Publications by authors named "Davide Guido"

45 Publications

The use of a non-biological, bridging, antiprotrusio cage in complex revision hip arthroplasty and periacetabular reconstructive oncologic surgery. Is still today a valid option?: A mid/long-term survival and complications' analysis.

Arch Orthop Trauma Surg 2021 May 24. Epub 2021 May 24.

Department of Orthopaedic Oncology and Reconstructive Surgery, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Largo Palagi 1, 50139, Florence, Italy.

Introduction: Burch-Schneider-like antiprotrusio cages (B-SlAC) still remain helpful implants to bridge severe periacetabular bone losses. The purpose of this study was to evaluate outcomes and estimate both cages' failures and complication risks in a series of B-SlAC implanted in revision of failed total hip arthroplasties (THA) or after resection of periacetabular primary or secondary bone malignancies. Risk factors enhancing the chance of dislocations and infections were checked.

Materials And Methods: We evaluated 73 patients who received a B-SlAC from January 2008 to January 2018. Group A, 40 oncological cases (22 primary tumors; 18 metastases); Group B, 33 failed THAs. We compared both Kaplan-Meier estimates of risk of failure and complication with the cumulative incidence function, taking account the competing risk of death. Cox proportional hazards model was utilized to identify possible predictors of instability and infection. Harris hip score HHS was used to record clinical outcomes.

Results: Medium follow-up was 80 months (24-137). Average final HHS was 61 (28-92), with no differences within the two groups (p > 0.05). The probabilities of failure and complications were 57% and 26%, respectively, lower in the oncologic group than in the rTHA group (p =0 .176; risk 0.43) (p = 0.52; risk 0.74). Extended ileo-femoral approach and proximal femur replacement (p =0.02, risk ratio = 3.2; p = 0.04, rr = 2.1) were two significant independent predictors for dislocations, while belonging to group B (p = 0.04, rr = 2.6) was predictable for infections.

Conclusion: Burch-Schneider-like antiprotrusio cages are a classical non-biological acetabular reconstruction method that surgeons should bear in mind when facing gross periacetabular bone losses, independently of their cause. However, dislocation and infection rates are high. Whenever possible, we suggest preserving the proximal femur in revision THA, and to use a less-invasive postero-lateral approach to reduce dislocation rates in non-oncologic cases.
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http://dx.doi.org/10.1007/s00402-021-03929-6DOI Listing
May 2021

Proximal femoral replacement: A salvage treatment of cephalomedullary nails' mechanical failures in the elderly population.

Injury 2021 Jul 16;52(7):1868-1874. Epub 2021 Apr 16.

University of Florence, Orthopaedic Clinic CTO, Largo Palagi 1 50139 Florence, Italy. Electronic address:

Background: The use of proximal femoral replacements (PFR) has been recently described for catastrophic internal fixation failures. PFR is an attractive treatment option because it is technically straightforward and allows for immediate mobilization of the patient. The aim of the study was to determine the survivorship, functional outcome and complications' rate in a group of elderly patients who underwent proximal femoral replacement as a salvage treatment after femur cephalomedullary nails' mechanical failures.

Methods: We evaluated 21 patients who underwent salvage of a failed cephalomedullary nail by using a single design PFR at our institution between 2014-2017. A cemented stem was used in all cases. Radiographs were assessed for fractures, sign of loosening, presence of heterotopic ossification and leg length discrepancy. Functional evaluation was performed through Harris Hip Score (HHS), FIM™ and Time Up and Go test (TUG). Kaplan-Meier estimator was used to determine the overall implants' survival.

Results: The average age at the time of surgery was 83years. The mean follow-up was 3.1years. We recorded 3 dislocations of which 2 required a revision. No case of septic or aseptic failure was reported. Two patients died respectively at 11 and 14 months after surgery. At the last follow-up the mean HHS, FIM™, and the TUG improved significantly (p<0.05).

Conclusion: Immediate weight bearing, good functional outcomes, low complications' and one-year mortality rate make the proximal femur replacement with megaprostheses a potential first line treatment of intertrochanteric/subtrochanteric fixations' failures among elderly, osteoporotic, frail patients. Dislocation is the most common complication to bear in mind within the first six months after surgery.
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http://dx.doi.org/10.1016/j.injury.2021.04.038DOI Listing
July 2021

Assessment of the Overall Mortality during the COVID-19 Outbreak in the Provinces of Milan and Lodi (Lombardy Region, Northern Italy).

Epidemiol Prev 2020 Sep-Dec;44(5-6 Suppl 2):244-251

UOC Epidemiology Unit, Agency for Health Protection of the Metropolitan Area of Milan (Italy);

Objectives: to describe the overall mortality increase in the provinces of Milan and Lodi - area covered by the Agency for Health Protection of Milan - during the COVID-19 epidemic in the first four months of 2020, compare it with the same time period in the years 2016-2019, and evaluate to what extent the mortality can be directly attributed to the outbreak.

Design: cohort study.

Setting And Participants: using a new information system developed during the pandemic, we gathered data on the number of daily deaths in the population residing in the provinces of Milan and Lodi by Local Health Unit (ASST) and age groups. To describe the case fatality of COVID-19, we performed a record linkage with a database specially constructed during the epidemic to identify deaths that occurred in confirmed cases.

Main Outcome Measures: mortality and excess mortality were analysed by comparing the number of observed deaths in the first 4 months of 2020 with the average deaths of the years 2016-2019 in the same calendar period and with expected deaths, estimated using a Poisson model. Furthermore, a measure of relative risk was calculated as observed/expected ratio with a 95% confidence interval.

Results: the increase in mortality for all causes occurring in the study population in the first 4 months of 2020 was 48.8%, 30.8% for ages between 60 and 69, 43.9% for ages between 70 and 79, and 56.7% for subjects above 80 years of age. Focusing on the epidemic period, from 1 March to 30 April, the excess is quantifiable as more than 2-fold and mainly concerns the population over 60 years of age. The excess mortality was observed in all local health units (ASSTs). The highest increments were in the province of Lodi and the North-East of Milan (ASST Nord). In the ASSTs of Lodi and Melegnano-Martesana the mortality excess was detectable from March 15th, while for the other ASSTs the increase began in the first week of April.

Conclusions: evaluation of overall mortality in the provinces of Milan and Lodi during the first wave of the Covid-19 epidemic showed a significant excess compared to the first 4 months of the years 2016-2019, mainly in the population over 60 years of age. However, this excess cannot be completely attributed directly to COVID-19 itself. This phenomenon was more intense in the Lodi ASST, with daily deaths up to 5 times higher than expected.
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http://dx.doi.org/10.19191/EP20.5-6.S2.124DOI Listing
January 2021

Describing the epidemic trends of COVID-19 in the area covered by Agency for Health Protection of the Metropolitan Area of Milan.

Epidemiol Prev 2020 Sep-Dec;44(5-6 Suppl 2):95-103

UOC Epidemiology Unit, Agency for Health Protection of the Metropolitan Area of Milan (Italy);

Objectives: to describe the epidemic trends of COVID-19 over time and by area in the territory covered by Milan's Agency for Health Protection (ATS-MI) from February to May 2020.

Design: descriptive study of COVID-19 cases.

Setting And Participants: a new information system was developed to record COVID-19 cases with positive nasopharyngeal swab. Patients resident in the area covered by ATS-MI with symptom onset between February and May 2020 were selected. Different epidemic periods were considered based on the timeline of the various regional and national containment measures.

Main Outcome Measures: case fatality ratios, incidence rates, and reproduction number by epidemic period and sub-area of ATS-MI.

Results: a total of 27,017 swab-positive COVID-19 cases were included. Mean age was 65 years and males were 45%. Incidence in the ATS-MI area was 776 per 100,000 population. The number of deaths was 4,660, the crude case fatality ratio was 17.3%, higher in males (21.2%) than in females (14.0%). The estimated reproduction number registered its peak (3.0) in the early stages of the epidemic and subsequently decreased. Territorial differences were observed in the epidemic spread, with a higher incidence in the Lodi area.

Conclusions: estimated incidence and case fatality ratios were higher than national estimates for Italy. Each ATS-MI area had different epidemic spread patterns.
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http://dx.doi.org/10.19191/EP20.5-6.S2.107DOI Listing
January 2021

Visual fixation in disorders of consciousness: Development of predictive models to support differential diagnosis.

Physiol Behav 2021 03 4;230:113310. Epub 2021 Jan 4.

Neurology, Public Health, Disability Unit - Coma Research Centre; Scientific Directorate, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, Milan, 20133, Italy. Electronic address:

The visual fixation represents a doubtful behavioral sign to discriminate Vegetative from Minimally Conscious State (MCS). To disentangle its meaning, we fitted univariate and multivariable logistic regression models matching different neurophysiological and neuroimaging data of 54 patients with Disorders of Consciousness to select the best model predicting which visual performance (visual blink or pursuit) was shown by patients and the best predictors set. The best models found highlighted the importance of the structural MRI and the visual evoked potentials data in predicting visual pursuit. Then, a qualitative pilot test was made on four patients showing visual fixation revealing that the obtained models correctly predict whether the patients' visual performance could support/correlate to a cognitively mediated behavior. The present pilot models could help clinicians to evaluate if the visual fixation response can support the MCS diagnosis.
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http://dx.doi.org/10.1016/j.physbeh.2021.113310DOI Listing
March 2021

Different reconstructive techniques for tumours of the distal tibia.

Bone Joint J 2020 Nov;102-B(11):1567-1573

IRCCS Policlinico di S.Orsola, Bologna, Italy.

Aims: The aim of this study was to report the results of three forms of reconstruction for patients with a ditsl tibial bone tumour: an intercalary resection and reconstruction, an osteoarticular reconstruction, and arthrodesis of the ankle.

Methods: A total of 73 patients with a median age of 19 years (interquartile range (IQR) 14 to 36) were included in this retrospective, multicentre study.

Results: Reconstructions included intercalary resection in 17 patients, osteoarticular reconstruction in 11, and ankle arthrodesis in 45. The median follow-up was 77 months (IQR 35 to 130). Local recurrence occurred in eight patients after a median of 14 months (IQR 9 to 36), without a correlation with adequacy of margins or reconstructive technique. Major complications included fracture of the graft in ten patients, nonunion of the proximal osteotomy in seven, and infection in five. In the osteoarticular group, three of 11 patients developed radiological evidence of severe osteoarthritis, but only one was symptomatic and required conversion to ankle arthrodesis. Functional evaluation showed higher values of the Musculoskeletal Tumour Society (MSTS) and American Orthopaedic Foot and Ankle Society (AOFAS) scores in the intercalary group compared with the others.

Conclusion: Preservation of the epiphysis in patients with a distal tibial bone tumour is a safe and effective form of limb-sparing treatment. It requires rigorous preoperative planning after accurate analysis of the imaging. When joint-sparing resection is not indicated, ankle arthrodesis, either isolated tibiotalar or combined tibiotalar and subtalar arthrodesis, should be preferred over osteoarticular reconstruction. Cite this article: 2020;102-B(11):1567-1573.
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http://dx.doi.org/10.1302/0301-620X.102B11.BJJ-2020-0127.R1DOI Listing
November 2020

Association between autoimmune diseases and COVID-19 as assessed in both a test-negative case-control and population case-control design.

Auto Immun Highlights 2020 Oct 6;11(1):15. Epub 2020 Oct 6.

Epidemiology Unit, Agency for Health Protection of Milan, Corso Italia 19, 20122, Milan, Italy.

Background: COVID-19 epidemic has paralleled with the so called infodemic, where countless pieces of information have been disseminated on putative risk factors for COVID-19. Among those, emerged the notion that people suffering from autoimmune diseases (AIDs) have a higher risk of SARS-CoV-2 infection.

Methods: The cohort included all COVID-19 cases residents in the Agency for Health Protection (AHP) of Milan that, from the beginning of the outbreak, developed a web-based platform that traced positive and negative cases as well as related contacts. AIDs subjects were defined ad having one the following autoimmune disease: rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjogren disease, ankylosing spondylitis, myasthenia gravis, Hashimoto's disease, acquired autoimmune hemolytic anemia, and psoriatic arthritis. To investigate whether AID subjects are at increased risk of SARS-CoV-2 infection, and whether they have worse prognosis than AIDs-free subjects once infected, we performed a combined analysis of a test-negative design case-control study, a case-control with test-positive as cases, and one with test-negative as cases (CC-NEG).

Results: During the outbreak, the Milan AHP endured, up to April 27th 2020, 20,364 test-positive and 34,697 test-negative subjects. We found no association between AIDs and being positive to COVID-19, but a statistically significant association between AIDs and being negative to COVID-19 in the CC-NEG. If, as likely, test-negative subjects underwent testing because of respiratory infection symptoms, these results imply that autoimmune diseases may be a risk factor for respiratory infections in general (including COVID-19), but they are not a specific risk factor for COVID-19. Furthermore, when infected by SARS-CoV-2, AIDs subjects did not have a worse prognosis compared to non-AIDs subjects. Results highlighted a potential unbalance in the testing campaign, which may be correlated to the characteristics of the tested person, leading specific frail population to be particularly tested.

Conclusions: Lack of availability of sound scientific knowledge inevitably lead unreliable news to spread over the population, preventing people to disentangle them form reliable information. Even if additional studies are needed to replicate and strengthen our results, these findings represent initial evidence to derive recommendations based on actual data for subjects with autoimmune diseases.
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http://dx.doi.org/10.1186/s13317-020-00141-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7537783PMC
October 2020

A structural equation model to assess the pathways of body adiposity and inflammation status on dysmetabolic biomarkers via red cell distribution width and mean corpuscular volume: a cross-sectional study in overweight and obese subjects.

Lipids Health Dis 2020 Jun 26;19(1):154. Epub 2020 Jun 26.

Neurology, Public Health, Disability Unit, Scientific Department, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.

Background: A study has been performed in overweight and obese subjects to assess the effects of adiposity and inflammation indicators on dysmetabolic biomarkers via red cell distribution width (RDW) and mean corpuscular volume (MCV), taking into account pro-antioxidant balance.

Methods: Data from 166 overweight subjects were analyzed by a path analysis model using structural equation modelling (SEM) to evaluate the direct and indirect pathway effects of adiposity, measured by body mass index (BMI) and waist circumference (WC), and inflammation status, measured by pro-antioxidant balance [reactive oxygen species (ROS)], lag-time and slope and C-reactive protein (CRP) values on dysmetabolic biomarkers, via RDW and MCV.

Results: BMI was strongly linked to CRP and ROS levels. Moreover, there was a significant negative decrease of MCV (1.546 femtoliters) linked to BMI indirectly via high CRP levels. Furthermore, WC affected RDW, indicating a possible mediatory role for RDW in relation to the relationship between WC and homeostatic model assessment (HOMA), insulin and high density lipoprotein (HDL), respectively. This was evident by the elevated HOMA and insulin levels and the decreased levels of HDL. Finally, ROS-related markers did not affect directly RDW and MCV.

Conclusion: The reported outcomes suggest that RDW might play a mediatory role in the relationship between WC and the dysmetabolic outcomes in overweight and obese individuals. CRP seems to modulate the linkage between BMI and MCV. This study provides the backbone structure for future scenarios and lays the foundation for further research on the role of RDW and MCV as suitable biomarkers for the assessment of cardiovascular disease (HDL-cholesterol), inflammatory bowels and insulin resistance.
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http://dx.doi.org/10.1186/s12944-020-01308-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7320558PMC
June 2020

Visual behaviors in disorders of consciousness: Disentangling conscious visual processing by a multimodal approach.

Eur J Neurosci 2020 11 12;52(10):4345-4355. Epub 2020 Jul 12.

Neurology, Public health, Disability Unit / Coma Research Centre, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.

One of the major challenges for clinicians who treat patients with Disorders of Consciousness (DoCs) concerns the detection of signs of consciousness that distinguish patients in Vegetative State from those in Minimally Conscious State. Recent studies showed how visual responses to tailored stimuli are one of the first evidence revealing that one patient is changing from one state to another. This study aimed to explore the integrity of the neural structures being part of the visual system in patients with DoCs manifesting a reflexive behavior (visual blink) and in those manifesting a cognitively and cortically mediated behavior (visual pursuit). We collected instrumental data using specialized equipment (EEG following the rules of the International 10-20 system, 3T Magnetic Resonance, and Positron Emission Tomography) in 54 DoC patients. Our results indicated that visual pursuit group showed a better fVEPs response than the visual blink group, because of a greater area under the N2/P2 component of fVEPs (AUC could be seen as an indicator of the residual activity of visual areas). Considering neuroimaging data, the main structural differences between groups were found in the retrochiasmatic areas, specifically in the right optic radiation and visual cortex (V1), areas statistically less impaired in patients able to perform a visual pursuit. FDG-PET analysis confirmed difference between groups at the level of the right calcarine cortex and neighboring right lingual gyrus. In conclusion, although there are methodological and theoretical limitations that should be considered, our study suggests a new perspective to consider for a future diagnostic protocol.
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http://dx.doi.org/10.1111/ejn.14875DOI Listing
November 2020

Pain rates in general population for the period 1991-2015 and 10-years prediction: results from a multi-continent age-period-cohort analysis.

J Headache Pain 2020 May 13;21(1):52. Epub 2020 May 13.

Neurology, Public Health and Disability Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, 20133, Milan, Italy.

Background: Pain is a common symptom, often associated with neurological and musculoskeletal conditions, and experienced especially by females and by older people. The aims of this study are to evaluate the temporal variations of pain rates among general populations for the period 1991-2015 and to project 10-year pain rates.

Methods: We used the harmonized dataset of ATHLOS project, which included 660,028 valid observations in the period 1990-2015 and we applied Bayesian age-period-cohort modeling to perform projections up to 2025. The harmonized Pain variable covers the content "self-reported pain experienced at the time of the interview", with a dichotomous (yes or no) modality.

Results: Pain rates were higher among females, older subjects, in recent periods, and among observations referred to cohorts of subjects born between the 20s and the 60s. The 10-year projections indicate a noteworthy increase in pain rates in both genders and particularly among subjects aged 66 or over, for whom a 10-20% increase in pain rate is foreseen; among females only, a 10-15% increase in pain rates is foreseen for those aged 36-50.

Conclusions: Projected increase in pain rates will require specific interventions by health and welfare systems, as pain is responsible for limited quality of subjective well-being, reduced employment rates and hampered work performance. Worksite and lifestyle interventions will therefore be needed to limit the impact of projected higher pain rates.
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http://dx.doi.org/10.1186/s10194-020-01108-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7218619PMC
May 2020

[Epidemiological analysis on the hospitalization from neurological diseases in the Province of Pavia (Lombardy Region, Northern Italy)].

Epidemiol Prev 2019 Jul-Aug;43(4):286-294

Unità di biostatistica ed epidemiologia clinica, Dipartimento di sanità pubblica, medicina sperimentale e forense, Università degli Studi di Pavia.

Objectives: to evaluate time and spatial distribution of hospitalization due to neurological diseases in the province of Pavia (Lombardy Region, Northern Italy).

Design: ecological study.

Setting And Participants: the study was performed on aggregate data of people residing in the province of Pavia in the period 2005-2014.

Main Outcome Measures: hospital discharge records of neurological diseases and raw and standardized hospitalization rates.

Results: hospitalization due to neurological diseases in the Province of Pavia showed a slight decreasing trend in time. For the year 2014, the spatial analysis of hospitalizations highlights excesses of risk in the Lomellina district, both in males and in females.

Conclusion: spatial analysis confirms previous results on specific neurological diseases and suggests more detailed analysis on hospitalization excesses in Lomellina area.
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http://dx.doi.org/10.19191/EP19.4.P286.079DOI Listing
April 2020

Effect of Rehabilitation Treatments on Disability in Persons With Disorders of Consciousness: A Propensity Score Study.

Arch Phys Med Rehabil 2020 01 26;101(1):95-105. Epub 2019 Aug 26.

Neurology, Public Health, Disability Unit Scientific Department, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.

Objective: To evaluate the effects of rehabilitation (physical and cognitive) treatments on the diagnosis severity and Disability Rating Scale (DRS) scores, adjusted for a number of potential confounders measured at baseline, in a large cohort of patients with disorders of consciousness across time.

Design And Setting: An observational, longitudinal (2 evaluations), multicenter project was made in 90 Italian centers.

Participants: Patients (N=364) with a diagnosis of disorders of consciousness.

Main Outcome Measures: Primary outcome was the severity of diagnosis, expressed on an ordinal scale (Other
Results: A total of 364 subjects having a complete set of demographic, clinical, and pharmacologic data were included in the propensity score (PS) analysis. Results showed that the rehabilitation treatments (physical and cognitive) reduced the clinical worsening over time in both severity diagnosis and DRS (around 6.5 points) in patients with disorders of consciousness across different propensity score strategies (ie, PS matching, PS adjustment, and PS-weighted procedures). In addition, cognitive protocols seem to be limited to patients with a median value of DRS=23.

Conclusions: Our propensity score analysis suggests that rehabilitation treatment protocols seem effective and should be applied to a broader spectrum of patients with disorders of consciousness.
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http://dx.doi.org/10.1016/j.apmr.2019.07.010DOI Listing
January 2020

Olfactory discrimination in disorders of consciousness: A new sniff protocol.

Brain Behav 2019 08 28;9(8):e01273. Epub 2019 Jun 28.

Neurology, Public Health and Disability Unit, Coma Research Center, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.

Background: The identification of salient stimuli useful for rehabilitation purposes is important in patients with disorders of consciousness (DOC): among these, olfactory stimuli might play an important role due to the functional coupling between olfactory and emotional processing. However, a high percentage of post brain injury patients present anosmia.

Aims Of The Study: The aim of this pilot research is to present an innovative approach to test olfactory functions at the bedside using four selected odors in patients with DOC.

Methods: Sixteen patients with DOC were tested with two assessment techniques the new olfactory discrimination protocol (ODP) and a functional magnetic resonance imaging paradigm to evaluate olfactory neural process. The Frequentist and Bayesian methods were used to analyze reliability properties of the new tool.

Results: Analysis showed a good agreement between assessment techniques and a substantial test-retest reliability of the ODP. Cohen's Ks were equal to 0.814 (95% CI = 0.471, 1) and 0.607 (0.118; 1) respectively, using the Frequentist approach, while they were 0.762 (95% HPD = 0.470; 0.966) and 0.650 (0.320; 0.913) with the Bayesian approach in the 11 patients analyzed.

Conclusions: Despite the limits of this preliminary research, the ODP can be useful for clinicians for the preliminary assessment of the olfactory discrimination in patients with DOC.
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http://dx.doi.org/10.1002/brb3.1273DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6710199PMC
August 2019

Release of paused RNA polymerase II at specific loci favors DNA double-strand-break formation and promotes cancer translocations.

Nat Genet 2019 06 20;51(6):1011-1023. Epub 2019 May 20.

Department of Experimental Oncology, IEO, European Institute of Oncology IRCCS, Milan, Italy.

It is not clear how spontaneous DNA double-strand breaks (DSBs) form and are processed in normal cells, and whether they predispose to cancer-associated translocations. We show that DSBs in normal mammary cells form upon release of paused RNA polymerase II (Pol II) at promoters, 5' splice sites and active enhancers, and are processed by end-joining in the absence of a canonical DNA-damage response. Logistic and causal-association models showed that Pol II pausing at long genes is the main predictor and determinant of DSBs. Damaged introns with paused Pol II-pS5, TOP2B and XRCC4 are enriched in translocation breakpoints, and map at topologically associating domain boundary-flanking regions showing high interaction frequencies with distal loci. Thus, in unperturbed growth conditions, release of paused Pol II at specific loci and chromatin territories favors DSB formation, leading to chromosomal translocations.
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http://dx.doi.org/10.1038/s41588-019-0421-zDOI Listing
June 2019

Mortality for neurological diseases and pesticides: etiological hypotheses by a spatial analysis in the province of Pavia.

Med Lav 2018 Dec 20;109(6):420-434. Epub 2018 Dec 20.

Unit of Biostatistics and Clinical Epidemiology, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Italy.

Background: Neurological and neurodegenerative diseases are multifactorial and their causes are not well understood yet. Among the relevant risk factors, pesticides and the productive activities in which they are used are included.

Objectives: To evaluate the association of mortality from neurological diseases within the Province of Pavia (Italy) with the agricultural activities, as a proxy of pesticides exposure.

Methods: Population data for 2012 were provided by the local health unit (ATS) and by the registry office of the Regional Health Service. Spatial analyses were carried out by both a classical and Bayesian approach, to obtain a mortality map of the relative risk for neurological diseases in the Province of Pavia. Spatial distribution of main agricultural activities within the same territory, used as proxy of pesticides use, was made possible by data from the Geoportale Territoriale of the Lombardy region. Finally, a comparison between spatial distribution of mortality from neurological diseases and spatial distribution of main agricultural activities has been conducted.

Results: Mortality for neurological diseases in the Province of Pavia in 2012 was 4.41 for men and 6.53 for women per 10,000 subjects living in this area. Female mortality for neurological diseases showed a cluster in the Oltrepò district, where viticulture and fruit/horticulture are more common than elsewhere. More precisely, Bayesian relative risk (RR) had higher values in comparison with the median RR of the Province (100.8), with a posterior probability (PP) between 0.75 and 0.95 (not significant). Similarly, mortality for Parkinson's disease in women showed RR greater than the median value of the Province (100.6), with PP between 0.25 and 0.75 (not significant).

Conclusions: Notwithstanding the ecological nature of the study, our results suggest the need to further investigate the possible link between pesticides exposure or related activities and neurological and neurodegenerative diseases, particularly Parkinson's disease. An ad hoc study on a random sample of the population living in the Province of Pavia, with the collection of individual data by means of standardized questionnaire, would allow to control for biases usually present when an ecological study design is applied.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7682186PMC
December 2018

Proposal of an innovative casting technique for correction of clubfoot according to Ponseti method: a pilot study.

J Pediatr Orthop B 2019 May;28(3):242-247

Neurology, Public Health and Disability Unit, Neurological Institute Carlo Besta IRCCS Foundation, Milan, Italy.

A total of 70 clubfeet were treated by a posterior above-knee cast (pressure points on the talus and on the first metatarsal) according to Ponseti method. At diagnosis, average Pirani score was 4.44, and mean time of treatment was 50.32 days. Overall, 27 (38.6%) clubfeet had only conservative treatment (5.29 casts) and 43 (61.4%) also had Achilles tenotomy (6.38 casts). At the end 61/70 feet (87.14%) had Pirani score 0; 10/70 feet (5.71%) had Pirani score 0.5. The Pirani score gain/cast was β=-0.432 (P<0.001). This new casting technique is safe and effective at avoiding some adverse issues related to the removal of the conventional cast.
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http://dx.doi.org/10.1097/BPB.0000000000000539DOI Listing
May 2019

A prospective pilot study of the effect on catecholamines of mindfulness training vs pharmacological prophylaxis in patients with chronic migraine and medication overuse headache.

Cephalalgia 2019 04 13;39(5):655-664. Epub 2018 Sep 13.

5 Research and Innovation (R&I), Padova, Italy.

Aim: To address whether, in patients with chronic migraine and medication overuse headache, mindfulness-based treatment is associated with changes in plasma levels of catecholamines and elusive amines that are similar to those observed in patients undergoing pharmacological prophylaxis.

Methods: In this non-randomized, clinic-based effectiveness study, patients aged 18-65, with a history of chronic migraine ≥ 10 years and overuse of triptans or non-steroidal anti-inflammatory drugs ≥ 5 years, were enrolled. Upon completion of a structured withdrawal program, patients received either pharmacological prophylaxis or six weekly sessions of mindfulness-based treatment and were followed for 12 months. Daily headache diaries were used to record headache frequency and medication intake; catecholamines (noradrenaline, epinephrine and dopamine) and levels of elusive amines were assayed from poor platelet plasma.

Results: Complete follow-up data were available for 15 patients in the pharmacological prophylaxis-group (14 females, average age 44.1) and 14 in the mindfulness treatment-group (all females, average age 46.4), and all variables were comparable between groups at baseline. At 12 months, significant improvement ( p < .001) was found in the pharmacological prophylaxis group for headache frequency and medication intake (by 51% and 48.7%, respectively), noradrenaline, epinephrine and dopamine (by 98.7%, 120.8% and 501.9%, respectively); patients in the mindfulness treatment-group performed similarly. For elusive amines, no longitudinal changes were found.

Conclusions: The similar improvement trends observed in the two groups of patients further support the utility of mindfulness-based treatment in migraine care, and reinforce the hypothesis that alteration and normalization of tyrosine metabolism are implicated in migraine chronification and in remission of chronic migraine.
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http://dx.doi.org/10.1177/0333102418801584DOI Listing
April 2019

Factors Related to Unemployment in Europe. A Cross-Sectional Study from the COURAGE Survey in Finland, Poland and Spain.

Int J Environ Res Public Health 2018 04 11;15(4). Epub 2018 Apr 11.

Neurological Institute C. Besta IRCCS Foundation, Neurology, Public Health and Disability Unit, 20133 Milan, Italy.

: Research addressing the impact of a large number of factors on unemployment is scarce. We aimed to comprehensively identify factors related to unemployment in a sample of persons aged 18-64 from Finland, Poland and Spain. : In this cross-sectional study, factors from different areas were considered: socio-demographic indicators, health habits, chronic conditions, health state markers, vision and hearing indicators, and social networks and built environment scores. : Complete data were available for 5003 participants, mean age 48.1 (SD 11.5), 45.4% males. The most important factors connected to unemployment were health status indicators such as physical disability (OR = 2.944), self-rated health (OR = 2.629), inpatient care (OR = 1.980), and difficulties with getting to the toilet (OR = 2.040), while the most relevant factor related to employment were moderate alcohol consumption (OR = 0.732 for non-heavy drinkers; OR = 0.573 for infrequent heavy drinkers), and being married (OR = 0.734), or having been married (OR = 0.584). Other factors that played a significant role included presence of depression (OR = 1.384) and difficulties with near vision (OR = 1.584) and conversation hearing (OR = 1.597). : Our results highlight the importance of selected factors related to unemployment, and suggest public health indications that could support concrete actions on modifiable factors, such as those aimed to promote physical activity and healthy behaviors, tackling depression or promoting education, in particular for the younger.
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http://dx.doi.org/10.3390/ijerph15040722DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5923764PMC
April 2018

Effects on the diagnosis change and on the disability level for individuals with disorder of consciousness: which predictors?

Int Clin Psychopharmacol 2018 05;33(3):163-171

Neurology, Public Health, Disability Unit - Scientific Directorate, Neurological Institute Carlo Besta IRCCS Foundation, Milan, Italy.

Prediction of the functional recovery in patients with disorders of consciousness (DOC) is still complex because of the different numbers of variables that influence the possibility of observing changes in clinical outcome. The aim of the present study is to identify the best set of predictors of the change in DOC diagnosis among different pharmacotherapy and nonpharmacotherapy indicators. This study analyzed data collected in a longitudinal, two-evaluation, multicenter project conducted in 90 centers. We analyzed the predictor effects of physical and cognitive treatments, duration of disease, etiology, age, and sex (nonpharmacological treatments) as well as the use of antiparkinson, psycholeptic, psychoanaleptic, and muscle-relaxant drugs (pharmacological variables). Ordered logistic models, linear regression models with bootstrap estimation, and model averaging procedures were used. The results showed that physical and cognitive treatments [best predictor: odds ratio (OR)=413.3, P<0.001], age (OR=0.964, P<0.001), and use of psycholeptic drugs (negative effect: OR=0.373, P=0.039) were the variables that contributed in general toward a change in diagnosis. Notably, the use of psycholeptic drugs seemed to impede the functional recovery in patients with DOC, so serious reflections on its use will be made.
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http://dx.doi.org/10.1097/YIC.0000000000000214DOI Listing
May 2018

Radiation dose exposure in patients affected by lymphoma undergoing repeat CT examinations: how to manage the radiation dose variability.

Radiol Med 2018 Mar 8;123(3):191-201. Epub 2017 Nov 8.

Department of Diagnostic and Interventional Radiology, University of Pisa, Via Roma 67, 56100, Pisa, Italy.

Purpose: To assess the variability of radiation dose exposure in patients affected by lymphoma undergoing repeat CT (computed tomography) examinations and to evaluate the influence of different scan parameters on the overall radiation dose.

Materials And Methods: A series of 34 patients (12 men and 22 women with a median age of 34.4 years) with lymphoma, after the initial staging CT underwent repeat follow-up CT examinations. For each patient and each repeat examination, age, sex, use of AEC system (Automated Exposure Control, i.e. current modulation), scan length, kV value, number of acquired scans (i.e. number of phases), abdominal size diameter and dose length product (DLP) were recorded. The radiation dose of just one venous phase was singled out from the DLP of the entire examination. All scan data were retrieved by our PACS (Picture Archiving and Communication System) by means of a dose monitoring software.

Results: Among the variables we considered, no significant difference of radiation dose was observed among patients of different ages nor concerning tube voltage. On the contrary the dose delivered to the patients varied depending on sex, scan length and usage of AEC. No significant difference was observed depending on the behaviour of technologists, while radiologists' choices had indirectly an impact on the radiation dose due to the different number of scans requested by each of them.

Conclusions: Our results demonstrate that patients affected by lymphoma who undergo repeat whole body CT scanning may receive unnecessary overexposure. We quantified and analyzed the most relevant variables in order to provide a useful tool to manage properly CT dose variability, estimating the amount of additional radiation dose for every single significant variable. Additional scans, incorrect scan length and incorrect usage of AEC system are the most relevant cause of patient radiation exposure.
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http://dx.doi.org/10.1007/s11547-017-0826-7DOI Listing
March 2018

Beyond Body Mass Index. Is the Body Cell Mass Index (BCMI) a useful prognostic factor to describe nutritional, inflammation and muscle mass status in hospitalized elderly?: Body Cell Mass Index links in elderly.

Clin Nutr 2018 06 24;37(3):934-939. Epub 2017 Mar 24.

University of Pavia, Department of Brain and Behavioral Sciences, Medical and Genomic Statistics Unit, Pavia, Italy; University of Pavia, Department of Public Health, Experimental and Forensic Medicine, Biostatistics and Clinical Epidemiology Unit, Pavia, Italy.

Background & Aim: The aim of this study was to establish the effectiveness of Body Cell Mass Index (BCMI) as a prognostic index of (mal)nutrition, inflammation and muscle mass status in the elderly.

Methods: A cross-sectional observational study has been conducted on 114 elderly patients (80 women and 34 men), with mean age equal to 81.07 ± 6.18 years. We performed a multivariate regression model by Structural Equation Modelling (SEM) framework. We detected the effects over a Mini Nutritional Assessment (MNA) stratification, by performing a multi-group multivariate regression model (via SEM) in two MNA nutritional strata, less and bigger (or equal) than 17.

Results: BCMI had a significant effect on albumin (β = +0.062, P = 0.001), adjusting for the other predictors of the model as Body Mass Index (BMI), age, sex, fat mass and cognitive condition. An analogous result is maintained in MNA<17 stratum. BMI has confirmed to be a solid prognostic factor for both free fat mass (FFM) (β = +0.480, P < 0.001) and Skeletal Muscle Index (SMI) (β = +0.265, P < 0.001), assessed by DXA. BCMI also returned suggestive evidences (0.05 < P < 0.10) for both the effect on FFM and on SMI in overall sample.

Conclusions: The main result of this study is that the BCMI, compared to BMI, proved to be significantly related to an important marker as albumin in geriatric population. Then, assessing the BCMI could be a valuable, inexpensive, easy to perform tool to investigate the inflammation status of elderly patients.
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http://dx.doi.org/10.1016/j.clnu.2017.03.021DOI Listing
June 2018

Awareness of radiation protection and dose levels of imaging procedures among medical students, radiography students, and radiology residents at an academic hospital: Results of a comprehensive survey.

Eur J Radiol 2017 Jan 31;86:135-142. Epub 2016 Oct 31.

Department of Diagnostic and Interventional Radiology, University of Pisa, Via Roma 67, 56100, Pisa, Italy.

Purpose: To evaluate the awareness of radiation protection issues and the knowledge of dose levels of imaging procedures among medical students, radiology residents, and radiography students at an academic hospital.

Material And Methods: A total of 159 young doctors and students (including 60 radiology residents, 56 medical students, and 43 radiography students) were issued a questionnaire consisting of 16 multiple choice questions divided into three separated sections (i.e., demographic data, awareness about radiation protection issues, and knowledge about radiation dose levels of common radiological examinations).

Results: Medical students claimed to have at least a good knowledge of radiation protection issues more frequently than radiology residents and radiography students (94.4% vs 55% and 35.7%, respectively; P<0.05), with no cases of perceived excellent knowledge among radiography students. However, the actual knowledge of essential radiation protection topics such as regulations, patient and tissue susceptibility to radiation damage, professional radiation risk and dose optimisation, as well as of radiation doses delivered by common radiological procedures was significantly worse among medical students than radiology residents and radiography students (P<0.05). Those latter significantly outperformed radiology residents as to knowledge of radiation protection issues (P<0.01). Overall, less than 50% of survey respondents correctly answered all questions of the survey.

Conclusions: Radiology residents, radiography students and medical students have a limited awareness about radiation protection, with a specific gap of knowledge concerning real radiation doses of daily radiological examinations. Both undergraduate and postgraduate teaching needs to be effectively implemented with radiation safety courses.
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http://dx.doi.org/10.1016/j.ejrad.2016.10.033DOI Listing
January 2017

Effects of Hazelnut Consumption on Blood Lipids and Body Weight: A Systematic Review and Bayesian Meta-Analysis.

Nutrients 2016 Nov 25;8(12). Epub 2016 Nov 25.

Department of Public Health, Experimental and Forensic Medicine, Endocrinology and Nutrition Unit, University of Pavia, Azienda di Servizi alla Persona di Pavia, Pavia 27100, Italy.

Hazelnuts are rich in monounsaturated fatty acids and antioxidant bioactive substances: their consumption has been associated with a decreased risk of cardiovascular disease events. A systematic review and a meta-analysis was performed to combine the results from several trials and to estimate the pooled (overall) effect of hazelnuts on blood lipids and body weight outcomes. Specifically, a Bayesian random effect meta-analysis of mean differences of Δ-changes from baseline across treatment (MDΔ) (i.e., hazelnut-enriched diet vs. control diet) has been conducted. Nine studies representing 425 participants were included in the analysis. The intervention diet lasted 28-84 days with a dosage of hazelnuts ranging from 29 to 69 g/day. Out of nine studies, three randomized studies have been meta-analyzed showing a significant reduction in low-density lipoprotein (LDL) cholesterol (pooled MDΔ = -0.150 mmol/L; 95% highest posterior density interval (95%HPD) = -0.308; -0.003) in favor of a hazelnut-enriched diet. Total cholesterol showed a marked trend toward a decrease (pooled MDΔ = -0.127 mmol/L; 95%HPD = -0.284; 0.014) and high-density lipoprotein (HDL) cholesterol remained substantially stable (pooled MDΔ = 0.002 mmol/L; 95%HPD = -0.140; 0.147). No effects on triglycerides (pooled MDΔ = 0.045 mmol/L; 95%HPD = -0.195; 0.269) and body mass index (BMI) (pooled MDΔ = 0.062 kg/m²; 95%HPD = -0.293; 0.469) were found. Hazelnut-enriched diet is associated with a decrease of LDL and total cholesterol, while HDL cholesterol, triglycerides and BMI remain substantially unchanged.
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http://dx.doi.org/10.3390/nu8120747DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5188407PMC
November 2016

MediterrAsian Diet Products That Could Raise HDL-Cholesterol: A Systematic Review.

Biomed Res Int 2016 1;2016:2025687. Epub 2016 Nov 1.

Department of Public Health, Experimental and Forensic Medicine, School of Medicine, Endocrinology and Nutrition Unit, University of Pavia, Azienda di Servizi alla Persona di Pavia, Pavia, Italy.

. High HDL-cholesterol (HDL-C) values are negatively correlated with cardiovascular diseases. This review analyses the effect of the supplementation with various Mediterranean diet products (artichoke, bergamot, and olive oil) and Asian diet products (red yeast rice) on the HDL-C value in dyslipidemic subjects. . A systematic review has been done involving all the English written studies published from the 1st of January 1958 to the 31st of March 2016. . The results of this systematic review indicate that the dietary supplementation with red yeast rice, bergamot, artichoke, and virgin olive oil has promising effects on the increase of HDL-C serum levels. The artichoke leaf extract and virgin olive oil appear to be particularly interesting, while bergamot extract needs further research and the effect of red yeast rice seems to be limited to patients with previous myocardial infarction. . Various MediterrAsian diet products or natural extracts may represent a potential intervention treatment to raise HDL-C in dyslipidemic subjects.
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http://dx.doi.org/10.1155/2016/2025687DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5108844PMC
January 2017

Carotid stenting versus endarterectomy in the same patient: A "direct" comparison.

Vascular 2017 Jun 3;25(3):290-298. Epub 2016 Nov 3.

6 Vascular Surgery Section, Department of Emergency and Organ Transplantation (DETO), University of Bari, Bari, Italy.

The aim of this study was to evaluate outcomes and feasibility of carotid artery stenting versus carotid endarterectomy, both procedures performed in the same patient. Forty-five subjects (33 males, 70 ± 7 years) underwent carotid endarterectomy or carotid artery stenting, the counter procedure on the contralateral carotid performed after a variable period. We evaluated the post-procedural percentage of carotid stenosis at 30, 180 days and one-year follow-up, and the occurrence of acute myocardial infarction, New York Heart Association class progression, stroke, death, cardiovascular death, angina, transient ischemic attack and renal failure. Carotid artery stenting treatment reduced the degree of re-stenosis after 180 days equally to carotid endarterectomy procedure (difference: 0.033%, P = 0.285). No statistically significant differences were observed according to the occurrence of acute myocardial infarction and New York Heart Association class progression, revealing odds ratio (OR) equal to 0.182 ( P = 0.361) for acute myocardial infarction and 0.303 ( P = 0.434) for New York Heart Association class progression. Carotid endarterectomy confirms its efficacy in carotid revascularization, but carotid artery stenting constitutes a good alternative when the procedures are selected based on patient-specific risk factors.
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http://dx.doi.org/10.1177/1708538116674375DOI Listing
June 2017

Multidimensional Effects of Soy Isoflavone by Food or Supplements in Menopause Women: a Systematic Review and Bibliometric Analysis.

Nat Prod Commun 2016 Nov;11(11):1733-1740

Isoflavones can exert their action on various levels: on cardiovascular system, bone and muscle health, on cancer, on menopausal symptoms, on obesity, on thyroid and on cognitive function. The aim of this systematic review is to evaluate the multidimensional effects of phytoestrogens in postmenopausal woman, and specifically to explore the impact on scientific literature. A research strategy was planned on PubMed and Scopus by defining the following key words:: menopause, climacteric, soy, isoflavone, phytoestrogens, cardiovascular system, bone mineral density, muscle mass, cancer, thyroid, obesity, cognitive. A total of 43 studies (in humans) were retrieved. The majority (12) describe the applications of soy isoflavones on cardiovascular disease, followed by effects on bone and muscle health (9), and studies concerning their action on menopausal symptoms (7), on cancer (6), on obesity (4), on cognitive function (3) and on thyroid function (2). The citation analysis revealed a growing interest for this topic and the papers on thyroid function are the most cited. Citation trends ofthe articles regarding the action on cardiovascular disease and on obesity are growing in the last years. Concerning the research areas, this review has assessed the effectiveness of various activities of isoflavones on welfare of menopausal women. In particular, literature show that a specific dosage of isoflavdnes reduces cardiovascular disease (from 20 to 100 mg/die), may be protective in osteoporosis and muscular fatigue (from 20 to 80 mg/die), may be useful for cancer prevention on endometrium, mammary glands and liver (from 50 to 100 mg/die), might improve menopausal symptoms, particularly in reducing the frequency of hot flashes (from 50 to 120 mg/die), can reduce abdominal fat and circulating inflammatory markers (from 80 to 160 mg/die), may ameliorate the pdssible interaction between endogenous estrogen and thyroid function (75 mg/die) and improve visual memory (from 50 to 100 mg/die).
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November 2016

Is Geo-Environmental Exposure a Risk Factor for Multiple Sclerosis? A Population-Based Cross-Sectional Study in South-Western Sardinia.

PLoS One 2016;11(9):e0163313. Epub 2016 Sep 26.

Department of Public Health, Clinical and Medical Science, University of Cagliari, Cagliari, Italy.

Background: South-Western Sardinia (SWS) is a high risk area for Multiple Sclerosis (MS) with high prevalence and spatial clustering; its population is genetically representative of Sardinians and presents a peculiar environment. We evaluated the MS environmental risk of specific heavy metals (HM) and geographical factors such as solar UV exposure and urbanization by undertaking a population-based cross-sectional study in SWS.

Methods: Geochemical data on HM, UV exposure, urbanization and epidemiological MS data were available for all SWS municipalities. Principal Component Analysis (PCA) was applied to the geochemical data to reduce multicollinearity and confounding criticalities. Generalized Linear Mixed Models (GLMM) were applied to evaluate the causal effects of the potential risk factors, and a model selection was performed using Akaike Information Criterion.

Results: The PCA revealed that copper (Cu) does not cluster, while two component scores were extracted: 'basic rocks', including cobalt, chromium and nickel, and 'ore deposits', including lead and zinc. The selected multivariable GLMM highlighted Cu and sex as MS risk factors, adjusting for age and 'ore deposits'. When the Cu concentration increases by 50 ppm, the MS odds are 2.827 (95% CI: 1.645; 5.07) times higher; females have a MS odds 2.04 times (95% CI: 1.59; 2.60) higher than males.

Conclusions: The high frequency of MS in industrialized countries, where pollution by HM and CO poisoning is widespread, suggests a relationship between environmental exposure to metals and MS. Hence, we suggested a role of Cu homeostasis in MS. This is a preliminary study aimed at generating hypotheses that will need to be confirmed further.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0163313PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5036813PMC
September 2016

Propensity Score-Based Analysis of Percutaneous Closure Versus Medical Therapy in Patients With Cryptogenic Stroke and Patent Foramen Ovale: The IPSYS Registry (Italian Project on Stroke in Young Adults).

Circ Cardiovasc Interv 2016 09;9(9)

From the Dipartimento di Scienze Cliniche e Sperimentali, Clinica Neurologica, Università degli Studi di Brescia, Italia (A.Pezzini, P. Costa, L.P. A.M., V.D.G., S.B., A. Padovani); Dipartimento di Scienze del Sistema Nervoso e del Comportamento, Unità di Statistica Medica e Genomica, Università di Pavia, Italia (M. Grassi, D.G.); Centro Trombosi, IRCCS Istituto Clinico Humanitas, Rozzano-Milano, Italia (C.L., P.F.); Stroke Unit, Azienda Ospedaliera Sant'Andrea, Università "La Sapienza," Roma, Italia (R.P., A.S., M.R., S.L.S.); Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili, Università di Genova, Italia (C.G., D.M.); Stroke Unit, Clinica Neurologica, Nuovo Ospedale Civile "S. Agostino Estense," AUSL Modena, Italia (A.Z., A.M.S.); Unità di Neurologia, Ospedale di Circolo, Università dell'Insubria, Varese, Italia (M.L.D.); Stroke Unit, Divisione di Medicina Cardiovascolare, Università di Perugia, Perugia, Italia (M.P., C.D.); Unità di Neurologia, Ospedale Galliera, Genova, Italia (M.D.S.); U.O.C. Neurologia, A.O Universitaria "San Giovanni di Dio e Ruggi d'Aragona," Salerno, Italia (A.T.); Dipartimento di Neuroscienze, Scienze Psichiatriche e Anestesiologiche, Clinica Neurologica, Università di Messina, Italia (R.M.); IRCCS, Centro Neurolesi Bonino-Pulejo, Messina, Italia (R.S.C.); UO Neurologia, Azienda Ospedaliera-Universitaria Borgo Trento, Verona, Italia (P.B., G.T.); Stroke Center, Dipartimento di Neurologia, Ospedale Sacro Cuore Negrar, Verona, Italia (A.A.); Stroke Unit, Dipartimento di Neuroscienze, Azienda Ospedaliera Carlo Poma, Mantova, Italia (G.S.); U.O Neurologia, Istituti Ospitalieri, Cremona, Italia (M.S.); Stroke Unit, IRCCS Fondazione Istituto "C. Mondino," Pavia, Italia (A. Cavallini); Neurologia d'Urgenza e Stroke Unit, IRCCS Istituto Clinico Humanitas, Rozzano-Milano, Italia (S.M.); Stroke Unit, U.O Neurologia, Ospedale "S. Chiara," Trento, Italia (D.M.B.); U.O.C Neurologia, Ospedale Vald

Background: We sought to compare the benefit of percutaneous closure to that of medical therapy alone for the secondary prevention of embolism in patients with patent foramen ovale (PFO) and otherwise unexplained ischemic stroke, in a propensity scored study.

Methods And Results: Between 2000 and 2012, we selected consecutive first-ever ischemic stroke patients aged 18 to 45 years with PFO and no other cause of brain ischemia, as part of the IPSYS registry (Italian Project on Stroke in Young Adults), who underwent either percutaneous PFO closure or medical therapy for comparative analysis. Primary end point was a composite of ischemic stroke, transient ischemic attack, or peripheral embolism. Secondary end point was brain ischemia. Five hundred and twenty-one patients qualified for the analysis. The primary end point occurred in 15 patients treated with percutaneous PFO closure (7.3%) versus 33 patients medically treated (10.5%; hazard ratio, 0.72; 95% confidence interval, 0.39-1.32; P=0.285). The rates of the secondary end point brain ischemia were also similar in the 2 treatment groups (6.3% in the PFO closure group versus 10.2% in the medically treated group; hazard ratio, 0.64; 95% confidence interval, 0.33-1.21; P=0.168). Closure provided a benefit in patients aged 18 to 36 years (hazard ratio, 0.19; 95% confidence interval, 0.04-0.81; P=0.026) and in those with a substantial right-to-left shunt size (hazard ratio, 0.19; 95% confidence interval, 0.05-0.68; P=0.011).

Conclusions: PFO closure seems as effective as medical therapy for secondary prevention of cryptogenic ischemic stroke. Whether device treatment might be more effective in selected cases, such as in patients younger than 37 years and in those with a substantial right-to-left shunt size, deserves further investigation.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003470DOI Listing
September 2016

Twenty-four-week effects of liraglutide on body composition, adherence to appetite, and lipid profile in overweight and obese patients with type 2 diabetes mellitus.

Patient Prefer Adherence 2016 24;10:407-13. Epub 2016 Mar 24.

Medical and Genomics Statistics Unit, Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy; Biostatistics and Clinical Epidemiology Unit, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Pavia, Italy.

Background: Liraglutide has well-known effects on glucose patterns. However, its several other metabolic properties are still controversial. Given this background, the aims of the present study are to evaluate the effects of 24-week liraglutide treatment on body composition, appetite, and lipid profile in overweight and obese type 2 diabetes mellitus (T2DM) patients.

Methods: A cohort study was carried out on overweight and obese T2DM patients with glycosylated hemoglobin A1c equal to 6% (42 mmol/mol)-10% (86 mmol/mol), under a 3-month treatment (at least) with maximal dose of metformin as stable regime, by adding liraglutide at doses up to 3 mg/d. Body composition markers were measured by dual-energy X-ray densitometry at baseline and after 24 weeks of liraglutide treatment. Glucose control was monitored by glucose, glycosylated hemoglobin A1c, insulin, and homeostasis model assessment. Finally, the appetite sensation and plasma lipids were also evaluated.

Results: Twenty-eight subjects (male/female: 16/12, mean age: 58.75±9.33 years, body mass index: 34.13±5.46 kg/m(2)) were evaluated. Accounting for the adjustment for age, sex, and duration of diabetes, we noted significant decreases in body mass index (-0.86 kg/m(2), P=0.024), fat mass (-2.01 kg, P=0.015), fat mass index (-0.71 kg/m(2), P=0.014), android fat (-1.72%, P=0.022), trunk fat (-1.52%, P=0.016), and waist circumference (-6.86 cm, P<0.001) from the baseline values. Haber score was increased by 3.82 units (P=0.009), and the number of metabolic syndrome risk factors was decreased (-0.69 units, P=0.012). The glucose control variables and total cholesterol/high-density lipoprotein cholesterol ratio also showed significant decreases from baseline values.

Conclusion: The 24-week liraglutide treatment leads to the reduction of fat mass, android fat, trunk fat, and appetite by improving the lipid profile, glucose control, and insulin sensitivity.
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http://dx.doi.org/10.2147/PPA.S97383DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4818054PMC
April 2016

Twenty-four-week effects of liraglutide on body composition, adherence to appetite, and lipid profile in overweight and obese patients with type 2 diabetes mellitus.

Patient Prefer Adherence 2016 24;10:407-13. Epub 2016 Mar 24.

Medical and Genomics Statistics Unit, Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy; Biostatistics and Clinical Epidemiology Unit, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Pavia, Italy.

Background: Liraglutide has well-known effects on glucose patterns. However, its several other metabolic properties are still controversial. Given this background, the aims of the present study are to evaluate the effects of 24-week liraglutide treatment on body composition, appetite, and lipid profile in overweight and obese type 2 diabetes mellitus (T2DM) patients.

Methods: A cohort study was carried out on overweight and obese T2DM patients with glycosylated hemoglobin A1c equal to 6% (42 mmol/mol)-10% (86 mmol/mol), under a 3-month treatment (at least) with maximal dose of metformin as stable regime, by adding liraglutide at doses up to 3 mg/d. Body composition markers were measured by dual-energy X-ray densitometry at baseline and after 24 weeks of liraglutide treatment. Glucose control was monitored by glucose, glycosylated hemoglobin A1c, insulin, and homeostasis model assessment. Finally, the appetite sensation and plasma lipids were also evaluated.

Results: Twenty-eight subjects (male/female: 16/12, mean age: 58.75±9.33 years, body mass index: 34.13±5.46 kg/m(2)) were evaluated. Accounting for the adjustment for age, sex, and duration of diabetes, we noted significant decreases in body mass index (-0.86 kg/m(2), P=0.024), fat mass (-2.01 kg, P=0.015), fat mass index (-0.71 kg/m(2), P=0.014), android fat (-1.72%, P=0.022), trunk fat (-1.52%, P=0.016), and waist circumference (-6.86 cm, P<0.001) from the baseline values. Haber score was increased by 3.82 units (P=0.009), and the number of metabolic syndrome risk factors was decreased (-0.69 units, P=0.012). The glucose control variables and total cholesterol/high-density lipoprotein cholesterol ratio also showed significant decreases from baseline values.

Conclusion: The 24-week liraglutide treatment leads to the reduction of fat mass, android fat, trunk fat, and appetite by improving the lipid profile, glucose control, and insulin sensitivity.
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http://dx.doi.org/10.2147/PPA.S97383DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4818054PMC
April 2016
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