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Background: Older women represent a significant and increasing population of patients with breast cancer, accounting for over 40% of new cases of breast cancer. However, this growing subgroup of patients is still underrepresented in clinical trials, and treatment is usually selected based on limited data from retrospective subgroup analyses. However, the ESMO guidelines for metastatic breast cancer (mBC) suggest that the management decision should not be based on age alone. Nab-paclitaxel (nab-P) was associated with improved efficacy and a better safety profile than solvent-based taxanes without steroid or antihistamine premedication, making this treatment appealing to elderly patients. Patients and methods: This is an observational, retrospective, multicenter study, evaluating the safety and activity of nab-paclitaxel (nab-P) in elderly patients (≥65 years old) with HER2-negative mBC from 11 Sicilian oncology centers. The primary endpoint of the study was the safety nab-P in elderly mBC patients; secondary endpoints included the overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Results: We included 70 patients, and all were evaluable for safety and efficacy. All patients had previously been pretreated with taxane-based chemotherapy in a (neo)-adjuvant or metastatic setting. One third of the patients received nab-P as a fourth line therapy. Most of the patients were treated with nab-P at doses of 260 mg/m2 3-weekly (87.1%), and 12.9% received a nab-P dose of 125 mg/m2 weekly. Patients’ characteristics included a median age of 67 years (range 65–83 years), a median ECOG PS of 1 (range 0–2), and the following intrinsic molecular subtypes: Luminal A (18.8%), Luminal B HER-2 negative (62.5%), and triple negative (18.8%). Nab-P was administered for a median of six cycles (range 1–21), with 35.5% of patients experiencing a dose reduction, and 11.5% treatment discontinuation due to toxicity. Adverse events were mainly G2-G3 and occurred mostly in patients treated with 3-weekly nab-P (85.7%). The ORR was 31.3% (CR in 6.3% and PR in 25% of pts) and the DCR was 70.4%. Median PFS was 6 months (95% CI, 2–38), and median OS was 40.5 months (95% CI, 7–255). Conclusions: Our real-life study showed that nab-P is an effective, well-tolerated regimen in elderly mBC patients, including taxane-pretreated patients, and can be safely administered in elderly mBC patients.

Nutrition is essential for human growth, particularly in newborns and children. An optimal growth needs a correct diet, in order to ensure an adequate intake of macronutrients and micronutrients. Macronutrients are the compounds that humans consume in largest quantities, mainly classified in carbohydrates, proteins and fats. Micronutrients are instead introduced in small quantities, but they are required for an adequate growth in the pediatric age, especially zinc, iron, vitamin D and folic acid. In this manuscript we describe the most important macro and micronutrients for children’s growth.

The chronic inflammation of Crohn's disease is caused, at least in part, by repression of TGF-β1 signaling, which is caused by high levels of SMAD7. This trial shows that mongersen, an antisense inhibitor of SMAD7 mRNA, induces disease remission in some persons. Crohn’s disease is a chronic inflammatory illness that primarily affects the terminal ileum and right colon. Crohn’s disease–related inflammation is segmental and transmural, leading to various degrees of tissue damage. 1 At disease onset, most patients have inflammatory lesions, which become predominantly strictures or penetrating lesions over time. 2 , 3 Mucosal healing can be promoted with the use of immunosuppressive drugs and anti–tumor necrosis factor α (TNF- α ) antibodies; however, more than one third of patients do not have a response to these therapies. The efficacy of these drugs may also diminish over time, and they can increase a patient’s risk . . .

Chloroquine is a 9-aminoquinoline known since 1934. Apart from its well-known antimalarial effects, the drug has interesting biochemical properties that might be applied against some viral infections. Chloroquine exerts direct antiviral effects, inhibiting pH-dependent steps of the replication of several viruses including members of the flaviviruses, retroviruses, and coronaviruses. Its best-studied effects are those against HIV replication, which are being tested in clinical trials. Moreover, chloroquine has immunomodulatory effects, suppressing the production/release of tumour necrosis factor α and interleukin 6, which mediate the inflammatory complications of several viral diseases. We review the available information on the effects of chloroquine on viral infections, raising the question of whether this old drug may experience a revival in the clinical management of viral diseases such as AIDS and severe acute respiratory syndrome, which afflict mankind in the era of globalisation.

Background: Eosinophilic esophagitis (EoE) is a chronic, progressive type 2 inflammatory disorder of the esophagus, characterized by abnormal eosinophil accumulation in esophageal epithelium. Undiagnosed or undertreated EoE leads to increased risk of fibrostenosis, strictures, and food impaction due to persistent inflammation, deeply impacting patients’ health-related quality of life (HRQoL). Objectives: To gather insights on comprehensive assessment of EoE, comprising clinical, endoscopic, histological outcomes, adaptive behaviors and HRQoL; to define proper evaluation of disease control and impact of continuous versus noncontinuous treatment to reach full disease control. Finally, to validate an algorithm for disease control, switching criteria, and follow-up. Design: Literature review, survey, and panel expert opinion building by a multidisciplinary Italian EoExpert Panel (EoExpert) of nine specialists from various Italian institutions. Methods: Non-systematic literature review, followed by a survey including 21 questions on the different topics. Results were then discussed and validated by EoExpert. Results: The current diagnostic pathway often does not allow early detection of EoE patients, especially in the presence of adaptive behaviors and unawareness of EoE best practices. In addition, there is a lack of a shared “control” definition. EoExpert reviewed, shared, and recommended two novel management tools for EoE, represented by I.M.P.A.C.T. Questionnaire to uncover adaptive behaviors and S.C.O.P.E. (Symptoms Control, Observation, Pathological Evaluation) scheme for comprehensive treatment efficacy evaluation. EoExpert’s recommendations were gathered and turned into a therapeutic management algorithm for the definition of disease control and switching criteria. Conclusion: This document provides a standardized approach to EoE management in pediatric and adult settings, highlighting the importance of timely diagnosis in a multidisciplinary setting, of using unified criteria for assessment of disease control through the adoption of a comprehensive approach and of following up patients. These recommendations highlight the critical role of increased awareness and standardized care in EoE clinical setting for lifelong management. Plain language summary Evolution in eosinophilic esophagitis care by improved diagnosis and therapeutic management strategy Eosinophilic esophagitis is often not timely diagnosed and/or properly managed, which causes its progression and negatively impacts patient’s health status and health related Quality of Life (HRQoL). It is therefore mandatory to highlight the importance and meaning of “complete disease control”, defining an algorithm that ensures diagnosis, treatment, and monitoring for an effective EoE management.

To date, data on effectiveness and safety of Adalimumab (ADA) biosimilars in inflammatory bowel diseases (IBDs) are lacking. Therefore, we aimed to verify the ability of ABP501 and SB5 to maintain the clinical and biochemical response induced by the ADA originator, after switching to them. We prospectively analyzed data collected from 55 patients with IBD who switched to ABP501, and 25 patients with IBD who switched to SB5, from ADA originator at four IBD Units between 2018 and 2020. In addition, we included an age and sex-matched control group (n = 38) who continued ADA originator for at least two years and who did not switch to a biosimilar drug. Clinical and biochemical data (C-Reactive Protein (CRP), fecal calprotectin (FC)), concomitant steroid and/or immunosuppressant therapy at the time of the switch and after six months were collected. At six months, in the ABP501 group, we did not observe statistically significant modifications in clinical activity of disease (p = 0.09) and FC values (p = 0.90) . Some patients (n = 8) needed to add steroids at six months after switching (p = 0.01), however the need for optimization was not significant between the two timepoints (p = 0.70). Finally, 14.5% patients stopped therapy after six months. Similarly, in the SB5 group we observed a stability of clinical activity and FC values (p = 0.90 and p = 0.20), and a concomitant statistically significant decrease in CRP (p = 0.03). There were no differences in steroids/immunosuppressants need or optimizing biological therapy in this group. Finally, drug survival curves of patients who switched from originator to ABP501 and those who continued ADA originator were similar (p = 0.20). Overall, biosimilar drugs seem to be as effective and safe as the originator. Further larger and longer studies are mandatory to understand the clinical implications of these findings.

The growing availability of mobile devices has lead to an arising development of smart cities services that share a huge amount of (personal) information and data. Without accurate and verified management, they could become severe back-doors for security and privacy. In this paper, we propose a smart city infrastructure able to integrate a distributed privacy-preserving identity management solution based on attribute-based credentials (p-ABC), a user-centric Consent Manager, and a GDPR-based Access Control mechanism so as to guarantee the enforcement of the GDPR’s provisions. Thus, the infrastructure supports the definition of specific purpose, collection of data, regulation of access to personal data, and users’ consents, while ensuring selective and minimal disclosure of personal information as well as user’s unlinkability across service and identity providers. The proposal has been implemented, integrated, and evaluated in a fully-fledged environment consisting of MiMurcia, the Smart City project for the city of Murcia, CaPe, an industrial consent management system, and GENERAL_D, an academic GDPR-based access control system, showing the feasibility.

Background Eosinophilic esophagitis (EoE) is a chronic immune-mediated rare disease, characterized by esophageal dysfunctions. It is likely to be primarily activated by food antigens and is classified as a chronic disease for most patients. Therefore, a deeper understanding of the pathogenetic mechanisms underlying EoE is needed to implement and improve therapeutic lines of intervention and ameliorate overall patient wellness. Methods RNA-seq data of 18 different studies on EoE, downloaded from NCBI GEO with faster-qdump ( https://github.com/ncbi/sra-tools ), were batch-corrected and analyzed for transcriptomics and metatranscriptomics profiling as well as biological process functional enrichment. The EoE TaMMA web app was designed with plotly and dash. Tabula Sapiens raw data were downloaded from the UCSC Cell Browser. Esophageal single-cell raw data analysis was performed within the Automated Single-cell Analysis Pipeline. Single-cell data-driven bulk RNA-seq data deconvolution was performed with MuSiC and CIBERSORTx. Multi-omics integration was performed with MOFA. Results The EoE TaMMA framework pointed out disease-specific molecular signatures, confirming its reliability in reanalyzing transcriptomic data, and providing new EoE-specific molecular markers including CXCL14, distinguishing EoE from gastroesophageal reflux disorder. EoE TaMMA also revealed microbiota dysbiosis as a predominant characteristic of EoE pathogenesis. Finally, the multi-omics analysis highlighted the presence of defined classes of microbial entities in subsets of patients that may participate in inducing the antigen-mediated response typical of EoE pathogenesis. Conclusions Our study showed that the complex EoE molecular network may be unraveled through advanced bioinformatics, integrating different components of the disease process into an omics-based network approach. This may implement EoE management and treatment in the coming years.

Irritable bowel syndrome with diarrhoea (IBS‐D) and functional diarrhoea (FDr) are the two major functional bowel disorders characterized by diarrhoea. In spite of their high prevalence, IBS‐D and FDr are associated with major uncertainties, especially regarding their optimal diagnostic work‐up and management. A Delphi consensus was performed with experts from 10 European countries who conducted a literature summary and voting process on 31 statements. Quality of evidence was evaluated using the grading of recommendations, assessment, development, and evaluation criteria. Consensus (defined as >80% agreement) was reached for all the statements. The panel agreed with the potential overlapping of IBS‐D and FDr. In terms of diagnosis, the consensus supports a symptom‐based approach also with the exclusion of alarm symptoms, recommending the evaluation of full blood count, C‐reactive protein, serology for coeliac disease, and faecal calprotectin, and consideration of diagnosing bile acid diarrhoea. Colonoscopy with random biopsies in both the right and left colon is recommended in patients older than 50 years and in presence of alarm features. Regarding treatment, a strong consensus was achieved for the use of a diet low fermentable oligo‐, di‐, monosaccharides and polyols, gut‐directed psychological therapies, rifaximin, loperamide, and eluxadoline. A weak or conditional recommendation was achieved for antispasmodics, probiotics, tryciclic antidepressants, bile acid sequestrants, 5‐hydroxytryptamine‐3 antagonists (i.e. alosetron, ondansetron, or ramosetron). A multinational group of European experts summarized the current state of consensus on the definition, diagnosis, and management of IBS‐D and FDr.