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3. Sacubitril/valsartan in real-life European patients with heart failure and reduced ejection fraction: a systematic review and meta-analysis

Author

Giovinazzo, S, Carmisciano, L, Toma, M, Benenati, S, Tomasoni, D, Sormani, M, Porto, I, Canepa, M, Senni, M, Metra, M, Ameri, P, Giovinazzo S, Carmisciano L, Toma M, Benenati S, Tomasoni D, Sormani MP, Porto I, Canepa M, Senni M, Metra M, Ameri P, Giovinazzo, S, Carmisciano, L, Toma, M, Benenati, S, Tomasoni, D, Sormani, M, Porto, I, Canepa, M, Senni, M, Metra, M, Ameri, P, Giovinazzo S, Carmisciano L, Toma M, Benenati S, Tomasoni D, Sormani MP, Porto I, Canepa M, Senni M, Metra M, and Ameri P

Abstract

Aims: We systematically reviewed the European real-world evidence (RWE) about sacubitril-valsartan for heart failure with reduced ejection fraction. Methods and results: Twenty-one articles, including 16 952 subjects, were identified until 31 October 2020. Taking as reference the PARADIGM-HF cohort, few baseline characteristics were presented in >80% of these studies, most often with high heterogeneity. In random-effects model meta-analysis, age was higher (mean difference +3.84, 95% CI 1.92–5.76), ischaemic aetiology (OR 0.76, 95% CI 0.64–0.91), hypertension (OR 0.55, 95% CI 0.37–0.82), and diabetes (OR 0.77, 95% CI 0.64–0.92) were less common, and the use of mineralocorticoid receptor antagonists was more frequent (OR 3.54, 95% CI 2.27–5.53) in real-life than in PARADIGM-HF. Other clinical and medical features were presented in 19–76% of the selected publications and suggested more severe heart failure with reduced ejection fraction. Sacubitril-valsartan was titrated to 97/103 mg b.i.d. in 35% (95% CI 23–47) and discontinued in 12.8% (95% CI 7.4–18.3) patients. When reported, the incidence of hyperkalaemia (six studies, no. 1076), all-cause mortality (five studies, no. 684), and any hospitalization (three studies, no. 390) was 12 (95% CI 5–19)/100 person-year, 8 (95% CI 4–12)/100 person-year, and 24 (95% CI 5–42)/100 person-year, respectively. Knowledge contribution, a metric measuring the proportion of RWE provided by each article based on the number of reported variables and the sample size, was 58.8% and 13.6% for the two biggest investigations (12 082 and 2037 patients), and <5% for all others (most with <100 subjects). Conclusions: Limited-quality RWE indicates that there are important differences between European patients prescribed sacubitril-valsartan and the PARADIGM-HF population, including the frequency of target dose achievement.

Published
2021

5. Revised upper limb module for spinal muscular atrophy: 12 month changes

Author

Pera, Maria Carmela, Coratti, Giorgia, Mazzone, Es, Montes, J, Scoto, M, De Sanctis, Roberto, Main, M, Mayhew, A, Muni Lofra, R, Dunaway Young, S, Glanzman, Am, Duong, T, Pasternak, A, Ramsey, D, Darras, B, Day, Jw, Finkel, Rs, De Vivo DC, Sormani, Mp, Bovis, F, Straub, V, Muntoni, F, Pane, Marika, Mercuri, Eugenio Maria, and iSMAC Consortium Group

Subjects
Adult, Male, Adolescent, Health Status, Walking, Spinal Muscular Atrophies of Childhood, Longitudinal Data, Outcome measures, Muscular Atrophy, Spinal, Upper Extremity, Young Adult, Settore MED/39 - NEUROPSICHIATRIA INFANTILE, MODULE FOR SPINAL, Humans, Longitudinal Studies, Functional assessment, Neuromuscular disorders, Spinal Muscular Atrophy, Upper limb, Child, Middle Aged, Reference Standards, Child, Preschool, Disease Progression, Female, Algorithms
Abstract

The aim of the study was to assess 12 month changes in upper limb function in patients affected by spinal muscular atrophy type 2 and 3.Longitudinal 12 month data was collected in 114 patients, 60 type 2 and 54 type 3, using the Revised Upper Limb Module.The 12 month changes ranged between -7 and 9 (mean: -0.41; SD: 2.93). The mean changes were not significantly different between the three spinal muscular atrophy groups (-0.45 in type 2, -0.23 in non-ambulant type 3 and -0.34 in ambulant type 3, p = 0.96) and the relationship between 12 month change and age classes was not significantly different among the three types of SMA patients.Our results confirm that the Module explores a wide range of functional abilities and can be used in ambulant and non-ambulant patients of different ages in conjunction with other functional scales. Muscle Nerve 59:426-430, 2019.

Published
2019

7. Assessing response to interferon-β in a multicenter dataset of patients with MS

Author

Sormani, Mp, Gasperini, C, Romeo, M, Rio, J, Calabrese, M, Cocco, E, Enzingher, C, Fazekas, F, Filippi, M, Gallo, A, Kappos, L, Marrosu, Mg, Martinelli, V, Prosperini, Luca, Rocca, Ma, Rovira, A, Sprenger, T, Stromillo, Ml, Tedeschi, G, Tintorè, M, Tortorella, C, Trojano, M, Montalban, X, Pozzilli, Carlo, Comi, G, De Stefano, N, MAGNIMS study group, Sormani, Maria Pia, Gasperini, Claudio, Romeo, Marzia, Rio, Jordi, Calabrese, Massimiliano, Cocco, Eleonora, Enzingher, Christian, Fazekas, Franz, Filippi, Massimo, Gallo, Antonio, Kappos, Ludwig, Marrosu, Maria Giovanna, Martinelli, Vittorio, Prosperini, Luca, Rocca, Maria Assunta, Rovira, Alex, Sprenger, Till, Stromillo, Maria Laura, Tedeschi, Gioacchino, Tintorè, Mar, Tortorella, Carla, Trojano, Maria, Montalban, Xavier, Pozzilli, Carlo, Comi, Giancarlo, De Stefano, Nicola, Sormani, Mp, Gasperini, C, Romeo, M, Rio, J, Calabrese, M, Cocco, E, Enzingher, C, Fazekas, F, Gallo, A, Kappos, L, Marrosu, Mg, Martinelli, V, Prosperini, L, Rocca, Ma, Rovira, A, Sprenger, T, Stromillo, Ml, Tedeschi, G, Tintorè, M, Tortorella, C, Trojano, M, Montalban, X, Pozzilli, C, and De Stefano, N.

Subjects
Time Factors, multiple sclerosis, interferon-β therapy, Magnetic Resonance Imaging, assessment, follow-up, risk of treatment failure, Expanded Disability Status Scale, relapse, worsening, Datasets as Topic, Kaplan-Meier Estimate, Relapsing-Remitting, Disability Evaluation, 0302 clinical medicine, Adolescent, Adult, Aged, Child, Europe, Follow-Up Studies, Humans, Immunologic Factors, Interferon-beta, Middle Aged, Multiple Sclerosis, Relapsing-Remitting, Retrospective Studies, Risk, Treatment Failure, Young Adult, Neurology (clinical), 030212 general & internal medicine, Young adult, medicine.diagnostic_test, Hazard ratio, medicine.medical_specialty, 03 medical and health sciences, Internal medicine, medicine, Proportional hazards model, business.industry, Multiple sclerosis, Magnetic resonance imaging, Retrospective cohort study, medicine.disease, Confidence interval, multiple-sclerosis patients, treatment optimization, clinical-practice, ifn-beta, mri, recommendations, predictors, score, business, 030217 neurology & neurosurgery
Abstract

To provide new insights into the role of markers of response to interferon-β therapy in multiple sclerosis (MS) in a multicenter setting, focusing on the relevance of MRI lesions in combination with clinical variables.A large multicenter clinical dataset was collected within the Magnetic Resonance Imaging in MS (MAGNIMS) network. This included a large cohort of patients with relapsing-remitting MS on interferon-β treatment, MRI and clinical assessments during the first year of treatment, and clinical follow-up of at least 2 additional years. Heterogeneity among centers was assessed before pooling the data. The association of 1-year MRI or clinical relapses with the risk of treatment failure (defined as Expanded Disability Status Scale [EDSS] worsening or treatment switch for inefficacy) and of EDSS worsening alone was evaluated using multivariate Cox models.A pooled dataset of 1,280 patients with relapsing-remitting MS from 9 MAGNIMS centers was analyzed. The risk of failure had a relevant increase with 1 relapse (hazard ratio [HR] 1.84, 95% confidence interval [CI] 1.39-2.44, p0.001) and ≥3 new T2 lesions (HR 1.55, 95% CI 0.92-2.60, p = 0.09). In patients without relapses and less than 3 new T2 lesions, the 3-year risk of failure and EDSS worsening were 17% and 15%; in patients with 1 relapse or ≥3 new T2 lesions, the risks were 27% and 22%; in patients with both conditions or more than 1 relapse, the risks were 48% (p0.001) and 29% (p0.001).Substantial MRI activity, particularly if in combination with clinical relapses, during the first year of treatment with interferon-β indicates significant risk of treatment failure and EDSS worsening in the short term.

Published
2016

8. The challenge of comorbidity in clinical trials for multiple sclerosis

Author

Marrie RA, Miller A, Sormani MP, Thompson A, Waubant E, Trojano M, O'Connor P, Reingold S, Cohen JA, attendees of the International Workshop on Comorbidity in Multiple Sclerosis, COMI , GIANCARLO, Marrie, Ra, Miller, A, Sormani, Mp, Thompson, A, Waubant, E, Comi, Giancarlo, Trojano, M, O'Connor, P, Reingold, S, Cohen, Ja, and attendees of the International Workshop on Comorbidity in Multiple, Sclerosis

Subjects
medicine.medical_specialty, Multiple Sclerosis, Population, Comorbidity, 03 medical and health sciences, 0302 clinical medicine, Pharmacovigilance, mental disorders, medicine, Humans, Generalizability theory, 030212 general & internal medicine, Intensive care medicine, Psychiatry, education, education.field_of_study, Clinical Trials as Topic, Views & Reviews, business.industry, Incidence (epidemiology), Clinical study design, medicine.disease, 3. Good health, Clinical trial, Tolerability, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Objective: We aimed to provide recommendations for addressing comorbidity in clinical trial design and conduct in multiple sclerosis (MS). Methods: We held an international workshop, informed by a systematic review of the incidence and prevalence of comorbidity in MS and an international survey about research priorities for studying comorbidity including their relation to clinical trials in MS. Results: We recommend establishing age- and sex-specific incidence estimates for comorbidities in the MS population, including those that commonly raise concern in clinical trials of immunomodulatory agents; shifting phase III clinical trials of new therapies from explanatory to more pragmatic trials; describing comorbidity status of the enrolled population in publications reporting clinical trials; evaluating treatment response, tolerability, and safety in clinical trials according to comorbidity status; and considering comorbidity status in the design of pharmacovigilance strategies. Conclusion: Our recommendations will help address knowledge gaps regarding comorbidity that interfere with the ability to interpret safety in monitored trials and will enhance the generalizability of findings from clinical trials to “real world” settings where the MS population commonly has comorbid conditions.

Published
2016

9. Cognitive clinico-radiological paradox in early stages of multiple sclerosis

Author

Uher, T, Krasensky, J, Sobisek, L, Blahova Dusankova, J, Seidl, Z, Kubala Havrdova, E, Sormani, MP, Horakova, D, Kalincik, T, Vaneckova, M, Uher, T, Krasensky, J, Sobisek, L, Blahova Dusankova, J, Seidl, Z, Kubala Havrdova, E, Sormani, MP, Horakova, D, Kalincik, T, and Vaneckova, M

Abstract

OBJECTIVE: To investigate whether the strength of the association between magnetic resonance imaging (MRI) metrics and cognitive outcomes differs between various multiple sclerosis subpopulations. METHODS: A total of 1052 patients were included in this large cross-sectional study. Brain MRI (T1 and T2 lesion volume and brain parenchymal fraction) and neuropsychological assessment (Brief International Cognitive Assessment for Multiple Sclerosis and Paced Auditory Serial Addition Test) were performed. RESULTS: Weak correlations between cognitive domains and MRI measures were observed in younger patients (age≤30 years; absolute Spearman's rho = 0.05-0.21), with short disease duration (<2 years; rho = 0.01-0.21), low Expanded Disability Status Scale [EDSS] (≤1.5; rho = 0.08-0.18), low T2 lesion volume (lowest quartile; <0.59 mL; rho = 0.01-0.20), and high brain parenchymal fraction (highest quartile; >86.66; rho = 0.01-0.16). Stronger correlations between cognitive domains and MRI measures were observed in older patients (age>50 years; rho = 0.24-0.50), with longer disease duration (>15 years; rho = 0.26-0.53), higher EDSS (≥5.0; rho = 0.23-0.39), greater T2 lesion volume (highest quartile; >5.33 mL; rho = 0.16-0.32), and lower brain parenchymal fraction (lowest quartile; <83.71; rho = 0.13-0.46). The majority of these observed results were confirmed by significant interactions (P ≤ 0.01) using continuous variables. INTERPRETATION: The association between structural brain damage and functional cognitive impairment is substantially weaker in multiple sclerosis patients with a low disease burden. Therefore, disease stage should be taken into consideration when interpreting associations between structural and cognitive measures in clinical trials, research studies, and clinical practice.

Published
2018

10. Gender Inequities in the Multiple Sclerosis Community: A Call for Action

Author

Waubant, E, Amezcua, L, Sicotte, N, Hellwig, K, Krupp, L, Weinstock-Guttman, B, Yeh, A, Lucas, RM, Longbrake, EE, Yadav, V, Rensel, M, Mar, S, Hersh, C, Block, V, Zipp, F, Han, MH, Spain, R, Kelland, EE, Charvet, L, Dimitri, D, Papeix, C, Cross, AH, Inglese, M, Amato, MP, Airas, L, Leray, E, Sormani, MP, Van der Walt, A, Vukusic, S, Castillo-Trivino, T, Tenembaum, S, Ciccarelli, O, Bommarito, G, Petracca, M, Celius, EG, Carson, MJ, Hua, LH, Van der Mei, I, Lubetzki, C, Jokubaitis, V, Trojano, M, Voskuhl, R, Tintore, M, Harbo, H, Asgari, N, Piccio, L, Burton, JM, Tremlett, H, Goldman, MD, Michel, L, Zhang, Y, Bove, R, Quandt, JA, Costello, F, Ionete, C, Lebrun-Frenay, C, Pakpoor, J, Bevan, C, Morrow, SA, Waldman, AT, Oh, J, Jacobs, D, Palace, J, Marrie, RA, Tiwari-Woodruff, SK, Metz, LM, Cortese, R, Chitnis, T, Benson, L, Benveniste, ET, Conway, J, Sand, IK, Murphy, JO, Kita, M, Riley, C, Goverman, JM, Langer-Gould, AM, Azevedo, CJ, Morales, IB, Barcellos, LF, Crabtree, E, Plummer, P, Shirani, A, Whartenby, K, Brilot-Turville, F, Kingwell, E, Coyle, P, Mowry, E, Zabad, R, Bielekova, B, Monson, N, Laule, C, Burnett, M, Schreiner, T, Grinspan, J, Dobson, R, Akassoglou, K, Graves, J, Gray, O, Smyth, P, Havrdova, EK, Preiningerova, JL, Banwell, B, Makhani, N, Lucchinetti, C, Arrambide, G, Maillart, E, Macklin, W, Gilmore, W, Waubant, E, Amezcua, L, Sicotte, N, Hellwig, K, Krupp, L, Weinstock-Guttman, B, Yeh, A, Lucas, RM, Longbrake, EE, Yadav, V, Rensel, M, Mar, S, Hersh, C, Block, V, Zipp, F, Han, MH, Spain, R, Kelland, EE, Charvet, L, Dimitri, D, Papeix, C, Cross, AH, Inglese, M, Amato, MP, Airas, L, Leray, E, Sormani, MP, Van der Walt, A, Vukusic, S, Castillo-Trivino, T, Tenembaum, S, Ciccarelli, O, Bommarito, G, Petracca, M, Celius, EG, Carson, MJ, Hua, LH, Van der Mei, I, Lubetzki, C, Jokubaitis, V, Trojano, M, Voskuhl, R, Tintore, M, Harbo, H, Asgari, N, Piccio, L, Burton, JM, Tremlett, H, Goldman, MD, Michel, L, Zhang, Y, Bove, R, Quandt, JA, Costello, F, Ionete, C, Lebrun-Frenay, C, Pakpoor, J, Bevan, C, Morrow, SA, Waldman, AT, Oh, J, Jacobs, D, Palace, J, Marrie, RA, Tiwari-Woodruff, SK, Metz, LM, Cortese, R, Chitnis, T, Benson, L, Benveniste, ET, Conway, J, Sand, IK, Murphy, JO, Kita, M, Riley, C, Goverman, JM, Langer-Gould, AM, Azevedo, CJ, Morales, IB, Barcellos, LF, Crabtree, E, Plummer, P, Shirani, A, Whartenby, K, Brilot-Turville, F, Kingwell, E, Coyle, P, Mowry, E, Zabad, R, Bielekova, B, Monson, N, Laule, C, Burnett, M, Schreiner, T, Grinspan, J, Dobson, R, Akassoglou, K, Graves, J, Gray, O, Smyth, P, Havrdova, EK, Preiningerova, JL, Banwell, B, Makhani, N, Lucchinetti, C, Arrambide, G, Maillart, E, Macklin, W, and Gilmore, W

Published
2018

11. Long-term disability trajectories in primary progressive MS patients: A latent class growth analysis

Author

Signori, A, Izquierdo, G, Lugaresi, A, Hupperts, R, Grand'Maison, F, Sola, P, Horakova, D, Havrdova, E, Prat, A, Girard, M, Duquette, P, Boz, C, Grammond, P, Terzi, M, Singhal, B, Alroughani, R, Petersen, T, Ramo, C, Oreja-Guevara, C, Spitaleri, D, Shaygannejad, V, Butzkueven, H, Kalincik, T, Jokubaitis, V, Slee, M, Fernandez Bolanos, R, Luis Sanchez-Menoyo, J, Pucci, E, Granella, F, Lechner-Scott, J, Iuliano, G, Hughes, S, Bergamaschi, R, Taylor, B, Verheul, F, Rio, ME, Amato, MP, Sajedi, SA, Majdinasab, N, Van Pesch, V, Sormani, MP, Trojano, M, Signori, A, Izquierdo, G, Lugaresi, A, Hupperts, R, Grand'Maison, F, Sola, P, Horakova, D, Havrdova, E, Prat, A, Girard, M, Duquette, P, Boz, C, Grammond, P, Terzi, M, Singhal, B, Alroughani, R, Petersen, T, Ramo, C, Oreja-Guevara, C, Spitaleri, D, Shaygannejad, V, Butzkueven, H, Kalincik, T, Jokubaitis, V, Slee, M, Fernandez Bolanos, R, Luis Sanchez-Menoyo, J, Pucci, E, Granella, F, Lechner-Scott, J, Iuliano, G, Hughes, S, Bergamaschi, R, Taylor, B, Verheul, F, Rio, ME, Amato, MP, Sajedi, SA, Majdinasab, N, Van Pesch, V, Sormani, MP, and Trojano, M

Abstract

BACKGROUND: Several natural history studies on primary progressive multiple sclerosis (PPMS) patients detected a consistent heterogeneity in the rate of disability accumulation. OBJECTIVES: To identify subgroups of PPMS patients with similar longitudinal trajectories of Expanded Disability Status Scale (EDSS) over time. METHODS: All PPMS patients collected within the MSBase registry, who had their first EDSS assessment within 5 years from onset, were included in the analysis. Longitudinal EDSS scores were modeled by a latent class mixed model (LCMM), using a nonlinear function of time from onset. LCMM is an advanced statistical approach that models heterogeneity between patients by classifying them into unobserved groups showing similar characteristics. RESULTS: A total of 853 PPMS (51.7% females) from 24 countries with a mean age at onset of 42.4 years (standard deviation (SD): 10.8 years), a median baseline EDSS of 4 (interquartile range (IQR): 2.5-5.5), and 2.4 years of disease duration (SD: 1.5 years) were included. LCMM detected three different subgroups of patients with a mild ( n = 143; 16.8%), moderate ( n = 378; 44.3%), or severe ( n = 332; 38.9%) disability trajectory. The probability of reaching EDSS 6 at 10 years was 0%, 46.4%, and 81.9% respectively. CONCLUSION: Applying an LCMM modeling approach to long-term EDSS data, it is possible to identify groups of PPMS patients with different prognosis.

Published
2018

12. Upper limb function in Duchenne muscular dystrophy: 24 month longitudinal data.

Author

Pane, M, Coratti, G, Brogna, C, Mazzone, E, Mayhew, A, Fanelli, L, Messina, S, D'Amico, A, Catteruccia, M, Scutifero, M, Frosini, S, Lanzillotta, V, Colia, G, Cavallaro, F, Rolle, E, De Sanctis, R, Forcina, N, Petillo, R, Barp, A, Gardani, A, Pini, A, Monaco, G, D'Angelo, Mg, Zanin, Renata, Vita, Gl, Bruno, C, Mongini, T, Ricci, Maria Francesca, Pegoraro, E, Bello, L, Berardinelli, A, Battini, R, Sansone, V, Albamonte, E, Baranello, G, Bertini, E, Politano, L, Sormani, Mp, Mercuri, E., Pane M (ORCID:0000-0002-4851-6124), Coratti G (ORCID:0000-0001-6666-5628), Brogna C, Mazzone ES, Catteruccia M, Cavallaro F, Battini R, Albamonte E, Baranello G, Bertini E, Mercuri E. (ORCID:0000-0002-9851-5365), Pane, M, Coratti, G, Brogna, C, Mazzone, E, Mayhew, A, Fanelli, L, Messina, S, D'Amico, A, Catteruccia, M, Scutifero, M, Frosini, S, Lanzillotta, V, Colia, G, Cavallaro, F, Rolle, E, De Sanctis, R, Forcina, N, Petillo, R, Barp, A, Gardani, A, Pini, A, Monaco, G, D'Angelo, Mg, Zanin, Renata, Vita, Gl, Bruno, C, Mongini, T, Ricci, Maria Francesca, Pegoraro, E, Bello, L, Berardinelli, A, Battini, R, Sansone, V, Albamonte, E, Baranello, G, Bertini, E, Politano, L, Sormani, Mp, Mercuri, E., Pane M (ORCID:0000-0002-4851-6124), Coratti G (ORCID:0000-0001-6666-5628), Brogna C, Mazzone ES, Catteruccia M, Cavallaro F, Battini R, Albamonte E, Baranello G, Bertini E, and Mercuri E. (ORCID:0000-0002-9851-5365)

Abstract

The aim of the study was to establish 24 month changes in upper limb function using a revised version of the performance of upper limb test (PUL 2.0) in a large cohort of ambulant and non-ambulant boys with Duchenne muscular dystrophy and to identify possible trajectories of progression. Of the 187 patients studied, 87 were ambulant (age range: 7-15.8 years), and 90 non-ambulant (age range: 9.08-24.78). The total scores changed significantly over time (p<0.001). Non-ambulant patients had lower total scores at baseline (mean 19.7) when compared to the ambulant ones (mean 38.4). They also had also a bigger decrease in total scores over 24 months compared to the ambulant boys (4.36 vs 2.07 points). Multivariate model analysis showed that the Performance of Upper Limb changes reflected the entry level and ambulation status, that were independently associated to the slope of Performance of Upper Limb changes. This information will be of help both in clinical practice and at the time of designing clinical trials.

Published
2018

13. Putative Predictive Parameters for the Outcome of Laparoscopic Splenectomy

Author

Casaccia, M, Torelli, P, Pasa, A, Sormani, Mp, Rossi, E, Casaccia M, IRLSS C. e. n. t. e. r. s., Valente, U, Spinoglio, G, Prete, F, Logrieco, G, Buccoliero, F, Berta, R, Donini, I, Donini, Annibale, Valeri, A, Prosperi, P, Saviano, M, Gelmini, R, Uggeri, F, Caprotti, R, Romano, F, Colecchia, G, Monteferrante, E, Pedrazzoli, C, Bigi, L, Barbieri, Im, Moraldi, A, Dallatorre, A, Basso, N, Silecchia, G, Rosati, R, Bona, S, Cavaliere, P, Bresadola, F, Terrosu, G, Mosca, F, Pietrabissa, A, Memeo, V, Puglisi, F, Dionigi, R, Benevento, A, Boni, L, Liboni, A, Feo, C, Borghi, F, Geretto, P, Moroni, R, Sorrentino, M, di Sebastiano, P, Ambrosio, A, Verdecchia, Gm, Cavaliere, D., Casaccia, M, Torelli, P, Pasa, A, Sormani, Mp, Rossi, E, Rosati, R, Sormani, M, Valente, U, Spinoglio, G, Prete, F, Logrieco, G, Buccoliero, F, Berta, R, Donini, I, Donini, A, Valeri, A, Prosperi, P, Saviano, M, Gelmini, R, Uggeri, F, Caprotti, R, Romano, F, Colecchia, G, Monteferrante, E, Pedrazzoli, C, Bigi, L, Barbieri, I, Moraldi, A, Dallatorre, A, Basso, N, Silecchia, G, Bona, S, Cavaliere, P, Bresadola, F, Terrosu, G, Mosca, F, Pietrabissa, A, Memeo, V, Puglisi, F, Dionigi, R, Benevento, A, Boni, L, Liboni, A, Feo, C, Borghi, F, Geretto, P, Moroni, R, Sorrentino, M, di Sebastiano, P, Ambrosio, A, Verdecchia, G, and Cavaliere, D

Subjects
Registrie, Adult, Male, Laparoscopic surgery, medicine.medical_specialty, Multivariate analysis, Adolescent, medicine.medical_treatment, Splenectomy, Postoperative Complications, Retrospective Studie, Risk Factors, MED/18 - CHIRURGIA GENERALE, medicine, Humans, Registries, Aged, Child, Child, Female, Italy, Laparoscopy, Middle Aged, Multivariate Analysis, Retrospective Studies, Treatment Outcome, Child, Multivariate Analysi, LAPAROSCOPIC SPLENECTOMY, Aged, 80 and over, medicine.diagnostic_test, business.industry, Risk Factor, Gold standard, Retrospective cohort study, Perioperative, Surgery, Endoscopy, Child, Preschool, Postoperative Complication, business, Human
Abstract

OBJECTIVE: To identify predictive risk factors for conversion to open splenectomy and postoperative complications in patients undergoing elective laparoscopic splenectomy. BACKGROUND: The laparoscopic approach represents the "gold standard" for splenectomy, but its use in the treatment of splenomegaly and malignant disease is controversial. Factors that influence immediate outcome are clinical, anatomic, and pathologic. METHODS: Univariate and multivariate analyses of data from the Italian Registry of Laparoscopic Surgery of the Spleen, a multicenter database supported by 25 referral centers. Analysis of data (1993-2007) was performed on a series of patients (n = 676) undergoing elective laparoscopic splenectomy. Demographic data, the operative indications, the surgical technique applied, and any intra- and/or postoperative complications with respect to the patients were assessed. Records were analyzed retrospectively using the Student t test, the chi test, and logistic regression. RESULTS: Conversion to open splenectomy was necessary in 39 cases (5.8%). Perioperative deaths occurred in 3 cases (0.4%). There were no complications in 560 patients (82.8%), with a mean hospital stay of 5 days (range, 2-54). Overall, morbidity occurred in 116 patients (17.2%). Multivariate analysis found that the body mass index (P = 0.01) and the presence of hematologic malignancy (P < 0.001) were independent predictors for intraoperative complications and surgical conversion. Spleen longitudinal diameter (P = 0.001) and surgical conversion (P = 0.001) were independent predictors for the occurrence of postoperative complications. CONCLUSIONS: This large multicenter study provides evidence for the significance of predictive risk factors for intra- and postoperative complications in laparoscopic splenic surgery. Besides splenic dimensions, other factors like the patient's habitus and the specific underlying hematologic pathology should be recognized by the surgeon to reduce complications and initiate adequate treatment.

Published
2010

14. Comparative effectiveness of dimethyl fumarate, teriflunomide, interferon-beta and glatiramer acetate on newly diagnosed patients: a propensity score-matched analysis from a multicenter Italian group

Author

Signori, A, Sormani, Mp, Maniscalco, Gt, Signoriello, E, Rossi, S, Gutierrez, Lp, Sacca, F, Russo, Cv, Lo Fermo, S, Repice, Am, Baroncini, D, Annovazzi, P, Clerico, M, Cerqua, R, Binello, E, Mataluni, G, Frau, J, Cocco, E, Zarbo, R, Laroni, A, Sartori, A, Cordioli, C, Rasia, S, Bonavita, S, Lavorgna, L, Esposito, S, Clerici, Valt, La Gioia, S, Frigeni, B, Barcella, V, Pontecorvo, S, Di Sapio, A, Grasso, R, Stromillo, Ml, Barrila, C, Gallo, F, and Lanzillo, R

Published
2017

15. Evidence-based guidelines: MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis-establishing disease prognosis and monitoring patients

Author

Wattjes MP, Rovira A, Miller DH, Yousry TA, Sormani MP, De Stefano N, Tintoré M, Auger C, Tur C, Rocca MA, Fazekas F, Kappos L, Polman CH, Barkhof F, Montalban X. on behalf of the MAGNIMS study group, FILIPPI , MASSIMO, Wattjes, Mp, Rovira, A, Miller, Dh, Yousry, Ta, Sormani, Mp, De Stefano, N, Tintoré, M, Auger, C, Tur, C, Filippi, Massimo, Rocca, Ma, Fazekas, F, Kappos, L, Polman, Ch, Barkhof, F, and Montalban X., on behalf of the MAGNIMS study group

Published
2015

16. Identification of multiple sclerosis patients at highest risk of cognitive impairment using an integrated brain magnetic resonance imaging assessment approach

Author

Uher, T, Vaneckova, M, Sormani, MP, Krasensky, J, Sobisek, L, Dusankova, JB, Seidl, Z, Havrdova, E, Kalincik, T, Benedict, RHB, Horakova, D, Uher, T, Vaneckova, M, Sormani, MP, Krasensky, J, Sobisek, L, Dusankova, JB, Seidl, Z, Havrdova, E, Kalincik, T, Benedict, RHB, and Horakova, D

Abstract

BACKGROUND AND PURPOSE: While impaired cognitive performance is common in multiple sclerosis (MS), it has been largely underdiagnosed. Here a magnetic resonance imaging (MRI) screening algorithm is proposed to identify patients at highest risk of cognitive impairment. The objective was to examine whether assessment of lesion burden together with whole brain atrophy on MRI improves our ability to identify cognitively impaired MS patients. METHODS: Of the 1253 patients enrolled in the study, 1052 patients with all cognitive, volumetric MRI and clinical data available were included in the analysis. Brain MRI and neuropsychological assessment with the Brief International Cognitive Assessment for Multiple Sclerosis were performed. Multivariable logistic regression and individual prediction analysis were used to investigate the associations between MRI markers and cognitive impairment. The results of the primary analysis were validated at two subsequent time points (months 12 and 24). RESULTS: The prevalence of cognitive impairment was greater in patients with low brain parenchymal fraction (BPF) (<0.85) and high T2 lesion volume (T2-LV) (>3.5 ml) than in patients with high BPF (>0.85) and low T2-LV (<3.5 ml), with an odds ratio (OR) of 6.5 (95% CI 4.4-9.5). Low BPF together with high T2-LV identified in 270 (25.7%) patients predicted cognitive impairment with 83% specificity, 82% negative predictive value, 51% sensitivity and 75% overall accuracy. The risk of confirmed cognitive decline over the follow-up was greater in patients with high T2-LV (OR 2.1; 95% CI 1.1-3.8) and low BPF (OR 2.6; 95% CI 1.4-4.7). CONCLUSIONS: The integrated MRI assessment of lesion burden and brain atrophy may improve the stratification of MS patients who may benefit from cognitive assessment.

Published
2017

17. Treatment of multiple sclerosis patients after 24 Natalizumab doses: a prospective observational study: the TY-STOP

Author

Clerico, Marinella, Schiavetti, I, DE MERCANTI, STEFANIA FEDERICA, Piazza, F, Gned, Dario, Brescia Morra, V, Lanzillo, Raffaella, Ghezzi, A, Bianchi, A, Salemi, G, Realmuto, S, Sola, P, Vitetta, F, Cavalla, Paola, Superti, G, Ferraro, D, Paolicelli, D, Trojano, M, Sormani, Mp, Durelli, Luca, Clerico, M, Schiavetti, I, De Mercanti, S, Piazza, F, Gned, D, Brescia Morra, V, Lanzillo, R, Ghezzi, A, Bianchi, A, Salemi, G, Realmuto, S, Sola, P, Vitetta, F, Cavalla, P, Superti, G, Ferraro, D, Paolicelli, D, Trojano, M, Sormani, MP, and Durelli, L

Subjects
Multiple Sclerosis, Natalizumab, Ty-STOP, Settore MED/26 - Neurologia
Published
2014

18. Autologous haematopoietic stem cell transplantation with an intermediate intensity conditioning regimen in multiple sclerosis: the Italian multi-centre experience

Author

Mancardi, Gl, Sormani, Mp, Di Gioia, M, Vuolo, L, Gualandi, F, Amato, Mp, Capello, E, Currò, D, Uccelli, A, Bertolotto, A, Gasperini, C, Lugaresi, A, Merelli, E, Meucci, G, Motti, L, Tola, Mr, Scarpini, E, Repice, Am, Massacesi, L, Saccardi, R, Donnini, I, Bosi, A, Guidi, S, Bagigalupo, A, Bonzano, L, Bruzzi, P, Roccatagliata, L, Antenucci, R, Granella, F, Martino, G, Rottoli, M, Solaro, C, Salvi, F, Ursino, E, Barilaro, A, Capobianco, M., Mancardi G, Sormani M, Di Gioia M, Vuolo L, Gualandi F, Amato M, Capello E, Currò D, Uccelli A, Bertolotto A, Gasperini C, Lugaresi A, Merelli E, Meucci G, Motti L, Tola M, Scarpini E, Repice A, Massacesi L, and Saccardi R

Subjects
Adult, medicine.medical_specialty, Time Factors, Transplantation Conditioning, Adolescent, medicine.medical_treatment, multiple sclerosis, treatment, prognosis, autologous stem cell transplantation, Kaplan-Meier Estimate, Severity of Illness Index, Transplantation, Autologous, Disease-Free Survival, Disability Evaluation, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Autologous stem-cell transplantation, Refractory, Predictive Value of Tests, medicine, Humans, Registries, Multi centre, Chi-Square Distribution, business.industry, Multiple sclerosis, Hematopoietic Stem Cell Transplantation, Immunosuppression, Middle Aged, Multiple Sclerosis, Chronic Progressive, medicine.disease, Magnetic Resonance Imaging, Surgery, Transplantation, Haematopoiesis, Treatment Outcome, Italy, Neurology, Disease Progression, Neurology (clinical), Stem cell, business
Abstract

Background: Over recent years numerous patients with severe forms of multiple sclerosis (MS) refractory to conventional therapies have been treated with intense immunosuppression followed by autologous haematopoietic stem cell transplantation (AHSCT). The clinical outcome and the toxicity of AHSCT can be diverse, depending on the various types of conditioning protocols and on the disease phase. Objectives: To report the Italian experience on all the consecutive patients with MS treated with AHSCT with an intermediate intensity conditioning regimen, named BEAM/ATG, in the period from 1996 to 2008. Methods: Clinical and magnetic resonance imaging outcomes of 74 patients were collected after a median follow-up period of 48.3 (range = 0.8–126) months. Results: Two patients (2.7%) died from transplant-related causes. After 5 years, 66% of patients remained stable or improved. Among patients with a follow-up longer than 1 year, eight out of 25 subjects with a relapsing–remitting course (31%) had a 6–12 months confirmed Expanded Disability Status Scale improvement > 1 point after AHSCT as compared with one out of 36 (3%) patients with a secondary progressive disease course ( p = 0.009). Among the 18 cases with a follow-up longer than 7 years, eight (44%) remained stable or had a sustained improvement while 10 (56%), after an initial period of stabilization or improvement with median duration of 3.5 years, showed a slow disability progression. Conclusions: This study shows that AHSCT with a BEAM/ATG conditioning regimen has a sustained effect in suppressing disease progression in aggressive MS cases unresponsive to conventional therapies. It can also cause a sustained clinical improvement, especially if treated subjects are still in the relapsing–remitting phase of the disease.

Published
2011

19. 6 Min walk test 12 month changes in DMD: correlation with the genotype

Author

Pane M, Mazzone E, Sormani MP, Scalise R, Berardinelli A, Messina S, Torrente Y, D'amico A, Doglio L, Viggiano E, D'Ambrosio P, Cavallaro P, Frosini S, Bello L, De Sanctis R, Fanelli L, Rolle E, Bianco F, Magri F, Vita GL, Motta MC, Donati MA, Mongini T, Pini a, Battini R, Pegoraro E, Previtali SC, Napolitano S, Bruno C, Comi GP, Bertini E, Mercuri E., POLITANO, Luisa, Pane, M, Mazzone, E, Sormani, Mp, Scalise, R, Berardinelli, A, Messina, S, Torrente, Y, D'Amico, A, Doglio, L, Viggiano, E, D'Ambrosio, P, Cavallaro, P, Frosini, S, Bello, L, De Sanctis, R, Fanelli, L, Rolle, E, Bianco, F, Magri, F, Vita, Gl, Motta, Mc, Donati, Ma, Mongini, T, Pini, A, Battini, R, Pegoraro, E, Previtali, Sc, Napolitano, S, Bruno, C, Politano, Luisa, Comi, Gp, Bertini, E, and Mercuri, E.

Published
2013

20. A multicentre study of motor functional connectivity changes in patients with multiple sclerosis

Author

Valsasina, P, Rocca, Ma, Absinta, M, Sormani, Mp, Mancini, L, DE STEFANO, Nicola, Rovira, A, Gass, A, Enzinger, C, Barkhof, F, Wegner, C, Matthews, Pm, Filippi, M., Radiology and nuclear medicine, NCA - Multiple Sclerosis and Other Neuroinflammatory Diseases, Valsasina, P, Rocca, Ma, Absinta, M, Sormani, Mp, Mancini, L, De Stefano, N, Rovira, A, Gass, A, Enzinger, C, Barkhof, F, Wegner, C, Matthews, Pm, and Filippi, Massimo

Subjects
Adult, Male, Multiple Sclerosis, sensorimotor network, Middle Aged, Motor Activity, Magnetic Resonance Imaging, connectivity, cortical reorganization, demyelination, magnetic resonance imaging, sensorimotor network, connectivity, cortical reorganization, Neural Pathways, Humans, Female, demyelination, Nerve Net
Abstract

""In this multicentre study involving eight European centres, we characterized the spatial pattern of functional connectivity (FC) in the sensorimotor network from 61 right-handed patients with multiple sclerosis (MS) and 74 age-matched healthy subjects assessed with the use of functional magnetic resonance imaging (fMRI) and a simple motor task of their right dominant hand. FC was investigated by using: (i) voxel-wise correlations between the left sensorimotor cortex (SMC) and any other area in the brain; and (ii) bivariate correlations between time series extracted from several regions of interest (ROIs) belonging to the sensorimotor network. Both healthy controls and MS patients had significant FC between the left SMC and several areas of the sensorimotor network, including the bilateral postcentral and precentral gyri, supplementary motor area, middle frontal gyri, insulae, secondary somatosensory cortices, thalami, and right cerebellum. Voxel-wise assessment of FC revealed increased connectivity between the left SMC and the right precentral gyrus, right middle frontal gyrus (MFG) and bilateral postcentral gyri in MS patients as compared with controls. ROI analysis also showed a widespread pattern of altered connectivity, characterized by increased FC between the right MFG, the left insula and the right inferior frontal gyrus in comparison with many regions of the sensorimotor network. These results provide further evidence for increased bihemispheric contributions to motor control in patients with MS relative to healthy controls. They further suggest that multicentre fMRI studies of FC changes are possible, and provide a potential imaging biomarker for use in experimental therapeutic studies directed at enhancing adaptive plasticity in the disease.""

Published
2011

21. Functional changes in Duchenne muscular dystrophy: a 12-month longitudinal cohort study

Author

MAZZONE E, VASCO G, SORMANI MP, TORRENTE Y, BERARDINELLI A, MESSINA S, D' AMICO A, DOGLIO L, CAVALLARO F, FROSINI S, BELLO L, BONFIGLIO S, ZUCCHINI E, DE SANCTIS R, SCUTIFERO M, BIANCO F, ROSSI F, MOTTA MC, SACCO A, DONATI MA, MONGINI T, PINI A, BATTINI R, PEGORARO E, PANE M, GASPERINI S, PREVITALI S, NAPOLITANO S, MARTINELLI D, BRUNO C, VITA G, COMI G, BERTINI E., POLITANO, Luisa, Mazzone, E, Vasco, G, Sormani, Mp, Torrente, Y, Berardinelli, A, Messina, S, D' AMICO, A, Doglio, L, Politano, Luisa, Cavallaro, F, Frosini, S, Bello, L, Bonfiglio, S, Zucchini, E, DE SANCTIS, R, Scutifero, M, Bianco, F, Rossi, F, Motta, Mc, Sacco, A, Donati, Ma, Mongini, T, Pini, A, Battini, R, Pegoraro, E, Pane, M, Gasperini, S, Previtali, S, Napolitano, S, Martinelli, D, Bruno, C, Vita, G, Comi, G, and Bertini, E.

Abstract

OBJECTIVE: The aim of the study was to assess different outcome measures in a cohort of ambulant boys with Duchenne muscular dystrophy (DMD) over 12 months in order to establish the spectrum of possible changes in relation to age and steroid treatment. METHODS: The study is a longitudinal multicentric cohort study. A total of 106 ambulant patients with DMD were assessed using the 6-minute walk test (6MWT) and North Star Ambulatory Assessment (NSAA) at baseline and 12 months. Clinical data including age and steroid treatment were collected. RESULTS: During the 12 months of the study, we observed a mean decline of 25.8 meters in the 6MWT with a SD of 74.3 meters. On NSAA, the mean decline was 2.2 points with a SD of 3.7. Not all the boys with DMD in our cohort showed a decline over the 12 months, with young boys showing some improvement in their 6MWT and NSAA scores up to the age of 7. NSAA and the 6MWT had the highest correlation (r = 0.52, p < 0.001). CONCLUSIONS: This study provides longitudinal data of NSAA and 6MWT over a 12-month period. These data can be useful when designing a clinical trial.

Published
2011

24. Non-permissive HLA-DPB1 disparity is a significant independent risk factor for mortality after unrelated hematopoietic stem cell transplantation

Author

Crocchiolo R, Zino E, Vago L, Oneto R, Bruno B, Pollicchieni S, Sacchi N, Sormani MP, Marcon J, Fanin R, Garbarino L, Miotti V, Bandini G, Bosi A, Bacigalupo A, Fleischhauer K., CICERI , FABIO, Crocchiolo, R, Zino, E, Vago, L, Oneto, R, Bruno, B, Pollicchieni, S, Sacchi, N, Sormani, Mp, Marcon, J, Fanin, R, Garbarino, L, Miotti, V, Bandini, G, Bosi, A, Ciceri, Fabio, Bacigalupo, A, and Fleischhauer, K.

Published
2009

25. Engraftment kinetics and graft failure after single umbilical cord blood transplantation using a myeloablative conditioning regimen

Author

Ruggeri A, Labopin M, Sormani MP, Sanz G, Sanz J, Volt F, Michel G, Locatelli F, Diaz De Heredia C, O'Brien T, Arcese W, Iori AP, Querol S, Kogler G, Lecchi L, Pouthier F, Garnier F, Navarrete C, Baudoux E, Fernandes J, Kenzey C, Eapen M, Gluckman E, Rocha V, Saccardi R, Eurocord, Cord Blood Committee EBMT, and Netcord

Subjects
surgical procedures, operative
Abstract

Umbilical cord blood transplant recipients are exposed to an increased risk of graft failure, a complication leading to a higher rate of transplant-related mortality. The decision and timing to offer a second transplant after graft failure is challenging. With the aim of addressing this issue, we analyzed engraftment kinetics and outcomes of 1268 patients (73% children) with acute leukemia (64% acute lymphoblastic leukemia, 36% acute myeloid leukemia) in remission who underwent single-unit umbilical cord blood transplantation after a myeloablative conditioning regimen. The median follow-up was 31 months. The overall survival rate at 3 years was 47%; the 100-day cumulative incidence of transplant-related mortality was 16%. Longer time to engraftment was associated with increased transplant-related mortality and shorter overall survival. The cumulative incidence of neutrophil engraftment at day 60 was 86%, while the median time to achieve engraftment was 24 days. Probability density analysis showed that the likelihood of engraftment after umbilical cord blood transplantation increased after day 10, peaked on day 21 and slowly decreased to 21% by day 31. Beyond day 31, the probability of engraftment dropped rapidly, and the residual probability of engrafting after day 42 was 5%. Graft failure was reported in 166 patients, and 66 of them received a second graft (allogeneic, n=45). Rescue actions, such as the search for another graft, should be considered starting after day 21. A diagnosis of graft failure can be established in patients who have not achieved neutrophil recovery by day 42. Moreover, subsequent transplants should not be postponed after day 42.

Published
2014

26. Defining the clinical course of multiple sclerosis: the 2013 revisions.Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28

Author

Lublin, Fd, Reingold, Sc, Cohen, Ja, Cutter, Gr, Sørensen, Ps, Thompson, Aj, Wolinsky, Js, Balcer, Lj, Banwell, B, Barkhof, F, Bebo B., Jr, Calabresi, Pa, Clanet, M, Comi, G, Fox, Rj, Freedman, Ms, Goodman, Ad, Inglese, M, Kappos, L, Kieseier, Bc, Lincoln, Ja, Lubetzki, C, Miller, Ae, Montalban, X, O'Connor, Pw, Petkau, J, Pozzilli, Carlo, Rudick, Ra, Sormani, Mp, Stüve, O, Waubant, E, and Polman, C. H.

Published
2014

28. A three-year, multi-parametric MRI study in patients at presentation with CIS

Author

Rocca MA, Agosta F, Sormani MP, Fernando K, Tintore M, Korteweg T, Tortorella P, Miller DH, Thompson A, Rovira A, Montalban X, Polman C, Barkhof F, Filippi M, Tintoré M, Thompson AJ, Polman CH, Rocca, Ma, Agosta, F, Sormani, Mp, Fernando, K, Tintore, M, Korteweg, T, Tortorella, P, Miller, Dh, Thompson, A, Rovira, A, Montalban, X, Polman, C, Barkhof, F, Filippi, M, Tintoré, M, Thompson, Aj, Polman, Ch, Radiology and nuclear medicine, Neurology, and Neuroscience Campus Amsterdam 2008

Subjects
Adult, Male, Pathology, medicine.medical_specialty, Multiple Sclerosis, Brain damage, Grey matter, Severity of Illness Index, Central nervous system disease, White matter, Disability Evaluation, Predictive Value of Tests, Risk Factors, Image Processing, Computer-Assisted, medicine, Humans, Mass Screening, Longitudinal Studies, Retrospective Studies, Clinically isolated syndrome, medicine.diagnostic_test, business.industry, Multiple sclerosis, Interferon beta-1a, Brain, Magnetic resonance imaging, Syndrome, Prognosis, medicine.disease, Magnetic Resonance Imaging, medicine.anatomical_structure, Neurology, Disease Progression, Female, Neurology (clinical), Atrophy, medicine.symptom, business, Nuclear medicine, medicine.drug
Abstract

To define the extent of overall brain damage in patients with clinically isolated syndromes (CIS) suggestive of multiple sclerosis (MS) and to identify non-conventional magnetic resonance (MR) metrics predictive of evolution to definite MS. Brain conventional and magnetization transfer (MT) MRI scans were obtained from 208 CIS patients and 55 matched healthy controls, recruited in four centres. Patients were assessed clinically at the time of MRI acquisition and after a median period of 3.1 years from disease onset. The following measures were derived: T2, T1 and gadolinium (Gd)- enhancing lesion volumes (LV), normalized brain volume (NBV), MTR histogram-derived quantities of the normal-appearing white matter (NAWM) and grey matter (GM). During the follow-up, 43 % of the patients converted to definite MS. At baseline, a significant inter-centre heterogeneity was detected for T2 LV (p = 0.003), T1 LV (p = 0.006), NBV (p < 0.001) and MTR histogram-derived metrics (p < 0.001). Pooled average MTR values differed between CIS patients and controls for NAWM (p = 0.003) and GM (p = 0.01). Gdactivity and positivity of International Panel (IP) criteria for disease dissemination in space (DIS), but not NAWM and GM MTR and NBV, were associated with evolution to definite MS. The final multivariable model retained only MRI IP criteria for DIS (p = 0.05; HR = 1.66, 95 % CI = 1.00–2.77) as an independent predictor of evolution to definite MS. Although irreversible tissue injury is present from the earliest clinical stages of MS, macroscopic focal lesions but not "diffuse" brain damage measured by MTR are associated to an increased risk of subsequent development of definite MS in CIS patients.

Published
2008

32. Intense immunosuppression followed by autologous stem cell transplantation in severe multiple sclerosis

Author

Capello E, Saccardi R, Murialdo A, Gualandi F, Pagliai F, Bacigalupo A, Marmont A, Uccelli A, Inglese M, Bruzzi P, Sormani MP, Cocco E, Meucci G, Massacesi L, Bertolotto A, Lugaresi A, Merelli E, Solari A, Filippi M, Mancardi GL, Italian GITMO-Neuro Intergroup on ASCT for Multiple Sclerosis, La Nasa G, Marrosu MG, Derchi V, Di Bartolomeo P, Farina D, Iarlori C, Tartaro A, Repice A, Pellicanò G, Dogliotti L, Parodi RC, Schenone A, Donelli A, Casoni F, Cavalleri F, Capobianco M, Guerrasio A, Duca S, Papineschi F, Scappini B, Mosti S, Abbruzzese A, Capello, E, Saccardi, R, Murialdo, A, Gualandi, F, Pagliai, F, Bacigalupo, A, Marmont, A, Uccelli, A, Inglese, M, Bruzzi, P, Sormani, Mp, Cocco, E, Meucci, G, Massacesi, L, Bertolotto, A, Lugaresi, A, Merelli, E, Solari, A, Filippi, M, Mancardi, Gl, Italian GITMO-Neuro Intergroup on ASCT for Multiple, Sclerosi, La Nasa, G, Marrosu, Mg, Derchi, V, Di Bartolomeo, P, Farina, D, Iarlori, C, Tartaro, A, Repice, A, Pellicanò, G, Dogliotti, L, Parodi, Rc, Schenone, A, Donelli, A, Casoni, F, Cavalleri, F, Capobianco, M, Guerrasio, A, Duca, S, Papineschi, F, Scappini, B, Mosti, S, and Abbruzzese, A

Subjects
Oncology, Adult, medicine.medical_specialty, Multiple Sclerosis, medicine.medical_treatment, Inflammation, Dermatology, Transplantation, Autologous, Severity of Illness Index, methods, Autologous stem-cell transplantation, Internal medicine, medicine, Humans, Severe disability, Salvage Therapy, Transplantation, Adult, Hematopoietic Stem Cell Transplantation, methods, Humans, Immunosuppressive Agents, therapeutic use, Italy, Magnetic Resonance Imaging, Multiple Sclerosis, diagnosis/immunology/therapy, Salvage Therapy, Severity of Illness Index, Transplantation, Autologous, Treatment Outcome, business.industry, Multiple sclerosis, Hematopoietic Stem Cell Transplantation, diagnosis/immunology/therapy, Immunosuppression, General Medicine, medicine.disease, Magnetic Resonance Imaging, Psychiatry and Mental health, Haematopoiesis, Treatment Outcome, Italy, therapeutic use, Neurology (clinical), medicine.symptom, Stem cell, business, Autologous, Immunosuppressive Agents
Abstract

Aggressive forms of multiple sclerosis (MS) represent a limited group of demyelinating diseases that rapidly progress to severe disability. Currently available therapies are poorly effective against these clinical entities. Recently, it has been demonstrated that intense immunosuppression followed by autologous haematopoietic stem cell transplantation (AHSCT) can affect the clinical course of individuals with severe MS and completely abrogate the inflammatory activity detected by MRI. We report the result of the Italian phase 2 GITMO study, a multicentre study in which 21 MS patients, who were rapidly deteriorating and not responding to the usual therapeutic strategies, were treated with this procedure. The clinical effect of the treatment is long lasting, with a striking abrogation of inflammation detected by MRI findings. These results support a role for intense immunosuppression followed by ASCT as treatment in rapidly evolving MS cases unresponsive to conventional therapies.

Published
2005

34. Evidence-based provisional clinical classification criteria for autoinflammatory periodic fevers.

Author

Federici, S, Sormani, MP, Ozen, S, Lachmann, HJ, Amaryan, G, Woo, P, Koné-Paut, I, Dewarrat, N, Cantarini, L, Insalaco, A, Uziel, Y, RIGANTE, DONATO, Quartier, P, Demirkaya, E, Herlin, T, Meini, A, Fabio, G, Kallinich, T, Martino, S, Butbul, AY, Olivieri, A, Kuemmerle-Deschner, J, Neven, B, Simon, A, Ozdogan, H, Touitou, I, Frenkel, J, Hofer, M, Martini, A, Ruperto, N, Gattorno, M, Federici, S, Sormani, MP, Ozen, S, Lachmann, HJ, Amaryan, G, Woo, P, Koné-Paut, I, Dewarrat, N, Cantarini, L, Insalaco, A, Uziel, Y, RIGANTE, DONATO, Quartier, P, Demirkaya, E, Herlin, T, Meini, A, Fabio, G, Kallinich, T, Martino, S, Butbul, AY, Olivieri, A, Kuemmerle-Deschner, J, Neven, B, Simon, A, Ozdogan, H, Touitou, I, Frenkel, J, Hofer, M, Martini, A, Ruperto, N, and Gattorno, M

Published
2015

35. Innovative quantitative testing of hand function in Charcot-Marie-Tooth neuropathy

Author

Alberti, MA, Mori, L, Francini, L, Poggi, I, Monti Bragadin, M, Bellone, E, Grandis, M, Maggi, G, Reni, L, Sormani, MP, Tacchino, A, PADUA, LUCA, Prada, V, Bove, M, Schenone, A, Alberti, MA, Mori, L, Francini, L, Poggi, I, Monti Bragadin, M, Bellone, E, Grandis, M, Maggi, G, Reni, L, Sormani, MP, Tacchino, A, PADUA, LUCA, Prada, V, Bove, M, and Schenone, A

Published
2015

42. Observational case-control study of the prevalence of chronic cerebrospinal venous insufficiency in multiple sclerosis: results from the CoSMo study

Author

Comi, G, Battaglia, Ma, Bertolotto, A, Del Sette, M, Ghezzi, A, Malferrari, G, Salvetti, M, Sormani, Mp, Tesio, L, Stolz, E, Zaratin, P, Mancardi, G, Baracchini, C, Bergamaschi, R, Bortolon, F, Bratina, A, Brescia Morra, V, Buccafusca, M, Busso, M, Capra, R, Carraro, N, Cavalla, P, Cecconi, P, Centonze, D, Ciampanelli, D, Cirrito, M, Ciuffoli, A, Coppo, L, Costantino, G, Cottone, S, Deboni, A, De Rossi, N, Di Maggio, L, Favaretto, E, Finocchi, C, Gaeta, R, Gallo, Paolo, Giometto, B, Granieri, E, Grazioli, S, Grimaldi, L, Guccione, A, Iemolo, F, Lochner, P, Lugaresi, A, Maimone, D, Mancini, M, Mantegazza, R, Marrosu, Mg, Menci, E, Monti, L, Motti, L, Nuzzaco, Gm, Pascazio, L, Patti, F, Protti, A, Provinciali, L, Rossato, D, Rovaris, M, Sanguigni, S, Sanzaro, E, Sette, G, Spinelli, M, Stecchi, S, Stefanini, M, Tezzon, F, Tola, Mr, Tonello, S, Trojano, M, Ulivelli, M, Uselli, S, Viaro, F, and Zedde, M. L.

Published
2013

46. A comparison of MR imaging with fast-FLAIR, HASTE-FLAIR, and EPI-FLAIR sequences in the assessment of patients with multiple sclerosis

Author

Massimo Filippi, Rocca, Ma, Wiessmann, M., Mennea, S., Cercignani, M., Yousry, Ta, Sormani, Mp, Comi, G., Filippi, Massimo, Rocca, Ma, Wiessmann, M, Mennea, S, Cercignani, M, Yousry, Ta, Sormani, Mp, and Comi, Giancarlo

Subjects
Adult, Male, Multiple Sclerosis, Fourier Analysis, Echo-Planar Imaging, Brain, Humans, Female, Middle Aged, Image Enhancement, Magnetic Resonance Imaging, Sensitivity and Specificity
Abstract

BACKGROUND AND PURPOSE: Fast fluid-attenuated inversion-recovery (FLAIR) sequences are sensitive for detecting lesions in patients with multiple sclerosis (MS). More rapid fast-FLAIR imaging of the brain can be achieved by the concomitant use of half-Fourier acquisition single-shot turbo spin-echo (HASTE-FLAIR) and echo-planar imaging (EPI-FLAIR). The present study was performed in a large cohort of subjects to assess and compare the number and volume of brain lesions detected by the fast-FLAIR, HASTE-FLAIR, and EPI-FLAIR sequences in patients with MS. METHODS: Fast-FLAIR, HASTE-FLAIR, and EPI-FLAIR sequences were obtained from 46 consecutive MS patients. Lesions seen on each type of sequence were counted and classified by consensus by two observers. Lesion volumes were measured using a semiautomated segmentation technique based on local thresholding. RESULTS: The quality of the fast-FLAIR images was significantly better than that of HASTE-FLAIR and EPI-FLAIR images. Fast-FLAIR revealed significantly more lesions and higher lesion volumes than did HASTE-FLAIR and EPI-FLAIR. A similar number of large lesions was detected by the three sequences, but HASTE-FLAIR and EPI-FLAIR showed significantly fewer small and intermediate lesions than did fast-FLAIR. The number of lesions seen on HASTE-FLAIR and EPI-FLAIR images was similar. CONCLUSION: HASTE-FLAIR and EPI-FLAIR sequences revealed as many large MS lesions as fast-FLAIR. Because their acquisition times are only a fraction of that needed for fast-FLAIR sequences, they may be useful for making a rapid diagnosis of MS in uncooperative patients. Their reduced ability to detect smaller lesions indicates that they should not be used as a routine approach to imaging patients with MS.

Published
1999

49. The daily diary and the questionnaire are not equivalent for the evaluation of bowel habits

Author

Bellini, M, Bove, A, Sormani, Mp, Battaglia, E, Bocchini, R, Alduini, P, Bassotti, G, Bruzzi, P, Pucciani, F, and Marchi, Santino

Subjects
Adult, Male, Questionnaires, Adolescent, Bowel habit, Concordance, Daily diary, Medical Records, Young Adult, Surveys and Questionnaires, 80 and over, Medicine, Humans, Defecation, Aged, Aged, 80 and over, Hepatology, business.industry, Significant difference, Gastroenterology, Diary card, Middle Aged, Female, business, Adolescent, Adult, Aged, Aged, 80 and over, Defecation, Female, Humans, Male, Medical Records, Middle Aged, Questionnaires, Young Adult, Clinical psychology
Abstract

Background It is unclear whether questionnaires and diary cards, which are widely used to collect data on bowel habits, provide analogous information. Aims We verified the concordance between the data provided by a daily diary and a retrospective questionnaire. Methods A 4-week diary (DIARY) concerning bowel habits was compiled by 221 subjects. They were also asked to fill out a questionnaire on their bowel habits before (BEF) and after (AFT) the diary period. Results Concerning bowel movements, no significant difference was detected in the concordance between BEF and DIARY (ρ: 0.80), AFT and DIARY (ρ: 0.84), or BEF and AFT (ρ: 0.84). The mean concordance in the other defecation-related parameters between BEF and DIARY (K: 0.62) and between DIARY and AFT (K: 0.63) were both significantly lower than that seen between BEF and AFT (K: 0.80; p Conclusion A considerable discrepancy between the two methods of assessment was found. The higher concordance between BEF and AFT than between DIARY and AFT regarding defecation-related parameters suggests that when a subject recalls events, even those from the recent past, he/she tends to generalize, reporting more or less the same data for different periods of time. These two instruments cannot be viewed as interchangeable, and their inherent differences must be taken into account when deciding which one to employ in different settings.

Published
2010

50. 6 minute walk test in duchenne MD patients with different mutations:12 month changes

Author

Pane, Marika, Mazzone, Elena Stacy, Sormani, Mp, Messina, S, Vita, Gl, Fanelli, L, Berardinelli, A, Torrente, Y, D'Amico, A, Lanzillotta, V, Viggiano, E, D'Ambrosio, P, Cavallaro, Fabio, Frosini, S, Bello, L, Bonfiglio, S, Scalise, Roberta, De Sanctis, R, Rolle, E, Bianco, F, Van der Haawue, M, Magri, F, Palermo, C, Rossi, F, Donati, Ma, Alfonsi, C, Sacchini, M, Arnoldi, Mt, Baranello, Giovanni, Mongini, T, Pini, A, Battini, Roberta, Pegoraro, E, Previtali, Sc, Napolitano, S, Bruno, C, Politano, L, Comi, Gp, Bertini, Enrico Silvio, Morandi, Laura, Gualandi, F, Ferlini, A, Goemans, N, Mercuri, Eugenio Maria, Pane, Marika (ORCID:0000-0002-4851-6124), Mercuri, Eugenio Maria (ORCID:0000-0002-9851-5365), Pane, Marika, Mazzone, Elena Stacy, Sormani, Mp, Messina, S, Vita, Gl, Fanelli, L, Berardinelli, A, Torrente, Y, D'Amico, A, Lanzillotta, V, Viggiano, E, D'Ambrosio, P, Cavallaro, Fabio, Frosini, S, Bello, L, Bonfiglio, S, Scalise, Roberta, De Sanctis, R, Rolle, E, Bianco, F, Van der Haawue, M, Magri, F, Palermo, C, Rossi, F, Donati, Ma, Alfonsi, C, Sacchini, M, Arnoldi, Mt, Baranello, Giovanni, Mongini, T, Pini, A, Battini, Roberta, Pegoraro, E, Previtali, Sc, Napolitano, S, Bruno, C, Politano, L, Comi, Gp, Bertini, Enrico Silvio, Morandi, Laura, Gualandi, F, Ferlini, A, Goemans, N, Mercuri, Eugenio Maria, Pane, Marika (ORCID:0000-0002-4851-6124), and Mercuri, Eugenio Maria (ORCID:0000-0002-9851-5365)

Abstract

OBJECTIVE: In the last few years some of the therapeutical approaches for Duchenne muscular dystrophy (DMD) are specifically targeting distinct groups of mutations, such as deletions eligible for skipping of individual exons. The aim of this observational study was to establish whether patients with distinct groups of mutations have different profiles of changes on the 6 minute walk test (6MWT) over a 12 month period. METHODS: The 6MWT was performed in 191 ambulant DMD boys at baseline and 12 months later. The results were analysed using a test for heterogeneity in order to establish possible differences among different types of mutations (deletions, duplications, point mutations) and among subgroups of deletions eligible to skip individual exons. RESULTS: At baseline the 6MWD ranged between 180 and 560,80 metres (mean 378,06, SD 74,13). The 12 month changes ranged between -325 and 175 (mean -10.8 meters, SD 69.2). Although boys with duplications had better results than those with the other types of mutations, the difference was not significant. Similarly, boys eligible for skipping of the exon 44 had better baseline results and less drastic changes than those eligible for skipping exon 45 or 53, but the difference was not significant. CONCLUSIONS: even if there are some differences among subgroups, the mean 12 month changes in each subgroup were all within a narrow Range: from the mean of the whole DMD cohort. This information will be of help at the time of designing clinical trials with small numbers of eligible patients.

Published
2014

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