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Introduction Idiopathic left bundle branch block (iLBBB) is an uncommon finding. Its benignity has been increasingly questioned, though its natural history remains poorly clarified. Similarly, LBBB-cardiomyopathy (LBBB-CM) has been also increasingly recognized as a distinct entity, where electromechanical dyssynchrony seems to play a central role in left ventricular dysfunction (LVD) development. Still, it remains a scarcely studied topic. There is an urgent need for investigation and evidence reinforcement in these areas. OBJECTIVES: two main objectives: (1) to explore the natural history of "asymptomatic" iLBBB carriers; (2) to characterize the outcomes and therapeutic approach used in a "real-world" cohort of possible LBBB-CMP patients (pts). METHODS: tertiary care centre retrospective study of pts with iLBBB and possible LBBB-CMP, screened from a large hospital electrocardiographic database from 2011 to 2017 (LBBB = 347). To assign the 1st objective, only pts with left ventricular ejection fraction (LVEF) ≥ 50% and available follow-up (FU) data were included (n = 152). Regarding the 2nd objective, possible LBBB-CMP pts were selected and defined as iLBBB pts with LVD (LVEF < 50%) and no secondary causes for LVD (n = 53). Data were based on pts' careful review of medical records. RESULTS: focusing our 1st objective, 152 iLBBB carriers were identified. Median FU time were 8 years, and 61% were female. During FU, approximately 25% developed LVD, 20% needed ≥ 1 cardiovascular (CV) hospitalization, and 15% needed a cardiac device implantation. The majority (2/3) of pts with LVD on FU (n = 35) had no secondary causes for LVD, being classified as possible LBBB-CMP pts. Time-to-LVD analysis showed no differences between pts with a known cause for LVD vs LBBB-CMP pts (Log-rank = 0.713). Concerning the 2nd objective, 53 possible LBBB-CMP pts were identified. Median FU time were 10 years, and 51% were female. During the FU, 77% presented heart failure (HF) symptoms, and 42% needed ≥ 1 CV hospitalization, mainly due to HF. Half presented severe LVD at some point in time, and 55% needed a cardiac device, most of them a cardiac resynchronization therapy (CRT) device. Comparing CRT with non-CRT pts, no differences were found in terms of medical therapy, but better outcomes were observed in CRT group: LVEF improvement was higher (median LVEF improvement of 11% in non-CRT vs 27% in CRT; p < 0.001), and fully recovery from LVD was more frequent (50% of CRT vs 14% non-CRT; p = 0.028). CONCLUSION: our data strengthen current evidence on natural history of iLBBB, showing significant CV morbidity associated with the presence of iLBBB, and reinforces the need for a serial and proper FU of these carriers. Our data on "real-world" possible LBBB-CMP pts shows high rates of CV events, namely HF-related events, and supports the growing evidence pointing out CRT as this subgroup of pts' cornerstone of treatment. In conclusion, our work sheds additional light on these largely unknown topics and underlines the urgent need for larger and prospective studies addressing the identification of LVD development predictors in iLBBB carriers, as well as the establishment of diagnostic criteria and therapeutic approach for LBBB-CMP.
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Dear Editor, We would like to thank Dr. Madias for his valuable comment on our original article entitled "QT interval prolongation in Takotsubo Syndrome: a frightening feature with no major prognostic impact" published in Monaldi Archives for Chest Disease on December 6, 2023...
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E. globulus leaves have been mainly exploited for essential oil recovery or for energy generation in industrial pulp mills, neglecting the abundance of valuable families of extractives, namely, triterpenic acids, that might open new ways for the integrated valorization of this biomass. Therefore, this study highlights the lipophilic characterization of E. globulus leaves before and after hydrodistillation, aiming at the integrated valorization of both essential oils and triterpenic acids. The lipophilic composition of E. globulus leaves after hydrodistillation is reported for the first time. Extracts were obtained by dichloromethane Soxhlet extraction and analyzed by gas chromatography-mass spectrometry. In addition, their cytotoxicity on different cell lines representative of the innate immune system, skin, liver, and intestine were evaluated. Triterpenic acids, such as betulonic, oleanolic, betulinic and ursolic acids, were found to be the main components of these lipophilic extracts, ranging from 30.63-37.14 g kg-1 of dry weight (dw), and representing 87.7-89.0% w/w of the total content of the identified compounds. In particular, ursolic acid was the major constituent of all extracts, representing 46.8-50.7% w/w of the total content of the identified compounds. Other constituents, such as fatty acids, long-chain aliphatic alcohols and ß-sitosterol were also found in smaller amounts in the studied extracts. This study also demonstrates that the hydrodistillation process does not affect the recovery of compounds of greatest interest, namely, triterpenic acids. Therefore, the results establish that this biomass residue can be considered as a promising source of value-added bioactive compounds, opening new strategies for upgrading pulp industry residues within an integrated biorefinery context.
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Eucalyptus , Óleos Voláteis , Triterpenos , Eucalyptus/química , Ácidos Graxos , Extratos Vegetais/farmacologia , Extratos Vegetais/química , Óleos Voláteis/farmacologia , Óleos Voláteis/química , Álcoois , Triterpenos/farmacologia , Triterpenos/químicaRESUMO
Despite the frequent and often severe repolarization abnormalities seen in Takotsubo syndrome (TTS), the underlying mechanism of life-threatening arrhythmias is incompletely understood, and the risk remains uncertain. TTS is considered a potential cause of acquired long QT syndrome; however, there is no robust evidence that QT prolongation has a major prognostic impact on these patients' outcomes. Our aim was to assess the prevalence and clinical implications of acquired long QT during TTS events and compare in-hospital and long-term outcomes between patients with and without corrected QT interval (QTc) prolongation. This is a retrospective cohort study that included 113 patients admitted to our tertiary care hospital with a diagnosis of TTS. The cohort was divided into two groups: a long QTc group (QTc≥460 milliseconds in any electrocardiogram at admission or during hospitalization) and a normal QTc group. Baseline characteristics, occurrences during hospitalization, and outcome data were obtained from the revision of medical registries and hospital visits. Of the 113 patients, 107 (94.7%) were female. The mean age was 67.6±11.7 years. QTc prolongation was found in 38%. Demographic characteristics, relevant chronic medication, prevalence of cardiovascular risk factors, and other comorbidities were similar between the groups, except for history of atrial fibrillation, which was more common in the long QTc group. Syncope was more prevalent in the long QTc group. In-hospital complications were not statistically different between patients with long and normal QTc (48.8% versus 44.2%, p=0.637), including ventricular arrhythmias and complete atrioventricular block (both 4.7% versus 1.4%, p=0.556). In-hospital mortality was 0.9%, corresponding to one patient in the long QTc group. The mean follow-up time was 4.8±3.8 years. 5-year all-cause mortality and the occurrence of the composite endpoint of major adverse cardiac and cerebrovascular events did not differ between the groups (p=0.511 and p=0.538, respectively). Our study found no association between prolonged QTc interval during TTS events and adverse prognosis, since in-hospital and long-term outcomes were similar between the groups. Our findings suggest that, although QT prolongation is usually a frightening feature on ECG, this repolarization abnormality during the acute phase has no major prognostic implications in the TTS population.
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AIMS: To study the correlation between the workload of intensive care nursing teams and the sociodemographic, anthropometric and clinical characteristics of patients in critical condition in a Portuguese Intensive Care Unit (ICU) during a 5-year period. BACKGROUND: Currently, indices of nursing workload quantification are one of the resources used for planning and evaluating ICUs. Evidence shows that there are several factors related to critical patients and their hospitalisation which potentially influence the nursing workload. DESIGN: Retrospective cohort analysis of a health record database from adult patients admitted to a Portuguese ICU between 1 January 2015-31 December 2019. METHODS: Simplified Therapeutic Intervention Scoring System (TISS-28) scores of 730 adult patients. Three TISS-28 assessments were considered: first assessment, last assessment and average. The STROBE guidelines were used in reporting this study. RESULTS: The TISS-28 has an average of 34.2 ± 6.9 points at admission, which is considered a high nursing workload. A somewhat lower result was found for the discharge and average assessments. It shows that basic activities accounted for the highest percentage of time spent (38.0%), followed by the cardiovascular support category (26.5%). The TISS-28 shows consistent results throughout the study period, despite a small trend reduction in the last 2 years. CONCLUSIONS: Lower workloads were found for age ≤44 years and with a shorter length of stay. Higher workload was more probable in patients classified in Cullen Class IV (OR = 2.5) and with a normal to higher weight percentile (OR = 1.9 and 1.5, respectively). RELEVANCE TO CLINICAL PRACTICE: Knowledge of the factors influencing the nursing workload facilitates the implementation of rules to improve performance in nursing interventions, based on the redefinition of care priorities, increased productivity, human resources management and reduction of additional costs to the organisation, related to possible adverse events, among others.
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Enfermagem de Cuidados Críticos , Recursos Humanos de Enfermagem Hospitalar , Carga de Trabalho , Adulto , Humanos , Unidades de Terapia Intensiva , Avaliação em Enfermagem , Estudos RetrospectivosRESUMO
INTRODUCTION: Sexual pain is a multideterminate phenomenon, resulting from the interplay between biopsychosocial dimensions. Research suggests that self-compassion plays a protective role on mental health through the enablement of adaptive emotion regulation strategies and that they both contribute to ease chronic pain experience. However, little is known about the role played by self-compassion and emotion regulation on female sexual pain. AIM: The study aims to identify differences between women with self-reported sexual pain, women with other self-reported sexual dysfunctions, and women without sexual complaints regarding self-compassion and emotion regulation. METHODS: A total of 220 women (Mage = 27.73 years, SD = 8.46) were divided into 3 groups based on their clinical condition - 53 women with self-reported sexual pain, 30 women with other self-reported sexual dysfunctions, and 137 women without sexual complaints - completed measures of sexual functioning (Female Sexual Function Index), self-compassion (Self-Compassion Scale), and difficulties in emotion regulation (Difficulties in Emotion Regulation Scale). Multivariate analyses of variance (MANOVAs) with post hoc analyses were performed. MAIN OUTCOME MEASURE: The main outcome measures were self-compassion, measured on a 5-point Likert scale using 26-item questionnaire, and difficulties in emotion regulation, assessed on a 5-point Likert scale using a 36-item questionnaire. RESULTS: Findings indicated that women with self-reported sexual dysfunction and particularly women with self-reported sexual pain report lower self-compassion (P values ranging between .001 and .044) and more difficulties in emotion regulation (P values ranging between .003 and .023) than women without sexual problems. CLINICAL IMPLICATIONS: Findings highlight the association between lower levels of self-compassion and more difficulties in emotion regulation with self-reported sexual complaints, particularly with genito-pelvic pain-related sexual complaints. STRENGTH & LIMITATIONS: This is the first study to address differences between groups with different self-reported sexual dysfunctions regarding self-compassion and emotion regulation. Findings suggest that women with self-reported sexual dysfunction, particularly female sexual pain, report decreased levels of self-compassion and emotion regulation. The absence of equity on sample dimension and the correlational nature of the study are limitations to be considered. CONCLUSION: Results indicated that self-compassion and emotion regulation are associated with sexual complaints, and particularly genito-pelvic pain complaints, suggesting the importance of conducting further investigation to address their potential positive outcomes in clinical intervention. Vasconcelos P, Oliveira C, Nobre P. Self-Compassion, Emotion Regulation, and Female Sexual Pain: A Comparative Exploratory Analysis. J Sex Med 2020;17:289-299.
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Dor Crônica/psicologia , Regulação Emocional , Comportamento Sexual/psicologia , Disfunções Sexuais Fisiológicas/psicologia , Adolescente , Adulto , Empatia , Feminino , Humanos , Pessoa de Meia-Idade , Dor Pélvica/psicologia , Autorrelato , Inquéritos e Questionários , Adulto JovemRESUMO
Acacia dealbata biomass, either from forest exploitation or from the management of invasive species, can be a strategic topic, namely as a source of high-value compounds. In this sense, the present study aimed at the detailed characterization of the lipophilic components of different morphological parts of A. dealbata and the evaluation of their cytotoxicity in cells representative of different mammals' tissues. The chemical composition of lipophilic extracts from A. dealbata bark, wood and leaves was evaluated using gas chromatography-mass spectrometry (GC-MS). Terpenic compounds (representing 50.2%-68.4% of the total bark and leaves extracts, respectively) and sterols (60.5% of the total wood extract) were the main components of these extracts. Other constituents, such as fatty acids, long-chain aliphatic alcohols, monoglycerides, and aromatic compounds were also detected in the studied extracts. All the extracts showed low or no cytotoxicity in the different cells tested, demonstrating their safety profile and highlighting their potential to be used in nutraceutical or pharmaceutical applications. This study is therefore an important contribution to the valorization of A. dealbata, demonstrating the potential of this species as a source of high value lipophilic compounds.
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Acacia/química , Ácidos Graxos/isolamento & purificação , Ácidos Graxos/farmacologia , Neoplasias/patologia , Fitosteróis/farmacologia , Extratos Vegetais/farmacologia , Animais , Sobrevivência Celular , Humanos , Camundongos , Neoplasias/tratamento farmacológico , Folhas de Planta/química , Células Tumorais CultivadasRESUMO
Background and Objectives: Given the considerable spatial, temporal, and ecological factors, heterogeneity, which affects emergency response, persistence, and dissemination of genetic determinants that confer microorganisms their resistance to antibiotics, several authors claim that antibiotics' resistance must be perceived as an ecological problem. The aim of this study was to determine the prevalence of broad-spectrum bla genes, not only Extended-spectrum ß-lactamases (ESBL) but also AmpC-types, in clinical strains of Escherichia coli isolated from Portugal (in the highest region of the country, Serra da Estrela) to disclose susceptibility profiles among different genotypes, and to compare the distribution of bla genes expressing broad-spectrum enzymes. Materials and Methods: Clinical strains of Escherichia coli presenting resistance to third generation (3G) cephalosporins and susceptibility to inhibition by clavulanic acid were studied by means of phenotypic and molecular profiling techniques for encoding ß-lactamases genes. Results: Strains were mainly isolated from hospital populations (97%). Molecular analysis enabled the detection of 49 bla genes, in which 55% (27/49) were identified as blaOXA-1-like, 33% (16/49) as blaCTX-M-group-1, 10% (5/49) as blaTEM, and 2% (1/49) were identified as genes blaCIT (AmpC). Among all blaOXA-1-like detected, about 59% of strains expressed at least another bla gene. Co-production of ß-lactamases was observed in 40% of strains, with the co-production of CTX-M group 1 and OXA-1-like occurring as the most frequent. Conclusions: This is the first study using microorganisms isolated from native people from the highest Portuguese mountain regions, showing an unprecedent high prevalence of genes blaOXA-1-like in this country.
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Proteínas de Bactérias/análise , Escherichia coli/genética , Mutação em Linhagem Germinativa/genética , beta-Lactamases/análise , Proteínas de Bactérias/genética , Cefalosporinas/farmacologia , Cefalosporinas/uso terapêutico , Resistência Microbiana a Medicamentos/genética , Infecções por Escherichia coli/tratamento farmacológico , Infecções por Escherichia coli/epidemiologia , Humanos , Portugal/epidemiologia , beta-Lactamases/genéticaRESUMO
The comorbidity between male genital pain and sexual dysfunction is highly prevalent. Previous studies have indicated that men with genital pain share some cognitive characteristics with men experiencing other sexual dysfunctions. However, there is little information on the role of these cognitive factors in understanding the relationship between pain intensity and sexual functioning. This study aims to test if negative sexually related thoughts mediate the relationship between pain intensity and sexual functioning in men with genital pain. A total of 50 men with self-reported genital pain completed an online survey assessing pain intensity, thoughts during sexual activity, and sexual functioning. Results showed a significant effect of negative sexually related thoughts on sexual functioning, ß = -.71, t(50) = -4.2, p <.001. Additionally, the Sobel test found a partial mediation effect (z = 2.23, p =.025) and a medium to large indirect effect size was observed (abcs =.474). Findings suggest that negative sexually related thoughts play an important role in explaining the impact of pain intensity on sexual functioning. Overall, the study emphasizes the relevance of cognitions in predicting sexual function/dysfunction in men with genital pain and suggests the use of cognitive techniques in the treatment of this clinical condition.
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Doenças dos Genitais Masculinos/fisiopatologia , Genitália Masculina/fisiopatologia , Comportamento Sexual/psicologia , Disfunções Sexuais Fisiológicas/fisiopatologia , Adulto , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Autorrelato , Parceiros Sexuais , Inquéritos e QuestionáriosRESUMO
A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the simultaneous determination of bisphenol A (BPA) and tetrabromobisphenol A (TBBPA) in different seafood samples was developed and validated. Sample preparation was based on a quick, easy, cheap, effective, rugged, and safe (QuEChERS)-based procedure through an extraction of target analytes with acidified acetonitrile (MeCN) added with inorganic salts (MgSO4, NaCl) followed by a liquid-liquid extraction (LLE) using hexane-tertbutylmethyl ether/hexane-benzene to eliminate matrix co-extracts. The developed method promotes a better removal of interferences than that achieved with the classic QuEChERS procedure. The method was validated following the guidelines of the European Union (EU) for relevant seafood matrices such as fish, mussel, and seaweed. Accuracy (81 % average of recovery), reproducibility (12 % average relative standard deviation for both intra-day and inter-day repeatability), and sensitivity for the target analytes (method detection limits of 0.07 ng/g wet weight (ww) and 0.06 ng/g ww for BPA and TBBPA, respectively) were evaluated for all the matrices studied. Graphical Abstract Simultaneous analysis of TBBPA and BPA in seaweeds, mussels and fish.
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Compostos Benzidrílicos/análise , Cromatografia Líquida/métodos , Contaminação de Alimentos/análise , Fenóis/análise , Bifenil Polibromatos/análise , Alimentos Marinhos/análise , Espectrometria de Massas em Tandem/métodos , Animais , Bivalves/química , Cromatografia Líquida/economia , Peixes/metabolismo , Análise de Alimentos/economia , Análise de Alimentos/métodos , Limite de Detecção , Extração Líquido-Líquido/métodos , Reprodutibilidade dos Testes , Alga Marinha/química , Espectrometria de Massas em Tandem/economia , Poluentes Químicos da Água/análiseRESUMO
Macroalgae have been seen as an alternative source of molecules with promising bioactivities to use in the prevention and treatment of current lifestyle diseases. In this vein, the lipophilic fraction of short-term (three weeks) cultivated Bifurcaria bifurcata was characterized in detail by gas chromatography-mass spectrometry (GC-MS). B. bifurcata dichloromethane extract was composed mainly by diterpenes (1892.78 ± 133.97 mg kg-1 dry weight (DW)), followed by fatty acids, both saturated (550.35 ± 15.67 mg kg-1 DW) and unsaturated (397.06 ± 18.44 mg kg-1 DW). Considerable amounts of sterols, namely fucosterol (317.68 ± 26.11 mg kg-1 DW) were also found. In vitro tests demonstrated that the B. bifurcata lipophilic extract show antioxidant, anti-inflammatory and antibacterial activities (against both Gram-positive and Gram-negative bacteria), using low extract concentrations (in the order of µg mL-1). Enhancement of antibiotic activity of drug families of major clinical importance was observed by the use of B. bifurcata extract. This enhancement of antibiotic activity depends on the microbial strain and on the antibiotic. This work represents the first detailed phytochemical study of the lipophilic extract of B. bifurcata and is, therefore, an important contribution for the valorization of B. bifurcata macroalgae, with promising applications in functional foods, nutraceutical, cosmetic and biomedical fields.
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Antibacterianos/farmacologia , Organismos Aquáticos , Bactérias Gram-Negativas/efeitos dos fármacos , Bactérias Gram-Positivas/efeitos dos fármacos , Extratos Vegetais/farmacologia , Alga Marinha , Animais , Antibacterianos/química , Lipídeos/química , Testes de Sensibilidade Microbiana , Extratos Vegetais/químicaAssuntos
Dor no Peito , Pericárdio , Dor no Peito/etiologia , Humanos , Pericárdio/diagnóstico por imagemRESUMO
Male genital pain is frequently associated with sexual dysfunction, and some studies suggest it is influenced by cognitive factors. However, there is little evidence on how these factors discriminate male genital pain from other sexual problems. This study intends to explore differences on sexual functioning and self-reported cognitions during sexual activity between men with genital pain, men with sexual dysfunction, and sexually healthy men. A total of 134 men divided in three groups based on their clinical condition (i.e., genital pain, sexual dysfunction, or no sexual/pain complaints) and matched for demographic variables completed measures of sexual functioning (IIEF) and thoughts during sexual activity (SMQ). Findings showed that men with genital pain and men with sexual dysfunctions reported significantly lower levels of overall satisfaction with sexual life, compared to men without sexual problems. Additionally, men with genital pain and men with sexual dysfunctions presented significantly more failure anticipation thoughts in comparison to sexually healthy men. Overall, findings emphasize the role of negative cognitions as a common factor associated with male genital pain and sexual dysfunctions, suggesting that genital pain should be regarded as a sexual problem and that clinical interventions should include sex therapy techniques as well as cognitive-behavioral procedures.
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Disfunção Cognitiva/fisiopatologia , Doenças dos Genitais Masculinos/fisiopatologia , Genitália Masculina/fisiopatologia , Disfunções Sexuais Fisiológicas/fisiopatologia , Adulto , Humanos , Masculino , Dor , Autoimagem , Parceiros Sexuais , Inquéritos e QuestionáriosRESUMO
INTRODUCTION: The specific cognitive-affective mechanisms involved in the activation and regulation of the subjective and genital components of sexual arousal are not fully understood yet. AIM: The aim of the present study was to investigate the contribution of self-reported thoughts and affect to the prediction of women's subjective and genital responses to erotica. METHODS: Twenty-eight sexually functional women (mean age = 32, SD = 6.29) were presented with sexually explicit and nonexplicit romantic films. Genital responses, subjective sexual arousal, state affect, and self-reported thoughts were assessed. MAIN OUTCOME MEASURES: Vaginal pulse amplitude was measured using a vaginal photoplethysmograph. Subjective sexual arousal, thoughts, and affective responses were assessed through self-report scales. RESULTS: Correlations between subjective and physiological sexual arousal were low (r = -0.05, P > 0.05). Self-reported thoughts and affect were significant predictors of subjective sexual arousal. The strongest single predictor of subjective arousal was sexual arousal thoughts (e.g., "I'm getting excited") (ß = 0.63, P < 0.01). None of the cognitive or affective variables predicted women's genital responses. CONCLUSIONS: Overall, results support the role of cognitive (self-reported thoughts) and affective dimensions in women's subjective sexual arousal to erotica and, consistent with previous findings, suggest that subjective and physiological sexual arousal may be impacted by different processes.
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Afeto , Cognição , Literatura Erótica , Mulheres/psicologia , Adulto , Nível de Alerta/fisiologia , Literatura Erótica/psicologia , Feminino , Humanos , Pessoa de Meia-Idade , Fotopletismografia , Autorrelato , Comportamento Sexual/psicologia , Vagina/fisiologia , Adulto JovemRESUMO
INTRODUCTION: Both emotions and cognitions seem to play a role in determining sexual arousal. However, no studies to date have tested the effects of self-reported thoughts on subjective sexual arousal and genital response using psychophysiological methods. AIM: The aim of the present study was to evaluate the role of self-reported thoughts and affect during exposure to erotic material in predicting subjective and genital responses in sexually healthy men. METHODS: Twenty-seven men were presented with two explicit films, and genital responses, subjective sexual arousal, self-reported thoughts, and positive and negative affect were assessed. MAIN OUTCOME MEASURES: Men's genital responses, subjective sexual arousal, affective responses, and self-reported thoughts during exposure to sexual stimulus were measured. RESULTS: Regression analyses revealed that genital responses were predicted by self-reported thoughts (explaining 20% of the variance) but not by affect during exposure to erotic films. On the other hand, subjective sexual arousal was significantly predicted by both positive and negative affect (explaining 18% of the variance) and self-reported thoughts (explaining 37% of the variance). Follow-up analyses using the single predictors showed that "sexual arousal thoughts" were the only significant predictor of subjective response (ß = 0.64; P < 0.01) and that "distracting/disengaging thoughts" were the best predictor of genital response (ß = -0.51; P < 0.05). CONCLUSIONS: The findings of this study suggest that both affect and sexual arousal thoughts play an important role in men's subjective sexual response, whereas genital response seems to be better predicted by distracting thoughts.
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Literatura Erótica , Homens/psicologia , Pênis/fisiologia , Comportamento Sexual , Adulto , Nível de Alerta , Cognição , Emoções , Humanos , Masculino , Autorrelato , Comportamento Sexual/psicologia , Pensamento , Adulto JovemRESUMO
Public Health Emergencies (PHE) have had repercussions on health systems on a global scale, and timely access to new health technologies is a challenge for health policy. The national regulatory authorities (NRA) play a key role in the evaluation and regulation of these technologies. The present study aims to analyze the main strategies and regulatory instruments used to deal with the challenges of regulating new technologies necessary for the health system's effective response during a PHE. This research, based on WHO and Brazilian NRA norms and documents, considered dimensions related to strategies for strengthening regulatory activities and regulatory instruments used to accelerate access to technologies, especially during PHEs. International cooperation between the NRA and the WHO were important strategies for strengthening the NRA, with emphasis on the use of reliance, regionalization, accelerated assessments, and work/information sharing, as well as the processes of regulatory harmonization and convergence. In addition to the use of existing regulatory instruments, efforts were also identified in order to implement new ones.
As Emergências em Saúde Pública (ESP) têm repercutido nos sistemas de saúde em escala global. O acesso às novas tecnologias em saúde em tempo oportuno é um desafio para a política de saúde. As autoridades reguladoras nacionais (ARN) têm papel fundamental na avaliação e regulação dessas tecnologias. O estudo objetiva analisar as principais estratégias e instrumentos regulatórios utilizados para lidar com os desafios da regulação de novas tecnologias necessárias à resposta do sistema de saúde durante as ESP. Trata-se de uma pesquisa normativa e documental, tendo como fonte a OMS e a ARN brasileira. Foram consideradas as dimensões relacionadas às estratégias para o fortalecimento das atividades regulatórias e os instrumentos regulatórios utilizados para acelerar o acesso às tecnologias, especialmente durante as ESP. A cooperação e a colaboração internacional entre as ARN e com a OMS foram importantes estratégias para o fortalecimento das ARN, com destaque para o uso de confiança, regionalização, avaliações aceleradas e compartilhamento de trabalho/informações, bem como os processos de harmonização e convergência regulatória. Identificou-se, além da utilização de instrumentos regulatórios já existentes, esforços na implementação de novos, com destaque para Autorização de Uso Emergencial.
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Emergências , Política de Saúde , Saúde Pública , Brasil , Humanos , Tecnologia Biomédica/legislação & jurisprudência , Organização Mundial da Saúde , Cooperação Internacional , Atenção à Saúde/organização & administração , Atenção à Saúde/legislação & jurisprudênciaRESUMO
Procedural memory is involved in the acquisition and control of skills and habits that underlie rule and procedural learning, including the acquisition of grammar and phonology. The serial reaction time task (SRTT), commonly used to assess procedural learning, has been shown to have poor stability (test-retest reliability). We investigated factors that may affect the stability of the SRTT in adults. Experiment 1 examined whether the similarity of sequences learned in two sessions would impact stability: test-retest correlations were low regardless of sequence similarity (r < .31). Experiment 2 added a third session to examine whether individual differences in learning would stabilise with further training. There was a small (but nonsignificant) improvement in stability for later sessions (Sessions 1 and 2: r = .42; Sessions 2 and 3: r = .60). Stability of procedural learning on the SRTT remained suboptimal in all conditions, posing a serious obstacle to the use of this task as a sensitive predictor of individual differences and ultimately theoretical advance.
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INTRODUCTION AND OBJECTIVES: Myocardial infarction with non-obstructive coronary arteries (MINOCA) is responsible for about 10% of all acute myocardial infarctions (AMI). Therapeutic strategies and prognosis depend on the underlying etiology, and a multimodal approach is essential. The objectives of this study were to characterize the group of patients diagnosed with MINOCA and to valuate the diagnostic yield of cardiovascular magnetic resonance (CMR). METHODS: This was a retrospective, observational, and analytical study, including 516 patients admitted for a non-ST-elevation MI and with no significant coronary disease on coronary angiography between January 2016 and September 2021. RESULTS: After the inclusion criteria, 163 patients remained of the 516 admitted to the study. They were divided into four groups based on the CMR results: MINOCA (n=51), Takotsubo syndrome (n=37), myocarditis (n=33), and without diagnosis (n=42). Most patients diagnosed with MINOCA were female with a mean age of 61.06±13.83 years. CMR identified the diagnosis in 74.2% of patients admitted for suspected acute MI, in which coronary angiography showed the absence of significant obstructions. The median time between hospital admission and CMR was significantly shorter in the groups that had a diagnosis compared with the group with no diagnosis (p=0.038), with a significant increase in diagnostic profitability if CMR was performed up to 14 days after admission (p=0.022). There were no deaths of cardiovascular etiology during the follow-up period. CONCLUSIONS: CMR was fundamental as it identified the diagnosis in three out of four patients; it should be performed in the first 14 days.