specchio, Luigi M., Ferlazzo, Edoardo, Aloisi, Paolo, Belcastro, Vincenzo, Benna, Paolo, Bianchi, Amedeo, Bogliun, Graziella, Brigo, Francesco, Buttinelli, Carla, Campostrini, Roberto, Cantello, Roberto, Anna, Teresa Cantisani, Cianci, Vittoria, Congia, Socrate, Consoli, Domenico, Costanzo, Erminio, De Falco Fabrizio, A., De Maria, Giovanni, Bonaventura, Carlo Di, Di Francesco Jacopo, C., Elia, Maurizio, Carlo, Andrea Galimberti, Giallonardo Anna, Teresa, Gigli Gian, Luigi, Iannacchero, Rosario, Iudice, Alfonso, La Neve, Angela, Latella Maria, Adele, Le Piane, Emilio, Marciani Maria, Grazia, Marino, Daniela, Mecarelli, Oriano, Michelucci, Roberto, Minicucci, Fabio, Monti, Fabrizio, Mumoli, Laura, Paciello, Nicola, Paladin, Francesco, Palumbo, Pasquale, Pisani, Francesco, Pisani Laura, Rosa, Sartucci, Ferdinando, Sasanelli, Francesco, Sofia, Vito, Striano, Pasquale, Striano, Salvatore, Strigaro, Gionata, Tinuper, Paolo, Verri, Annapia, Villani, Flavio, Zaccara, Gaetano, Capovilla, Giuseppe, Ferlisi, Monica, Aguglia, U, Sueri, C, Gasparini, S, Beghi, E, Labate, A, Gambardella, A, Specchio, L.M, Ferlazzo, E, Epilepsy Study Group of the Italian Neurological Society and of the Subcommission on Status Epilepticus of the Italian League Against Epilepsy [, Tinuper, P., and ]

Subjects
0301 basic medicine, medicine.medical_specialty, MEDLINE, Context (language use), Status epilepticus, Neurology, Neurology (clinical), 03 medical and health sciences, Therapeutic approach, 0302 clinical medicine, Text mining, Status Epilepticus, medicine, Humans, Relevance (information retrieval), Electroencephalography, Intensive care medicine, SE, Epilepsy, business.industry, 030104 developmental biology, status epilepticu, medicine.symptom, business, 030217 neurology & neurosurgery
Abstract

n.a.

Published
2016

183. Profile of brivaracetam and its potential in the treatment of epilepsy

Author

Ferlazzo, Edoardo, Russo,Emilio, Mumoli,Laura, Sueri,Chiara, Gasparini,Sara, Palleria,Caterina, Labate,Angelo, Gambardella,Antonio, De Sarro,Giovambattista, and Aguglia,Umberto

Subjects
Neuropsychiatric Disease and Treatment
Abstract

Edoardo Ferlazzo,1,2 Emilio Russo,3 Laura Mumoli,1 Chiara Sueri,2 Sara Gasparini,1,2 Caterina Palleria,3 Angelo Labate,1 Antonio Gambardella,1 Giovambattista De Sarro,3 Umberto Aguglia1,2 1Department of Medical and Surgical Sciences, Magna Græcia University, Catanzaro, 2Regional Epilepsy Centre, Bianchi-Melacrino-Morelli Hospital, Reggio Calabria, 3Institute of Pharmacology, Magna Græcia University, Catanzaro, Italy Abstract: Brivaracetam (BRV) (UCB 34714) is currently under review by the US Food and Drug Administration and European Medicines Agency for approval as an add-on treatment for adult patients with partial seizures. Similar to levetiracetam (LEV), BRV acts as a high-affinity ligand of the synaptic vesicle protein 2A, however, it has been shown to be 10- to 30-fold more potent than LEV. Moreover, BRV does not share the LEV inhibitory activity on the high voltage Ca2+ channels and AMPA receptors, and it has been reported to act as a partial antagonist on neuronal voltage-gated sodium channels. The pharmacokinetic profile of BRV is favorable and linear, and it undergoes an extensive metabolism into inactive compounds, mainly through the hydrolysis of its acetamide group. Furthermore, it does not significantly interact with other antiepileptic drugs and more than 95% is excreted through the urine, with an unchanged fraction of 8%–11%. BRV has a half-life of approximately 8–9 hours and it is usually given twice daily. To date, a wide range of experimental studies have reported the effectiveness of BRV with regards to partial and generalized seizures. In humans, six randomized, placebo-controlled trials and two meta-analyses highlighted the efficacy, or good tolerability, of BRV as an add-on treatment for patients with uncontrolled partial seizures. A wide dose range of BRV has been evaluated in those trials (5–200 mg), but the most suitable for clinical use appears to be 50–100 mg/day. The most common adverse reactions to BRV are mild to moderate, transient, often improve during the course of the treatment, and mainly consist of central nervous system symptoms, such as fatigue, dizziness, and somnolence. The aim of this paper is to critically review the literature data regarding experimental animal models and clinical trials on BRV, and to define its potential usefulness for the clinicians who manage patients with epilepsy. Keywords: seizures, animal, therapy, drug, antiepileptic

Published
2015

186. Validation Study of Italian Version of Inventory for Déjà Vu Experiences Assessment (I-IDEA): A Screening Tool to Detect Déjà Vu Phenomenon in Italian Healthy Individuals

Author

Mumoli, Laura, primary, Tripepi, Giovanni, additional, Aguglia, Umberto, additional, Augimeri, Antonio, additional, Baggetta, Rossella, additional, Bisulli, Francesca, additional, Bruni, Antonella, additional, Cavalli, Salvatore, additional, D’Aniello, Alfredo, additional, Daniele, Ornella, additional, Di Bonaventura, Carlo, additional, Di Gennaro, Giancarlo, additional, Fattouch, Jinane, additional, Ferlazzo, Edoardo, additional, Ferrari, Alessandra, additional, Giallonardo, Annateresa, additional, Gasparini, Sara, additional, Nigro, Salvatore, additional, Romigi, Andrea, additional, Sofia, Vito, additional, Tinuper, Paolo, additional, Vaccaro, Maria, additional, Zummo, Leila, additional, Quattrone, Aldo, additional, Gambardella, Antonio, additional, and Labate, Angelo, additional

Published
2017
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188. Cerebral small vessel disease predisposes to temporal lobe epilepsy in spontaneously hypertensive rats

Author

Russo, Emilio, primary, Leo, Antonio, additional, Scicchitano, Francesca, additional, Donato, Annalidia, additional, Ferlazzo, Edoardo, additional, Gasparini, Sara, additional, Cianci, Vittoria, additional, Mignogna, Chiara, additional, Donato, Giuseppe, additional, Citraro, Rita, additional, Aguglia, Umberto, additional, and De Sarro, Giovambattista, additional

Published
2017
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189. Deep Learning Representation from Electroencephalography of Early-Stage Creutzfeldt-Jakob Disease and Features for Differentiation from Rapidly Progressive Dementia

Author

Morabito, Francesco Carlo, primary, Campolo, Maurizio, additional, Mammone, Nadia, additional, Versaci, Mario, additional, Franceschetti, Silvana, additional, Tagliavini, Fabrizio, additional, Sofia, Vito, additional, Fatuzzo, Daniela, additional, Gambardella, Antonio, additional, Labate, Angelo, additional, Mumoli, Laura, additional, Tripodi, Giovanbattista Gaspare, additional, Gasparini, Sara, additional, Cianci, Vittoria, additional, Sueri, Chiara, additional, Ferlazzo, Edoardo, additional, and Aguglia, Umberto, additional

Published
2016
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