Safety and efficacy of natalizumab in children with multiple sclerosis.

OBJECTIVE: To describe the effect of natalizumab in the treatment of subjects with active multiple sclerosis (MS) treated before the age of 18 years. METHODS: Nineteen pediatric subjects with MS (mean age 14.6 +/- 2.2 years, mean number of attacks 5.2 +/- 1.9 during the pretreatment phase of 27.7 +/- 19.7 months, median pretreatment Expanded Disability Status Scale score [EDSS] 2.5, range 1.0-5.0) were treated with natalizumab at the dose of 300 mg every 28 days. After treatment initiation, patients were reassessed clinically every month; brain MRI was performed at baseline and every 6 months. RESULTS: Patients received a median number of 15 infusions (range 6-26). A transient reversible worsening of preexisting symptoms occurred in 1 subject during and following the first infusion. All the patients remained relapse-free during the whole follow-up. The median EDSS decreased from 2.5 to 2.0 at the last visit (p < 0.001). EDSS remained stable in 5 cases, decreased by at least 0.5 point in 6 cases, and decreased by at least 1 point in 8 cases. At baseline, the mean number of gadolinium-enhancing lesions was 4.1 (range 1-20). During the follow-up, no gadolinium-enhancing lesions were detected (p = 0.008); 3 patients developed new T2-visible lesions at month 6 scan but the overall number of T2 lesions remained stable during the subsequent follow-up. Transient and mild side effects occurred in 8 patients. CONCLUSIONS: Natalizumab was well-tolerated in all subjects. A strong suppression of disease activity was observed in all subjects during the follow-up. Classification of evidence: This study provides Class IV evidence that natalizumab, 300 mg IV once every 28 days, decreased EDSS scores in pediatric patients with MS over a mean treatment period of 15.2 months

The impact of psychological distress on weight regain in post-bariatric patients during the COVID-19 pandemic: A latent profile analysis

Objective: The COVID-19 pandemic has caused a global health crisis disrupting healthcare delivery for people with severe obesity who have undergone bariatric surgery. This study examined the role of psychological distress during the first Italian COVID-19 lockdown in predicting post-operative outcomes in post-bariatric patients reaching the end of the 12-18&nbsp;months follow-up during the lockdown. By using a person-centered approach, groups of patients with different psychological distress profiles were identified. We hypothesized that compared to post-bariatric patients with low psychological distress, post-bariatric patients with high psychological distress will be more at risk of weight regain. Methods: A total of 67 patients (71.6% female, Mage&nbsp;=&nbsp;45.9) participated in this observational retrospective cohort study. Patients' anthropometric data were gathered from medical records while the weight at the end of the lockdown through phone interviews. Psychological distress, operationalized with anxiety symptoms, depressive symptoms, and sleep disturbances, was assessed by an online self-report questionnaire. Results: Significant differences were highlighted in the high and low psychological distressed group in weight changes, F(1,58)&nbsp;=&nbsp;5.2, p&nbsp;&lt;&nbsp;0.001, η2&nbsp;=&nbsp;0.3. Specifically, compared to post-bariatric patients in the low psychological distress group, those in the high psychological distressed group reported weight regained (95% CI&nbsp;=&nbsp;1.0, 2.6). Conclusion: Results highlight the need to target post-bariatric patients with high psychological distress who are at risk for weight regain during the COVID-19 pandemic. Interventions mitigating psychological distress and obesogenic behaviors during future pandemics or in post-COVID times are needed in vulnerable post-bariatric patients reporting high psychological distress

Pirfenidone in idiopathic pulmonary fibrosis: real-life experience in the referral centre of Siena

Background: Idiopathic pulmonary fibrosis (IPF) is the most common idiopathic interstitial pneumonia and has a median survival after diagnosis of 2–5 years. Pirfenidone is the first approved antifibrotic drug for the treatment of IPF. Here we report the functional progress, side effects and survival data of a population of patients with IPF, diagnosed at our centre and treated with pirfenidone. Methods: We enrolled 91 patients with IPF (71 males) treated with pirfenidone. Clinical, survival and functional details were collected retrospectively at start of therapy and after 12, 24, 36 and 48 months of treatment. Lung function tests at least 12 months before starting therapy were available for 40 patients and were entered in the database, as well as side effects. Results: During the observation period (922 ± 529 days), 27 patients died, 5 patients underwent lung transplant and 10 patients interrupted therapy due to adverse events or IPF progression. The median survival was 1606 days. There was a significant reduction in disease progression rate, as measured by trend of forced vital capacity, after 1 year of therapy with respect to before treatment (p = 0.0085). Forced vital capacity reduction rate was progressively higher in the subsequent years of treatment. Treatment-related side effects were reported in 25 patients and were predominantly mild. Overall, four patients discontinued therapy due to severe photosensitivity. Conclusions: Our findings confirm the efficacy of pirfenidone in reducing functional progression of IPF and its excellent safety profile in a real-life setting. This study, designed on a long-term follow up, contributes to the growing evidence on safety, tolerability and efficacy of pirfenidone in IPF. The reviews of this paper are available via the supplemental material section

Orphan crops of archaeology-based crop history research

So-called ‘forgotten’ or ‘orphan’ crops are an important component of strategies aimed at preserving and promoting biodiversity. Knowledge of historical cultivation, usage, and geographic and evolutionary trajectories of plants, that is, crop history research, is important for the long-term success of such efforts. However, research biases in the crops chosen for study may present hurdles. This review attempts to systematically identify patterns in crop species representativeness within archaeology-based crop history research. A meta-analysis and synthesis of archaeo- botanical evidence (and lack thereof) is presented for 268 species known to have been cultivated for food prior to 1492 CE from the Mediterranean region to South Asia. We identified 39 genera with known crop plants in this geographical and histor- ical context that are currently absent from its archaeobotanical record, constituting ‘orphan’ crops of archaeobotany. In addition, a worldwide synthesis of crop species studied using geometric morphometric, archaeogenetic and stable isotope analyses of archaeological plant remains is presented, and biases in the species represented in these disciplines are discussed. Both disciplinary methodological biases and economic agenda-based biases affecting species representativeness in crop history research are apparent. This study also highlights the limited geographic diffusion of most crops and the potential for deeper historical perspectives on how crops become marginal- ized and ‘forgotten’

A Real-Life Multicenter National Study on Nintedanib in Severe Idiopathic Pulmonary Fibrosis

Background: Two therapeutic options are currently available for patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF): pirfenidone and nintedanib. To date, there is still insufficient data on the efficacy of these 2 agents in patients with more severe disease. Objectives: This national, multicenter, retrospective real-life study was intended to determine the impact of nintedanib on the treatment of patients with severe IPF. Methods: All patients included had severe IPF and had to have at least 6 months of follow-up before and at least 6 months of follow-up after starting nintedanib. The aim of the study was to compare the decline in lung function before and after treatment. Patient survival after 6 months of therapy with nintedanib was assessed. Results: Forty-one patients with a forced vital capacity (FVC) 6450% and/or a diffusing capacity of the lung for carbon monoxide (DLCO) 6435% predicted at the start of nintedanib treatment were enrolled. At the 6-month follow-up, the decline of DLCO (both absolute and % predicted) was significantly reduced compared to the pretreatment period (absolute DLCO at the -6-month, T0, and +6-month time points (5.48, 4.50, and 5.03 mmol/min/kPa, respectively, p = 0.03; DLCO% predicted was 32.73, 26.54, and 29.23%, respectively, p = 0.04). No significant beneficial effect was observed in the other functional parameters analyzed. The 1-year survival in this population was 79%, calculated from month 6 of therapy with nintedanib. Conclusions: This nationwide multicenter experience in patients with severe IPF shows that nintedanib slows down the rate of decline of absolute and % predicted DLCO but does not have significant impact on FVC or other lung parameters

Effects of Bariatric Surgery on COVID-19: a Multicentric Study from a High Incidence Area

Introduction: The favorable effects of bariatric surgery (BS) on overall pulmonary function and obesity-related comorbidities could influence SARS-CoV-2 clinical expression. This has been investigated comparing COVID-19 incidence and clinical course between a cohort of patients submitted to BS and a cohort of candidates for BS during the spring outbreak in Italy. Materials and Methods: From April to August 2020, 594 patients from 6 major bariatric centers in Emilia-Romagna were administered an 87-item telephonic questionnaire. Demographics, COVID-19 incidence, suggestive symptoms, and clinical outcome parameters of operated patients and candidates to BS were compared. The incidence of symptomatic COVID-19 was assessed including the clinical definition of probable case, according to World Health Organization criteria. Results: Three hundred fifty-three operated patients (Op) and 169 candidates for BS (C) were finally included in the statistical analysis. While COVID-19 incidence confirmed by laboratory tests was similar in the two groups (5.7% vs 5.9%), lower incidence of most of COVID-19-related symptoms, such as anosmia (p: 0.046), dysgeusia (p: 0.049), fever with rapid onset (p: 0.046) were recorded among Op patients, resulting in a lower rate of probable cases (14.4% vs 23.7%; p: 0.009). Hospitalization was more frequent in C patients (2.4% vs 0.3%, p: 0.02). One death in each group was reported (0.3% vs 0.6%). Previous pneumonia and malignancies resulted to be associated with symptomatic COVID-19 at univariate and multivariate analysis. Conclusion: Patients submitted to BS seem to develop less severe SARS-CoV-2 infection than subjects suffering from obesity

First finds of Prunus domestica L. in Italy from the Phoenician and Punic periods (6th-2nd centuries BC)

Abstract During the archaeological excavations in the Phoenician and Punic settlement of Santa Giusta (Oristano, Sardinia, Italy), dating back to the 6th–2nd centuries bc, several Prunus fruitstones (endocarps) inside amphorae were recovered. The exceptional state of preservation of the waterlogged remains allowed morphometric measurements to be done by image analysis and statistical comparisons made with modern cultivated and wild Prunus samples collected in Sardinia. Digital images of modern and archaeological Prunus fruitstones were acquired with a flatbed scanner and analysed by applying image analysis techniques to measure 26 morphometric features. By applying stepwise linear discriminant analysis, a morphometric comparison was made between the archaeological fruitstones of Prunus and the modern ones collected in Sardinia. These analyses allowed identification of 53 archaeological fruitstones as P. spinosa and 11 as P. domestica. Moreover, the archaeological samples of P. spinosa showed morphometric similarities in 92.5% of the cases with the modern P. spinosa samples currently growing near the Phoenician and Punic site. Likewise, the archaeological fruitstones identified as P. domestica showed similarities with the modern variety of P. domestica called Sanguigna di Bosa which is currently cultivated near the village of Bosa. Currently, these findings represent the first evidence of P. domestica in Italy during the Phoenician and Punic periods. Keywords Archaeobotany · Image analysis · Morphometric features · Prunus · Sardini

Impact of COVID-19 on the oncological outcomes of colorectal cancer surgery in northern Italy in 2019 and 2020: multicentre comparative cohort study

BACKGROUND: This study compared patients undergoing colorectal cancer surgery in 20 hospitals of northern Italy in 2019 versus 2020, in order to evaluate whether COVID-19-related delays of colorectal cancer screening resulted in more advanced cancers at diagnosis and worse clinical outcomes. METHOD: This was a retrospective multicentre cohort analysis of patients undergoing colorectal cancer surgery in March to December 2019 versus March to December 2020. Independent predictors of disease stage (oncological stage, associated symptoms, clinical T4 stage, metastasis) and outcome (surgical complications, palliative surgery, 30-day death) were evaluated using logistic regression. RESULTS: The sample consisted of 1755 patients operated in 2019, and 1481 in 2020 (both mean age 69.6 years). The proportion of cancers with symptoms, clinical T4 stage, liver and lung metastases in 2019 and 2020 were respectively: 80.8 versus 84.5 per cent; 6.2 versus 8.7 per cent; 10.2 versus 10.3 per cent; and 3.0 versus 4.4 per cent. The proportions of surgical complications, palliative surgery and death in 2019 and 2020 were, respectively: 34.4 versus 31.9 per cent; 5.0 versus 7.5 per cent; and 1.7 versus 2.4 per cent. Cancers in 2020 (versus 2019) were more likely to be symptomatic (odds ratio 1.36 (95 per cent c.i. 1.09 to 1.69)), clinical T4 stage (odds ratio 1.38 (95 per cent c.i. 1.03 to 1.85)) and have multiple liver metastases (odds ratio 2.21 (95 per cent c.i. 1.24 to 3.94)), but were not more likely to be associated with surgical complications (odds ratio 0.79 (95 per cent c.i. 0.68 to 0.93)). CONCLUSION: Colorectal cancer patients who had surgery between March and December 2020 had an increased risk of advanced disease in terms of associated symptoms, cancer location, clinical T4 stage and number of liver metastases

The Botanical Record of Archaeobotany Italian Network - BRAIN: a cooperative network, database and website

The BRAIN (Botanical Records of Archaeobotany Italian Network) database and network was developed by the cooperation of archaeobotanists working on Italian archaeological sites. Examples of recent research including pollen or other plant remains in analytical and synthetic papers are reported as an exemplar reference list. This paper retraces the main steps of the creation of BRAIN, from the scientific need for the first research cooperation to the website which has a free online access since 2015

Gender differences in asthma perception and its impact on quality of life: A post hoc analysis of the PROXIMA (Patient Reported Outcomes and Xolair\uae in the Management of Asthma) study

Background: Gender differences in asthma perception and control have been reported. The PROXIMA observational study assessed these outcomes in a cohort of Italian severe allergic asthma (SAA) patients. This post hoc analysis of the PROXIMA results was aimed at assessing gender differences in SAA in a real-world setting, focusing on disease perception and impact on quality of life (QoL). Methods: The PROXIMA study was an observational, multicenter study, consisting of a cross-sectional and a prospective longitudinal phase, including adult outpatients diagnosed with SAA at step 4 requiring a therapeutic step-up. Patients on omalizumab treatment at baseline were included in the 12-month longitudinal phase. Disease control was assessed by the Asthma Control Questionnaire (ACQ) score, patients' disease perception by the Brief Illness Perception Questionnaire (BIPQ), and QoL by the EuroQoL five-dimensional three-level questionnaire (EQ-5D-3 L) at baseline and after 6 and 12 months. Two regression models were used to evaluate the association between gender and BIPQ total score and EQ-5D-3L score, respectively. Results: 357 patients (65% females) were analyzed for the cross-sectional phase and 99 (62.6% females) for the longitudinal phase. The prevalence of perennial and seasonal aeroallergens was similar between genders. ACQ score decreased similarly during omalizumab treatment at 6 and 12 months in both genders; no gender differences were observed in control rates. Asthma perception was worse among females at all study visits reaching statistical significance at 12 months (mean (SD) B-IPQ total score 41.8 (9.4) vs 35.6 (12.0); T test p-value (males vs females) &lt; 0.05). Statistically significant gender differences were observed for some specific items, with males reporting less symptom experience, concern about the disease, and emotional impact at 12-months. The results of the multivariate regression model for repeated measures showed that overall treatment with omalizumab improved disease perception overtime regardless from gender. Males reported a significantly better QoL compared to females at both 6 and 12 months. Conclusions: In this real-world setting, females confirmed to have a worse perception of asthma, feel it as more symptomatic and suffer a greater impact on their QoL, even though having similar baseline severity and obtaining similar level of control