Search Results (671)

Background: The 4CMenB vaccine (Bexsero^®) contains surface proteins from Neisseria meningitidis serogroup B and is recommended from 2 months of age. The most frequently reported adverse events are fever, injection site pain, and fatigue. Thus, this study aimed to estimate the incidence of local and systemic adverse events associated with the administration of the 4CMenB (Bexsero^®) vaccine. Methods: A systematic review and meta-analysis of clinical trials published up to 28 February 2025 were conducted using PubMed, ScienceDirect, and Web of Science. Human studies available in English, Spanish, French, German, or Italian were exclusively included. Adverse events following the first dose of the vaccine were analyzed. Pooled proportions with 95% confidence intervals were calculated, and heterogeneity across studies was assessed using the I² statistics. Results: Ten clinical trials comprising 13,345 participants were included. The most common adverse event was local pain (occurring in up to 94% of cases), followed by induration, erythema, and edema, with frequencies ranging from 25% to 45%. The most frequently reported systemic events were irritability (up to 75%), fatigue (51–59%), fever (up to 60%), headache (42–49%), and persistent crying (50–65%). Most adverse events were mild and self-limiting. Conclusions: The 4CMenB (Bexsero) vaccine exhibits a favorable safety profile, characterized by a predominance of mild and transient local adverse events. Although several systemic events were reported, their overall frequency was generally low. These findings support the continued inclusion of Bexsero^® in routine childhood immunization programs. Full article

A group of Spanish experts of different specialties participated in the ENFOCA2 project, promoted by the Spanish Oncology Genitourinary Group (SOGUG), which was designed to provide updated information on current and novel aspects contributing to the optimal care of prostate cancer (PCa) patients. In localized disease, it is important to implement strategic alliances with other institutions for improving adherence to active surveillance in low-risk groups and to explore genetic testing for a better indication of focal therapy. Local control of the disease should be maximized to prevent local failure and biochemical recurrence. In patients with locally advanced disease, with PSMA PET/CT-positive lesions in M0 staging on conventional imaging techniques, therapeutic decisions should be carefully evaluated due to insufficient evidence regarding the gold standard in this setting. In patients with metastatic castration-resistant PCa (mCRPC), assessment of BRCA somatic and germline mutations provides prognostic information and familial cancer risk and informs treatment decisions. Combinations of androgen receptor signaling inhibitor (ARSi) agents and poly-ADP ribose polymerase inhibitors (PARPi) are emerging alternatives for advanced PCa. The oldest segment of PCa patients (>70 years of age) may require geriatric assessment to evaluate physical and functional reserves, tailoring treatment to their individual characteristics and circumstances. The concept of a comprehensive multidisciplinary approach together with inter-center and/or inter-specialty therapeutic alliances should be implemented in the routine care of patients with PCa. Full article

Objective: To synthesize the current evidence on the cardiovascular effects of electronic cigarettes (ECs) in young adults (18–30 years), distinguishing between acute and chronic exposure, and comparing their effects to conventional tobacco (CT) use. Methods: A systematic review and meta-analysis (PROSPERO: CRD420251072847) was conducted following PRISMA guidelines. A total of 21 studies (12 RCTs, 8 case–control, 1 cohort) involving 17241 participants were included. Results: Acute EC use, particularly with nicotine, significantly increased systolic blood pressure (SBP: MD = 3.14 mmHg, 95% CI: 0.76 to 5.52), diastolic blood pressure (DBP: MD = 2.05 mmHg, 95% CI: 0.85 to 3.25), and heart rate (HR: MD = 4.23 bpm, 95% CI: 2.10 to 6.37), with effects most pronounced at 0 min post-exposure and dissipating within 1 h. Chronic EC use was associated with reduced endothelium-dependent vasodilation and early atherosclerotic changes. Nicotine-free ECs induced fewer cardiovascular alterations. Comparisons with CT revealed less severe cardiovascular damage with ECs, though still significant when compared to non-smokers. Conclusion: Nicotine-containing EC use in young individuals is associated with modest, predominantly acute and dose-dependent, cardiovascular effects, including transient increases in BP and HR. While initially less harmful than CT, the evidence is largely from cross-sectional studies and acute use, so ECs cannot be considered safe and their use warrants caution in youth. Full article

Background/Objectives: The susceptibility of Corynebacterium spp. to antimicrobial agents is species-related, with increasing levels of resistance to fluoroquinolones in several species related to their continued use in clinical practice. The objectives were to determine the in vitro activity of delafloxacin in comparison with other fluoroquinolones against clinical isolates of Corynebacterium spp., to compare MICs of delafloxacin obtained with gradient strips and with reference microdilution, and to investigate the mechanisms related to fluoroquinolone resistance in the tested strains. Methods: Fifty-three clinical isolates, assigned to five species of Corynebacterium spp., were evaluated using reference microdilution for delafloxacin, ciprofloxacin, levofloxacin, and moxifloxacin (with and without reserpine or phenylalanine-arginine β-naphthylamide), and gradient strips for delafloxacin. The QRDR of the gyrA gene was amplified using primers specific to the different species, and mutations were defined after aligning against the corresponding reference sequences. Results: Delafloxacin was the most active compound with MIC₅₀/MIC₉₀ values of 0.5/8 mg/L. Single mutations at the QRDR were observed in isolates, with MICs of delafloxacin ranging from 0.016 to 4 mg/L, while double mutations occurred in isolates, with MICs ranging from 0.125 to 16 mg/L. The delafloxacin gradient strips showed an essential agreement of 88.7%, bias of −5%, and a Kappa index of 0.848. Conclusions: Increased MICs of delafloxacin against Corynebacterium spp. are related to the presence of non-conservative mutations in the QRDR of gyrA. Delafloxacin gradient strips could be a reasonable alternative for use in the clinical routine of the microbiology laboratory. Delafloxacin could represent an alternative for treating infections due to some species of Corynebacterium. Full article

Background/Objectives: Malignant neoplasms in children include leukemias. The main types are B-cell acute lymphoblastic leukemia (B-ALL) and acute myeloid leukemia (AML). Treatments are expensive, which is a particular problem in low-income countries. The main objective of this work was to develop specific nanosystems with small amounts of drug, allowing for affordable treatments. To this end, we designed ternary gold nanosystems (Au@16-Ph-16/DNA–Dauno) composed of daunomycin, a DNA biopolymer as a stabilizer, and the cationic surfactant gemini (TG) as a compacting agent for the DNA–daunomycin complex. Methods: Fluorescence, UV–visible, and CD spectroscopy, DLS and zeta potential, cell viability assays, TEM, AFM, and confocal microscopy were used to characterize and optimize nanocomposites. Results: The nanoparticles (Au@TG) obtained were small, stable, and highly charged in solution, allowing for optimal absorption and efficacy, capable of inducing the aggregation of the ternary nanosystem upon entering the cell, further enhancing its anticancer effect. Using nanoparticles, treatments can be redirected to the site of action, increasing the solubility and stability of the drug, minimizing the side effects of traditional treatments, and helping to overcome resistance to chemotherapy Conclusions: A significant decrease in the growth of pediatric B-ALL-derived cell lines (SEM and SUP-B15), constituting a potential and more affordable therapy for this type of pathology. Full article

Objectives: To examine the association between social media (SM) use and content exposure with the risk of developing eating disorders (EDs) among adolescents. Methods: A descriptive observational study was conducted using a structured questionnaire incorporating validated scales. The instrument assessed quantitative and qualitative variables related to eating habits, SM usage, self-esteem, and body image. The sample comprised students aged 12–17 years from a school in Córdoba, Spain. Results: A total of 115 students participated in the study. Among them, 43.5% were identified as being at risk of developing EDs. Of this subgroup, 54.0% were female, with male gender appearing as a protective factor against ED risk. A significant association was found between increased hours of SM use and higher ED risk, with an odds ratio (OR) of 5.54 (95% confidence interval [CI]: 2.03–14.33). Conclusions: The findings suggest that low self-esteem and negative body image are key factors associated with increased ED risk, and that SM may act as an amplifying influence. Preventive interventions should focus on enhancing self-esteem and fostering critical and conscious engagement with SM among adolescents to mitigate the development of eating disorders. Full article

Background: Patients with congenital heart disease can associate malformations. The most frequent complications are those related to the airways, which produce prolonged cardiovascular postoperative. Objectives: Describe pathology, bronchoscopy indications, and findings in patients with heart pathology and persistent breath failure to improve prognosis and determine an early treatment. Methods: Retrospective descriptive study of bronchoscopies performed during 24 years in pediatric patients with congenital heart disease with surgery indication and persistent respiratory symptomatology. Results: We performed 199 fibrobronchoscopies in 144 patients, with an average of 1.4 fibrobronchoscopies per patient. A total of 58% were male. The mean age was 27.5 months (5 days–13 years). Valvular disease was the most frequent congenital heart disease, followed by the transposition of large vessels. The most frequent indications were stridor (42.7%) and persistent atelectasis (24.6%), followed by extubation failure (12.4%) and pump output (6.2%). The majority of the findings were found in the upper airway (56%), with a clear predominance of malacias (32%), while in the lower airway, extrinsic compression was highlighted (42%). Conclusions: Flexible fiberoptic bronchoscopy is a useful and rapid method for the diagnosis of airway malformations associated with congenital heart diseases that may have a relevant role in its management and prognosis. Full article

Background/Objectives: Evaluating coronary artery abnormalities (CAAs) in Kawasaki disease (KD) is essential for treatment decisions and long-term management and prognosis. Accurate diagnosis is challenging due to differing criteria across guidelines. This study aimed to assess the variability in CAA prevalence using Japanese Ministry of Health (JMH) criteria and Z score formulas and identify the formula pair with the highest CAA diagnostic agreement. Methods: Echocardiographic data from 309 patients with acute KD were collected. CAA prevalence was evaluated using JMH criteria and Z score formulas of Kobayashi, de Zorzi, Kurotobi, McCrindle, Olivieri and Dallaire. Prevalence differences were analyzed using McNemar’s t-tests, Z score values with paired samples t-test, and agreement between Z score formula pairs with Cohen’s Kappa (κ) coefficients and Bland–Altman plots. Results: The CAA prevalence varied significantly across definitions. For the right CA, prevalence was lower by JMH criteria than by Z scores (32.7% vs. 37.2–39.8%). For the left main CA, JMH (47.6%) and Kobayashi (44.8%) showed higher prevalence compared to other formulas (25.8–42.9%). Variability was greater at higher Z score values (>5 mm, medium/large aneurysm). Overall, the Kobayashi–Dallaire and McCrindle–Dallaire pairs showed the highest agreement (κ = 0.745–0.831 and 0.569–0.870, respectively); however, the McCrindle–Dallaire reached only moderate agreement for the left main CA (κ = 0.569). Conclusions: The Kobayashi and Dallaire formulas appear most suitable for evaluating CAA in predominantly Caucasian populations. Larger validation studies are warranted to refine diagnostic criteria and optimize global KD care. Full article

The development of viral vaccines faces persistent scientific and logistical challenges, particularly in the wake of the COVID-19 pandemic. This review critically examines emerging strategies to overcome key barriers in viral vaccine design and deployment. We focus on four major areas: (1) structure-guided antigen engineering to stabilize conformations; (2) the mRNA platform and its delivery system; (3) advanced adjuvant systems that enhance cellular and humoral immunity; and (4) approaches to mitigate immune imprinting and antigenic variability, such as chimeric antigens and glycan shielding. We also explore anti-idiotypic vaccination strategies and the limitations of current animal models in predicting human immune responses. In addition, to address vaccine hesitancy and inequitable access, we advocate for global collaboration in manufacturing, distribution, and public education to ensure inclusive immunization strategies. By integrating molecular insights with platform technologies, we aim to inform the rational design of future vaccines with improved efficacy and public acceptance. Full article

The spread of carbapenemase-producing Gram-negative bacteria poses a significant clinical challenge due to their association with severe Difficult-to-Treat nosocomial infections, as available therapies are drastically reduced. Rapid and accurate detection of carbapenemase-producing Gram-negative bacteria is critical for effective patient management, guiding appropriate antibiotic therapy, and implementing infection control measures to limit their dissemination within healthcare settings. Lateral flow immunoassays that detect the five main carbapenemases have become cornerstones in the fight against carbapenemase-producing Gram-negative bacteria. Carbapenemases evolve in response to antibiotic exposure, and therefore regular evaluation of these lateral flow immunoassays is crucial. Here, we have evaluated a novel assay, the KINVO assay (Medomics Medical Technology) and compared it to the Gold Standard of LFIAs for carbapenemase detection, the NG-TEST CARBA 5 assay (NG-Biotech) on a large panel of carbapenemase variants. The comparison between the two assays highlighted that both share key advantages such as rapidity and simplicity. However, NG-Test CARBA 5 demonstrated superior performance overall, particularly in accurately detecting IMP-type carbapenemases and the OXA-48 variant OXA-505. In contrast, the KINVO assay was more effective at detecting a broader range of KPC variants, including some that have lost carbapenem-hydrolyzing activity but gained resistance to ceftazidime/avibactam. If we consider these variants no longer as carbapenemases, and thus that they should not be detected, the NG-Test CARBA 5 performed better for KPC carbapenemase detection. Full article

Fecal microbiota transplantation (FMT) is a safe and effective treatment for recurrent Clostridiodes difficile infection (rCDI). However, experience with the oral biologic product MKB-01 remains limited. We describe a series of 13 patients with rCDI treated with FMT using MKB-01 capsules administered orally. Each patient received a single dose of 4 capsules (≥2.1–2.5 × 10¹¹ microorganisms) with water after a 2 h fasting period. Antibiotic therapy was discontinued pre FMT. Clinical evaluation was performed at weeks 8 and 12. The mean number of prior recurrences was 1.5 (range: 1–3 episodes). In 12 patients (92.3%), FMT was administered after resolution of the current episode; in one patient (7%), it was administered on day 3 of fidaxomicin therapy, prior to symptom resolution. At week 8, clinical cure (Absence of baseline symptoms for at least 72 h) was achieved in 11 patients (84.6%). An additional patient (7%) responded to a second FMT. One recurrence occurred at 8 weeks and was resolved with a second FMT. Therefore, the overall clinical response rate after one or more FMTs was 12 out of 13 patients (92.3%). The procedure was well tolerated; only one patient experienced self-limited diarrhea. These findings support oral FMT with MKB-01 capsules as a safe and effective option for treating rCDI. Full article

Background/Objectives: Type 1 diabetes mellitus (T1D) is the most common metabolic disorder in children, with significant physical and emotional impacts. Achieving optimal glucometric control is challenging due to the complex management and limitations of insulin therapy. Advances in pharmacology and technology, including continuous glucose monitoring (CGM) systems, offer new options for diabetes management. We developed Andiacare, an open-source platform for macro/micro-management of diabetes and analyzed its application in a pediatric T1D cohort to evaluate glucometric control patterns. Methods: A retrospective cohort study was conducted in a pediatric population (<18 years old) in Andalusia, Spain. Patients treated with Multiple Daily Injections of Insulin (MDI) and FreeStyle Libre 2 System (Abbott, Spain) were included. The patient data were analyzed using the Andiacare platform, which categorizes patients based on the Advanced Technologies and Treatments for Diabetes (ATTD) panel’s targets for glucometric control. Results: The study included 2215 patients from 18 pediatric hospitals. The Andiacare platform categorized patients into four groups based on glucometric control parameters, enabling patient stratification based on their glucometric control. Only 25.8% of the cohort achieved the recommended Time in Range (TIR), and 9.5% of the patients achieved all target parameters of glucometric control. Age is a determinant factor in adherence and achievement of set goals. Conclusions: This study offers insights into glucometric control in a large pediatric population with T1D in Andalusia. Few patients achieved the recommended glucometric control targets, highlighting the need for improved management strategies. The use of digital platforms such as Andiacare might contribute to facilitating the management of large pediatric cohorts. New algorithms integrating glucometric and non-glucometric parameters are required for improved individual and cohort categorization to optimize therapeutic interventions. Full article

Given the rising use of neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) in advanced epithelial ovarian cancer (EOC), we sought to assess practice trends in overall survival (OS), complete gross resection (R0), and postoperative mortality following debulking surgery. The National Cancer Database (NCDB) was used to identify 34,982 stage IIIC and IV EOC patients between 2010 and 2017 who underwent surgery. Annual proportions of patients receiving IDS and PDS were calculated. Median OS was estimated using the Kaplan–Meier method. Joinpoint models were fitted to evaluate surgical trends. Statistics were performed using SPSS and Joinpoint. Of 34,982 patients, 10,460 (29.9%) underwent IDS. IDS patients were older, more likely to have stage IV disease, and more likely to be non-White. Median OS was higher in the PDS group (54 vs. 38.8 months, p < 0.001). Postoperative 90-day mortality was lower in the PDS group (1.7% vs. 2.4%, p < 0.001), though IDS patients had a lower 30-day readmission rate (6.2% vs. 3.1%, p < 0.001). IDS patients were less likely to undergo extensive surgery (27.4% vs. 36.7%, p < 0.001) and more likely to achieve R0 resection (42% vs. 38.6%, p < 0.001). The IDS rate increased from 18.9% to 40.6% (annual percentage change (APC): 11.8%, p < 0.05) from 2010 to 2017. Median OS improved from 46.6 to 51 months (APC: 1.9%, p < 0.05), driven by the PDS cohort. The R0 resection rate rose from 34.8 to 41% (APC: 2.65%, p < 0.01), driven by the PDS cohort (APC: 2.83%, p < 0.01). Postoperative 90-day mortality decreased from 2.4% to 1.5% (APC: −4.64%, p < 0.05), due to a reduction in PDS patients (APC: −6.83%, p < 0.05). There was no change in the rate of extensive surgery over time. In conclusion, from 2010 to 2017, increased triage of patients to NACT was accompanied by a higher R0 resection rate and reduced postoperative mortality in PDS patients, with no observed detriment to OS. This data suggests improvement in case selection between IDS and PDS. Full article

Background/Objectives: Information on the economic impact and healthcare resource utilization (HCRU) associated with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is lacking. Methods: A retrospective review of medical records identified patients diagnosed with BPDCN between 2009 and 2023. Data on outpatient resource use, reimbursement, frequency and duration of hospitalizations, and transfusion burden were collected from diagnosis to death or last follow-up. Results: A total of 38 patients with a median age of 66 years were included. Conventional intensive chemotherapy (CHT) regimens were initially administered to 58% of patients, while targeted therapies were used in 37% of cases. The ratio of total days hospitalized to the overall follow-up period was 17%, with a total of 182 hospitalizations (average of 5 per patient; mean duration 20 days). The mean total reimbursement was EUR 109,104 per patient, primarily attributed to hospital admissions (EUR 89,158; EUR 18,118 per hospitalization). Hospitalizations before or without any allogeneic hematopoietic stem cell transplant (alloHSCT) accounted for 70% of total admissions, with an average overall cost of EUR 50,285 per patient (EUR 12,427 per hospitalization). AlloHSCT-period hospitalizations occurred in 18 patients, with a mean total reimbursement of EUR 122,497 per patient and EUR 30,464 per hospitalization. Conclusions: The active treatment of BPDCN imposes a high economic burden and extensive HCRU. Comparative pharmacoeconomic studies evaluating the cost-effectiveness of new therapies for BPDCN are needed to identify patient subgroups that may benefit most from these treatments. Full article