Extracellular vesicles (EVs) are nanosized vesicles released by almost all body tissues, representing important mediators of cellular communication, and are thus promising candidate biomarkers for neurodegenerative diseases like Alzheimer’s disease (AD). The aim of the present study was to isolate total EVs from plasma and characterize their microRNA (miRNA) contents in AD patients. We isolated total EVs from the plasma of all recruited subjects using ExoQuickULTRA exosome precipitation solution (SBI). Subsequently, circulating total EVs were characterized using Nanosight nanoparticle tracking analysis (NTA), transmission electron microscopy (TEM), and Western blotting. A panel of 754 miRNAs was determined with RT-qPCR using TaqMan OpenArray technology in a QuantStudio 12K System (Thermo Fisher Scientific). The results demonstrated that plasma EVs showed widespread deregulation of specific miRNAs (miR-106a-5p, miR-16-5p, miR-17-5p, miR-195-5p, miR-19b-3p, miR-20a-5p, miR-223-3p, miR-25-3p, miR-296-5p, miR-30b-5p, miR-532-3p, miR-92a-3p, and miR-451a), some of which were already known to be associated with neurological pathologies. A further validation analysis also confirmed a significant upregulation of miR-16-5p, miR-25-3p, miR-92a-3p, and miR-451a in prodromal AD patients, suggesting these dysregulated miRNAs are involved in the early progression of AD.

Background: The lengthening of the lifespan led to an increase in breast cancer (BC) diagnosed in very old age, but the treatment recommendations in this patient group usually lack evidence-based practice. We conducted a prospective observational monocentric study specifically targeting patients diagnosed with invasive BC at 80 years of age or older. Methods: We enrolled 88 patients consecutively observed for a new BC diagnosis at 80 years or older. The aim was to investigate progression-free (PFS) and overall survival (OS), with a long follow-up period, along with clinico-pathological characteristics of the population. Results: At the end of the 5-year follow-up, the estimated OS and PFS probabilities were 82.9% (95% CI: 71.3–95.3%) and 64.0% (95% CI: 51.7–79.2%), respectively. After 8.5 years from the BC diagnosis, 48.9% died. The cause of death was BC in 32.6% of patients, different from BC in 13.9%, and unknown in the remaining. Surgery was performed in 69.3% of the cases and was associated with improved 12-month PFS (p < 0.001). Adjuvant systemic therapy and radiotherapy were omitted in 32% and 93% of eligible patients, respectively. A higher rate of metastatic disease at the diagnosis was observed in comparison with data described in younger people, as well as a significantly high rate of drop-out (27.3%). Conclusions: Ultra-old patients have a not negligible life expectancy; therefore, the oncologic treatment should be optimal and should adequately fight BC, always considering the quality of life of these frail patients. Future research should focus on developing personalized treatment protocols that incorporate comprehensive geriatric assessments and quality-of-life metrics. Additionally, larger, multicentric studies are needed to validate our findings and explore the role of emerging therapies in this age group.

Diarrhea continues to be a global health problem as acute diarrhea carries the risk of dehydration, while both acute and chronic diarrhea can significantly affect patients’ quality of life and reduce productivity. The innovative medical device Actitan, which consists of a complex of natural molecules, could be an effective option for the treatment of diarrhea from various causes. The aim of this post-market cross-sectional study was to evaluate the perceived efficacy, safety and usage pattern of the two formulations for adults (Actitan-P) and children (Actitan-F) among patients/child caregivers, physicians and pharmacists. Participants completed online questionnaires with closed multiple-choice questions that were rated on a verbal 5-point Likert scale. These surveys were conducted via the online platform Real World Data, which provides digital questionnaires for patients, doctors and pharmacists. Two separate surveys were conducted for the two formulations, with a total of 2630 participants (1488 participants for Actitan-P and 1142 participants for Actitan-F). Overall, the results indicate a high level of efficacy and safety of the product. In the case of Actitan-F, more than 96% of caregivers rated safety as good or excellent, and over 92% rated efficacy as good or excellent. Actitan-P also received positive feedback: nearly 86% of patients reported good/excellent efficacy, and more than 93% rated safety as good or excellent. These positive evaluations were confirmed by physicians and pharmacists, who also did not report adverse effects. In summary, this study confirms the role of Actitan as a safe and effective option for the treatment of diarrhea of different causes and in different patient groups, including young children.

Background: Hemorrhoidal disease (HD) is a common anorectal condition characterized by symptoms such as bleeding, pain, discomfort and itching. While often underdiagnosed due to patient reluctance to seek care, HD significantly impacts quality of life (QoL). Conservative treatments are preferred for low-grade HD, with increasing interest in natural substance-based therapies. Materials and Methods: A large-scale survey was conducted using a digital platform to collect real-world data (RWD) from patients, pharmacists and physicians. The research assessed perceived effectiveness, safety, tolerability, quality of life (QoL) and usage patterns of NeoFitoroid BioOintment. Quantitative analysis was also performed using a global score (GS) based on Likert scale ratings and their distribution. Results: A total of 2618 participants were included. A strong concordance across the three participating cohorts in the answers provided for all items of the questionnaire was observed. The descriptive analysis revealed high grades of effectiveness, safety and tolerability. Indeed, over 90% of respondents rated the product as “good” or “excellent” in terms of effectiveness and safety. Conclusions: These findings underscore the treatment’s effectiveness, safety, tolerability and positive influence on QoL in HD patients.

Hemorrhoidal disease (HD) is one of the most common anorectal conditions seen in general practice, but the true prevalence in the general population is not well understood, partly because many patients do not seek treatments. There are many factors which can favour the onset of haemorrhoidal disease. The most common of these are constipation, pregnancy, dietary factors, overweight, obesity, sedentary lifestyles, exertion and sport, heredity. The HD is classified according to their location and degree of prolapse. There are 3 types of haemorrhoids: internal haemorrhoids, external haemorrhoids and mixed haemorrhoids (internal and external). By analyzing the real-word data (RWD) obtained through this survey, it is possible to notice how patients, pharmacists and physicians have reported a very positive effectiveness profile of Neofitoroid BioOintment associated with a very favorable perception of its efficacy and safety profile. In addition, the data indicate that the ointment is widely used both as a monotherapy and in combination with other treatments, underscoring its versatility and clinical relevance across a range of therapeutic contexts. From this point of view, it was observed that all three populations showed a strong concordance and coherence on all items of the questionnaire. The quali-quantitative analyses revealed higher levels of effectiveness , safety and tolerability. A hypothetical parametric distribution (HPD), was used as control, in order to compare RW results to find the significant differences (p<0.05). These findings underscore the treatment’s effectiveness, safety, tolerability, and positive influence on quality of life for patients with hemorrhoids.

Background/Objectives: Irritable Bowel Syndrome (IBS) is a widely prevalent chronic disorder of brain–gut interaction which represents a clinical challenge due to its complex underlying causes and the lack of a standardized treatment approach. This cross-sectional research collected real-world data (RWD) on the effectiveness, safety, and usage pattern of a natural substance-based medical device, Colilen IBS, indicated for the treatment of IBS. Methods: Surveys were conducted both in Italy and Germany with 6101 participants, including 4425 patients, 1014 pharmacists, and 662 physicians using a structured GxP web platform that allows voluntary participants to share their experiences with the device. The validated platform was designed to comply with post-market surveillance requirements of EU Regulation 2017/745. Statistical analyses included descriptive evaluations of responses to gauge overall effectiveness and safety of the device. Results: The effectiveness reported with the medical device was judged extreme or great by 79.2% of patients, with 89.2% of whom observed symptom improvement within one month. Both safety and tolerability were rated extreme or great by 90.7% of patients. Healthcare professionals reported a similar rate on the overall effectiveness, with 94.9% of pharmacists and 95.9% of physicians indicating it extreme or great. Similarly, the safety profile was corroborated by nearly all pharmacists (97.0%) and physicians (98.2%) reporting extreme or great satisfaction with both safety and tolerability of the medical device. Conclusions: This research provides RWD supporting the effectiveness and safety of the product for treating IBS. The strong coherence among patients, pharmacists, and physicians in positively rating the device’s performance suggests that this medical device represents a therapeutic option that effectively addresses patient needs while minimizing safety concerns. Continuous RWD collection is essential, as it offers insights into real-world practice and ensures ongoing confirmation of the product’s safety and effectiveness. Ultimately, this will advance IBS patient care by integrating real-world evidence into clinical management.