Search

The authors offer a response to comments made by Ivan Fort on their articles on computational fluid dynamics (CFD) simulation of stirred tanks. They agree with Fort that the commented reviews provide useful pieces of knowledge for different applications such as developing reliable design procedures, mixing and blending, and bio-reactions. They provide answers to queries raised by Fort including one about laser doppler anemometry (LDA) measurements.

The size distribution, shape and aspect ratio of particles are the common factors that affect their packing in a particle bed. Agitated powder beds are commonly used in the process industry for various applications. The stresses arising as a result of shearing the bed could result in undesirable particle breakage with adverse impact on manufacturability. We report on our work on analysing the stress distribution within an agitated particle bed with several particle aspect ratios by the Discrete Element Method (DEM). Rounded cylinders with different aspect ratios are generated and incorporated into the DEM simulation. The void fraction of the packing of the static and agitated beds with different particle aspect ratios is analysed. Principal and deviatoric stresses are quantified in the regions of interest along the agitating impeller blade for different cases of particle aspect ratios. The relationship between the particle aspect ratio and the stress distribution of the bed over the regions of interest is then established and will be presented.

Amorphous solid dispersion (ASD) is an enabling approach utilized to deliver poorly soluble compounds. ASDs can spontaneously generate drug-rich amorphous nanoparticles upon dissolution, which can act as a reservoir for maintaining supersaturation during oral absorption. But, conventional ASDs are often limited in drug loadings to < 20 %. For indications where the dose is high, this can translate into a significant pill burden. The aim of this research was to develop a high drug loading (DL) amorphous nanoparticle (ANP) formulation that can release the drug-rich nanoparticles into solution upon contact with aqueous environment. Nanoparticles were directly engineered using solvent/anti-solvent precipitation. The obtained nanoparticle suspension was then concentrated followed by solidification to a re-dispersible amorphous dosage form using spray drying or lyophilization. The impact of process variables was studied using dynamic light scattering (DLS), scanning electron microscopy (SEM), high performance liquid chromatography (HPLC), nuclear magnetic resonance (NMR) and differential scanning calorimetry (DSC). It was observed that spray drying led to a non-re-dispersible formulation. Sucrose and trehalose containing lyocakes resulted in re-dispersible formulations. The trehalose containing lyocakes, in a dog study, gave comparable performance to the reference tablet in the fasted state but lower area under the curve (AUC) in fed state., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: AbbVie sponsored and funded the study; contributed to the design; participated in collection, analysis, and interpretation of data; and in writing, reviewing, and approval of the final version. Hitesh S. Purohit, Mengqi Yu, Hardeep Oberoi, Angélica de L Rodríguez López, Manish Kelkar, Yan He, Bradley Gates, Nandkishor Nere, Devalina Law are AbbVie employees and may own AbbVie stock. Maryam Zaroudi contributed to the research during her summer internship at AbbVie. Deliang Zhou contributed to the research during his employment at AbbVie., (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

This study is focused on the fact that in the context of increasing global aging and cancer diagnoses, additional challenges arise in clinical care. Adequate functionality and body composition are key to coping with antineoplastic treatment, which can lead to better treatment tolerance, survival, and quality of life. This is a cross-sectional comparative study focused on the assessment and comparison of body composition and functionality between cancer patients and a reference population, with the aim of establishing meaningful baseline values. Techniques such as manual dynamometry, the Five-Times Sit-to-Stand test, and bioimpedance were used to collect data from 374 oncologic patients and 1244 reference individuals. The results reveal significant disparities in functionality and body composition among participants, and provide age group-specific adjusted baseline values for those diagnosed with cancer. These findings may have crucial clinical implications for applying particular cut-off points designed for this population group, which makes the assessment process faster and more accurate, enhances the capacity of medical personnel to act quickly, and improves the management of frailty in cancer patients.

Background: Throughout the evolution of the COVID-19 pandemic, the severity of the disease has varied. The aim of this study was to determine how patients' comorbidities affected and were related to, different outcomes during this time., Methods: Retrospective cohort study of all patients testing positive for SARS-CoV-2 infection between March 1, 2020, and January 9, 2022. We extracted sociodemographic, basal comorbidities, prescribed treatments, COVID-19 vaccination data, and outcomes such as death and admission to hospital and intensive care unit (ICU) during the different periods of the pandemic. We used logistic regression to quantify the effect of each covariate in each outcome variable and a random forest algorithm to select the most relevant comorbidities., Results: Predictors of death included having dementia, heart failure, kidney disease, or cancer, while arterial hypertension, diabetes, ischemic heart, cerebrovascular, peripheral vascular diseases, and leukemia were also relevant. Heart failure, dementia, kidney disease, diabetes, and cancer were predictors of adverse evolution (death or ICU admission) with arterial hypertension, ischemic heart, cerebrovascular, peripheral vascular diseases, and leukemia also relevant. Arterial hypertension, heart failure, diabetes, kidney, ischemic heart diseases, and cancer were predictors of hospitalization, while dyslipidemia and respiratory, cerebrovascular, and peripheral vascular diseases were also relevant., Conclusions: Preexisting comorbidities such as dementia, cardiovascular and renal diseases, and cancers were those most related to adverse outcomes. Of particular note were the discrepancies between predictors of adverse outcomes and predictors of hospitalization and the fact that patients with dementia had a lower probability of being admitted in the first wave., Competing Interests: The authors declare that they have no conflict of interest., (© 2024 The Authors. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.)

Objective: The aim of this study was to create a prognostic instrument for COPD with a multidimensional perspective that includes physical activity (PA). The score also included health status, dyspnoea and forced expiratory volume in 1 s (HADO.2 score)., Methods: A prospective, observational, non-intervention study was carried out. Patients were recruited from the six outpatient clinics of the respiratory service of a single university hospital. The component variables of the HADO.2 score and BODE index were studied, and PA was measured using an accelerometer. The outcomes for the HADO.2 score were mortality and hospitalisations during follow-up and an exploration of the correlation with health-related quality of life at the moment of inclusion in the study., Results: 401 patients were included in the study and followed up for three years. The HADO.2 score showed good predictive capacity for mortality: C-index 0.79 (0.72-0.85). The C-index for hospitalisations was 0.72 (0.66-0.77) and the predictive ability for quality of life, as measured by R2, was 0.63 and 0.53 respectively for the Saint George's Respiratory Questionnaire and COPD Assessment Test., Conclusions: There was no statistically significant difference between the mortality predictive capacity of the HADO.2 score and the BODE index. Adding PA to the original BODE index significantly improved the predictive capacity of the index. The HADO.2 score, which includes PA as a key variable, showed good predictive capacity for mortality and hospitalisations. There were no differences in the predictive capacity of the HADO.2 score and the BODE index., Competing Interests: Conflict of interest: No financial, consultative, institutional and other relationships that might lead to bias or a conflict of interest exist for any of the authors of this study., (Copyright ©The authors 2024.)

Background: An optimal and correctly balanced metabolic status is essential to improve sports performance in athletes. Recent advances in omic tools, such as the lipid profile of the mature erythrocyte membranes (LPMEM), allow to have a comprehensive vision of the nutritional and metabolic status of these individuals to provide personalized recommendations for nutrients, specifically, the essential omega-3 and omega-6 fatty acids, individuating deficiencies/unbalances that can arise from both habitual diet and sportive activity. This work aimed to study the LPMEM in professional female football players during the football season for the first time and compare it with those defined as optimal values for the general population and a control group., Methods: An observational study was carried out on female football players from the Athletic Club (Bilbao) playing in the first division of the Spanish league. Blood samples were collected at three points: at the beginning, mid-season, and end of the season for three consecutive seasons (2019-2020, 2020-2021, and 2021-2022), providing a total of 160 samples from 40 women. The LPMEM analysis was obtained by GC-FID by published method and correlated to other individual data, such as blood biochemical parameters, body composition, and age., Results: We observed a significant increase in docosahexaenoic acid (DHA) ( p 0.048) and total polyunsaturated fatty acid (PUFA) ( p 0.021) in the first season. In the second season, we observed a buildup in the membrane arachidonic acid (AA) ( p  < .001) and PUFA ( p  < .001) contents when high training accumulated. In comparison with the benchmark of average population values, 69% of the football players showed lower levels of omega-6 dihomo-γ-linolenic acid (DGLA), whereas 88%, 44%, and 81% of the participants showed increased values of AA, eicosapentaenoic acid (EPA), and the ratio of saturated and monounsaturated fatty acids (SFA/MUFA), respectively. Regarding relationships between blood biochemical parameters, body composition, and age with LPMEM, we observed some mild negative correlations, such as AA and SFA/MUFA ratio with vitamin D levels (coefficient = -0.34 p = .0019 and coefficient = -.25 p  = .042); DGLA with urea and cortisol (coefficient = -0.27 p  < .006 and coefficient = .28 p  < .0028) and AA with age (coefficient = -0.33 p  < .001)., Conclusion: In conclusion, relevant variations in several fatty acids of the membrane fatty acid profile of elite female football players were observed during the competitive season and, in comparison with the general population, increased PUFA contents were confirmed, as reported in other sportive activities, together with the new aspect of DGLA diminution, an omega-6 involved in immune and anti-inflammatory responses. Our results highlight membrane lipidomics as a tool to ascertain the molecular profile of elite female football players with a potential application for future personalized nutritional strategies (diet and supplementation) to address unbalances created during the competitive season.

Objectives: Tools to identify patients with mild to moderate COVID-19 are as yet unavailable. Our aims were to identify factors associated with nonadverse outcomes and develop a scale to predict nonadverse evolution in patients with COVID-19 (the CoNAE scale) in hospital emergency departments., Material and Methods: Retrospective cohort study of patients who came to one of our area's national health service hospitals for treatment of SARS-CoV-2 infection from July 1, 2020, to July 31, 2021. From case records we collected sociodemographic information, underlying comorbidity and ongoing treatments, other relevant medical history details, and vital constants on arrival for triage. Multilevel multivariable logistic regression models were used to identify predictors., Results: The model showed that patients who had nonadverse outcomes were younger, female, and vaccinated against COVID-19 (2 doses at the time of the study). They arrived with normal vital signs (heart rate, diastolic and systolic pressures, temperature, and oxygen saturation) and had none of the following concomitant diseases or factors: heart failure other heart disease, hypertension, diabetes, liver disease, dementia, history of malignant tumors, and they were not being treated with oral or other systemic corticosteroids or immunosuppressant therapy. The area under the receiver operating characteristic curve for the model was 0.840 (95% CI, 0.834-0.847)., Conclusion: We developed the CoNAE scale to predict nonadverse outcomes. This scale may be useful in triage for evaluating patients with COVID-19. It may also help predict safe discharge or plan the level of care that patients require not only in a hospital emergency department but also in urgent primary care settings or out-of-hospital emergency care.

The condition monitoring of an overhead contact line (OCL) is investigated by developing an innovative monitoring system for a pantograph on an electrical multiple unit of a regional line. Kinematic and dynamic modelling of the pantograph is conducted to support the designed monitoring system. The modelling is proved through rigorous test-rig experiments, while the proposed methodology is then validated through extensive field tests. The field tests serve a dual purpose: First, to validate the monitoring system using benchmark measurements of the tCat ® trolley, and second, to assess the reproducibility of measurements in a realistic case. This paper presents the OCL monitoring system developed in the framework of the H2020 project SIA. The accuracy of our results is not far from that of other commercial systems, with just 12 mm of absolute error in the height measurement. Therefore, they provide reliable information about trends in various key performance indicators (KPIs) that facilitates the early detection of failures and the diagnosis of anomalies. The results highlight the importance of model calibration and validation in enabling novel health monitoring capabilities for the pantograph. By continuously monitoring the parameters and tracking their degradation trends, our approach allows for optimized scheduling of maintenance tasks for the OCL.

Background: Nursing home residents (NHRs) have experienced disproportionately high risk of severe outcomes due to COVID-19 infection., Aim: We investigated the impact of COVID-19 vaccinations and previous SARS-CoV-2 episodes in preventing hospitalization and mortality in NHRs., Methods: Retrospective study of a cohort of all NHRs in our area who were alive at the start of the vaccination campaign. The first three doses of SARS-CoV-2 vaccine and prior COVID-19 infections were registered. The main outcomes were hospital admission and mortality during each follow up. Random effects time-varying Cox models adjusted for age, sex, and comorbidities were fitted to estimate hazard ratios (HRs) according to vaccination status., Results: COVID-19 hospitalization and death rates for unvaccinated NHRs were respectively 2.39 and 1.42 per 10,000 person-days, falling after administration of the second dose (0.37 and 0.34) and rising with the third dose (1.08 and 0.8). Rates were much lower amongst people who had previously had COVID-19. Adjusted HRs indicated a significant decrease in hospital admission amongst those with a two- and three-dose status; those who had had a previous COVID-19 infection had even lower hospital admission rates. Death rates decreased as NHRs received two and three doses, and the probability of death was much lower among those who had previously had the infection., Conclusions: The effectiveness of current vaccines against severe COVID-19 disease in NHRs remains high and SARS-CoV-2 episodes prior to vaccination entail a major reduction in hospitalization and mortality rates. The protection conferred by vaccines appears to decline in the following months., Trial Registration: ClinicalTrials.gov Identifier: NCT04463706., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objectives: To assess the effectiveness of the EFICANCER individualized and supervised exercise program for people with gastrointestinal, breast, or non-small cell lung stage IV cancer, in terms of quality of life and functional capacity., Data Sources: Randomized controlled clinical trial with two parallel groups: EFICANCER (n = 47) and control (n = 43). Both groups received standard oncological care. In addition, the EFICANCER group participated in a nurse-supervised exercise program. Primary outcome was cancer-specific (EORTC QLQ-C30 questionnaire) and general quality of life (SF-36) at baseline and after 2, 6, and 12 months. Secondary outcomes were functional capacity (6-minute walking test), strength, and fatigue. The evolution in both groups was compared over 12 months using mixed-effect longitudinal models; 74.47% of patients completed at least one session of the program. At 12 months, EFICANCER group had better scores in cancer-related quality of life, with a difference between groups of 15.7 points (95% confidence interval 4.4 to 25.9) and in functional capacity, with a difference of 4.5 points (95% confidence interval -0.5 to 9.5). No significant differences in any other secondary variables were observed., Conclusion: The EFICANCER primary care nurse supervised exercise program is safe and feasible and improves cancer patient's outcomes., Implications for Nursing Practice: Providing the best care and trying to improve the quality of life of cancer patients are essential parts of nursing practice. Eficancer adds a new dimension to nursing practice by providing greater attention and care to patients during treatment through the supervision of physical exercise, thereby contributing to improve the quality of life of this population., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Gonzalo Grandes Odriozola reports financial support was provided by Carlos III Health Institute., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

The phase angle, an increasingly studied healthcare tool, was studied to explore its relationship with psychological factors in cancer patients. The aim of this study was to investigate the relationship between the phase angle (PhA), obtained by the bioimpedance analysis of body composition, and psychological factors measured by questionnaire in cancer patients. The study included 311 patients who underwent bioimpedance testing to determine their PhA value; their psychological profiles were assessed using SF-36, FACIT, QLQ-C30, and GHQ-12 questionnaires. Mixed linear regression models were used to analyze the relationship between PhA and the psychological tests. The results showed a statistical correlation between PhA and the GHQ-12, FACIT, and SF-36 questionnaires, with higher PhA values associated with better results on the questionnaires. In the QLQ-C30 questionnaire, a correlation was observed between PhA and the functioning scales ( p < 0.001), except for emotional and cognitive functioning ( p = 0.148 and p = 0.544, respectively), but not in most of the symptom scales. The PhA is a useful tool for assessing the subjective health perception of cancer patients, especially with regard to psychological factors. While there is a statistically significant correlation, further research is required before confidently applying it in clinical practice. The current predictive value of this predictor for certain psychological aspects is limited, underscoring the need for additional research.

Objective: We identify factors related to SARS-CoV-2 infection linked to hospitalization, ICU admission, and mortality and develop clinical prediction rules., Methods: Retrospective cohort study of 380,081 patients with SARS-CoV-2 infection from March 1, 2020 to January 9, 2022, including a subsample of 46,402 patients who attended Emergency Departments (EDs) having data on vital signs. For derivation and external validation of the prediction rule, two different periods were considered: before and after emergence of the Omicron variant, respectively. Data collected included sociodemographic data, COVID-19 vaccination status, baseline comorbidities and treatments, other background data and vital signs at triage at EDs. The predictive models for the EDs and the whole samples were developed using multivariate logistic regression models using Lasso penalization., Results: In the multivariable models, common predictive factors of death among EDs patients were greater age; being male; having no vaccination, dementia; heart failure; liver and kidney disease; hemiplegia or paraplegia; coagulopathy; interstitial pulmonary disease; malignant tumors; use chronic systemic use of steroids, higher temperature, low O2 saturation and altered blood pressure-heart rate. The predictors of an adverse evolution were the same, with the exception of liver disease and the inclusion of cystic fibrosis. Similar predictors were found to be related to hospital admission, including liver disease, arterial hypertension, and basal prescription of immunosuppressants. Similarly, models for the whole sample, without vital signs, are presented., Conclusions: We propose risk scales, based on basic information, easily-calculable, high-predictive that also function with the current Omicron variant and may help manage such patients in primary, emergency, and hospital care., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objective: To see the relationship between the population deprivation index and the use of the health services, adverse evolution and mortality during the COVID-19 pandemic., Method: Retrospective cohort study of patients with SARS-CoV-2 infection from March 1, 2020 to January 9, 2022. The data collected included sociodemographic data, comorbidities and prescribed baseline treatments, other baseline data and the deprivation index, estimated by census section. Multivariable multilevel logistic regression models were performed for each outcome variable: death, poor outcome (defined as death or intensive care unit), hospital admission, and emergency room visits., Results: The cohort consists of 371,237 people with SARS-CoV-2 infection. In the multivariable models, a higher risk of death or poor evolution or hospital admission or emergency room visit was observed within the quintiles with the greatest deprivation compared to the quintile with the least. For the risk of being hospitalized or going to the emergency room, there were differences between most quintiles. It has also been observed that these differences occurred in the first and third periods of the pandemic for mortality and poor outcome, and in all due for the risk of being admitted or going to the emergency room., Conclusions: The groups with the highest level of deprivation have had worse outcomes compared to the groups with lower deprivation rates. It is necessary to carry out interventions that minimize these inequalities., (Copyright © 2023 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.)

Maintaining the physical performance of cancer patients is increasingly considered due to the growing number of cancer patients and the aggressiveness of the treatments. For this reason, bioimpedance is now being used to record patients' body composition by obtaining the phase angle (PhA). Although there is a direct relationship between PhA, age, sex and disease prognosis, it has not been measured as an analysis of physical performance in oncology patients and is a valid tool in the follow-up of cancer patients. For this purpose, 311 patients were evaluated, and both bioelectrical impedance analysis (BIA) and physical performance measurements were performed. The modification of the results concerning PhA was found to be highly relational, as a variation in one of the variables affected the other. It was concluded that each degree increase in PhA modified -22.57 s [-27.58; -17.53] in 400-m walking test (400 mWT); 13.25 kg [10.13; 16.35] in upper-body strength (UBS); 6.3 [4.95; 7.65] in lower-body strength (LBS); 1.55 mL/kg/min [0.98; 2.12] in VO 2peak ; 6.53 Watts [3.83; 9.20] in ventilatory threshold 1 (VT1); 10.36 Watts [7.02; 13.64] in ventilatory threshold 2 (VT2). It was also noted that age was a factor that affected the relationship between PhA and 400 mWT; the older the age, the higher the relationship. PhA data has been shown to be highly correlated with physical performance. This is of great importance in clinical practice because a cancer patient's physical performance levels can be assessed during treatment.

Backgrounds: Due to the COVID-19 pandemic that we are currently facing, many governments across the world have declared a state of emergency and even confinements. This stressful situation, in addition to prolonged stays at home, may imply a radical change in lifestyle behavior and physical activity (PA). The aim of this study is to evaluate the physiological and psychological effects in cancer patients who changed their PA habits during the COVID-19 state of emergency in Spain., Methods: Thirty-three participants were evaluated pre- and post-state of emergency. A series of questionnaires was used to assess cancer-specific quality of life., Results: The most relevant results revealed significantly lower walking time ( p  < 0.001) and sitting time ( p  = 0.014). Upper and lower body strength also decreased significantly ( p  = 0.009 and 0.012, respectively) and oxygen consumption (VO2 peak) ( p  = 0.023). None of the parameters analysed showed significant differences for psychological aspects (QLQ-C-30 and SF-36) and body composition., Conclusion: Lower physical activity leads to negative physiological adaptation, particularly affecting cardiovascular and strength levels. While it is important to maintain the general population's amount and intensity of exercise, this particularly vulnerable group's physical capacity is vital to their health and well-being., Competing Interests: Conflict of interestThe authors declare that they have no conflict of interest., (© The Author(s) 2022.)

Background: Despite the established benefits of regular exercise for patients with cancer to counteract the deleterious effects of the disease itself and treatment-related adverse effects, most of them do not engage in sufficient levels of physical activity and there is a paucity of data on the integration of efficacious exercise programs that are accessible and generalizable to a large proportion of patients with cancer into routine cancer care., Objective: We intend to examine the effects attributable to the implementation of a community-based exercise program on cardiorespiratory functional capacity and quality of life for patients with cancer., Methods: This will be a hybrid study. In the first experimental phase, patients diagnosed with any type of cancer will be randomized into two parallel groups. One group immediately performs Bizi Orain, a 3-month supervised exercise program (3 times a week), in addition to behavioral counseling in a primary health care setting; the other is a reference group that starts the exercise program 3 months later (delayed treatment). In the second observational phase, the entire cohort of participants will be followed-up for 5 years. Any person diagnosed with cancer in the previous 2 years is eligible for the program. The program evaluation involves the uptake, safety, adherence, and effectiveness assessed after completion of the program and with follow-ups at 3, 6, 12, 24, 36, 48, and 60 months. The primary outcomes of the experimental study, to be compared between groups, are improved physical function and quality of life, whereas overall survival is the main objective of the prospective study. To analyze the association between changes in physical activity levels and overall survival, longitudinal mixed-effects models will be used for repeated follow-up measures., Results: A total of 265 patients have been enrolled into the study since January 2019, with 42 patients from the hematology service and 223 from the oncology service., Conclusions: Bizi Orain is the first population-based exercise program in Spain that will offer more insight into the implementation of feasible, generalizable, and sustainable supportive care services involving structured exercise to extend survival of patients with cancer, improve their physical function and quality of life, and reverse the adverse effects of their disease and related treatments, thereby reducing the clinical burden., Trial Registration: ClinicalTrials.gov NCT03819595; http://clinicaltrials.gov/ct2/show/NCT03819595., International Registered Report Identifier (irrid): DERR1-10.2196/24835., (©Maria Soledad Arietaleanizbeaskoa, Erreka Gil Rey, Nere Mendizabal Gallastegui, Arturo García-Álvarez, Ibon De La Fuente, Silvia Domínguez-Martinez, Susana Pablo, Aitor Coca, Borja Gutiérrez Santamaría, Gonzalo Grandes. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.08.2021.)

Background: Chronic illnesses are the leading cause of morbidity and mortality and threaten the sustainability of healthcare systems worldwide. There is limited evidence in terms of the best modality and intensity of physical activity for improving cardiorespiratory capacity and quality of life in patients with chronic conditions. The objective of the EfiKroniK study is to estimate the common effect of innovative, individualized and supervised physical exercise, on cardiorespiratory functional capacity and quality of life across people with different chronic conditions., Methods/design: This is a multicentre clinical trial with a type I hybrid effectiveness-implementation design, including 370 patients each with one of four different chronic illnesses: solid cancer, blood cancer, chronic obstructive pulmonary disease or schizophrenia. Patients will be randomly divided into two parallel groups, stratified by illness type. Patients in both groups will receive a standard healthy life prescription (PVS, from the Spanish "Prescribe Vida Saludable") and additionally, the EfiKroniK group will be prescribed a physical exercise programme tailored to each patient in terms of intensity in each session. The primary outcome variables will be cardiorespiratory functional capacity and quality of life. The secondary outcome variables will be signs and symptoms, psychological and social factors and specific laboratory parameters. We will also analyse the dose-response effect of the physical exercise programme. Qualitative variables will describe patients' perception of the utility and suitability of the EfiKroniK programme, as well as their expectations and satisfaction, identifying barriers to and facilitators of the EfiKroniK implementation process through discussion groups. The study will be carried out on an intention-to-treat basis, comparing changes throughout the 1-year follow-up between groups, adjusting for baseline, by performing mixed-effect analysis of covariance. We will estimate the effect of time on repeated measures in each subject and changes in the EfiKroniK and PVS groups over time., Discussion: The study will provide the data necessary to allow us to prescribe physical exercise in a similar way to a drug and as a key part of the treatment of chronic illnesses within our healthcare system., Trial Registration: NCT03810755 . Date and version identifier: October 9, 2020. Version2.0.

Methylmercury (MeHg) is the most bioavailable and toxic form of the globally distributed pollutant Hg. Organisms of higher trophic levels living in aquatic ecosystems have potentially higher concentrations of MeHg. In this work, we analysed both MeHg and inorganic Mercury (Hg(II)) concentrations from dorsal feathers of chicks from ten colonies of Yellow-legged Gull (Larus michahellis) in the south-eastern part of the Bay of Biscay. Overall, we detected a high mean MeHg concentration that, however, differed among colonies. Additionally, based on stable isotopes analysis (δ 13 C and δ 15 N) and conducting General Linear Mixed Models, we found that chicks which were mostly/mainly fed with prey of marine origin had higher levels of MeHg. We propose Yellow-legged Gull as a reliable biomonitor for Hg species, as it is easy for sampling and in compliance with the Minamata convention on Mercury., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Colorectal cancer (CRC) is a major public health problem due to its incidence and mortality. Screening programmes help decrease its impact on the population through early detection. However, the uneven distribution of social determinants of health can cause inequalities. The aim of this study is to identify the social inequalities in the participation in CRC screening programmes., Methods: A systematic review of the literature was carried out, searching in both health and social databases for papers published since 2000 in English, Spanish, Portuguese and French. The search strategies combined terms regarding screening, CRC, participation and social inequalities. Included papers were quantitative or qualitative primary studies analyzing gender and socioeconomic inequalities in the participation in CRC screening programmes implemented by public and private health-care providers and addressing 45- to 75-year-old population., Results: A total of 96 studies, described in 102 articles, were included. Most were quantitative observational studies and analyzed population-based screening programmes. They were carried out mainly in the UK (n=29) and the USA (n=18). Participation in screening programmes varied from 1.1% to 82.8% using several methods. A total of 87 studies assessed participation by sex and one focussed on men, but only two provided an analysis from a gender perspective. Although men are at a higher risk of developing CRC, they generally were less likely to participate in screening programmes. Screening attendance was higher among the least deprived areas., Conclusions: Gender and socioeconomic inequalities in CRC screening participation should be addressed through the design of tailored interventions with a multidimensional focus., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.)

Computational fluid dynamics (CFD) has been extensively used for the USP paddle apparatus II, but limited CFD studies have been conducted on the USP basket apparatus I. We expanded on past CFD basket studies to consider the presence of a tablet inside the basket, compared predictions to in vivo conditions, and confirmed observations around the complexity of nonuniform hydrodynamics. Tablets near the basket perimeter experienced near 5-fold increase in maximum velocity and surface shear stress compared to tablets placed at the center of the basket. At higher basket speeds, the predicted velocities at the center of the basket were closer to in vivo predictions but the surface shear stress was about 2 orders of magnitude lesser. Simulations with a high viscosity fluid (1 Pa-s) showed a 10-fold increase in shear stress on a tablet but a decrease in strain rate compared to low-viscosity medium (0.001 Pa-s) which could impact dissolution rates. Also presented are the insights into turbulent energy dissipation rates that could help in a priori prediction of dissolution rates. Overall, the CFD analysis presented in this work reveals significant differences between the basket and in vivo conditions and will help inform relevant in vitro testing., (Copyright © 2020. Published by Elsevier Inc.)

Background: This study evaluates the effectiveness of adding a diet smartphone application to standard counseling to modify dietary composition over the long term (12 months)., Methods: A randomized, controlled, multicenter clinical trial was conducted involving the participation of 833 subjects from primary care clinics (415 to the intervention (counseling + application) group (IG) and 418 to the control (counseling) group (CG)). Both groups were counseled about a healthy diet and physical activity. For the 3-month intervention period, the IG was also trained to use a diet smartphone application that involved dietary self-monitoring and tailored feedback. Nutritional composition was estimated using a self-reported food frequency questionnaire., Results: An analysis of repeated measures revealed an interaction between the group and the percentages of carbohydrates ( p = 0.031), fats ( p = 0.015) and saturated fats ( p = 0.035) consumed. Both groups decreased their energy intake (Kcal) at 12 months (IG: -114 (95% CI: -191 to -36); CG: -108 (95% CI: -184 to -31)). The IG reported a higher percentage intake of carbohydrates (1.1%; 95% CI: 0.1 to 2.0), and lower percentage intakes of fats (-1.0%; 95% CI: -1.9 to -0.1) and saturated fats (-0.4%; 95%CI: -0.8 to -0.1) when compared to the CG., Conclusions: Better results were achieved in terms of modifying usual diet composition from counseling and the diet smartphone application compared to counseling alone. This was evaluated by a self-reported questionnaire, which indicated an increased percentage intake of carbohydrates, and decreased percentage intakes of fats and saturated fats.

Background: Evidence on the efficacy of smartphone applications (apps) for reducing body weight and other measurements of adiposity sustainably is not conclusive., Objective: To evaluate the effect of adding an app for 3 months to traditional counselling on physical activity (PA) and a heart-healthy diet for the modification of measurements of adiposity at 3 and 12 months after intervention., Methods: This randomised clinical trial included 833 subjects. The counselling and app group (IG) had 415 subjects, while 418 were included in the counselling only group (CG). The primary outcome was adiposity measurements at 3 and 12 months after intervention. The secondary outcome was the effect of the intervention by sex., Intervention: Counselling on a heart-healthy diet and PA was given to both groups. The IG also received training in the use of a smartphone app designed to promote a heart-healthy diet and PA, and this group was given access to this application for 3 months. Outcome measurements included waist circumference (WC), body mass index (BMI) and Clínica Universidad de Navarra - body adiposity estimator (CUN-BAE)., Results: In the IG at 12 months, the following decreased: WC -0.72 cm (95% confidence interval [CI]: -2.35 to -0.02) and CUN-BAE -0.35 (95% CI: -0.63 to -0.06). These decreases were only observed in women. After baseline adjustment, the beneficial effect was maintained in the IG compared to the CG at 12 months in terms of WC (-0.67; 95% CI: -0.29 to -0.02) and CUN-BAE (-0.57; 95% CI: -1.10 to -0.04), but only in women., Conclusions: An intervention of nutritional counselling and PA plus the smartphone app with personalised recommendations compared to CG showed beneficial results in terms of reduction of abdominal obesity and the percentage of body fat in women, but not in men.

Scale-up and technology transfer of lyophilization processes remains a challenge that requires thorough characterization of the laboratory and larger scale lyophilizers. In this study, computational fluid dynamics (CFD) was employed to develop computer-based models of both laboratory and manufacturing scale lyophilizers in order to understand the differences in equipment performance arising from distinct designs. CFD coupled with steady state heat and mass transfer modeling of the vial were then utilized to study and predict independent variables such as shelf temperature and chamber pressure, and response variables such as product resistance, product temperature and primary drying time for a given formulation. The models were then verified experimentally for the different lyophilizers. Additionally, the models were applied to create and evaluate a design space for a lyophilized product in order to provide justification for the flexibility to operate within a certain range of process parameters without the need for validation., (Published by Elsevier B.V.)

Surface functionalization of orthopedic implants is being intensively investigated to strengthen bone-to-implant contact and accelerate bone healing process. A hybrid coating, consisting of 45S5 bioactive glass (BG) individually wrapped and interconnected with fibrous cellulose nanocrystals (CNCs), is deposited on 316L stainless steel from aqueous suspension by a one-step electrophoretic deposition (EPD) process. Apart from the codeposition mechanism elucidated by means of zeta-potential and scanning electron microscopy measurements, in vitro characterization of the deposited CNCs-BG coating in simulated body fluid reveals an extremely rapid mineralization of BG particles on the coating (e.g., the formation of hydroxyapatite crystals layer after 0.5 day). A series of comparative trials and characterization methods were carried out to comprehensively understand the mineralization process of BG interacting with CNCs. Furthermore, key factors for satisfying the applicability of an implant coating such as coating composition, surface topography, and adhesion strength were quantitatively investigated as a function of mineralization time. Cell culture studies (using MC3T3-E1) indicate that the presence of CNCs-BG coating substantially accelerated cell attachment, spreading, proliferation, differentiation, and mineralization of extracellular matrix. This study has confirmed the capability of CNCs to enhance and regulate the bioactivity of BG particles, leading to mineralized CNCs-BG hybrids for improved bone implant coatings.

Background: While it is known that a variety of factors (biological, behavioural and interventional) play a major role in the health of individuals and populations, the importance of the role of social determinants is less clear. The effect of social inequality on population-based screening for colorectal cancer (CRC) could limit the value of such programmes. The present study aims to determine whether such inequalities exist., Methods: Data was obtained from the population-based screening programme administered in the Autonomous Community of the Basque Country, Spain, with a target population aged 50 to 69, first invited to participate between 2009 and 2011. The magnitude of inequality was analysed using the odds ratio (taking the least disadvantaged socioeconomic quintile as the reference population), the population attributable risk and the relative index of inequality, based on the regression, which is the ratio of the rates in the most and least disadvantaged socioeconomic groups., Results: The target population comprised 242,394 people, with the test kit successfully sent to 95.1 % (230,510). The overall response rate was 64.3 % (67.1 in women and 61.4 % men). Among women, the highest participation was in the third quintile (71.5 %) and the lowest in the first - the least disadvantaged (65.7 %). The lowest and highest rates of people with identified lesions were in the second and fourth quintiles (14.7/1000 and 17.0/1000 respectively). Among men, the response rate was lowest in the fifth - most disadvantaged - quintile (60.2 %). The highest rate of identified lesions was in the fifth quintile; 38 % higher than the first (55.7/1000 compared to 41.0/1000)., Conclusions: Sex and socioeconomic group influence the rate of participation in the CRC programme and the rate of lesions found in the participants. Any public health programme is morally and ethically obliged to strive for equity and effectiveness. Improving participation of men and socially disadvantaged groups should be taken in account.

Background and Aims: Among fruits, kiwi is one of the richest in vitamins and polyphenols and has strong anti-oxidant effects. We aimed to analyze the relationship between the consumption of kiwi and plasma lipid values, fibrinogen, and insulin resistance in adults within the context of a normal diet and physical-activity., Methods: Cross-sectional study. Participants (N = 1469), who were free of cardiovascular diseases, completed a visit, which included the collection of information concerning the participant's usual diet and kiwi consumption using a previously validated, semi-quantitative, 137-item food-frequency-questionnaire. Fasting laboratory determinations included plasma lipids, fibrinogen and insulin resistance. Regular physical-activity was determined using accelerometry., Results: Consumers of at least 1 kiwi/week presented higher plasma values of HDL-cholesterol (mean difference 4.50 [95% CI: 2.63 to 6.36]) and lower triglyceride values (mean difference -20.03 [95% CI: -6.77 to -33.29]), fibrinogen values (mean difference -13.22 [95% CI: -2.18 to -24.26]) and HOMAir values (mean difference -0.30 [95% CI: -0.09 to -0.50]) (p < 0.05, for all comparisons) than those who consumed less than 1 kiwi per week. In an adjusted logistic regression analysis, this group had a lower odds-ratio for presenting plasmatic fibrinogen concentrations above 400 mg/dL (OR = 0.68, 95% CI 0.49 to 0.95), HDL-Cholesterol plasma values below 45 mg/dL (OR = 0.57, 95% CI 0.36 to 0.91) and a HOMAir above 3 (OR = 0.61, 95% CI 0.37 to 1.00)., Conclusions: Consumption of at least one kiwi/week is associated with lower plasma concentrations of fibrinogen and improved plasma lipid profile in the context of a normal diet and regular exercise.

This study presents the electrophoretic deposition (EPD) of cellulose nanocrystals (CNs) and CNs-based alginate composite coatings for biomedical applications. The mechanism of anodic deposition of CNs and co-deposition of CNs/alginate composites was analyzed based on the results of zeta-potential, Fourier transform infrared spectroscopy and scanning electron microscopy (SEM) analyses. The capability of the EPD technique for manipulating the orientation of CNs and for the preparation of multilayer CNs coatings was demonstrated. The nanotopographic surface roughness and hydrophilicity of the deposited coatings were measured and discussed. Electrochemical testing demonstrated that a significant degree of corrosion protection of stainless steel could be achieved when CNs-containing coatings were present. Additionally, the one-step EPD-based processing of free-standing CNs/alginate membranes was demonstrated confirming the versatility of EPD to fabricate free-standing membrane structures compared to a layer-by-layer deposition technique. CNs and CNs/alginate nanocomposite coatings produced by EPD are potential candidates for biomedical, cell technology and drug delivery applications., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Purpose: Non-alcoholic fatty liver disease (NAFLD) is an important cause of chronic liver injury that has gained concern in clinical hepatology. The principal aim of this study was to find differences in protein expression between patients with NAFLD and healthy controls., Experimental Design: Changes in protein expression of liver samples from each of the three groups of subjects, controls, non-alcoholic steatosis, and non-alcoholic steatohepatitis (NASH), were analyzed by DIGE combined with MALDI TOF/TOF analysis, a proteomic approach that allows to compare hundreds of proteins simultaneously., Results: Forty-three proteins exhibiting significant changes (ratio ≥1.5, p<0.05) were characterized, 22 comparing steatosis samples versus control samples and 21 comparing NASH versus control samples. Ten of these proteins were further analyzed by Western blot in tissue samples to confirm the observed changes of protein expression using DIGE. The proteins validated were further tested in serum samples of different cohorts of patients., Conclusions and Clinical Relevance: Following this approach we identified two candidate markers, carbamoyl phosphate synthase 1 and 78  kDa glucose-regulated protein, differentially expressed between control and NASH. This proteomics approach demonstrates that DIGE combined with MALDI TOF/TOF and Western blot analysis of tissue and serum samples is a useful approach to identify candidate markers associated with NAFLD, resulting in proteins whose level of expression can be correlated to a disease state., (Copyright © 2010 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)

The endometrial fluid is a noninvasive sample which contains numerous secreted proteins representative of endometrial function and reflects the state of the endometrium. In this study, we describe, for the first time, a comprehensive catalogue of proteins of the endometrial fluid during the secretory phase of the menstrual cycle. To achieve this objective, three different but complementary strategies were used: First, in-solution digestion followed by reverse phase high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS); second, protein separation by denaturing one-dimensional electrophoresis (SDS-PAGE) followed by HPLC-MS/MS analysis. Finally, two-dimensional polyacrylamide gel electrophoresis (2D-PAGE) followed by MALDI-TOF/TOF analysis. The combination of the three strategies led to the successful identification of 803 different proteins in the International Protein Index (IPI) human database (v3.48). An extensive description of the endometrial fluid proteome will help provide the basis for a better understanding of a number of diseases and processes, including endometriosis, endometrial cancer and embryo implantation. We believe that the thorough catalogue of proteins presented here can serve as a valuable reference for the study of embryo implantation and for future biomarker discovery involved in pathologic alterations of endometrial function.

E2F transcription factors are important regulators of proliferation, differentiation and apoptosis. We have previously shown that E2F2-/- mice develop late-onset autoimmune features, similar to systemic lupus erythematosus. E2F2-deficient T lymphocytes exhibit enhanced T cell receptor (TCR)-stimulated proliferation, which is presumably responsible for causing autoimmunity in E2F2-deficient mice. The comparison of E2F2-/- and wild-type T lymphocyte expression profiles by 2-DE followed by MS identification has revealed a set of deregulated proteins involved in TCR-mediated signaling, cell survival and stress responses. The deregulation of these proteins may account for the hyperproliferative phenotype that characterizes E2F2-/- T cells. Our work shows that proteomic analysis of gene-knockout strains can be a useful methodology to study the functional role of specific genes.