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Purpose To compare visual outcomes of two newly developed monofocal intraocular lenses (IOLs) (I-Stream H and CT Lucia 211P) implanted in patients undergoing surgery for senile cataract. Methods This prospective, comparative, single-center, randomized study included 94 eyes of 94 patients undergoing cataract surgery. Patients were randomized to receive the implantation of I-Stream H IOL (Group 1) or CT Lucia 211P IOL (Group 2). Each patient underwent a complete ocular examination before (V0), 1 month (V1), 3 months (V2) and 6 months (V3) after surgery, including visual acuity testing, objective refraction, slit-lamp biomicroscopy, contrast sensitivity testing and visual function index questionnaire (VF-14). Results After surgery, a significant increase of best-corrected visual acuity (BCVA), CS and VF-14 and a significant decrease of SE were detected in both groups at each time point compared to baseline (always p0.05). Eyes with an actual refraction within 0.25, 0.50 and 1 D were 53.1%, 85.1% and 100% for Group 1 and 55.3%, 87.2% and 100% for Group 2 (p>0.05). Conclusion I-Stream H and CT Lucia 211P allowed a satisfied recovery of visual function after senile cataract surgery; both IOLs were shown to have similar outcomes of visual performance.

Aims Adults affected by obesity are at higher risk of premature mortality. Medications can help to lose weight and to maintain weight loss. Aim of this meta-analysis was to assess whether anti-obesity medications affect all-cause mortality, mortality due to cardiovascular events, cardiovascular risk factors and body weight. Data synthesis A Medline search was performed to identify randomized controlled trials (RCTs) of anti-obesity medications in adults with overweight or obesity reporting data on all-cause mortality, cardiovascular mortality or non-fatal cardiovascular events, with a follow-up of at least 6 months. We identified 28 RCTs with 50,106 participants. The median follow-up was 52 weeks. Evidence did not show superiority of anti-obesity medications over placebo in reducing all-cause mortality (risk ratio 1.03, 95%Confidence Interval [CI] 0.87 to 1.21) or cardiovascular mortality (risk ratio 0.92, 95%CI 0.72 to 1.18). All-cause mortality rate was positively associated with weight loss (β = 0.0007; p = 0.045); hence, for each kg of body weight lost there was a 0.07% decrease of all-cause mortality. The pharmacological treatment reduced total-cholesterol (7.15 mg/dl; 95%CI 1.46–12.85), LDL-cholesterol (5.06 mg/dl; 95%CI 1.12–9.00), and triglycerides levels (9.88 mg/dl; 95%CI 5.02–14.75), while it increased HDL-cholesterol (1.37 mg/dl; 95%CI 0.17–2.57). Systolic blood pressure decreased (0.90 mmHg; 95%CI 0.15–1.64). Conclusions Although we were unable to demonstrate a superiority of anti-obesity medications over placebo on mortality, metaregression showed that even a small weight reduction tends to reduce all-cause mortality in obesity. Our data support public health measures to reduce the obesity burden by including the use of anti-obesity medications. Registration number (PROSPERO) CRD42020210329.

BACKGROUND/AIM The high rate of root resorption resulting from tooth replantation represents a serious clinical problem. In order to prevent ankylosis and replacement resorption, the contemporary literature highlights the importance of using a flexible stabilization for traumatized teeth. For this purpose, orthodontic devices may be promising for obtaining a better prognosis and periodontal repair. The aim of this study was to evaluate the effect of an active splinting protocol with controlled force in dog's teeth following replantation. MATERIAL AND METHODS Sixty premolar roots from three dogs were used. They were submitted to endodontic treatment, hemisected, atraumatically extracted and subsequently replanted. They were divided into four groups: Passive Stabilization (n = 20)-after 20 min in a dry medium; Active Stabilization (n = 20)-after 20 min in a dry medium; Negative control (n = 10)-immediate replantation and passive Stabilization; and Positive control (n = 10)-90 min of extra-alveolar time and passive Stabilization. The samples were collected and submitted to histologic processing. They were then evaluated for the count of inflammatory cells, expression of neurotrophin 4, osteoclasts, apoptotic cells and collagen fibres. The results were submitted to ANOVA or Kruskal-Wallis statistical tests followed by Tukey or Dunn post-tests (α = 5%). RESULTS Passive Stabilization with orthodontic brackets without traction used after replantation had the highest number of inflammatory cells (p = .0122), osteoclasts (p = .0013) and percentage of collagen fibres in the periodontal ligament (p

Background: No uniform criteria for a sensitive identification of the transition from relapsing–remitting multiple sclerosis (MS) to secondary-progressive multiple sclerosis (SPMS) are available. Objective: To compare risk factors of SPMS using two definitions: one based on the neurologist judgment (ND) and an objective data-driven algorithm (DDA). Methods: Relapsing-onset MS patients ( n = 19,318) were extracted from the Italian MS Registry. Risk factors for SPMS and for reaching irreversible Expanded Disability Status Scale (EDSS) 6.0, after SP transition, were estimated using multivariable Cox regression models. Results: SPMS identified by the DDA ( n = 2343, 12.1%) were older, more disabled and with a faster progression to severe disability ( p 40 years, higher baseline EDSS score and a higher number of relapses; the most consistent protective factor was the disease-modifying therapy (DMT) exposure. DMT exposure during SP did not impact the risk of reaching irreversible EDSS 6.0. Conclusion: A DDA definition of SPMS identifies more aggressive progressive patients. DMT exposure reduces the risk of SPMS conversion, but it does not prevent the disability accumulation after the SP transition.

Background. Maxillary bone atrophy with a considerable amount of pneumatization and anterior expansion of the maxillary sinus might be a situation limiting oral rehabilitation with osseointegrated implants. Therefore, the present study aimed to biomechanically evaluate two rehabilitation techniques for maxillary bone atrophy: all-on-four and long trans-sinus implants. Methods. Two three-dimensional models consisting of atrophic maxilla with four implants were simulated. In the M1 model, two axially inserted anterior implants and two tilted implants, 15 mm in length, placed tangential to the maxillary sinus’s anterior wall were used. In the M2 model, two axially inserted anterior implants and two trans-sinus tilted implants, 24 mm in length, were used. For the finite element analysis (FEA), an axial load of 100 N was applied on the entire extension of the prosthesis, simulating a rehabilitation with immediate loading. The peri-implant bone and the infrastructure were analyzed according to the Mohr-Coulomb and Rankine criteria, respectively. Results. The results were similar when the stresses on peri-implant bone were compared: 0.139 and 0.149 for models 1 and 2, respectively. The tension values were lower in the model with trans-sinus implants (27.99 MPa). Conclusion. It was concluded that the two techniques exhibited similar biomechanical behavior, suggesting that the use of long trans-sinus implants could be a new option for atrophic maxilla rehabilitation.

The objective of this study was to evaluate the effect of non-steroidal anti-inflammatory drugs (NSAIDs) in controlling pulpal and periapical inflammation in vivo as a potential coadjutant systemic therapy for pulpitis. A suspension containing E. coli lipopolysaccharide (LPS; 1.0 μg/μL) was inoculated into the pulp chamber of the first molars of C57BL/6 mice (n = 72), and the animals were treated daily with indomethacin or celecoxib throughout the experimental periods. After 7, 14, 21, and 28 days, the tissues were removed for histopathological, histoenzymology, histometric, and immunohistochemical evaluation. Inoculation of LPS into the pulp chamber induced the synthesis of the enzyme cyclooxygenase-2 (COX-2) in dental pulp and periapical region. Indomethacin and celecoxib treatment changed the profile of inflammatory cells recruited to dental pulp and to the periapex, which was characterized by a higher mononuclear cell infiltrate, compared to LPS inoculation alone which recruited a higher amount of polymorphonuclear neutrophils. Administration of indomethacin for 28 days resulted in the development of apical periodontitis and increased osteoclast recruitment, unlike celecoxib. NSAIDs indomethacin and celecoxib changed the recruitment of inflammatory cells to a mononuclear profile upon inoculation of LPS into the pup chamber, but indomethacin enhanced periapical bone loss whereas celecoxib did not. Celecoxib, a selective COX-2 inhibitor, can change the profile of inflammatory cells recruited to the dental pulp challenged with LPS and might a be potential systemic coadjutant for treatment of pulpitis.

Background Contralateral delayed endolymphatic hydrops (CDEH) is a clinical entity characterized by fluctuating low frequency hearing loss and/or vertigo, mimicking Meniere’s disease (MD), that manifests after the appearance of severe non-hydropic hearing loss (NHHL) at the other ear. Objectives to describe the clinical features and the course of 57 patients affected by CDEH. Method this is a retrospective study; 57 patients affected by CDEH, out of 1065 patients seen in the same period and affected by MD, were subjected to otoscopy, PTA threshold evaluation, impedance testing, ABR, research of positioning nystagmus, vestibular function evaluated by means of bithermal caloric test under video-oculographic, and MRI with gadolinium. Results the CDEH was definite in 24 cases (42%), probable in 2 (4%) and possible in 31 (54%). The mean PTA threshold at the hydropic ear was 41 dB. At the last follow-up, 40 patients (70%) did not report vertigo or fluctuating hearing loss. Among the 17 patients who still reported symptomatology, 11 (64%) were affected by fluctuating hearing loss alone, 4 (23%) reported a subjective worsening of hearing loss and 2 (12%) an acute vertigo crisis. Conclusions contralateral delayed endolymphatic hydrops is a relatively rare form of Meniere disease that manifests more frequently as a definite form or with fluctuating low-frequency hearing loss. The prognosis at a long term follow-up is relatively good in terms of vertigo resolution. Contralateral delayed endolymphatic hydrops rarely determines a severe hearing loss in the better ear.

BACKGROUND From population studies, solid organ transplant recipients are at increased risk of mortality from RT-PCR confirmed COVID-19 infection. The risk factors associated with infection acquisition and mortality in transplant recipients using serological data have not been reported. METHODS From 1725 maintenance transplant recipients, 855 consecutive patients were screened for SARS-CoV-2 antibodies. Serological screening utilized assays to detect both the N protein and receptor binding domain antibodies. Thirty-three of 855 (3.9%) of the screened patients had prior infection confirmed with RT-PCR. Twenty-one additional patients from our 1725 maintenance cohort with RT-PCR confirmed infection were included in our analysis. RESULTS Eighty-nine of 855 (10.4%) patients tested positive for SARS-CoV-2 antibodies. Fifty-nine of 89 (66.3%) cases were patients newly identified as exposed, while 30/89 (33.7%) seropositive patients had previous infection confirmed by RT-PCR. A diagnosis of SARS-CoV-2 (RT-PCR or Ab+) was associated with being from a noncaucasoid background, P = 0.015; having a diagnosis of diabetes, P = 0.028 and a history of allograft rejection, P

Introduction Primary aim was to provide real-world evidence of the outcomes after the switch to glargine 300 U/ml (Gla-300) from other basal insulins (first or second generation) in Italy. Methods Multicenter, observational, retrospective study based on electronic medical records. Results Overall, 953 T2DM insulin ± OAD treated people switched to Gla-300 or Gla-100 from January 2015 to July 2018. Three clinically relevant cohorts were identified: patients switching to Gla-300 from first-generation basal insulin (cohort 1), patients switching to Gla-300 from degludec-100 (Deg-100) (cohort 2), and those switching to Gla-100 from any basal insulin (cohort 3). The three cohorts differed in terms of age, diabetes duration, and metabolic control. HbA1c changes after 6 months from the switch were − 0.27% (95% CI − 0.38; − 0.16), − 0.06% (95% CI − 0.31; 0.19), and − 0.30% (95% CI − 0.51; − 0.09) in the three cohorts, respectively. FPG significantly decreased in cohort 1 (− 14.07 mg/dl, 95% CI − 20.25; − 7.89), while body weight significantly decreased in cohort 2 (− 1.47 kg, 95% CI − 2.55; − 0.39). Doses of insulin marginally changed during the follow-up (+ 0.89 U in basal insulin daily dose in cohort 1 and + 2.07 U in short-acting insulin daily dose in cohort 2). Conclusions Switching to Gla-300 from first-generation basal insulin in the real world is associated with improvements in metabolic control despite a suboptimal titration of both basal and short-acting insulins. Inertia in insulin titration documented in the Gla-100 cohort is also observed with the second-generation basal insulin. The switch to Gla-300 from Deg-100 was associated with a decrease in body weight of − 1.47 kg despite a slight increase in short-acting insulin daily doses of about + 2 U.

Aim The objective of the study was to estimate the conicity of the root canals of maxillary central and lateral incisors by computed nanotomography (Nano-CT). Design This in vitro study included nine extracted primary maxillary central incisors and 12 maxillary lateral incisors, which were subjected to Nano-CT analysis. The resulting images of each tooth were reconstructed using the OnDemand3D software, and root canal area, volume, and taper analysis were performed using the free FreeCAD 0.18 software for the 3D computer-aided design (CAD) model. Data were statistically analysed using the Stata v14.0 software, adopting a significance level of 5%. Results The results presented the mean value of the diameter and area of the root canal of primary central and lateral incisors. In addition, the taper values for both dental groups between points D0-D5, D5-D7, and D7-D10 were determined. Considering the diameters obtained over the entire length of the root, with a length of 12 mm, a conical model was constructed. Conclusion Detailed knowledge of root morphology of maxillary central and lateral incisors of primary dentition by means of Nano-CT is important to achieve faster, more accurate, and efficient endodontic treatments.

Background The objective was to analyze clinical, microbiological, and immunological periodontal parameters in patients in corrective orthodontic treatment. Materials and methods Twenty-eight patients were selected. Plaque index (PI), bleeding on probing (BOP), width of keratinized gingiva, levels of 40 bacterial species, and of 3 cytokines (IL-1β, MMP-8, and TNF-α) in gingival crevicular fluid (GCF) were evaluated at T0, before orthodontic treatment; T1, 6 months; and T2, 12 months post-treatment. Non-parametric, Friedman, Wilcoxon, ANOVA, and Spearman correlation coefficient tests were used for statistical analyses, with the significance level of 5%. Results No significant difference was found for the width of keratinized gingiva, but PI presented a significant increase at T1 and T2 (p p p > 0.05). In the microbiological analysis, red complex pathogens were in significantly greater proportions in T2 compared with T0 (p r = 0.49 p = .01) and TNF-α (r = 0.39 and p = .05). Conclusion In conclusion, corrective orthodontic treatment caused clinical periodontal alterations regarding biofilm accumulation and gingival bleeding, with alteration of periodontopathogens.

Summary Background Cardiovascular and kidney outcome trials have shown that sodium-glucose co-transporter-2 (SGLT2) inhibitors slow progression of chronic kidney disease in patients with type 2 diabetes with or without chronic kidney disease. The aim of this study was to assess whether these benefits extend to patients with type 2 diabetes treated in routine clinical practice. Methods CVD-REAL 3 was a multinational observational cohort study in which new users of SGLT2 inhibitors and other glucose-lowering drugs with measurements of estimated glomerular filtration rate (eGFR) before and after (within 180 days) initiation were identified via claims, medical records, and national registries in Israel, Italy, Japan, Taiwan, and the UK. Propensity scores for SGLT2 inhibitor initiation were developed in each country, with 1:1 matching with initiators of other glucose-lowering drugs. Propensity score included (in addition to other clinical and demographic variables) baseline eGFR and eGFR slope before SGLT2 inhibitor or other glucose-lowering drug initiation. The main outcome measure was rate of eGFR decline (slope) calculated with a linear mixed regression model. Differences in eGFR slope between SGLT2 inhibitors and other glucose-lowering drugs were calculated and pooled. We also assessed a composite outcome of 50% eGFR decline or end-stage kidney disease. Findings After propensity matching, there were 35 561 episodes of treatment initiation in each group, from 65 231 individual patients. Dapagliflozin, empagliflozin, canagliflozin, ipragliflozin, tofogliflozin, and luseogliflozin accounted for 57·9%, 34·1%, 5·7%, 1·4%, 0·5%, and 0·4% of SGLT2 inhibitor initiation episodes, respectively. At baseline, 29 363 (41·3%) of 71 122 initiations were in women, mean age was 61·3 years, mean HbA1c was 72 mmol/mol (8·71%), and mean eGFR was 90·7 mL/min per 1·73 m2. During follow-up, SGLT2 inhibitor initiation was associated with reduced eGFR decline (difference in slope for SGLT2 inhibitors vs other glucose-lowering drugs 1·53 mL/min per 1·73 m2 per year, 95% CI 1·34–1·72, p Interpretation In this large, international, real-world study of patients with type 2 diabetes, initiation of SGLT2 inhibitor therapy was associated with a slower rate of kidney function decline and lower risk of major kidney events compared with initiation of other glucose-lowering drugs. These data suggest that the benefits of SGLT2 inhibitors on kidney function identified in clinical trials seem to be largely generalisable to clinical practice. Funding AstraZeneca.

An ever-expanding number of disease-modifying drugs for multiple sclerosis have become available in recent years, after demonstrating efficacy in clinical trials. In the real-world setting, however, disease-modifying drugs are prescribed in patient populations that differ from those included in pivotal studies, where extreme age patients are usually excluded or under-represented. In this multicentre, observational, retrospective Italian cohort study, we evaluated treatment exposure in three cohorts of patients with relapsing-remitting multiple sclerosis defined by age at onset: paediatric-onset (≤18 years), adult-onset (18–49 years) and late-onset multiple sclerosis (≥50 years). We included patients with a relapsing-remitting phenotype, ≥5 years follow-up, ≥3 Expanded Disability Status Scale (EDSS) evaluations and a first neurological evaluation within 3 years from the first demyelinating event. Multivariate Cox regression models (adjusted hazard ratio with 95% confidence intervals) were used to assess the risk of reaching a first 12-month confirmed disability worsening and the risk of reaching a sustained EDSS of 4.0. The effect of disease-modifying drugs was assessed as quartiles of time exposure. We found that disease-modifying drugs reduced the risk of 12-month confirmed disability worsening, with a progressive risk reduction in different quartiles of exposure in paediatric-onset and adult-onset patients [adjusted hazard ratios in non-exposed versus exposed >62% of the follow-up time: 8.0 (3.5–17.9) for paediatric-onset and 6.3 (4.9–8.0) for adult-onset, P

PURPOSE: To identify predictors of bubble formation and type during big-bubble deep anterior lamellar keratoplasty (BB-DALK) performed in keratoconus at different stages of severity. DESIGN: Retrospective Cohort Study. METHODS: Setting: University Magna Græcia (Catanzaro, Italy); Study Population: Consecutive keratoconus patients undergoing BB-DALK from September 2014 to Feb- ruary 2019; Observation Procedure: Keratometric astigmatism, mean keratometry value (K-mean), highest keratometry value (K-max), thinnest point, anterior segment Optical Coherence Tomography (AS-OCT)-based stage of ectasia. Main Outcome Measures: Rate of bubble formation and type; number and fate of micro/macro-perforation; conver- sion to mushroom keratoplasty (MK); comparison of parameters in patients with bubble formation vs failure and in type 1 vs type 2 bubble; areas under the curves (AUC) of preoperative parameters for distinguishing between bubble types. RESULTS: Pneumatic dissection succeeded in 113/155 eyes (72.9%), with 100 type 1 bubbles (88.4%), 11 type 2 (9.8%) and 2 mixed-type (1.8%). Micro-perforations were managed conservatively in type-1 bubbles; macro-perforations occurring in both types of bubbles required conversion to MK. Preoperative K-mean and K-max values were significantly higher in eyes in which bubble formation succeeded (respectively, P=0.006 and P

Background Psychological well-being and quality of life (QoL) are important outcomes of lifestyle interventions, as a positive impact may favour long-term maintenance of behaviour change. Objective This study investigated the effect of a behavioural intervention for adopting and maintaining an active lifestyle on psychological well-being and health-related QoL in individuals with type 2 diabetes. Methods Three hundred physically inactive and sedentary patients were randomized 1:1 to receive 1 month’s theoretical and practical counselling once a year (intervention group, INT) or standard care (control group, CON) for 3 years. Psychological well-being and QoL, assessed using the World Health Organization (WHO)-5 and the 36-Item Short Form (SF-36) questionnaire, respectively, were pre-specified secondary endpoints. The primary endpoint was sustained behaviour change, as assessed by accelerometer-based measurement of physical activity (PA) and sedentary time. Results WHO-5 and SF-36 physical and mental component summary (PCS and MCS) scores increased progressively in the INT group and decreased in the CON group, resulting in significant between-group differences (WHO-5: mean difference 7.35 (95% confidence interval (CI) 3.15–11.55), P = 0.0007; PCS 4.20 (95% CI 2.25–6.15), P P = 0.0025). Percentage of participants with likely depression decreased in the INT group and increased in the CON group. PA volume changes were independently associated with WHO-5 changes, which were significantly higher in participants who accumulated > 150 min·wk−1 of moderate-to-vigorous intensity PA versus those who did not (13.06 (95% CI 7.51–18.61), P Conclusion A counselling intervention that was effective in promoting a sustained change in PA and sedentary behaviour significantly improved psychological well-being and QoL. Trial Registration ClinicalTrials.gov; NCT01600937; 10 October 2012.

OBJECTIVE In the Italian Diabetes and Exercise Study_2 (IDES_2), behavioral counseling promoted a sustained increase in physical activity (PA) volume (+3.3 MET h ⋅ week−1), moderate- to vigorous-intensity PA (MVPA) (+6.4 min ⋅ day−1), and light-intensity PA (LPA) (+0.8 h ⋅ day−1) and decrease in sedentary time (SED-time) (−0.8 h ⋅ day−1). Here, we investigated the relationships of changes in PA/SED-time with changes in physical fitness and cardiometabolic risk profile in individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS In this 3-year randomized clinical trial, 300 physically inactive and sedentary patients were randomized 1:1 to receive 1-month theoretical and practical counseling once a year or standard care. Changes in physical fitness and cardiovascular risk factors/scores according to quartiles of accelerometer-measured changes in PA/SED-time were assessed, together with univariate and multivariable associations between these parameters, in the whole cohort and by study arm. RESULTS Physical fitness increased and HbA1c and coronary heart disease 10-year risk scores decreased with quartiles of MVPA and SED-time change. In quartile IV of MVPA increase and SED-time decrease, cardiorespiratory fitness increased by 5.23 and 4.49 mL ⋅ min−1 ⋅ kg−1 and HbA1c decreased by 0.73 and 0.85%, respectively. Univariate correlations confirmed these relationships, and mean changes in both MPVA and SED-time predicted changes in physical fitness and cardiovascular risk factors/scores independently of one another and of other confounders. Similar findings were observed with LPA and PA volume and in each group separately. CONCLUSIONS Even modest increments in MVPA may have a clinically meaningful impact, and reallocating SED-time to LPA may also contribute to improved outcomes, possibly by increasing total energy expenditure.

Introduction Real-world evidence on the effectiveness and safety of insulin degludec (IDeg) in patients with diabetes is a priority. We have therefore evaluated the effectiveness and safety of IDeg, including impact on metabolic control, glycemic variability, weight gain and hypoglycemia, in patients with type 1 diabetes under routine clinical practice conditions. Methods This was an observational longitudinal multicenter study. A retrospective chart review of all patients with type 1 diabetes who were switched from basal insulin to IDeg was performed, and temporal trends in clinical outcomes were assessed. Results Data obtained from 195 patients, with a median age of 42.8 [interquartile range (IQR) 24.6–56.4] years and a median diabetes duration of 16 (IQR 10.0–28) years, were analyzed. Median follow-up was 9.5 (IQR 7.7–11.3) months. Improvements were found in glycated hemoglobin (− 0.34%; p

AimsTo evaluate deep corneal densitometry and visual outcomes after big-bubble (BB-DALK) and visco-bubble (VB-DALK) deep anterior lamellar keratoplasty performed in patients with keratoconus.MethodsProspective comparative study of 50 advanced keratoconic patients who underwent DALK surgery; 25 eyes (group I) were completed with BB-DALK and 25 eyes (group II) with VB-DALK after the failure of pneumatic dissection. Best spectacle-corrected visual acuity (BSCVA), corneal tomographic parameters and endothelial cell count were recorded 1, 3, 6, 12 and 24 months after surgery. Densitometric analysis of the deep corneal interface was obtained using Scheimpflug tomography at each visit; values recorded were compared between the two groups and statistically analysed.ResultsBSCVA was significantly better in the BB-DALK group than the VB-DALK group (0.39±0.29 vs 0.65±0.23 logarithm of the minimum angle of resolution, respectively) for the first 3 months; and in the same time period, densitometry was significantly higher in the VB-DALK group than those recorded in the BB-DALK group (23.97±5.34 vs 17.13±4.44 grayscale units). However, densitometric values and visual acuity did not differ significantly in the two groups at 1 year. No statistically significant difference for the other variables analysed at any time frame was found.ConclusionThe use of viscoelastic substance in the VB-DALK technique may induce modification of interface stromal reflectivity resulting in reduced visual acuity up to 3 months postoperatively. However, this initial negative effect on the interface quality does not affect the long-term visual outcome, with densitometric values and visual outcomes similar in the two groups from 6 months postoperatively.

The present case report describes a multidisciplinary approach involving endodontic, restorative, surgical and periodontal treatment and rehabilitation of a central incisor with crown-root fracture (CRF) in an 11-year-old child. Although in the future possible sequelae and complications should be considered since it is an extensive trauma, the prognosis of the present case is favorable, with the occurrence of repair, evidenced by clinical, radiographic and tomographic success, after one year and six months of follow-up. It was concluded that the association of prolonged flexible splint, biological endodontic treatment, gingivoplasty and restorative/rehabilitative procedures seem to be an adequate and conservative management for CRF cases.

There are conflicting data about the role of transplant nephrectomy and immunosuppression withdrawal on the development of allosensitization and the impact on re-transplantation. We divided 109 first graft recipients into two groups according to whether they underwent nephrectomy (NX+, n = 61) or their graft was left in situ (NX-, n = 48). Sera were assessed for HLA-A/B/Cw/DR/DQ antibodies at the time of NX/transplant failure and after 3, 6, 12, 24 months. The NX+ group showed a higher rate of donor specific antibody (DSA) and non-DSA human leukocyte antigen (HLA) antibody production at all the time points. Multivariable analysis showed that nephrectomy was a strong, independent risk factor for the development of DSAs after 12 and 24 months (P = 0.005 and 0.008). In the NX- group, low tacrolimus levels correlated with DSA formation (AUC 0.817, P = 0.002; best cut-off level 2.9 ng/ml). Analysis with a standardized pool of UK donors showed a more difficult grade of HLA matchability following nephrectomy compared with the NX- group. Nephrectomy is followed by the long-term production of DSA and non-DSA HLA antibodies and negatively impacts on the chances of finding a HLA-compatible kidney. Tacrolimus levels ≥3 ng/ml are protective against the development of allosensitization and could facilitate re-transplantation in the NX- group.

BackgroundThere is a high incidence of cardiovascular disease in diabetes. Weight variability has been reported as independent risk factor for cardiovascular disease in the general population and preliminarily also in people with type 2 diabetes.MethodsUsing data from the Swedish National Diabetes Register the possible link between visit-to-visit body weight variability and the risk of cardiovascular complications among people with type 2 diabetes and without prevalent cardiovascular diseases at baseline has been evaluated. Overall, 100,576 people with type 2 diabetes, with at least five measurements of body weight taken over three consecutive years, were included. Variability was expressed as quartiles of the standard deviation of the measures during the three years. The primary composite outcome included non-fatal myocardial infarction, non-fatal stroke, and all-cause mortality and was assessed during five years following the first 3 years of exposure to weight variability.ResultsAfter adjusting for known cardiovascular risk factors, the risk of the primary composite outcome significantly increased with increasing body weight variability [upper quartile HR = 1.45; 95% confidence interval 1.39–1.52]. Furthermore, elevated body weight variability was associated with almost all the other cardiovascular complications considered (non-fatal myocardial infarction, non-fatal stroke, all-cause mortality, peripheral arterial disease, peripheral vascular angioplasty, hospitalization for heart failure, foot ulcer, and all-cause mortality).ConclusionsHigh body weight variability predicts the development of cardiovascular complications in type 2 diabetes. These data suggest that any strategy to reduce the body weight in these subjects should be aimed at maintaining the reduction in the long-term, avoiding oscillations.

Aim: The in vitro study evaluated the effect of different concentrations of green tea extract solution (GT) on the bonding durability of etch-and-rinse adhesive system to caries dentin affected (CAD). Methods: Dentinal surfaces of human third molars were polished and submitted to a microbiological caries induction protocol for 14 days. After removal of the infected dentin layer, the samples were randomly divided into 4 groups (n= 10), according to the concentration of GT solution applied in CAD, after acid etching: 0.05%; 0.2%; 2% and NT (no treatment – control). After application of a etch-and-rinse adhesive system (Adper Single Bond 2, 3M ESPE), composite resin restorations were performed on the dentin. After 24 hours, the resin-dentin blocks were sectioned 1mm2 specimens, which were subjected to the microtensile test immediately or after 6 months of storage in water. Data were submitted to two-way ANOVA for randomized blocks and Tukey test (α= 5%). Results: There was no effect of double interaction (p= 0.934). The application of 0.2% GT promoted a statistically significant increase in dentin bond strength values in comparison to the condition where GT was not used (p=0.012). There was a significant decrease of bond strength after 6 months of storage, regardless of dentin pretreatment (p = 0.007). The G test identified that there was no statistical difference regarding failure mode (p= 0.326). Conclusion: The concentration of 0.2% improved the bond strength of an etch-and-rinse adhesive system to caries affected dentin, however, none of dentin pretreatments could prevent the decrease in bond strength over time.

Background and Aims The knowledge of the impact of peritoneal dialysis (PD) program in terms of hospitalization rate can provide solid guidance for nephrologists for management purpose. In a historical cohort of adult PD patients, we examined the hospitalization rates and causes of hospital admissions. Method One hundred ninety-one consecutive PD patients between January 1st 2000 to December 31st 2018 were enrolled. The maximum follow up was 194 months. Their mean age was 65±15 years, 110 were males, 56 had co-morbidities and 67 were diabetics. The median PD vintage was 35 months (interquartile range 20-63 months). Results During the follow-up, 163 out of 191 patients (85%) underwent hospital admission for a total of 356 hospitalizations [57 hospitalizations per 100-person-years]. The most frequent cause of admission was infection (20 hospitalizations per 100-person-years) mainly due to peritonitis (12 hospitalizations per 100-person-years) followed by cardiovascular diseases (17 hospitalizations per 100-person-years). Hospitalizations due to miscellaneous causes were 21 per 100-person-years. In the whole group, high NYHA score [Incidence Rate Ratio (IRR): 1.52, 95%CI 1.21-1.89, P65 years) (IRR 1.26, 95%CI 1.02-1.56, P=0.03) and were associated to all-cause hospitalizations. In an analysis by hospitalization type, the factors related to admission for infection diseases was malnutrition (IRR: 1.91, 95%CI 1.16-3.03, P=0.005) and high NYHA score (IRR: 1.52, 95%CI 1.03-2.22, P=0.02). As expected, hospitalizations due to cardiovascular causes were strongly related to older age (>65 years) (IRR 2.02, 95%CI 1.35-3.03, P Conclusion Analyzing the causes and the rate of hospitalization in PD patients allows more accurate management of these high risk category of patients and contributes to a more efficient organization of a renal department.

Background and Aims A 21 year old boy with a diagnosis of Autosomal Recessive Polycystic Kidney Disease and Caroli disease reached a final stage of chronic kidney disease (CKD) and started haemodialysis. Method After 3 years in haemodialysis he underwent a kidney transplant from a cadaveric donor. His transplanted kidney worked fairly well until the patients was 31 year old when he developed graft dysfunction (serum creatinine from 2.7 to 5 mg/dL in a very short period). There was a concomitant increase in serum phosphate levels (8.3 mg/dl) and iPTH that progressively increased to 1032 pg/ml despite a traditional therapy. Results At age 32, the patient returned to haemodialysis treatment thrice weekly with a concomitant a progressive worsening of hyperparathyroidism with bone pain . Cinacalcet at a dosage of 30 mg daily treatment was initiated, then it was increased to 120 mg daily without any benefit. Two years later, being the clinical situation without any improvement and being the patient scarcely compliant to the therapy and because a further enlargement of parathyroid glands was observed, a Parathyroidectomy (PTX) was advised. Nevertheless, PTX was not performed because of patient’s refusal. Furthermore, despite Erythropoietic Stimulating Agent (ESA) therapy, he developed severe anemia that required regular and frequent blood transfusions. iPTH increased to 4500 pg/ml [Fig.1] with a parallel rise in alkaline phosphatase >600 UI/L [Fig.2]. A Computed Tomography scan showed multiple bone-thickening lesions. He thus initiated Etelcalcetide 5 mg e.v. 3 times a week, after the HD session but without any benefit. The dosage was then increased to 7.5 mg but the patient gradually became frail and developed pancytopenia and low-grade fever. Hematological evaluation with bone marrow biopsy was performed in December 2019. Bone marrow histology showed severe fibrosis [Myelofibrosis (MF) grade 3] with normal bone marrow cytogenetics. Blood samples for mutations in JAK-2, CALR, and MPL and BCR-ABL rearrangement were negative. There was no evidence for a myeloproliferative neoplasm (MPN) or metastatic lesions. During the following months, while on a 7,5 mg dose of etalcalcetide, there was a gradual reduction in iPTH [Fig.1] and serum alkaline phosphatase [Fig.2], up to 500 pg/dl and 200 IU/L respectively. The patient developed asymptomatic, often severe, hypocalcemia which was managed with therapy. The patient’s clinical conditions gradually improved, anemia responded to lower doses of ESAs. A bone marrow biopsy was repeated after one year (December 2020) and it showed a reduction in fibrosis (MF grade varying from 1-2). Then etelcalcetide dosage was reduced while serum calcium and phosphate levels were in the normal limit. Conclusion Myelofibrosis secondary to renal osteodystrophy is an uncommon complication. It has been rarely reported and usually is associated with primary hyperparathyroidism. Marrow fibrosis and pancytopenia is related to the excessive iPTH that upregulates production of cytokines and paracrine factors in the bone marrow (IL-1a, IL-6, FNF-a, TGF–b, and platelet-derived growth factor) and it has an important stimulatory effect on fibroblast proliferation. It is known that surgical parathyroidectomy is associated with a reduction of bone marrow fibrosis in primary hyperparathyroidism. To our knowledge, this is probably the first case of tertiary hyperparathyroidism in which the effect of etelcalcetide is comparable to parathyroidectomy as far as on calcium-phosphate balance, and a significant improvement in bone marrow fibrosis and hemoglobin. In conclusion, etelcalcetide at least in this patient seems as effective as PTX on bone balance, bone marrow and anemia.

Background: The optimal timing of treatment starts for achieving the best control on the long-term disability accumulation in multiple sclerosis (MS) is still to be defined. Objective: The aim of this study was to estimate the optimal time to start disease-modifying therapies (DMTs) to prevent the long-term disability accumulation in MS, using a pooled dataset from the Big Multiple Sclerosis Data (BMSD) network. Methods: Multivariable Cox regression models adjusted for the time to first treatment start from disease onset (in quintiles) were used. To mitigate the impact of potential biases, a set of pairwise propensity score (PS)-matched analyses were performed. The first quintile, including patients treated within 1.2 years from onset, was used as reference. Results: A cohort of 11,871 patients (median follow-up after treatment start: 13.2 years) was analyzed. A 3- and 12-month confirmed disability worsening event and irreversible Expanded Disability Status Scale (EDSS) 4.0 and 6.0 scores were reached by 7062 (59.5%), 4138 (34.9%), 3209 (31.1%), and 1909 (16.5%) patients, respectively. The risk of reaching all the disability outcomes was significantly lower ( p < 0.0004) for the first quintile patients’ group. Conclusion: Real-world data from the BMSD demonstrate that DMTs should be commenced within 1.2 years from the disease onset to reduce the risk of disability accumulation over the long term.

BackgroundThe purpose of this study was to evaluate the incidence, timing and risk factors of corneal neovascularisation (NV) after deep anterior lamellar keratoplasty (DALK) for corneal ectasia.MethodsThis study included 616 eyes who underwent DALK between 2012 and 2020 in two tertiary referral centres. In one centre topical corticosteroids were discontinued after complete suture removal 1 year after surgery, whereas in the other they were discontinued 3–4 months after surgery. The presence and severity of corneal NV was ascertained based on slit lamp photographs. Potential risk factors for corneal NV were evaluated using the Cox proportional hazards model.ResultsThe cumulative incidence of corneal NV was 8.7% at 1 year after surgery and 13.2% at 5 years. Mean time interval from surgery to development of corneal NV was 12.8±16.2 months, with 68.9% of cases occurring before complete suture removal. Early discontinuation of topical steroids, older age and ocular allergy were associated with an increased risk of developing corneal NV (respectively, HR=2.625, HR=1.019, HR=3.726, all pConclusionsThe risk of corneal NV is higher in the first year following DALK. Early discontinuation of topical steroids, ocular allergy and older age are significant predictors of corneal NV.

Introduction There are limited data pertaining to comparative outcomes of remaining on dialysis versus kidney transplantation as the threat of coronavirus disease 2019 (COVID-19) remains. In this study we delineate the differential risks involved using serologic methods to help define exposure rates. Methods From a cohort of 1433 patients with end-stage kidney disease (ESKD), we analyzed COVID-19 infection rates and outcomes in 299 waitlist patients compared with 237 transplant recipients within their first year post-transplant. Patients were followed over a 68-day period from the time our transplant program closed due to COVID-19. Results The overall mortality rates in waitlist and transplant populations were equivalent (P = 0.69). However, COVID-19 infection was more commonly diagnosed in the waitlist patients (P = 0.001), who were more likely to be tested by reverse transcriptase polymerase chain reaction (P = 0.0004). Once infection was confirmed, mortality risk was higher in the transplant patients (P = 0.015). The seroprevalence in dialysis and transplant patients with undetected infection was 18.3% and 4.6%, respectively (P = 0.0001). After adjusting for potential screening bias, the relative risk of death after a diagnosis of COVID-19 remained higher in transplant recipients (hazard ratio = 3.36 [95% confidence interval = 1.19–9.50], P = 0.022). Conclusions Although COVID-19 infection was more common in the waitlist patients, a higher COVID-19‒associated mortality rate was seen in the transplant recipients, resulting in comparable overall mortality rates.

To investigate the correlation between postoperative corneal astigmatism (PCA) and values of intraoperative keratoscopy analyzed with a newly developed automated technique in patients undergoing big-bubble (BB) deep anterior lamellar keratoplasty (DALK). Photographs of keratoscope rings taken at the end of BB-DALK were analyzed using ImageJ for the calculation of “roundness” (R): values = 1 indicate a perfect circle. Pearson’s correlation was used to evaluate the relationship between R and PCA that measured 1 week (V1), 3 months (V2), and 18 months (V3), postoperatively. The area under the curve (AUC) of receiver operating characteristic (ROC) curve was used to evaluate the accuracy of R for identifying patients with PCA

Animal studies have shown that irisin is a myokine secreted following physical exercise, and that it induces the remodeling of white adipose tissue toward brown adipose tissue. Therefore, a protective role of irisin against obesity, diabetes, and other metabolic and cardiovascular conditions has been hypothesized. However, data in humans are contradictory and few data are available concerning the general population.We aimed to evaluate the association between serum irisin concentrations and habitual physical activity, as well as other metabolic and cardiovascular factors in a general population in a Mediterranean area.We considered 858 consecutive individuals included in the ABCD (Alimentazione, Benessere Cardiovascolare e Diabete) study (ISRCTN15840340), a longitudinal observational single-center study of a cohort representative of the general population of Palermo, Sicily. Irisin serum concentrations (Phoenix Europe, Germany), habitual physical activity (HPA) level, and other blood and clinical variables were measured.The irisin serum concentrations were not normally distributed in the cohort (Shapiro-Wilk test=0.94; P0.001). A significant association between irisin concentrations and HPA was observed (P0.001). Irisin concentrations were higher in women than in men (P0.01), and significantly correlated with serum concentrations of HDL-cholesterol (P0.05) and hs-C-reactive protein (hs-CRP; P0.05). Binary logistic regression analysis demonstrated that high (⩾ median value) irisin serum concentrations were significantly associated with female gender (OR=1.63; 95% CI=1.16-2.28), high serum hs-CRP concentrations (OR=1.61; 95% CI=1.02-2.54) and the HPA level (OR=1.42; 95% CI=1.02-1.96).Our study confirms, in a cohort of a general population, that irisin concentrations gradually increase with the usual level of habitual physical activity.

Objective The aim of this work was to assess through a questionnaire the features of vertiginous episodes, accompanying symptoms, familial history, and migraine precursors in a sample of 252 subjects with a diagnosis of definite vestibular migraine. Background Migraine is a common neurological disorder characterized by episodic headaches with specific features. About two-thirds of cases run in families, and patients may refer symptoms occurring in infancy and childhood, defined as episodic syndromes that may be associated with migraine. Migraine is associated with episodic vertigo, called vestibular migraine, whose diagnosis mainly relies on clinical history showing a temporary association of symptoms. Methods In this cross-sectional multicentric study, 252 subjects were recruited in different centers; a senior specialist through a structured questionnaire assessed features of vestibular symptoms and accompanying symptoms. Results The age of onset of migraine was 23 years, while onset of vertigo was at 38 years. One hundred and eighty-four subjects reported internal vertigo (73%), while 63 subjects (25%) reported external vertigo. The duration of vertigo attacks was less than 5 minutes in 58 subjects (23%), between 6 and 60 minutes in 55 (21.8%), between 1 and 4 hours in 29 (11.5%), 5 and 24 hours in 44 (17.5%), up to 3 days in 14 (5.5%), and more than 3 days in seven (2.8%); 14 subjects (5.5%) referred attacks lasting from less than 5 minutes and up to 1 hour, nine (3.6%) referred attacks lasting from less than 5 minutes and up to 1 to 4 hours, six (2.4%) referred attacks lasting from less than 5 minutes and up to 5 to 24 hours, and five (2%) cases referred attacks lasting from less than 5 minutes and up to days. Among accompanying symptoms, patients referred the following usually occurring, in order of frequency: nausea (59.9%), photophobia (44.4%), phonophobia (38.9%), vomiting (17.8%), palpitations (11.5%), tinnitus (10.7%), fullness of the ear (8.7%), and hearing loss (4%). In total, 177 subjects referred a positive family history of migraine (70.2%), while 167 (66.3%) reported a positive family history of vertigo. In the sample, 69% of patients referred at least one of the pediatric precursors, in particular, 42.8% of subjects referred motion sickness. The age of onset of the first headache was lower in the subsample with a familial history of migraine than in the total sample. Among the pediatric precursors, benign paroxysmal vertigo - BPV, benign paroxysmal torticollis, and motion sickness were predictive of a lower age of onset of vertigo in adulthood; cyclic vomiting was predictive for vomiting during vertigo attacks in adults. Conclusions Our results may indicate that vestibular symptoms in pediatric patients may act as a predisposing factor to develop vestibular migraine at an earlier age in adulthood.

Migraine is a common neurological disorder characterized by episodic headaches with specific features, presenting familial aggregation. Migraine is associated with episodic vertigo, named Vestibular Migraine (VM) whose diagnosis mainly rely on clinical history showing a temporary association of symptoms. Some patient refers symptoms occurring in pediatric age, defined "episodic symptoms which may be associated with migraine." The aim of this cross sectional observational study was to assess migraine-related clinical features in VM subjects. For the purpose, 279 patients were recruited in different centers in Europe; data were collected by a senior neurologist or ENT specialist through a structured questionnaire. The age of onset of migraine was 21.8 ± 9. The duration of headaches was lower than 24 h in 79.1% of cases. Symptoms accompanying migrainous headaches were, in order of frequency, nausea (79.9%), phonophobia (54.5%), photophobia (53.8%), vomiting (29%), lightheadedness (21.1%). Visual or other auras were reported by 25.4% of subjects. A familial aggregation was referred by 67.4%, while migraine precursors were reported by 52.3% of subjects. Patients reporting nausea and vomiting during headaches more frequently experienced the same symptoms during vertigo. Comparing our results in VM subjects with previously published papers in migraine sufferers, our patients presented a lower duration of headaches and a higher rate of familial aggregation; moreover some common characters were observed in headache and vertigo attacks for accompanying symptoms like nausea and vomiting and clustering of attacks.

The increase in disease-modifying drugs (DMDs) allows individualization of treatment in relapsing multiple sclerosis (RMS); however, the long-term impact of different treatment sequences is not well established. This is particularly relevant for MS patients who may need to postpone more aggressive DMD strategies. To evaluate different therapeutic strategies and their long-term outcomes, measured as relapses and confirmed disability progression (CDP), in MS ‘real-world’ settings. Multicentre, observational, retrospectively acquired cohort study evaluating the long-term impact of different treatment strategies on disability outcomes in patients with RMS in the Italian MS Register. We evaluated 1152 RMS-naive patients after propensity-score adjustment. Patients included were receiving: interferon beta-1a (IFN-β1a) 44 µg switching to fingolimod (FTY; IFN-switchers; n = 97); FTY only (FTY-stayers; n = 157); IFN-β1a only (IFN-stayers; n = 849). CDP and relapses did not differ between FTY-stayers and IFN-switchers [HR (95% CI) 0.99 (0.48–2.04), p = 0.98 and 0.81 (0.42–1.58), p = 0.55, respectively]. However, IFN-stayers showed increased risk of relapses compared with FTY-stayers [HR (95% CI) 1.46 (1.00–2.12), p = 0.05]. The ideal treatment option for MS is becoming increasingly complex, with the need to balance benefit and risks. Our results suggest that starting with FTY affects the long-term disease outcome similarly to escalating from IFN-β1a to FTY.

Context Hypoglycemic drugs with proven cardiovascular (CV) benefits are recommended for patients with type 2 diabetes and CV disease. Whether the beneficial effects extend to those at lower risk remains unclear. Aim We investigated the long-term CV effects of pioglitazone or sulfonylureas (SUs) across the spectrum of pretreatment CV risk. Methods Among 2820 participants of the TOSCA.IT trial, four subgroups with different risk of outcome-a composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, urgent coronary revascularization-were identified by the RECursive Partitioning and AMalgamation (RECPAM) method. Within each group, the effect of SUs or pioglitazone on the outcome was evaluated. Results Sex was the first splitting variable, followed by urinary albumin-to-creatinine ratio (UACR) (>9 mg/g or ≤9 mg/g) and body mass index (BMI) (>28.7 or ≤28.7 kg/m2). Female patients had the lowest risk (reference); male patients with UACR >9 mg/g and BMI >28.7 kg/m2 had the highest risk [hazard ratio (HR), 5.58; 95% CI, 3.32 to 9.69]. Patients in this group present a cluster of conditions suggestive of marked insulin resistance (higher BMI, waist circumference, triglycerides, blood pressure, and UACR and lower high-density lipoprotein cholesterol) than the other groups. Treatment with pioglitazone in this group was associated with a significantly lower occurrence of the outcome than SUs (HR, 0.48; 95% CI, 0.25 to 0.76). No significant difference between study treatments was observed in the other RECPAM classes. Conclusions It is possible to identify patients with type 2 diabetes early in the stage of their disease and who are largely free from evident CV disease in whom add-on pioglitazone to metformin confers CV protection as compared with SUs.

Background Current guidelines suggest to consider dual antiplatelet therapy (DAPT) continuation for longer than 12 months in selected patients with myocardial infarction (MI). Hypothesis We sought to assess the criteria used by cardiologists in daily practice to select patients with a history of MI eligible for DAPT continuation beyond 1 year. Methods We analyzed data from the EYESHOT Post-MI, a prospective, observational, nationwide study aimed to evaluate the management of patients presenting to cardiologists 1 to 3 years from the last MI event. Results Out of the 1633 post-MI patients enrolled in the study between March and December 2017, 557 (34.1%) were on DAPT at the time of enrolment, and 450 (27.6%) were prescribed DAPT after cardiologist assessment. At multivariate analyses, a percutaneous coronary intervention (PCI) with multiple stents and the presence of peripheral artery disease (PAD) resulted as independent predictors of DAPT continuation, while atrial fibrillation was the only independent predictor of DAPT interruption for patients both at the second and the third year from MI at enrolment and the time of discharge/end of the visit. Conclusions Risk scores recommended by current guidelines for guiding decisions on DAPT duration are underused and misused in clinical practice. A PCI with multiple stents and a history of PAD resulted as the clinical variables more frequently associated with DAPT continuation beyond 1 year from the index MI.

Background The risk of COVID-19 infection in transplant recipients is unknown. Patients on dialysis may be exposed to greater risk of infection due to an inability to isolate. Consideration of these competing risks is important before restarting suspended transplant programs. This study compared outcomes in kidney and kidney/pancreas transplant recipients with those on the waiting list, following admission with COVID-19 in a high prevalence region. Methods Audit data from all 6 London transplant centres were amalgamated. Demographic and laboratory data were collected and outcomes included mortality, intensive care (ITU) admission and ventilation. Adult patients who had undergone a kidney or kidney/pancreas transplant, and those active on the transplant waiting list at the start of the pandemic were included. Results 121 transplant recipients (TR) and 52 waiting list patients (WL) were admitted to hospital with COVID-19. 36 TR died (30%), whilst 14 WL patients died (27% p=0.71). There was no difference in rates of admission to ITU or ventilation. 24% of TR required renal replacement therapy, and 12% lost their grafts. Lymphocyte nadir and D-dimer peak showed no difference in those who did and did not die. No other co-morbidities or demographic factors were associated with mortality, except for age (odds ratio of 4.3 [95% CI 1.8 - 10.2] for mortality if aged over 60 years) in TR. Conclusions Transplant recipients and waiting list patients have similar mortality rates after hospital admission with COVID-19. Mortality was higher in older transplant recipients. These data should inform decisions about transplantation in the COVID era.

The aim of this study was to assess the impact of osteopathic manipulative treatment (OMT) on newborn babies admitted at a neonatal intensive care unit (NICU). This was an observational, longitudinal, retrospective study. All consecutive admitted babies were analyzed by treatment (OMT vs. usual care). Treatment group was randomly assigned. Between-group differences in weekly weight change and length of stay (LOS) were evaluated in the overall and preterm populations. Among 1249 babies (48.9% preterm) recorded, 652 received usual care and 597 received OMT. Weight increase was more marked in the OMT group than in the control group (weekly change: +83 g vs. +35 g, p &lt, 0.001). Similar trends were found in the subgroup of preterm babies. A shorter LOS was found in the OMT group vs. the usual care group both in overall population (average mean difference: &minus, 7.9 days, p = 0.15) and in preterm babies (&minus, 12.3 days, p = 0.04). In severe preterm babies, mean LOS was more than halved as compared to the control group. OMT was associated with a more marked weekly weight increase and, especially in preterm babies, to a relevant LOS reduction: OMT may represent an efficient support to usual care in newborn babies admitted at a NICU.

Trauma-induced coagulopathy (TIC) is well documented in injured children. However, many important features of pediatric hemostasis are still in development in early childhood and may impact TIC. Certain pediatric subgroups are at a higher risk. Traumatic brain injury, which occurs with a higher rate in children, and physical child abuse are known risk factors for TIC that deserve special consideration. Resuscitation of a pediatric trauma patient follows many of the same goals as in the injured adult trauma, although some key aspects of pediatric resuscitation require ongoing investigation. Venous thromboembolism occurs with higher rates in certain high-risk groups of pediatric trauma patients, although overall it is considerably less frequent in children as compared with adults.

Purpose. To evaluate the feasibility and the initial outcomes of a novel standardized surgical technique of femtosecond laser- (FSL-) assisted big-bubble deep anterior lamellar keratoplasty (BBDALK) for eyes with keratoconus. Methods. This prospective interventional case series included 11 consecutive FSL-assisted BBDALK procedures performed for the eyes with keratoconus from September 2019 to December 2019. The FSL was used to create (i) an intrastromal channel incision (1.7 mm in length, 4.6 mm in width, 80% depth, and cut energy of 1.70 μJ) and (ii) a 9.0 mm diameter circular lamellar side cut 65 μm above the endothelium (cut energy of 0.90 μJ) intersecting the intrastromal incision. In the operating room, a blunt dissector was used to open the intrastromal channel incision, through which a blunt spatula was inserted, tangentially advanced towards the center of the cornea, and replaced with a blunt cannula for pneumatic dissection. The subsequent surgical steps did not differ from the conventional technique. Main outcome measures were the success rate of pneumatic dissection and the percentage of intraoperative complications. Results. Eleven eyes of 11 patients (6 males and 5 females; mean age: 34.54 ± 13.23 years) underwent FSL-assisted DALK. Using the FSL, both corneal incisions (lamellar side cut and intrastromal channel incision) were successfully created in all cases without the need for repeat docking or additional dissection. Pneumatic dissection with type 1 bubble formation succeeded in all 11 eyes (100%). DALK surgery was completed uneventfully in all cases. Descemet membrane perforation did not occur in any case, and no procedure was converted to penetrating keratoplasty. Conclusion. Using standardized FSL parameters for both incision design and cut energy in BBDALK surgery, pneumatic dissection can be achieved in a very high rate of cases with minimal risk of intraoperative complications.

To report the first two cases of sterile corneal perforation secondary to vitamin A deficiency after biliopancreatic diversion with duodenal switch (BPD/SW). Observational case series. Two patients with a history of BPD/SW presented with corneal perforation associated with conjunctival xerosis and keratopathy. In both cases, serum vitamin A level dosage revealed a marked deficit, and the patients admitted poor compliance with vitamin supplementation. Oral therapy with vitamin A was started immediately, and in one case ocular surgery was performed to preserve the integrity of the globe. Ophthalmologists should carefully examine the ocular surface of patients undergone bariatric surgery in order to promptly recognize the signs of vitamin A deficiency and avoid serious sight-threatening complications.

In the last years, due to new regulatory guidelines requiring a stringent documentation of cardiovascular (CV) safety of novel drugs for type 2 diabetes, cardiovascular outcomes safety trials (CVOTs) are requested. CVOTs increase the knowledge about the safety profile of the new drugs, but they have intrinsic limits that make difficult their transferability to clinical practice. For this reason, real world evidence is considered an important complement to experimental data. Among the glucagon-like peptide-1 receptor agonists, liraglutide in the LEADER CVOT demonstrated superiority in reducing the risk of major CV events (MACEs) vs. placebo. We conducted an observational, retrospective, longitudinal study based on 307 patients with T2DM treated with liraglutide under routine clinical practice conditions. Real world impact of liraglutide on metabolic control, CV risk factors, hypoglycemia and CV events was assessed. Improvements during 36 months were found in HbA1c (–1.0%; p Incidence of MACEs in this cohort was lower than in the LEADER study (2.59 vs. 3.4 events per 100 person-years), confirming CV safety of liraglutide even in the real world. On the other hand, a higher incidence of CV event in patients with established CV disease was documented (8.1 events per 100 person-years), in spite of the use of liraglutide. In conclusion, 36-month durability and CV safety of liraglutide were documented in a real world cohort of T2DM patients, with sustained benefits on a large array of CV risk factors.

Rice starches and flours have unique attributes that make them interesting ingredients in the food industry (e.g. hypo-allergenic, gluten-free, bland in flavour, capable of giving consistency). In particular, the rheological properties of the starchy matrix during food processing and storage strongly influence the quality and shelf-life of the final products. Even though several works in literature concern rice gels rheology, none of them deeply investigated the steps associated with the conversion of rice slurries into gels, and the influence of the thermal and mechanical history, in addition to flour composition, on the rheological properties of the resulting gels. This study explores the variations in the rheological properties of the slurries obtained from two rice flours having a different amylose content and subjected to specific hydrothermal and mechanical profiles while developing into gels. First, rice flours were characterized for their proximate composition and pasting properties. Then, the slurries collected after different processing times were submitted to fundamental rheological measurements. Additional evaluations were performed on the gels during 4 days ageing at 4 °C. The amylose content strongly influenced the pasting profiles and the viscoelastic properties of the developing gels to different extents in relation to their hydrothermal history. Results evidenced that the thickening and networking action are determined mainly by the starch amount during the first stages of gel development, and by the amylose content later on. The obtained results can be useful in fully understanding the rice gel behaviour and in addressing the processability of rice flour for food applications.

Background Older adults dialysis patients represent the frailest subgroup of the End Stage Renal Disease (ESRD) population and physical exercise program may mitigate the age-related decline in muscle mass and function. Methods Dialysis patients of the EXCITE trial aged > 65 years (n = 115, active arm, n = 53; control arm, n = 62) were submitted in random order to a home based, low intensity physical exercise program. At baseline and 6 months after exercise training 6-min walking distance (6MWD) and 5-time sit-to-stand test (5STS) were performed, and quality of life (QoL) was tested. Results The training program improved both the 6MWD (6-months: 327 ± 86 m versus baseline: 294 ± 74 m; P

Background/aim The extra-alveolar dry period and storage medium in which a tooth is kept prior to replantation remain critical factors affecting the survival and repair potential of the periodontal ligament in avulsed teeth. When replantation is not immediate, replacement root resorption (RRR) is the most common complication. The aim of this histological study was to evaluate the effect of immediate controlled-orthodontic forces in periodontal healing of replanted teeth in a canine model. Material and methods Sixty maxillary and mandibular premolar roots were endodontically treated in vivo and subsequently hemisected and extracted. Roots were replanted after an extraoral dry time of 20 minutes and randomly assigned to two experimental groups: Group 1: root was stabilized with a flexible and passive bracket/stainless steel wire splint for 2 weeks; Group 2: root was stabilized with a flexible bracket/NiTi wire splint activated with orthodontic elastics for 2 weeks. After 4 months, the dogs were euthanized, and all specimens were processed for histology and microscopically evaluated. Results The mean percentage of RRR for Group 2 was 3.17 compared with 12.13 in Group 1. Eighty-three percent of specimens from Group 2 exhibited similar healing to the negative control group, compared to 60.5% of the specimens from Group 1. No statistical difference was found in periodontal healing between experimental groups. Conclusion Immediate application of mild and controlled orthodontic forces was not detrimental to the periodontal healing of teeth replanted after 20 minutes extraoral dry time, although no significant improvement on periodontal healing was observed.