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OBJECTIVE: The aim of this study was to evaluate the effectiveness of cognitive behavioral therapy in the treatment of vasomotor, sexual dysfunction, and recurrent depression in postmenopausal women. METHODS: This prospective, open study evaluated 112 postmenopausal women with vasomotor symptoms. Sexual dysfunction has cultural, social, biological, and emotional issues and divided into two groups: G1, without depression (n=65) and G2, with recurrent depression (n=47). The subjects underwent 12 sessions of in-person cognitive behavioral therapy and 12 sessions of home-based activity over a period of 6 months. They were evaluated at 3 months following the completion of therapy. Depression, memory, and attention-related functions, as well as climactic symptoms, were assessed using a questionnaire. RESULTS: In the depression questionnaire, the G1 group had a lower initial score than the G2 group (p<0.01). Following 6 months of therapy, both groups had similar improved scores. In the depression questionnaire, the women in group G1 had higher baseline values. In the assessment of vasomotor symptoms, the values in both groups were similar and showed an improvement in vasomotor symptoms after 24 weeks of treatment, but these effects disappeared after the follow-up of 48 weeks in the G2 group. Both groups improved the sexual dysfunction after 24 weeks. CONCLUSION: Cognitive behavioral therapy may be effective in reducing vasomotor symptoms and ameliorate the sexual dysfunction and recurrent depression in postmenopausal women after 24 weeks of treatment.
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Terapia Cognitivo-Conductual , Posmenopausia , Humanos , Femenino , Posmenopausia/fisiología , Posmenopausia/psicología , Terapia Cognitivo-Conductual/métodos , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento , Encuestas y Cuestionarios , Sofocos/terapia , Sofocos/psicología , Depresión/terapia , Disfunciones Sexuales Fisiológicas/terapia , Recurrencia , Anciano , Disfunciones Sexuales Psicológicas/terapia , Disfunciones Sexuales Psicológicas/psicologíaRESUMEN
The social isolation imposed by the COVID-19 pandemic interrupted in-person activities, which were immediately followed by adaptations to ensure, for example, the continuity of teaching. This generated emotional impacts on the academic community. Emotional states may trigger or emphasize conditions such as temporomandibular dysfunction (TMD), causing pain and limiting masticatory function. This study aimed to compare the students and the faculty of a medical school first in terms of the TMD-caused pain they experienced during social isolation and reported two months later, according to their recollections, using the TMD-Pain Screener questionnaire. The second basis for comparison was the emotional state generated by social isolation and its connection with TMD symptoms assessed through the Depression, Anxiety and Stress Scale (DASS-21), which considers perceptions at the time of data collection. Both questionnaires were responded to in May 2022 after the end of social isolation. The data were analyzed by the IBM-SPSS software for Windows 22.0 with a 5% level of significance. The results show that the self-reported TMD symptoms were more widespread (p = 0.002) and intense (p = 0.013) among students than among faculty and that all of the former's DASS-21 domains (depression, anxiety, and stress) were also more strongly evident (p<0.05). Only anxiety was more significant among the faculty (p = 0.027). Both groups pointed to social isolation as an aggravating factor of the symptoms (p<0.05). The conclusion is that the self-reported TMD-caused pain and all DASS-21 domains as experienced during social isolation were stronger and more prevalent among students than among faculty, and that only anxiety was statistically significant among faculty. Also, the emotional states resulting from social isolation may have aggravated TMD-caused pain in both groups.
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COVID-19 , Emociones , Autoinforme , Aislamiento Social , Estudiantes de Medicina , Trastornos de la Articulación Temporomandibular , Humanos , COVID-19/psicología , COVID-19/epidemiología , Masculino , Femenino , Estudiantes de Medicina/psicología , Estudios Transversales , Trastornos de la Articulación Temporomandibular/psicología , Trastornos de la Articulación Temporomandibular/epidemiología , Adulto , Aislamiento Social/psicología , Encuestas y Cuestionarios , Adulto Joven , Ansiedad/epidemiología , Ansiedad/psicología , Facultades de Medicina , Pandemias , Dolor/psicología , Dolor/epidemiología , Depresión/epidemiología , Depresión/psicología , SARS-CoV-2/aislamiento & purificaciónRESUMEN
BACKGROUND: Infection remains a relevant complication after kidney transplantation (KT). A well-established strategy in modern medicine is the application of bundles of evidence-based practice in clinical settings. The objective of this study is to explore the application of a personalized bundle of measures aimed to reduce the incidence of infection in the first 12 months after KT. METHODS: A single-center prospective cohort of 148 patients undergoing KT between February 2018 and September 2019 that received an individualized infection prevention strategy was compared to a preintervention cohort (n = 159). The bundle comprised a review of the patient's immunization history, infection risk by country of origin, screening for latent tuberculosis infection (LTBI), antimicrobial prophylaxis, and immunological assessment. Individualized recommendations were accordingly provided at a scheduled visit at day +30 after transplantation. RESULTS: The intervention cohort showed a higher compliance rate with the recommended vaccine schedule, screening for geographically restricted infections and LTBI, and intravenous immunoglobulin and vitamin D supplementation (p values <.001). The 1-year incidence rate of infection was lower in the intervention cohort (42.6% vs. 57.9%; p value = .037), as was the rate of infection-related hospitalization (17.6% vs. 32.1%; p value = .003) and the incidence of severe bacterial infection. There were no differences in graft rejection or mortality rates between groups. CONCLUSIONS: A multifaceted intervention, including a bundle of evidence-based practices, enhanced compliance with recommended preventive measures and was correlated with a reduction in the 12-month incidence of infection after KT.
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Gender relations are a set of socially determined norms and rules that assign values, characteristics, and expectations to individuals based on their biological sex. These aspects also influence the clinician-patient relationship, since it has been for a long time based on cisheteronormativity. However, this attitude alienated the LGBTQIA+ community from health services. Global and specific gynecologic care needs to be offered to the LGBTQIA+ population, which has demands for sexual and reproductive health care. In this narrative review, we bring conceptual aspects, gender identity and expression, sexual history, screening for cancer and other care to the community.
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Gender equality has been a crosscutting issue in Horizon 2020 with three objectives: gender balance in decision-making, gender balance and equal opportunities in project teams at all levels, and inclusion of the gender dimension in research and innovation content. Between 2017 and 2022, the EU funded, in collaboration with national agencies, 13 transnational projects under "GENDER-NET Plus" that explored how to best integrate both sex and gender into studies ranging from social sciences, humanities, and health research. As the projects neared completion, forty researchers from these interdisciplinary teams met in November 2022 to share experiences, discuss challenges, and consider the best ways forward to incorporate sex and gender in research. Here, we summarize the reflections from this workshop and provide some recommendations for i) how to plan the studies (e.g., how to define sex and/or gender and their dimensions, rationale for the hypotheses, identification of data that can best answer the research question), ii) how to conduct them (e.g., adjust definitions and dimensions, perform pilot studies to ensure proper use of terminology and revise until consensus is achieved), and iii) how to analyze and report the findings being mindful of any real-world impact.
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A LOx-based electrochemical biosensor for high-level lactate determination was developed. For the construction of the biosensor, chitosan and Nafion layers were integrated by using a spin coating procedure, leading to less porous surfaces in comparison with those recorded after a drop casting procedure. The analytical performance of the resulting biosensor for lactate determination was evaluated in batch and flow regime, displaying satisfactory results in both modes ranging from 0.5 to 20 mM concentration range for assessing the lactic acidosis. Finally, the lactate levels in raw serum samples were estimated using the biosensor developed and verified with a blood gas analyzer. Based on these results, the biosensor developed is promising for its use in healthcare environment, after its proper miniaturization. A pH probe based on common polyaniline-based electrochemical sensor was also developed to assist the biosensor for the lactic acidosis monitoring, leading to excellent results in stock solutions ranging from 6.0 to 8.0 mM and raw plasma samples. The results were confirmed by using two different approaches, blood gas analyzer and pH-meter. Consequently, the lactic acidosis monitoring could be achieved in continuous flow regime using both (bio)sensors.
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Técnicas Biosensibles , Técnicas Electroquímicas , Ácido Láctico , Técnicas Biosensibles/métodos , Técnicas Biosensibles/instrumentación , Concentración de Iones de Hidrógeno , Ácido Láctico/sangre , Técnicas Electroquímicas/métodos , Técnicas Electroquímicas/instrumentación , Humanos , Acidosis Láctica/sangre , Acidosis Láctica/diagnóstico , Quitosano/química , Polímeros de Fluorocarbono/química , Compuestos de Anilina/química , Enzimas Inmovilizadas/química , Oxigenasas de Función MixtaRESUMEN
Background: Coronavirus disease 2019 (COVID-19) novel severe acute respiratory syndrome affected the world population with an infectious condition for which therapeutic forms are limited and vascular sequelae are major challenges. Pregnant women are physiologically immunocompromised and can be more affected by the pandemic than the general population. Extra precaution measures against COVID-19 during and after the outbreak are essential to ensure the safety of the newborn. The aim of the present study was to report the cesarean birth of a female child with Klippel-Trenaunay of a mother currently infected by COVID-19. Case Description: A newborn of a 21-year-old mother with COVID-19 in the final stage of the disease was born through a cesarean section at full term. The physical examination at birth revealed substantial edema of the left lower limb associated with port-wine stains on the limb and left torso. The ultrasound revealed venous-lymphatic malformation affecting the entire left lower limb, suprapubic region and ipsilateral abdominal region. Two evaluations for COVID-19 were performed and both were negative. Infants of mothers with active COVID-19 infection during the birth period have a low probability of being positive for the disease, but precautions should be taken. Conclusions: The association with malformations, such as the rare Klippel-Trenaunay syndrome (KTS), constitutes another challenge regarding the diagnosis and proper conduct to be taken with these children.
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BACKGROUND: Anti-TNF drugs have revolutionized the treatment of Crohn's disease (CD) and have set new therapeutic targets. A direct correlation between anti-TNF trough levels and endoscopic healing in IBD patients has been established, but the association between drug levels and transmural healing assessed by ultrasound is not yet clearly defined. AIMS: To evaluate the correlation between the serum concentration of adalimumab (ADA) and sonographic transmural healing in CD patients at different times during the follow-up of patients. METHODS: In this retrospective, cross-sectional study all patients with CD who were undergoing treatment with ADA in our center were included. Intestinal ultrasound (IUS) was performed before the initiation of the drug and for response monitoring. ADA serum-through levels were compared between patients with and without transmural healing at different periods of time. RESULTS: 92 patients were included, all patients showed signs of inflammatory activity in the baseline IUS. In the IUS monitoring of the response to ADA, 34 (34.8%) patients presented transmural healing. Among patients in the first year of treatment, those with sonographic healing showed higher median levels than patients without transmural healing (12.0 µg/mL vs. 9.3 µg/mL, respectively; p= 0.007). There was no correlation found between adalimumab levels and sonographic healing in patients undergoing treatment for over a year. CONCLUSIONS: Higher adalimumab through levels were corelated with transmural healing with ultrasound during the first year of treatment. This correlation was not found after one year of treatment.
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AIM: Due to the limited data from clinical trials and real-world settings in the realm of nusinersen, there is a need for further evidence. This study seeks to assess the impact of nusinersen, when combined with standard care, on bulbar function, respiratory function, and the necessity for respiratory support among pediatric patients with spinal muscular atrophy (SMA). METHODS: Prospective observational study, involving pediatric SMA patients (types 1-3) undergoing nusinersen treatment at the Hospital Universitario Virgen del Rocío in Spain over at least a 24-month period. The cohort included 11 SMA type 1 patients, comprising 6 type 1b and 5 type 1c, 12 SMA type 2 patients, and 5 SMA type 3 patients. RESULTS: 28 pediatric patients were enrolled, with a majority being male (n=20). Patients with type 1 were diagnosed and received treatment significantly earlier than those with types 2 and 3 (P<0.001). Additionally, there was a longer period between diagnosis and the start of treatment in types 2/3 (P=0.002). Follow-up revealed statistically improved functional and respiratory outcomes associated with earlier initiation of nusinersen treatment at 6, 12, and 24 months in all phenotypes. The ability to swallow and feed correctly remained unchanged throughout the study, with SMA type 1c patients maintaining oral feeding in contrast to patients with SMA type 1b. Notably, no deaths were recorded. CONCLUSIONS: This study provides important insights into the real-world clinical progress of pediatric SMA patients and their response to nusinersen treatment, highlighting the significance of early intervention for better functional and respiratory outcomes.
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INTRODUCTION: This study was designed to examine the capacity of intraoperative optical coherence tomography (OCT) to predict the postimplant position of the glaucoma drainage device PreserfloTM. METHODS: 13 eyes (mean age 65.42 (14.89) years) underwent PreserfloTM (Santen, Osaka, Japan) placement. Before surgery, participants were subjected to a comprehensive ophthalmic examination (intraocular pressure (IOP), cup to disk ratio (C/D), visual field, OCT, endothelial cell count). Anterior segment OCT scans were obtained intraoperatively using a Rescan 700 OCT system (Carl Zeiss Meditec, Inc., Oberkochen, Germany). One day postsurgery, anterior segment OCT using the Spectralis OCT (Heidelberg Engineering GmbH) was performed in a sitting position to capture the same chamber cross-section as before. The main outcome variables were tube-endothelium distance (T-E) and tube length (TL) in the anterior chamber measured using both OCT systems. Correlation between intraoperative and office measurements was examined through Pearson correlation (r) and intraclass correlation coefficients (ICC). RESULTS: Mean intraoperative and in-office T-E were 625.26 (SD 366.60) versus 561.16 (SD 364.62) µm respectively (p = 0.540). Intraoperative and in-office anterior chamber TL were 1386 (SD 701.82) and 1433.91 (SD 713.55) µm, respectively (p = 0.029). Excellent correlation was observed between both sets of T-E (r = 0.992; p = 0.008) and TL (r = 0.984; p = 0.016) values. Both OCT systems showed good agreement yielding ICCs of 0.992 (p < 0.001) for T-E and 0.995 (p = 0.001) for TL. DISCUSSION: Excellent correlation was observed between our intraoperative and postoperative OCT measurements. These results support the usefulness of intraoperative OCT to confirm the correct position of an implanted PreserfloTM microshunt.
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Diabetes-related foot osteomyelitis (DFO) is a common yet complex condition, often complicated by concurrent soft tissue infections (STIs). This study evaluates the efficacy of a two-step conservative surgical approach, hypothesizing that it offers comparable outcomes to a one-step procedure. Conducted on a cohort of 93 patients with DFO, the study categorized cases into two types: OM1 (osteomyelitis without STI) and OM2 (osteomyelitis with STI). OM2 was further subdivided into OM2a (early diagnosis) and OM2b (late diagnosis), with OM2 patients undergoing initial soft tissue debridement followed by elective bone surgery. The results indicated no significant differences in infection recurrence or amputation rates between the two surgical approaches, with recurrence observed in 20.7% of cases and amputations in 10.8%. The two-step procedure was associated with higher inflammatory responses and greater need for antibiotics and hospital admissions. However, these factors did not translate into increased recurrence or amputation compared to the one-step procedure. The study supports the two-step approach as a safe and effective method for managing complicated DFO cases, providing a viable alternative to immediate amputation or single-stage surgery. Despite some limitations, including regional specificity and potential underdiagnosis in late-diagnosed cases, the findings offer valuable insights for clinical management and suggest further research to refine treatment protocols. The study's strengths include confirmed histopathological diagnoses and consistent follow-up, reinforcing the validity of the two-step surgical approach for complex DFO treatment.
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PURPOSE: To evaluate the cost-effectiveness of a multifaceted workplace intervention to reduce musculoskeletal pain (MSP) in nursing staff. METHODS: The study was a 1-year cluster-randomized controlled trial. The intervention combined participatory ergonomics, health promotion, and case management. The control group received usual care. Societal and health system perspectives were used. Costs included direct health and indirect costs. The effects were MSP and quality-adjusted life years (QALYs). MSP was measured using the Standardized Nordic Questionnaire at baseline and 6- and 12-month follow-up. QALYs were measured using the EuroQol-5D-3L at 6- and 12-month follow-up. Incremental costs and QALYs were modelled using generalized linear models. MSP was analysed through generalized logistic models. Incremental cost-effectiveness ratios (ICERs) were calculated, and cost-effectiveness planes and acceptability curves were constructed. RESULTS: Total mean costs per person were 614 and 216 for the intervention and control group, respectively, with a societal perspective. The intervention mean cost was 38/person. From the societal perspective, the ICER showed that overall additional 68 (9 from a health system perspective) were required to achieve 1-extra-percentage-point reduction of MSP. ICERs were 34 from the societal and 4 from the health system perspectives for neck, shoulders and upper back pain; 53 and 7 for low back; 179 and 23 for hands; 39 and 5 for legs; 115 and 14 for the knees; 36 and 5 for feet For MSP in the elbows. For participants with pain in the elbow, and for QALYs, the ICER showed that the intervention group was dominated by the control group. CONCLUSION: This intervention was not cost-effective in terms of QALYs. However, in terms of MSP, with a willingness to pay of 100, the probability of the intervention being cost-effective was around 90%. Further studies incorporating our recommendations are needed to confirm these findings. STUDY REGISTRATION: ISRCTN15780649, retrospectively registered.
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Nursing has proven to be an essential healthcare profession, especially in the face of the COVID-19 pandemic crisis. In this chapter, it shows the essential aspects of the discipline of care and its application in the face of the pandemic from an Informatics Nursing approach. The conceptual bases include the conception of care and its historical evolution. Thus, the Personal Care Knowledge Model, the clinical care sequence and its standardized languages allow Taxonomic Triangulation to be developed. Taxonomic Triangulation is a technique created by nurses that allows managing information and that served to extract knowledge from documents and clinical experiences. The application of this vision of care and its knowledge management models have been tested in different situations: from the identification of care diagnoses in a World Health Organization clinical guide to the design of a care plan manual in a hospital. On the other hand, a secondary result is the resilience shown by the nurses. A resilience based on theoretical models centered on the person and on a language that can represent life from care. In addition, nursing includes a comprehensive perspective that addresses the emotional and spiritual area. In conclusion, nurses and their specialization with skills in knowledge management allow giving visibility to care. A professional care whose purpose is to improve health systems through solutions based on care so that people can achieve their best health situation.
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COVID-19 , Humanos , COVID-19/epidemiología , SARS-CoV-2/patogenicidad , Competencia Clínica , PandemiasRESUMEN
Trypanosoma and Leishmania species are responsible of a range of Neglected Tropical Diseases (NTDs) from disfiguring conditions to fatal processes in humans. Both genera also affect wild and domestic animals causing diseases of public health significance and high economic impact on farm economy of developing areas. Japan has been actively involved in overseas cooperation and the country has a large scientific community. However, there is no information on the scientific output of Japanese scientists and institutions on these two NTDs. To explore the Japanese contribution and its profile, we have mined Web of Science database from 1971 to 2022 the articles by Japanese scientists, scientific areas and institutions, time-related variations of these parameters, and involvement in cooperation activities with foreign scientists. Research on Trypanosoma has been present in all the studied period, with higher production, whereas Leishmania-related activities showed a delay. A steady increased of Japanese scientific output was found up to the beginning of 2000s, whereas a certain stagnation was found in the present century. Low growth rate of research output on these two NTDs by Japanese authors in the 21st century is not correlated neither to the pattern found globally nor the situation in other parasitic infections. Thus, other elements should be considered in future analysis including the actual number of scientists involved and the available funding. Reinforcement of research groups from Japanese institutions and widening the scope of collaborations, particularly with health and academic centers from endemic regions, could trigger the Japanese productivity in the research area.
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In an open randomized controlled trial, we compared one vial (10 mL) to two vials (20 mL) of EchiTAb-plus-ICP (EPI) antivenom among children with systemic carpet viper (Echis romani) envenoming of moderate severity in northeastern Nigeria. Systemic envenoming, presenting with incoagulable blood, was diagnosed using the 20-minute whole blood clotting test (20WBCT). Eligible patients with positive 20WBCT whose guardians assented were recruited and randomly allocated to receive either one vial or two vials of EPI administered either as a bolus or as a slow continuous infusion. The primary outcome was permanent restoration of blood coagulability 6 hours after the start of treatment, assessed by the 20WBCT and repeated at 6, 12, 24, and 48 hours after treatment. Secondary outcomes were the incidences of early adverse reactions to antivenom treatment. Initial doses permanently restored blood coagulability at 6 hours in 34/39 (87.2%) of those treated with one vial and 39/41 (95.1%) of those treated with two vials of EPI (P = 0.258). However, the proportion with permanent restoration of clotting at 6 hours among patients randomized to bolus administration was 41 of 42 (97.6%) patients compared with 32 of 38 (84.2%) patients randomized to slow infusion of EPI antivenom (P = 0.049); however, the difference was not sustained through the remaining time points. There was no difference in early adverse reactions between those treated with the two different doses or modes of delivery. We conclude that the one-vial dose compared favorably to two vials of EPI antivenom with regards to effectiveness and safety among children with carpet viper envenoming of moderate severity in Nigeria.
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BACKGROUND: Earlier statements suggested a negative impact of coronavirus disease 2019 (COVID-19) infection on sports performance and injury risk. With the COVID-19 pandemic under control and the dominance of a less-severe strain of the virus, there is a need to confirm whether these adverse effects still apply to the current situation. HYPOTHESIS: Infected players would have a higher noncontact muscle injury incidence compared with noninfected counterparts. STUDY DESIGN: Cohort observational study. LEVEL OF EVIDENCE: Level 3. METHODS: Seven teams (n = 147 players) competing in the Spanish professional women's football league (Liga F) were prospectively monitored during the 2021-2022 season. Data from noncontact injuries were recorded and classified following the latest consensus statement from the International Olympic Committee. COVID-19 was certified by the medical staff by regular polymerase chain reaction analysis. RESULTS: Ninety-two players suffered at least 1 noncontact muscle injury during the season. Injury incidence during the season was similar in players with COVID-19 (n = 83) and players without infection (5.1 ± 6.7 versus 4.9 ± 10.0 injuries/1000 h of play, respectively; P = 0.90). Players with COVID-19 were not more likely to suffer noncontact injuries compared with those players without infection (R2 = 0.02; odds ratio [OR] 95% confidence interval [95% CI] = 0.36-1.38; P = 0.31). There was no effect of COVID-19 on the days of absence due to injury (R2 = 0.01; OR 95% CI = 1.00-1.01; P = 0.44) or in the classification of the severity of the injury (P = 0.79). CONCLUSION: COVID-19 has no significant effect on noncontact injury incidence and severity in professional female football players. CLINICAL RELEVANCE: Currently, COVID-19 infection does not alter noncontact muscle injury risk in professional football and requires no further attention in terms of injury management. Usual return-to-play protocols apply to COVID-19 considering the particularities of each player since the severity of infection, period of inactivity, and effects on the player's health and performance.
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Graphene oxide (GO) is a very attractive material for use in a vast number of applications. However, before its widespread use, it is important to consider potential issues related to environmental safety to support its safe application. The aim of this study was to investigate effects on fish (rainbow trout) following GO exposure. Using both an in vitro approach with the RTL W1 rainbow trout liver cell line, and in vivo exposures, following OECD TG 203, disturbances at the cellular level as well as in the gills and liver tissue of juvenile trout were assessed. In RTL W1 cells, a time and concentration-dependent loss in cell viability, specifically plasma membrane integrity and lysosomal function, was observed after 96 hours of exposure to GO at concentrations ≥ 18.75 mg/L. Additionally, increased reactive oxygen species (ROS) levels were evidenced at concentrations ≥ 18.75 mg/L, and an enhancement of metabolic activity was noted with concentrations ≥ 4.68 mg/L. In vivo exposures to GO did not provoke mortality in rainbow trout juveniles following 96 h exposure but led to histological alterations in gills and liver tissues, induction of enzymatic detoxification activities in the liver, as well as aryl hydrocarbon receptor (ahr)-cytochrome P450 1a (cyp1a) gene expression downregulation, and upregulation of pro-inflammatory cytokines il1b and il8 at GO concentrations ≥ 9.89 mg/L.
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BACKGROUND: Acute coronary syndrome (ACS), specifically ST-segment elevation myocardial infarction is a major cause of morbidity and mortality throughout Europe. Diagnosis in the acute setting is mainly based on clinical symptoms and physician's interpretation of an electrocardiogram (ECG), which may be subject to errors. ST-segment elevation is the leading criteria to activate urgent reperfusion therapy, but a clear ST-elevation pattern might not be present in patients with coronary occlusion and ST-segment elevation might be seen in patients with normal coronary arteries. METHODS: The ASSIST project is a retrospective observational study aiming to improve the ECG-assisted assessment of ACS patients in the acute setting by incorporating an artificial intelligence platform, Willem™ to analyze 12lead ECGs. Our aim is to improve diagnostic accuracy and reduce treatment delays. ECG and clinical data collected during this study will enable the optimization and validation of Willem™. A retrospective multicenter study will collect ECG, clinical, and coronary angiography data from 10,309 patients. The primary outcome is the performance of this tool in the correct identification of acute myocardial infarction with coronary artery occlusion. Model performance will be evaluated internally with patients recruited in this retrospective study while external validation will be performed in a second stage. CONCLUSION: ASSIST will provide key data to optimize Willem™ platform to detect myocardial infarction based on ECG-assessment alone. Our hypothesis is that such a diagnostic approach may reduce time delays, enhance diagnostic accuracy, and improve clinical outcomes.
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The multidimensional view of disease is fundamental in the care of complex diseases such as chronic kidney disease (CKD). It is appropriate to define and unify concepts that allow the different professionals involved in care to provide a multidisciplinary approach tailored to the needs of each individual. Given the increasing incidence of CKD worldwide and the fact that the disease may progress at different rates, there is a need to establish personalized, comprehensive approaches for each patient and their families at an earlier stage. This approach goes beyond the simple control of uremic symptoms or congestion and consists of addressing not only symptomatic but also functional, social and coping problems at an early stage, facilitating decision making both in the CKD and in acute situations, potentially irreversible or interventions that do not improve life expectancy. To ensure excellence in care, it is important to assess indicators of palliative care and kidney support, such as the presence of advance and shared care planning, the inclusion of psychosocial, ethical, spiritual and bereavement care. This enables the provision of comprehensive, humanized, and high-quality care for patients and their families. Palliative and kidney care is not just about patients in the last days of life. Defining, unifying, and evaluating the concepts will allow them to be applied in a timely manner at each specific moment of the CKD trajectory.
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BACKGROUND: Treatment for haemophilia A has expanded from plasma-derived factor VIII (pdFVIII) and standard half-life (SHL) recombinant FVIII (rFVIII) to extended half-life (EHL) rFVIII and non-factor products that mimic FVIII activity. OBJECTIVE: To determine amounts of clotting factor concentrates (CFCs) and emicizumab dispensed and associated healthcare expenditures in Japanese patients with haemophilia A. METHODS: This retrospective, non-interventional, observational study analysed data from 2016 to 2020 from a large-scale, hospital-based administrative database. Patients had haemophilia A without inhibitors and ≥ 2 prescriptions of the same CFC or emicizumab. RESULTS: In total, 974 patients with haemophilia A (median age, 30.0 years; median follow-up, 3.7 years) were included. Outpatient use of EHL rFVIII and emicizumab increased, although pdFVIII/SHL rFVIII were still used over the study. Median annual total healthcare expenditures/patient increased from ¥9,200,230 in 2016 to ¥19,748,221 in 2020. Overall, the median annual drug expenditure/patient increased from ¥8,723,120 in 2016 to ¥18,051,689 in 2020. Drug expenditure was highest with emicizumab, with an increase in median annual expenditure/patient from 2018 (n = 4, ¥26,030,206) to 2020 (n = 107, ¥45,430,408). Overall, 233 patients (23.9%) switched from an SHL to an EHL product. Although amounts of FVIII prescribed increased in the 3 months after switching, overall, there was no noticeable difference before and after switching. Median total healthcare and FVIII product expenditures increased following switching. CONCLUSIONS: Prescribing of EHL products increased over the study and healthcare expenditures increased for patients who switched from SHL to EHL rFVIII products.