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Predictive low-glucose suspend (PLGS) and hybrid closed-loop (HCL) systems may improve glucose control and quality of life in type 1 diabetic individuals. This is a cross-sectional, single-center study to compare the effect on metabolic control and glucose variability of PLGS and HCL systems as compared to standard sensor-augmented pump (SAP) therapy.We retrospectively analyzed 136 adults (men/women 69/67, mean age 47.3 ± 13.9 years) with T1D on insulin pump therapy, divided accordingly to type of insulin pump system (The analysis of CGM metrics, in the three groups, showed a statistically significant different percentage of time within the target range, defined as 70-180 mg/dl, with a higher percentage in group 3 and significantly less time spent in the hypoglycemic range in groups 2 and 3. The three groups were statistically different also for the glucose management indicator and coefficient of variation percentage, which were progressively lower moving from group 1 to group 3. In the HCL group, 52.4% of subjects reached a percentage of time passed in the euglycemic range above 70%, as compared to 32.7% in those with PLGS and 20.2% in those with SAP. A positive correlation between the higher percentage of TIR and the use of auto-mode was evident in the HCL group. Finally, the three groups did not show any statistical differences regarding the quality-of-life questionnaire, but there was a significant negative correlation between CV and perceived CSII-use convenience (r = -0.207, p = 0.043).HCL systems were more effective in improving glucose control and in reducing the risk of hypoglycemia in patients with type 1 diabetes, thereby mitigating risk for acute and chronic complications and positively affecting diabetes technologies' acceptance.

Purpose: To evaluate if jugular vein flow restoration in various venographic defects indicative of chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS) patients can have positive effects on cerebral lesions identified using magnetic resonance imaging (MRI). Materials and Methods: The Brave Dreams trial ( ClinicalTrials.gov identifier NCT01371760) was a multicenter, randomized, parallel group, double-blind, sham-controlled trial to assess the efficacy of jugular venoplasty in MS patients with CCSVI. Between August 2012 and March 2016, 130 patients (mean age 39.9±10.6 years; 81 women) with relapsing/remitting (n=115) or secondary/progressive (n=15) MS were randomized 2:1 to venography plus angioplasty (n=86) or venography (sham; n=44). Patients and study personnel (except the interventionist) were masked to treatment assignment. MRI data acquired at 6 and 12 months after randomization were compared to the preoperative scan for new and/or >30% enlargement of T2 lesions plus new gadolinium enhancement of pre-existing lesions. The relative risks (RR) with 95% confidence interval (CI) were estimated and compared. In a post hoc assessment, venograms of patients who underwent venous angioplasty were graded as “favorable” (n=38) or “unfavorable” (n=30) for dilation according to the Giaquinta grading system by 4 investigators blinded to outcomes. These subgroups were also compared. Results: Of the 130 patients enrolled, 125 (96%) completed the 12-month MRI follow-up. Analysis showed that the likelihood of being free of new cerebral lesions at 1 year was significantly higher after venoplasty compared to the sham group (RR 1.42, 95% CI 1.00 to 2.01, p=0.032). Patients with favorable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavorable venograms (RR 1.82, 95% CI 1.17 to 2.83, p=0.005) or patients in the sham arm (RR 1.66, 95% CI 1.16 to 2.37, p=0.005). Conclusion: Expanded analysis of the Brave Dreams data that included secondary/progressive MS patients in addition to the relapsing/remitting patients analyzed previously showed that venoplasty decreases new cerebral lesions at 1 year. Post hoc analysis confirmed the efficacy of the Giaquinta grading system in selecting patients appropriate for venoplasty who were more likely to be free from accumulation of new cerebral lesions at MRI.

Background We performed a qualitative study to investigate the experiences of participants in a multicentre randomized controlled trial on a home-based palliative approach (HPA) for adults with severe multiple sclerosis (MS) and their caregivers. Our aim was to explore the strengths and challenges of the intervention, and circumstances that may have influenced its efficacy. Methods Participants to the qualitative study were the patients, their caregivers, patient referring physicians, and the teams who delivered the HPA intervention. We performed semi-structured one-on-one interviews with 12 patients and 15 informal caregivers chosen using a maximum variation strategy, two focus group meetings with patient referring physicians (4 participants each), and one with the HPA teams (9 participants). Results From data analysis (framework method) 38 sub-categories emerged, which were grouped into 10 categories and 3 themes: 'expectations,' 'met and unmet needs', and 'barriers’. Intervention benefits were improved control of symptoms and reduced sense of isolation of the patient-caregiver dyads. Limitations were: factors related to experimental design (difficulty of dyads in identifying examiner and team roles, additional burden for caregivers); team issues (insufficient team building /supervision, competing priorities); limitations of the intervention itself (insufficient length, lack of rehabilitation input); and external factors (resource limitations, under-responsive services/professionals). The referring physician focus groups provided little experiential data. Conclusions The HPA reduced patient symptoms and sense of isolation in patients and caregivers. The indirect role of the HPA teams, and insufficient length of the intervention were key limitations. The experimental design imposed additional burdens on the dyads. Key barriers were the paucity of available services, the demanding administrative procedures, and lack of networking facilities. These findings suggest that two major requirements are necessary for home palliative care to be effective in this patient population: HPA teams well-connected with MS rehabilitation services, and care delivered over the long-term, with variable intensity. Trial registration Current Controlled Trials ISRCTN73082124 (Registered 19/06/2014).

Background: Evidence on the efficacy of palliative care in persons with severe multiple sclerosis (MS) is scarce. Objective: To assess the efficacy of a home-based palliative approach (HPA) for adults with severe MS and their carers. Methods: Adults with severe MS-carer dyads were assigned (2:1 ratio) to either HPA or usual care (UC). At each center, a multi-professional team delivered the 6-month intervention. A blind examiner assessed dyads at baseline, 3 months, and 6 months. Primary outcome measures were Palliative care Outcome Scale-Symptoms-MS (POS-S-MS) and Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW, not assessed in severely cognitively compromised patients). Results: Of 78 dyads randomized, 76 (50 HPA, 26 UC) were analyzed. Symptom burden (POS-S-MS) significantly reduced in HPA group compared to UC ( p = 0.047). Effect size was 0.20 at 3 months and 0.32 at 6 months, and statistical significance was borderline in per-protocol analysis ( p = 0.062). Changes in SEIQoL-DW index did not differ in the two groups, as changes in secondary patient and carer outcomes. Conclusion: HPA slightly reduced symptoms burden. We found no evidence of HPA efficacy on patient quality of life and on secondary outcomes.

Background: The precise relationships among quality of life, depression, fatigue and cognitive impairment in multiple sclerosis (MS) are complex and poorly understood. Objective: To assess the effects of subcutaneous interferon beta-1a on quality of life, depression and fatigue over 3 years in the COGIMUS study, and to examine the relationship between these outcomes and baseline cognitive status. Methods: COGIMUS was an observational 3-year trial assessing cognitive function in 459 patients with relapsing–remitting MS treated with subcutaneous interferon beta-1a. Results: In total, 331 patients completed the study (168 received interferon beta-1a, 44 µg subcutaneously three times weekly, and 163 received interferon beta-1a, 22 µg subcutaneously three times weekly). Mean MS Quality of Life-54 (MSQoL-54) composite scores did not change over time. There were no significant differences between groups in MSQoL-54 composite scores when patients were grouped by treatment dose and baseline cognitive status. Mean (standard deviation) Hamilton Depression Rating Scale score decreased from 6.8 (4.9) at baseline to 5.8 (5.9) at year 3. Mean total Fatigue Impact Scale scores were low ( Conclusion: Quality of life, depression and fatigue remained largely stable over 3 years; no effects of treatment dose or baseline cognitive status were found.

Background: Few studies have investigated wellbeing and burden in carers of peoplewith severe multiple sclerosis (PwSMS). Objectives: To assess the impact of providing care to PwSMS, and explore variables associated with perceived carer burden. Methods: Cross-sectional assessment of health-related quality of life (HRQOL), mood symptoms (Hospital Anxiety and Depression Scale, HADS), and perceived carer burden (22-item Zarit Burden Interview, ZBI) in 78 PwSMS carers. Multivariate linear regression explored carer and PwSMS factors associated with ZBI score. Results: Carers (61%women, mean age 60.2 years, 53% spouse/partner) had significantly lower HRQOL (all SF-36 scales) than the norm, especially for Role Limitation Emotional/Physical, and Emotional Wellbeing. Sixty-eight percent had pathologic (≥8) Anxiety, and 44% had pathologic Depression scores on HADS. Nonetheless, perceived carer burdenwas only moderate (mean ZBI score 35.6, SD 14.3). High carer anxiety (p < 0.0001), low household income (p= 0.009), and living with the PwSMS (p= 0.02) were independent predictors of perceived burden. Conclusions: Caring for PwSMS has a detrimental effect on HRQOL and psychological wellbeing. High carer anxiety, loweconomic status, and living in predict higher burden. It is crucial to recognize PwSMS carers as full partners in the provision of care, and to respond to their own needs.

Preliminary evidence suggests that palliative care may be useful for people with severe multiple sclerosis (MS). The aim of this study is to determine the effectiveness of a home-based palliative approach (HPA) for people with severe MS and their carers. This is a single-blind randomized controlled trial with a nested qualitative study. Seventy-five severe MS-carer dyads are being randomized (at three centers, one in each area of Italy) to HPA or usual care (UC) in a 2:1 ratio. Each center has a specially trained team consisting of four professionals (physician, nurse, psychologist, social worker). The team makes a comprehensive assessment of the needs of the dyads. HPA content is then agreed on, discussed with the patient’s caring physician, and delivered over six months. The intervention is not intended to replace existing services. At later visits, the team checks the HPA delivery and reviews/modifies it as necessary. HPA and UC dyads are assessed at home by a blind examiner at baseline, and three and six months later; they also receive monthly telephone interviews. Dyads assigned to UC receive the examiner’s visits and telephone interviews, but not the team visits. Primary outcome measures are changes in symptoms (Palliative care Outcome Scale-Symptoms-MS, POS-S-MS), and quality of life (the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), not assessed in patients with severe cognitive compromise) at three and six months. Other outcomes are changes in patient functional status and mood; changes in carer quality of life, mood and caregiving burden; costs; incorporation with standard care; unplanned hospital admissions; referrals to hospice; and deaths. The experience of participants will be evaluated qualitatively by individual semi-structured interviews (HPA patients and carers) and focus group meetings (HPA patients’ caring physicians). The results of our study will show whether the HPA is feasible and beneficial to people with severe MS and their carers living in the three Italian geographic areas. The nested qualitative study will add to the understanding of the strengths and limitations of the intervention. The trial was registered with Current Controlled Trials (identifier: ISRCTN73082124 ) on 19 June 2014.

Pier Luigi Nervi (1891-1979), poliedrico progettista, teorico, docente, costruttore e imprenditore, è stato senza dubbio uno dei protagonisti dell’architettura e dell’ingegneria del Novecento. Proprio l’essere riuscito a unire in sé le due figure – ormai da tempo distinte, nella formazione come nella professione – dell’ingegnere e dell’architetto, è stato uno dei fattori-chiave della sua opera, nella quale l’invenzione di nuove forme non è disgiunta dalla capacità di costruirle. Questo profilo interdisciplinare si è costruito negli anni della sua formazione nella Scuola di Applicazione per Ingegneri di Bologna, grazie agli insegnamenti ricevuti dai suoi maestri e alle esperienze di conoscenza e di pratica professionale, orientati a una “cultura politecnica”, alla coraggiosa volontà di sperimentazione e alla conoscenza della realtà tecnica e costruttiva.

Nonalcoholic fatty liver disease (NAFLD) has been described in adult GH deficiency syndrome. Furthermore, chronic liver disease can be associated with significant changes in levels of IGF-I, GH-binding protein (GHBP), IGF-binding proteins (IGFBPs) and acid-labile subunit (ALS). However, the effect of liver steatosis on the GHBP production has not been investigated yet.To explore whether GH secretion and/or levels of IGF-I, IGFBP-3, ALS and GHBP could be altered in obese patients in relation to the presence of liver steatosis.A total of 115 obese patients (BMI30) were enrolled in the protocol (65 patients with liver steatosis and 50 age- and BMI-matched controls). In all patients, the following parameters were studied: serum levels of glucose, insulin, the HOMA index, IGF-I, GHBP, IGFBP-3, ALS and GH after GHRH and arginine stimulation test.As expected, patients with NAFLD had blood glucose, insulin, HOMA-R significantly higher than controls, indicating a more severe insulin-resistance state in NAFLD. Furthermore, patients with NAFLD had higher levels of GHBP and IGFBP-3 and lower GH peak and IGF-I levels as compared to controls. No difference was found in ALS levels between the groups. In a multivariate analysis, GHBP was positively associated with hepatic steatosis while IGF-1 was negatively associated with hepatic steatosis.This study demonstrates that in patients with NAFLD, the GHBP levels are increased, and that the GH/IGF-I axis is significantly altered probably leading to reduced IGF-I bioavailability at tissue level.

In the paper an interleaved soft switching dc-dc converter for applications in electric vehicle is proposed. The used topology raises the efficiency and the power density of the dc/dc converter minimizing switching losses by adopting a simple auxiliary active clamping circuit. Such auxiliary circuit is operational regardless of boost or buck mode of operation. The configuration guarantees fixed switching frequency, active clamped zero voltage switching operations of the main switches and bidirectional power flow. ZVS operations are guaranteed with wide load range. In the paper the operating principle, soft-switching conditions and steady state analysis are presented. A 27 kW prototype is designed and simulation results to verify the theoretical analysis are provided.

Introduzione: E' entrata in vigore il 3 aprile 2010 la Legge del 15 marzo 2010, n. 38, “Disposizioni per garantire l’accesso alle cure palliative e alla terapia del dolore” che modifica il Testo unico sugli stupefacenti (D.P.R. 309/90). Si tratta del terzo provvedimento che il Parlamento italiano ha varato negli ultimi dieci anni per favorire la diffusione della terapia del dolore. Obiettivo: Presentare la nuova legge italiana che semplifica la prescrizione dei medicinali stupefacenti necessari per la terapia del dolore Discussione e conclusione: La nuova legge, pur semplificando gli adempimenti, regola due aspetti molto diversi tra loro: l’utilizzo terapeutico degli stupefacenti e le tossicodipendenze (produzione, traffico internazionale e spaccio di droga, Servizi territoriali per le tossicodipendenze, comunità terapeutiche, ecc.). Per favorire la diffusione della terapia del dolore occorre che i due aspetti vengano regolati da leggi diverse: una per le sostanze d’abuso con sanzioni di carattere penale ed una per i medicinali con sanzioni di carattere amministrativo. Si dovrebbero assegnare all’Aifa le competenze sui medicinali stupefacenti e all’Ufficio centrale stupefacenti quelle sulle tossicodipendenze., One of the most important modifications originated in foods during thermal treatment is Maillard reaction, in which amino acids and reducing sugars are participants. This reaction can improve the organoleptic characteristics of foods but, moreover, can lead to nutritional value losses and apparition of toxicological compounds. Infant cereals are hydrolyzed during processing, increasing reducing sugar levels thereby Maillard reaction can be favored in toasted or dried samples. Infants are especially susceptible to the decreased nutritional value and to the toxicological compounds consumption. Thus it is important to know the development rate of this reaction in these products. In this study acrylamide and furosine content in raw and toasted flour and in infant formulas were determined, in order to evaluate Maillard reaction evolution. Furosine content ranged from 11.5 to 34.6 mg/100 g of proteins in toasted flour samples and from 122 to 1193 mg/100 g of proteins in formula samples. Acrylamide was not detected in flour samples ranging from 0.22 and 9.6 Eg/kg in formula samples. Lysine losses can be considered to be high in several samples, but it does not suppose a nutritional deficiency risk because these products are consumed together with milk. Acrylamide only was found in quantified levels in four samples and in very low concentrations. These values are lower than the maximum dose allowed and, therefore, they should not represent adverse problems after their consumption.