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Objective: We aimed to compare the results of phase III and IV clinical trials examining drugs to treat multiple sclerosis (MS) registered at ClinicalTrials.gov to those published in peer-reviewed journals. Methods: After identifying trials registered at ClinicalTrials.gov, consecutive searches were conducted in PubMed, EMBASE and Google Scholar for matching publications. Information regarding participants and efficacy and safety results was extracted and compared. The degree of consistency was classified as 'concordant', 'discrepant' or 'not comparable'. The Kaplan–Meier method was used to model time to reporting. Results: In total, 65 trials were appraised. The median time from completion to reporting was shorter for ClinicalTrials.gov (16.4 vs 27.3 months; p = 0.010). Information availability was generally higher in journals except for serious adverse events (SAEs) (86.2% vs 100.0%, p = 0.029) and their description (78.2% vs 100.0%, p < 0.001). However, 45 trials had at least one reporting discrepancy (69.2%). Three studies omitted one or more primary outcomes in the matching journal publication. Regarding safety results, the lowest consistencies were found for causes of death (60.0%) and description of SAEs (27.9%). Conclusion: Consulting both ClinicalTrials.gov and journals increases the accessibility to MS clinical trial results. Some data were frequently missing or disagreed between sources, raising concerns about transparency and generalizability of results. [ABSTRACT FROM AUTHOR]

Background: Chronic heart failure (CHF) is a major health problem, representing the main cause of hospitalization in people over 65 years of age. Several studies have associated the Mediterranean diet with a cardioprotective function, improving prognoses in patients with high cardiovascular risk. Our main objective is to determine whether higher adherence to the Mediterranean diet is associated with a lower severity of CHF, based on the number of decompensations and disease complications. Methods: This study was a single-center retrospective cohort study conducted at the Virgen del Rocío Hospital (Seville). Adherence to a Mediterranean diet was determined by the Mediterranean Diet Adherence Screener (MEDAS) in patients with chronic heart failure in a state of clinical stability, the number of decompensations in the 12 months before inclusion, cardiac biomarkers (NT-proBNP and CA125), evaluation of dyspnea, and quality of life assessment according to NYHA and KCCQ scales and analytical profiles. Results: Seventy-two patients were included (35 with high adherence to the Mediterranean diet and 37 with low adherence). The mean age was 81.29 ± 0.86 years. A trend towards fewer decompensations (1.49 ± 0.14 vs. 1.92 ± 0.17, p = 0.054) and lower NT-proBNP values (2897.02 ± 617.16 vs. 5227.96 ± 1047.12; p = 0.088) was observed in patients with high adherence compared to those with low adherence to the Mediterranean diet. Conclusions: Our results suggest that patients with CHF and high adherence to the Mediterranean diet have a tendency towards an improved cardiac profile, indicated by fewer decompensations and lower NT-proBNP levels. Future clinical trials are needed to substantiate these hypotheses. [ABSTRACT FROM AUTHOR]

Women of reproductive age are particularly vulnerable to low‐quality diets due to their higher micronutrients needs. The minimum dietary diversity for women (MDDW) is a proxy for micronutrient adequacy in this group of women. Its relationship with other aspects that lead to malnutrition is not fully elucidated and depends on the context. In this study, we assessed the prevalence of MDDW among women of a rural area in Chad and its association with socioeconomical, agricultural, dietary and food security data. A cross‐sectional study was conducted. Following a multistage cluster sampling, 984 women of reproductive age were randomly selected and interviewed in March 2019. We obtained food consumption data through unquantified 24 h recalls and computed MDDW as consuming at least five out of 10 predefined food groups. We constructed a Food Production Diversity Score (FPDS) with crop and livestock information. We obtained multivariable logistic regression models including different covariates. MDDW was achieved by only 33% of women in the sample. In our final model, we identified a significant association of MDDW with the FPDS and gathering of wild plants. Women in households with the highest FPDS had 70% more chances of achieving MDDW than those with the lowest FPDS. Gathering wild plants doubled these chances. Areas of cultivated land, Water, Sanitation and Hygiene resources, and a high level of food security, measured with the Household Food Insecurity Access Scale, were also significantly related to the achievement of MDDW. This illustrates the importance of nutrition‐sensitive policies, also considering biodiversity and food production diversification. [ABSTRACT FROM AUTHOR]

Introduction: Malnutrition has always been a problem in CF (cystic fibrosis) patients; however, new treatments with CFTR (cystic fibrosis transmembrane conductance regulator protein) modulators have led to weight gain, with some patients at risk of overweight and obesity. Objective: Our study aimed to analyze the evolution of BMI (body mass index) after one year of treatment with triple therapy and the factors associated with weight gain in CF patients undergoing treatment with triple therapy with CFTR protein modulators (ETI) (elexacaftor/tezacaftor/ivacaftor). Methods: We conducted a prospective, observational, longitudinal, multicenter study in patients diagnosed with cystic fibrosis, aged 18 years or older, with at least one F508del allele and who underwent ETI therapy for at least one year, from 2020 to 2023. One hundred and eight patients from two cystic fibrosis units in Spain, Princess University Hospital of Madrid (74 patients) and Central University Hospital of Asturias (HUCA) (34 patients), were included. Demographic data, anthropometric data, lung function, and exacerbations were collected, comparing the data in the previous year to the start of therapy with the results after one year of treatment. Multivariant models were developed to account for repeated weight and BMI measurements, using a mixed effects model approach and accounting for possible modifying factors Results: One hundred and eight patients were included in the study, 58 men (53.7%) and 50 women (46.3%) with a mean age of 29.5 ± 9.4 years (18–59). Patient weight and BMI were recorded at baseline and at 3-month intervals during the study period. The weight increased from 59.6 kg to 62.6 kg and BMI increased from 21.9 kg/m2 to 23.0 kg/m2 after one year of treatment (p < 0.0001 for both). The proportion of underweight individuals decreased after one year of ETI therapy, from 9.3% to 1.9%, while the proportion of overweight or obese individuals increased from 8.3% to 22.9 % at the same time (p < 0.001). In relation to exacerbations, there is a significant increase in the number of patients who did not have any exacerbations after one year of treatment, which increased from 10.2% to 46.2% (p < 0.001), while the number of patients who had >4 exacerbations decreased significantly, from 40.7% to 1.9% (p < 0.001). FEV1% (forced expiratory volume) increased from 63.9 ± 20.9 to 76.8 ± 21.4 (p < 0.001) and the VR/TLC (residual volume/total lung capacity) value decreased from 45.1 ± 10.9 to 34.9 ± 6.2 (p < 0.001). The proportion with FEV1% > 80% increased from 23.1% before ETI therapy to 49.1% one year after ETI therapy. We performed multivariate mixed models to evaluate the evolution of BMI changes with time, accounting for repeated measures and for possible modifying factors. After the introduction of the triple therapy, patients included in the study had significant weight gain during the 12 months, and when including different covariates in the multivariate mixed model, we found that lower baseline BMI, lower baseline FEV1 and FVC (forced vital capacity), and higher VR/TLC value and higher number of exacerbations were associated with higher BMI changes over the study period. Conclusions: CF patients treated with triple therapy experience significant weight gain, increasing the proportion of overweight patients. CF patients who experienced greater weight gain were those with worse BMI at the start of treatment, as well as patients with worse lung function and a greater number of exacerbations in the year before starting ETI therapy. [ABSTRACT FROM AUTHOR]

Objective: To establish a methodology for objectively estimating the Lens Equatorial Plane (LEP) from clinical images, comparing LEP with dilated versus non‐dilated pupils. Methods: A cohort of 91 eyes from 60 patients undergoing preoperative assessments for cataract surgery was evaluated. Anterior Segment Optical Coherence Tomography (AS‐OCT) images were analysed under conditions of pharmacologically induced pupil dilation versus a non‐dilated pupil. Geometrical parameters, including LEP, intersection diameter (ID), lens thickness (LT), anterior and posterior lens thickness were automatically calculated by applying standard image processing techniques to clinical AS‐OCT images. Results: Significant differences in lens parameters, including LEP, were observed between dilated and non‐dilated conditions (all p < 0.001). A strong linear correlation was found across all geometrical variables under both conditions (r[LEP] = 0.64, r[ID] = 0.78, r[LT] = 0.99, all p < 0.001); enabling reliable correction of these differences. Conclusion: The study introduces an objective methodology for LEP calculation, emphasising the need to consider the eye's physiological state during preoperative measurements. Incorporating LEP into future intraocular lens (IOL) power calculation formulas and replacing the habitual effective lens position may potentially improve the accuracy of IOL power estimation and thus postoperative visual outcomes. [ABSTRACT FROM AUTHOR]

Background: Lung cancer remains the leading cause of cancer-related mortality worldwide with non-small cell lung cancer (NSCLC) accounting for the majority of cases. The stage of detection significantly influences survival rates with early-stage diagnosis offering the best prognosis. This study investigates the prognostic impact of the omega-6/omega-3 ratio and tumor infiltration by CD8+ lymphocytes and CD68+ macrophages on overall survival (OS) and disease-free survival (DFS) in NSCLC patients undergoing pulmonary resection. Methods: We conducted a retrospective analysis of 53 patients with early-stage NSCLC who underwent pulmonary resection between September 2017 and January 2020. The omega-6/omega-3 ratio was quantified using gas chromatography and spectrometry. Tumor infiltration by CD8 and CD68 was assessed through immunohistochemistry. Survival outcomes were evaluated using Kaplan-Meier and Cox regression analyses. Results: An increased omega-6/omega-3 ratio and higher CD68+ macrophage infiltration were associated with a trend towards worse OS and DFS in NSCLC patients, though these results did not reach statistical significance. CD8+ T-cell infiltration was associated with improved survival outcomes, confirming its role as a favorable prognostic marker. Comparative analysis with existing datasets revealed similar demographic and clinical characteristics, reinforcing the generalizability of our findings. Conclusions: The omega-6/omega-3 ratio and CD68+ macrophage infiltration serve as important factors potentially influencing prognosis in NSCLC patients undergoing pulmonary resection. These findings highlight the need for further research to refine the prognostic utility of these biomarkers and to explore therapeutic strategies targeting inflammation and immune cell infiltration. [ABSTRACT FROM AUTHOR]

Background and Hypothesis Corollary discharge mechanism suppresses the conscious auditory sensory perception of self-generated speech and attenuates electrophysiological markers such as the auditory N1 Event-Related Potential (ERP) during Electroencephalographic (EEG) recordings. This phenomenon contributes to self-identification and seems to be altered in people with schizophrenia. Therefore, its alteration could be related to the anomalous self-experiences (ASEs) frequently found in these patients. Study Design To analyze corollary discharge dysfunction as a possible substrate of ASEs, we recorded EEG ERP from 43 participants with schizophrenia and 43 healthy controls and scored ASEs with the 'Inventory of Psychotic-Like Anomalous Self-Experiences' (IPASE). Positive and negative symptoms were also scored with the 'Positive and Negative Syndrome Scale for Schizophrenia' (PANSS) and with the 'Brief Negative Symptom Scale' (BNSS) respectively. The N1 components were elicited by two task conditions: (1) concurrent listening to self-pronounced vowels (talk condition) and (2) subsequent non-concurrent listening to the same previously self-uttered vowels (listen condition). Study Results The amplitude of the N1 component elicited by the talk condition was lower compared to the listen condition in people with schizophrenia and healthy controls. However, the difference in N1 amplitude between both conditions was significantly higher in controls than in schizophrenia patients. The values of these differences in patients correlated significantly and negatively with the IPASE, PANSS, and BNSS scores. Conclusions These results corroborate previous data relating auditory N1 ERP amplitude with altered corollary discharge mechanisms in schizophrenia and support corollary discharge dysfunction as a possible underpinning of ASEs in this illness. [ABSTRACT FROM AUTHOR]

Objectives. The COVID-19 pandemic, remote work and new technologies have heightened workplace pressures. Effective response and essential organizational changes require business leaders to be more adaptable, with managers' presence playing a pivotal role in successful implementation. The study assesses a brief mindfulness-based emotional regulation for managers (MBERM) intervention, to reduce workplace stress and enhance managerial well-being. Methods. An 8-week non-randomized controlled trial was conducted with a waiting list control group and an intervention group. Pre–post differences were measured by Student's t test or Wilcoxon test, and effect size calculated using the Hedge's g formula. The sample included 23 managers (17 men and six women) with average age 50 years. The study assessed anxiety and depressive symptoms, psychological flexibility, perceived self-efficacy, general work-related well-being, perceived stress and mindfulness. Results. Statistically significant changes were observed in the intervention group in depression, anxiety, work-related acceptance and action, general self-efficacy, exhaustion, alienation, stress and non-reactivity. The control group showed no statistically significant changes in any of the variables. Conclusion. The MBERM intervention could improve the emotional and work-related well-being of managers and reduce stress levels and burnout. Further study of this intervention is needed to promote adherence and ensure a long-term improvement. [ABSTRACT FROM AUTHOR]