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The food industry is encouraged to develop new sustainable foodstuffs, and agri-food by-products can serve as valuable ingredients in these formulations. In this work, olive pomace (OP), a by-product of olive oil production, was incorporated as an ingredient in pasta. The changes in the nutritional composition and consumer acceptance were assessed, aiming to scale up the production. OP contains dietary fibre (55%), fat (9%), α-tocopherol (43 mg/kg), and oleic acid (76%) after moisture elimination. For that, the following two drying procedures were tested: 40 °C for 48 h (OP40) and 70 °C for 24 h (OP70). Both samples were sieved to remove the stone pieces. Drying at 70 °C (OP70) was the fastest method, revealed a better nutritional profile than OP40, and was the product selected for the incorporation into the pasta. The enriched pasta, containing 7.5% of OP70, was compared to a control. It showed an improved nutritional value with higher contents of fat, ash, fibre, vitamin E, oleic acid, phenolics, and flavonoids, a composition related to potential health benefits. Consumers appreciated the appearance, colour, shine, and aroma of the obtained pasta, making it a prototype with commercial viability. However, several improvements need to be implemented, namely, at the textural levels. Corrective actions, such as the optimisation of the amount of incorporated OP, the use of other ingredients for flavour masking, and textural adjustments, are advisable, thereby making this product more appealing and accepted by a larger number of consumers. This prototype can be a good approach for the circular economy, environmental sustainability, and food security.
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BACKGROUND: Patient-focused approaches to capturing day-to-day variability in sleep disturbance are needed to properly evaluate the sleep benefits of new treatments. Such approaches rely on patient-reported outcome (PRO) measures validated in the target patient population. METHODS: Using atopic dermatitis (AD) as an example of a disease in which sleep is commonly disturbed, we developed a strategy for measuring sleep disturbance in AD trials. In developing this strategy, we conducted a targeted literature review and held concept elicitation interviews with adolescents and adults with AD. We subsequently identified potentially suitable PRO measures and cognitively debriefed them. Finally, we evaluated their psychometric properties using data from phase 2b (NCT03100344) and phase 3 (NCT03985943 and NCT03989349) clinical trials. RESULTS: The literature review confirmed that sleep disturbance is a key impact of AD but failed to identify validated PRO measures for assessing fluctuations in sleep disturbance. Subsequent concept elicitation interviews confirmed the multidimensional nature of sleep disturbance in AD and supported use of a single-item measure to assess overall sleep disturbance severity, complemented by a diary to capture individual components of sleep disturbance. The single-item sleep disturbance numerical rating scale (SD NRS) and multi-item Subject Sleep Diary (SSD)-an AD-adapted version of the Consensus Sleep Diary-were identified as potentially suitable PRO measures. Cognitive debriefing of the SD NRS and SSD demonstrated their content validity and their understandability to patients. Psychometric analyses based on AD trial data showed that the SD NRS is a well-defined, reliable, and fit-for-purpose measure of sleep disturbance in adults with AD. Furthermore, the SD NRS correlated with many SSD sleep parameters, suggesting that most concepts from the SSD can be covered using the SD NRS. CONCLUSIONS: Using these findings, we developed an approach for measuring sleep disturbance in AD trials. Subject to further research, the same approach could also be applied to future trials of other skin diseases where itch causes sleep disturbance.
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Dermatite Atópica , Medidas de Resultados Relatados pelo Paciente , Transtornos do Sono-Vigília , Humanos , Dermatite Atópica/complicações , Transtornos do Sono-Vigília/diagnóstico , Adulto , Adolescente , Masculino , Feminino , Psicometria/métodos , Adulto Jovem , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Ensaios Clínicos como AssuntoRESUMO
Women living with human immunodeficiency virus are at an increased risk of developing cancers related to human papillomavirus (HPV). Thus, it is important to combine clinical assessments, serological screening, and HPV data for planning prevention policies. This study aimed to identify HPV and its specific types in the cervical, anal, and oral mucosa of HIV-seropositive women, associating it with viral load and lymphocyte count. Sociodemographic characteristics, health data (CD4+ and CD8+ T cell counts and viral load), and biological samples (cervical, anal, and oral) were collected from 86 HIV-positive women undergoing antiretroviral therapy. Data were classified according to the presence or absence of HPV-DNA, HPV-DNA presence at one or more anatomic sites, and level of oncogenic risk, considering low- and high-risk oncogenic HPV-DNA groups. The presence of HPV in the cervicovaginal site was 65.9%, 63.8% in anal canal, and 4.2% in oral mucosa. A viral load ≥75 HIV copies/mL was associated with the presence of HPV-DNA. There was an association between viral load and the low-risk HPV or high-risk HPV groups. We found a high prevalence of HPV infection in HIV-seropositive women, particularly in the cervical and anal mucosa, with viral load ≥75 HIV copies/mL being associated with HPV-DNA presence.
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Colo do Útero , DNA Viral , Infecções por HIV , Infecções por Papillomavirus , Carga Viral , Humanos , Feminino , Infecções por Papillomavirus/complicações , Adulto , Infecções por HIV/complicações , Infecções por HIV/virologia , DNA Viral/análise , Colo do Útero/virologia , Papillomaviridae/genética , Papillomaviridae/isolamento & purificação , Pessoa de Meia-Idade , Contagem de Linfócitos , Mucosa Bucal/virologia , Canal Anal/virologia , Prevalência , Estudos Transversais , Fatores Socioeconômicos , Contagem de Linfócito CD4 , Fatores de Risco , Papillomavirus HumanoRESUMO
Cervical cancer ranks as the third most common female cancer in Cape Verde and is the leading cause of cancer-related deaths among women in the country. While Human Papillomavirus (HPV) vaccination, which started in 2021, is anticipated to significantly reduce disease incidence, cervical screening remains crucial for non-vaccinated women. We retrospectively reviewed gynecologic cytology exams and HPV tests performed in Cape Verde between 2017 and April 2023 and processed at IMP Diagnostics. For this study, we considered 13035 women with cytology examinations performed and, 2013 of these, also with an HPV molecular test. Cytology diagnostics comprised 83 % NILM cases; 12 % ASC-US; 2.7 % LSIL; 1.2 % ASC-H; 0.5 % HSIL and 0.1 % SCC. In 505 (25.1 %) high-risk HPV infection was detected. Prevalence of HPV infection varied with age, peaking at young ages - ≤24 years old (55.5 %) and 25-35-year-old women (31.5 %) - and the lowest after 66 years old (9.7 %). Herein we present a comprehensive study regarding Cape Verde's cervical cytology and HPV distribution, aiming to provide a snapshot of the country's cervical cytology results and HPV distribution in recent years. Moreover, these data may contribute to establish a baseline to assess, in the future, the vaccination impact in the country.
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Infecções por Papillomavirus , Vacinas contra Papillomavirus , Neoplasias do Colo do Útero , Humanos , Feminino , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/prevenção & controle , Infecções por Papillomavirus/virologia , Adulto , Vacinas contra Papillomavirus/administração & dosagem , Pessoa de Meia-Idade , Neoplasias do Colo do Útero/prevenção & controle , Neoplasias do Colo do Útero/virologia , Neoplasias do Colo do Útero/epidemiologia , Adulto Jovem , Estudos Retrospectivos , Idoso , Cabo Verde/epidemiologia , Vacinação/estatística & dados numéricos , Papillomaviridae/imunologia , Prevalência , Adolescente , Detecção Precoce de Câncer , Colo do Útero/virologia , Colo do Útero/patologia , Esfregaço Vaginal , CitologiaRESUMO
INTRODUCTION AND OBJECTIVES: Cardiovascular diseases (CVD) and cancer are some of the most recognized causes of mortality and morbidity worldwide. Cancer is the second leading cause of death in heart failure (HF) populations. Recent studies have hypothesized that HF might promote the development and progression of cancer. We aim to analyze and discuss the most recent evidence on the relationship between HF and cancer development. METHODS: From inception to November 2022, we searched PubMed, Web of Science and ClinicalTrials.gov for relevant articles on patients with HF and a subsequent cancer diagnosis that reported outcomes of overall and site-specific cancer incidence, or mortality. RESULTS: Of 2401 articles identified in our original search, 13 articles met our criteria. Studies reporting risk rate estimates were summarized qualitatively. Studies reporting hazard ratios (HRs), or relative risks were combined in a meta-analysis and revealed that HF was associated with an increased overall cancer incidence with a HR=1.30 (95% CI: 1.04-1.62) compared with individuals without HF. Subgroup analyses by cancer type revealed increased risk for lung cancer (HR=1.87; 95% CI: 1.28-2.73), gastrointestinal cancer (HR=1.22; 95% CI: 1.03-1.45), hematologic cancer (HR=1.60; 95% CI: 1.23-2.08) and female reproductive cancer (HR=1.67; 95% CI: 1.27-2.21). Mortality from cancer was higher in HF patients compared with non-HF subjects with a HR=2.17 (95% CI: 1.23-3.84). CONCLUSIONS: Our systematic review and meta-analysis revealed that HF may result in a subsequent increase in cancer incidence as well as in cancer-related mortality. The most common cancer subtypes in HF patients were lung, female reproductive system, and hematologic cancers. Further research is needed to understand this association better and to provide the best cardiological and oncological care.
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Insuficiência Cardíaca , Neoplasias , Humanos , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/complicações , Neoplasias/complicações , Neoplasias/epidemiologia , IncidênciaRESUMO
Complete blood counts (n=566) and serum biochemistry (n=426) were assessed in seven coastal seabirds species that underwent rehabilitation along the southeastern and southern coast of Brazil from Saquarema, Rio de Janeiro State (22°56'16.44â³S, 42°18'24.16â³W) to Laguna, Santa Catarina State (28°29'43â³S, 48°45'39.2â³W), from August 2016 to August 2020. Blood samples were collected from four species of Charadriiformes, including Kelp Gull (Larus dominicanus, n=136), South American Tern (Sterna hirundinacea, n=25), Cabot's Tern (Thalasseus acuflavidus, n=17), and Common Tern (Sterna hirundo, n=14) as well as three species of Suliformes, the Brown Booby (Sula leucogaster, n=212), Magnificent Frigatebird (Fregata magnificens, n=104), and Neotropic Cormorant (Nannopterum brasilianum, n=58). The individuals were sampled as part of the protocol required before their release into the wild when considered healthy. This work aimed to establish the normal hematologic and biochemical reference values of those seabird species and, when possible, to analyze variations among age class and sex and to compare those with the available data in the literature. In addition, we provide the first baseline data for the South American Tern, Cabot's Tern, and Neotropic Cormorant. Baseline hematologic data are crucial for assessing health status of individuals and to support management and conservation actions, including release of seabirds into the wild.
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Charadriiformes , Hematologia , Animais , Brasil , AvesRESUMO
BACKGROUND: Hidradenitis suppurativa (HS), a chronic skin condition that causes pain and physical dysfunction, can impact significantly on quality of life. Disease-specific tools have been designed to assess the impact of HS on patients, including the HS Symptom Daily Diary (HSSDD), the HS Symptom Questionnaire (HSSQ), and the HS Quality of Life (HiSQOL©) questionnaire, which have been developed into electronic instruments (eHSSDD, eHSSQ, and eHiSQOL©). OBJECTIVES: The objective of this study was to establish the content validity of the electronic version of the HSSDD and HSSQ, and the acceptability and usability of the HSSDD, HSSQ, and HiSQOL©, using concept elicitation and cognitive debriefing interviews. METHODS: This was a non-interventional qualitative video interview study involving participants aged ≥18 years with moderate to severe HS recruited from a single clinical site in the USA. Interviews gathered feedback on participants' symptom experience, followed by training and completion of the eHSSDD, eHSSQ, and eHiSQOL© questionnaires on electronic handheld devices. Participants were then interviewed on the content of the eHSSDD and eHSSQ and the acceptability and usability of all three instruments. Interviews were transcribed and qualitatively analysed. RESULTS: Twenty participants with moderate to severe HS (median age: 41.5 [range: 20.0-64.0]; n = 16/20 female) were included. All participants found the eHSSDD, eHSSQ, and eHiSQOL© instructions clear and described the instruments as "easy", "simple" and "self-explanatory". Overall understanding of individual items within the eHSSDD and eHSSQ was high; however, 6/20 participants had difficulty in understanding the average skin pain item in the eHSSDD. All participants were able to accurately recall their symptoms within the recall periods of the eHSSDD and eHSSQ, although 4/20 participants found the 24-h recall period of the eHSSDD limiting. Completion time was quick across all instruments, and usability was high, with the majority of participants reporting no difficulty in completing questionnaires on electronic devices. CONCLUSION: The concepts covered in the eHSSDD and eHSSQ are relevant and important to patients, supporting their content validity. The findings also provide evidence of acceptability and usability of the eHSSDD, eHSSQ, and eHiSQOL©. A limitation was that all participants were recruited from a single site, which may have introduced selection bias and thus limited the generalisability of results.
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Hidradenite Supurativa , Humanos , Feminino , Adolescente , Adulto , Hidradenite Supurativa/diagnóstico , Hidradenite Supurativa/psicologia , Qualidade de Vida , Inquéritos e Questionários , Dor , Medidas de Resultados Relatados pelo PacienteRESUMO
ABSTRACT Women living with human immunodeficiency virus are at an increased risk of developing cancers related to human papillomavirus (HPV). Thus, it is important to combine clinical assessments, serological screening, and HPV data for planning prevention policies. This study aimed to identify HPV and its specific types in the cervical, anal, and oral mucosa of HIV-seropositive women, associating it with viral load and lymphocyte count. Sociodemographic characteristics, health data (CD4+ and CD8+ T cell counts and viral load), and biological samples (cervical, anal, and oral) were collected from 86 HIV-positive women undergoing antiretroviral therapy. Data were classified according to the presence or absence of HPV-DNA, HPV-DNA presence at one or more anatomic sites, and level of oncogenic risk, considering low- and high-risk oncogenic HPV-DNA groups. The presence of HPV in the cervicovaginal site was 65.9%, 63.8% in anal canal, and 4.2% in oral mucosa. A viral load ≥75 HIV copies/mL was associated with the presence of HPV-DNA. There was an association between viral load and the low-risk HPV or high-risk HPV groups. We found a high prevalence of HPV infection in HIV-seropositive women, particularly in the cervical and anal mucosa, with viral load ≥75 HIV copies/mL being associated with HPV-DNA presence.
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Goat milk is an interesting product from a nutritional and health standpoint, although its physico-chemical composition presents some technological challenges, mainly for being less stable than cow's milk at high temperatures. As pasteurization and ultra-high temperature processing are universally employed to ensure milk quality and safety, non-thermal methods, such as pulsed electric fields (PEFs), reduce the microbial load and eliminate pathogens, representing an interesting alternative for processing this product. This study demonstrates how the combined use of a PEF with short thermal processing and moderate temperature can be effective and energy-efficient in goat milk processing. A combination of thermal treatment at 63 °C after a low-intensity PEF (50 µs pulses, 3 Hz, and 10 kV·cm-1) caused the same reduction effect on the population of Listeria monocytogenes (goat's raw milk artificially spiked), as compared to a thermal treatment at 72 °C without a PEF. However, z values are significantly higher when PEF is used as a pre-treatment, suggesting that it may induce heat resistance in the survival population of L. monocytogenes. The sensitivity of L. monocytogenes to high temperatures is less pronounced in goat's milk than cow's milk, with a more pronounced impact of a PEF on lethality when combined with lower temperatures in goat's milk. The effect of a PEF on Escherichia coli viability was even more pronounced. It was also observed that thermal treatment energy needs with a PEF as a pre-treatment can be reduced by at least 50% of the total energy requirements.
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Importance: Because of a paucity of qualitative research on prurigo nodularis (PN), the symptoms and impacts of PN that are most important to patients are poorly understood. Objective: To explore patients' perspectives on their PN symptoms and to understand the impacts of the condition. Design, Setting, and Participants: One-on-one qualitative telephone interviews were held with English-speaking US adults aged 18 years or older with a confirmed diagnosis of PN, severe pruritus, and moderate to severe sleep disturbance. Participants were recruited via patient associations, patient panels, and social media posts. Interviews took place between September 10, 2020, and March 16, 2021. Main Outcomes and Measures: The main symptoms of PN and their impacts on quality of life were identified by content analysis of deidentified interview transcripts. Results: A total of 21 adults with PN (mean [SD] age, 53.1 [11.8] years; 15 [71%] female; 2 African American or Black patients [10%], 1 Asian patient [5%], and 18 White patients [86%]; of these, 1 patient [ 5%] had Hispanic or Latino ethnicity) participated in the interviews. All participants reported itch, pain associated with PN, bleeding or scabbing, and dry skin. Other frequently reported symptoms included lumps or bumps (95%), having a crust on the skin (95%), burning (90%), stinging (90%), lesions or sores (86%), skin discoloration (86%), and raw skin (81%). Of the 17 participants who indicated what their worst symptoms were, 15 (88%) identified itching as the worst or 1 of the worst symptoms. The most frequently reported impacts of PN for quality of life were changes in sleep (100%), daily life (100%), feelings or mood (95%), relationships (95%), social life (81%), and work or school (71%). Overall, the worst impact of PN was its association with impaired feelings or mood. Conclusions and Relevance: This qualitative study suggests the importance of itching, sleep disturbance, and other symptoms and impacts of PN. This information can be used to guide end point selection in clinical trials and to inform patient-centric decision-making in clinical practice.
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Prurigo , Adulto , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Prurigo/diagnóstico , Prurigo/tratamento farmacológico , Qualidade de Vida , Prurido/tratamento farmacológico , Pele , Etnicidade , DorRESUMO
Temperature, pH, and hydrochemistry of terrestrial hot springs play a critical role in shaping thermal microbial communities. However, the interactions of biotic and abiotic factors at this terrestrial-aquatic interface are still not well understood on a global scale, and the question of how underground events influence microbial communities remains open. To answer this, 11 new samples obtained from the El Tatio geothermal field were analyzed by 16S rRNA amplicon sequencing (V4 region), along with 191 samples from previous publications obtained from the Taupo Volcanic Zone, the Yellowstone Plateau Volcanic Field, and the Eastern Tibetan Plateau, with their temperature, pH, and major ion concentration. Microbial alpha diversity was lower in acid-sulfate waters, and no significant correlations were found with temperature. However, moderate correlations were observed between chemical parameters such as pH (mostly constrained to temperatures below 70°C), SO4 2- and abundances of members of the phyla Armatimonadota, Deinococcota, Chloroflexota, Campilobacterota, and Thermoplasmatota. pH and SO4 2- gradients were explained by phase separation of sulfur-rich hydrothermal fluids and oxidation of reduced sulfur in the steam phase, which were identified as key processes shaping these communities. Ordination and permutational analysis of variance showed that temperature, pH, and major element hydrochemistry explain only 24% of the microbial community structure. Therefore, most of the variance remained unexplained, suggesting that other environmental or biotic factors are also involved and highlighting the environmental complexity of the ecosystem and its great potential to test niche theory ecological associated questions. IMPORTANCE This is the first approach to investigate whether geothermal processes could have an influence on the ecology of thermal microbial communities on a global scale. In addition to temperature and pH, microbial communities are structured by sulfate concentrations, which depends on the tectono-magmatic settings (such as the depth of magmatic chambers) and the local settings (such as the availability of a confining layer separating NaCl waters from steam after phase separation) and the possibility of mixing with more diluted fluids. Comparison of microbial communities from different geothermal areas by homogeneous sequence processing showed that no significant geographic distance decay was detected on the microbial communities according to Bray-Curtis, Jaccard, unweighted, and weighted Unifrac similarity/dissimilarity indices. Instead, an ancient potential divergence in the same taxonomic groups is suggested between globally distant thermal zones.
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INTRODUCTION: Validated patient report tools for quantifying patient experiences of itch in prurigo nodularis (PN) are limited. This study aimed to evaluate the validity of the 11-point peak pruritus numerical rating scale (PP NRS) as a single-item patient-reported outcome (PRO) measure for assessing itch severity in PN. METHODS: Content validity of the PP NRS was evaluated through qualitative interviews with adults with PN. The PP NRS was then psychometrically evaluated using data from a placebo-controlled trial of nemolizumab in adults with PN, during which patients completed the PP NRS daily. Meaningful within-patient change was estimated from the qualitative interviews and by anchor- and distribution-based analyses of trial data. RESULTS: The interview participants (N = 21) all understood the PP NRS and reported itch as their worst symptom overall. The PP NRS showed good test-retest reliability and demonstrated convergent validity and known-groups validity. PP NRS scores improved more in patients classified as "improved" on other clinical outcome measures than in those classified as "worsened/unchanged". Triangulation of the different estimates identified a 2- to 5-point decrease in PP NRS score as a meaningful within-patient change threshold. CONCLUSION: The PP NRS is a content-valid and reliable PRO measure for quantifying itch severity in adults with PN in clinical trials. TRIAL REGISTRATION NUMBER: NCT03181503.
Prurigo nodularis is a skin disease where the skin becomes inflamed and very itchy. Itching and scratching can ruin the lives of people with prurigo nodularis. For doctors to know how well treatments for prurigo nodularis are working, they need to be able measure how bad their patients' itching is. Here we tested whether a tool called the peak pruritus numeric rating scale (PP NRS) can be used to reliably measure itching in patients with prurigo nodularis. The PP NRS asks patients to rate their itch "at the worst moment during the previous 24 h" on a scale from 0 ("no itch") to 10 ("worst itch imaginable"). We interviewed 21 patients with prurigo nodularis. Overall, itch was their worst symptom. They were able to use the PP NRS with few or no problems. To further explore whether the PP NRS can be used by patients with prurigo nodularis, we also obtained data from a clinical study. In this clinical study, patients with prurigo nodularis received a drug that might one day be used to treat their disease. They completed the PP NRS daily during the time they received the drug. When we analyzed the data from the clinical study, we found that the PP NRS has the properties a tool like this needs to be useful. We also concluded that a decrease of 25 points on the PP NRS scale would be a meaningful improvement in itching for patients with prurigo nodularis.
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INTRODUCTION: Sleep is often disturbed in patients with prurigo nodularis (PN). To address the lack of validated patient-reported outcome (PRO) measures for quantifying sleep disturbance in PN, we evaluated the Sleep Disturbance Numerical Rating Scale (SD NRS) as a single-item PRO measure for quantifying sleep disturbance in PN. METHODS: Adults with PN participated in qualitative interviews, which included concept elicitation and cognitive debriefing of the SD NRS. The SD NRS was evaluated psychometrically using data from a phase 2 randomized trial in adults with PN (NCT03181503). Other PRO assessments included the Average Pruritus (AP) NRS, AP Verbal Rating Scale (VRS), peak pruritus (PP) NRS, PP VRS, and Dermatology Life Quality Index (DLQI). Reliability, validity, and responsiveness of the SD NRS were evaluated, and meaningful within-patient change was estimated from qualitative interview responses and quantitative trial data. RESULTS: All interview participants (N = 21) experienced sleep disturbance and most (95%) understood the SD NRS as intended. The SD NRS demonstrated test-retest reliability based on intra-class correlation coefficients for itch-stable participants of 0.87 for the AP VRS and 0.76 for the PP VRS. At baseline, Spearman's rank-order correlation coefficients were moderate to strong (0.3-0.8) between the SD NRS and the AP NRS, AP VRS, PP NRS, PP VRS, and DLQI. Known-groups validity was demonstrated by higher (worse) SD NRS scores in participants with worse scores on the AP NRS, AP VRS, PP VRS, and DLQI. Improvements in SD NRS scores were greater in participants classified as "improved" versus "worsened/unchanged" on the anchor PROs. A 2- to 4-point decrease on the 11-point SD NRS scale was identified as a meaningful within-patient change. CONCLUSION: The SD NRS is a well-defined, reliable, and valid PRO measure that can be used in daily practice and clinical trials to capture sleep disturbance in adults with PN.
Patients with the skin disease prurigo nodularis often sleep badly because their skin is very itchy in the evening and at night. In assessing the effectiveness of new treatments for prurigo nodularis, it is useful to know whether patients sleep better when taking them. Here, we tested whether the "Sleep Disturbance Numerical Rating Scale" (SD NRS), a tool for measuring sleep, can be used by patients with prurigo nodularis. The SD NRS asks patients to score their sleep loss during the previous night on a scale of 0 ("no sleep loss") to 10 ("I did not sleep at all"). When we interviewed 21 patients with prurigo nodularis, 19 of them had problems falling asleep and 18 of them woke up every night. Most of the patients found the SD NRS easy to use. To further explore whether the SD NRS is suitable for patients with prurigo nodularis, we also analyzed data from a European clinical study in which patients with prurigo nodularis received nemolizumab, a new treatment being developed for the disease. Patients completed the SD NRS each morning during the clinical study. We found that the SD NRS has the necessary properties to be useful for assessing sleep on a daily basis. We also determined that a 2- to 4-point decrease on the SD NRS scale would represent a meaningful improvement in sleep for patients with prurigo nodularis. We conclude that the SD NRS is a useful tool for assessing sleep in prurigo nodularis patients participating in clinical studies.
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Introduction: Breast cancer (BC) is a public health problem in developing countries, including Cape Verde. Immunohistochemistry (IHC) is the gold standard technique used for BC phenotypic characterisation to support efficient therapeutic decisions. However, IHC is a demanding technique that requires knowledge, trained technicians, expensive antibodies and reagents, controls, and results validation. The low number of cases in Cape Verde increases the risk of expiring the validity of the antibodies, and manual procedures often jeopardise the quality of the results. Thus, IHC is limited in Cape Verde, and an alternative technically easy solution is needed. A point-of-care messenger RNA (mRNA) STRAT4 BC assay to assess estrogen (ER), progesterone (PR), hormone growth factor 2 receptor (HER2), and Ki67, using the GeneXpert platform, has been recently validated on tissues from internationally accredited laboratories, showing excellent concordance with IHC results.To assess whether this technology can be implemented in Cape Verde to guide BC treatment we decided to study the level of agreement between the findings yielded by BC STRAT4 and the results are the same cases obtained by IHC. Methods: Formalin-fixed and paraffin-embedded (FFPE) tissue samples from 29 Cabo Verdean BC patients diagnosed in Agostinho Neto University Hospital were analysed by applying IHC and BC STRAT4 assay. The time between sample collection and pre-analytic procedures is unknown. All the samples were pre-processed in Cabo Verde (fixed in formalin and embedded in paraffin). IHC studies were performed in referenced laboratories in Portugal. STRAT4 and IHC result concordance was assessed by calculating the percentage of results agreement and Cohen's Kappa (K) statistics. Results: STRAT4 assay failed in 2 out of the 29 analysed samples. Of the 27 successfully analysed samples, STRAT4/IHC results for ER, PR, HER2, and Ki67 were concordant in 25, 24, 25, and 18 cases, respectively. Ki67 was indeterminate in three cases, and PR was indeterminate once.The percentage of agreement between STRAT4 and IHC results for ER, PR, HER2, and Ki67 was 92.59%, 92.31%, 92.59% and 81.82%, respectively. The Cohen's K statistic coefficients for each biomarker were 0.809, 0.845, 0.757 and 0.506, respectively. Conclusions: According to our preliminary results, a point-of-care mRNA STRAT4 BC assay may be an alternative in laboratories unable to provide quality and/or cost-efficient IHC services. However, more data and improvement on sample pre-analytic processes are required to implement this BC STRAT4 Assay in Cape Verde.
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Several diseases have been reported as affecting endangered wild sea turtle population worldwide, including spirorchiidiasis. This parasitic infection results in serious circulatory disorders in sea turtles, as well as tissue damage due to the presence of spirorchiids eggs. However, few reports of organs severely affected by tissue replacement caused by granulomatous inflammatory processes due to spirorchiidiasis in sea turtles are available. In this regard, this study describes massive lesions in 16 juvenile green turtles from southeastern Brazil presenting no other detectable diseases or injuries, associated to parasitic compression of air spaces, parasitic thyroid atrophy, parasitic encephalic compression and parasitic splenic lymphoid depletion. These rare injuries were categorized as extremely severe, affecting most spirorchiidiasis-infected organs. Spirorchiidiasis was, thus, noted herein as capable of causing a variety of lethal injuries to vital or extremely important organs in sea turtles. Spirorchiidiasis should, therefore, also be considered a potential cause of death in stranded green sea turtle monitoring efforts.
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BACKGROUND: Equid herpesvirus (EHV) commonly affects horses causing neurologic and respiratory symptoms beside spontaneous abortions, meaning huge economic losses for equine industry worldwide. In foals, the virus can facilitate secondary infections by Rhodococcus equi, important in morbidity and mortality in equines. A total of five genotypes of EHV were previously described in Brazil including EHV-1, EHV-2, EHV-3, EHV-4, and EHV-5. EHV-2 genotype had only been previously described in Brazil in asymptomatic animals. We report the investigation of the dead of 11 foals in Middle-west region of Brazil showing respiratory and neurological symptoms, as well as several abortions in mares from the same farm. METHODS: Clinical and laboratory exams were performed in this case study. Lung, whole blood, serum, and plasma samples were analyzed by necroscopic and histopathologic techniques followed by molecular assays (conventional and qPCR and Sanger sequencing). RESULTS AND CONCLUSION: Laboratory exams revealed neutrophilia leukocytosis. Necroscopic and histopathologic findings were suppurative bronchopneumonia and ulcerative enteritis. Molecular assays point to the absence of the bacteria Rhodococcus equi and other viruses (including other EHV). The presence of EHV-2 DNA was confirmed by sequencing in serum sample from one foal. This is the first confirmed outbreak of EHV-2 causing disease in Brazilian horses with confirmed presence of the virus, and which highlight the important role of EHV-2 in equine respiratory disease and spontaneous abortions in equid in Brazil.
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Aborto Espontâneo , Infecções por Herpesviridae , Herpesvirus Equídeo 1 , Doenças dos Cavalos , Rhadinovirus , Gravidez , Feminino , Humanos , Animais , Cavalos , Infecções por Herpesviridae/epidemiologia , Infecções por Herpesviridae/veterinária , Aborto Espontâneo/epidemiologia , Herpesvirus Equídeo 1/genética , Doenças dos Cavalos/epidemiologia , Surtos de Doenças/veterináriaRESUMO
Leptospirosis is a bacterial disease caused by the infection of pathogenic strains of the genus Leptospira, endemic in tropical and subtropical regions. Although well documented in terrestrial animals and humans, little information is available on its distribution and impact on marine animals. Despite clinical manifestations that may occur, the occurrence of carriers was suggested in some species. Nevertheless, there are few studies regarding the infection by Leptospira sp. in marine mammals. In this context, and considering the One Health approach, the present aimed to investigate pinnipeds' role as Leptospira sp. carriers. Kidneys of 47 pinnipeds of two species, Arctocephalus australis (n = 40) and Arctocephalus tropicalis (n = 7) were collected. DNA was extracted and the diagnosis was performed through LipL32-PCR and genetic characterization based on secY gene sequencing. Phylogenetic analysis and haplotype networks were constructed. Pathogenic Leptospira sp. DNA was detected in 31.9% (15/47) of the tested pinnipeds. It was possible to amplify and sequence eight strains (6 for A. australis, 2 for A. tropicalis), all identified as L. interrogans, with high similarity with sequences from Icterohaemorrhagiae serogroup. Phylogenetic analysis revealed sequences from the present study grouped in species-specific unique clusters, but very close to others from humans, wild animals, and domestic animals. We demonstrate that pinnipeds could act as carriers, and play an important role in leptospirosis dynamics.
Assuntos
Caniformia , Otárias , Leptospira , Leptospirose , Animais , Caniformia/microbiologia , Otárias/microbiologia , Leptospira/genética , Leptospirose/epidemiologia , Leptospirose/veterinária , Leptospirose/microbiologia , FilogeniaRESUMO
PURPOSE: Establishing a meaningful within-individual change (MWIC) threshold is a key aspect for interpreting scores used as endpoints for evaluating treatment benefit. A new patient-reported outcome (PRO), a sleep disturbance numerical rating scale (SD NRS), was developed in adults and adolescents with moderate-to-severe atopic dermatitis (AD). This research aims to establish a MWIC threshold of the SD NRS score in the context of a drug development program. METHODS: An explanatory sequential mixed-methods design was used to address the research objective. This mixed-methods design used phase IIb data and a stand-alone qualitative study. Quantitative anchor-based and distribution-based approaches supported by qualitative-based approaches were conducted, and results were triangulated to determine preliminary MWIC thresholds of the SD NRS score. RESULTS: Triangulation of results from both quantitative and qualitative approaches suggested that a 2- to 6-point decrease in the SD NRS score change constitutes a preliminary range of MWIC threshold estimates. CONCLUSION: This research determined MWIC threshold estimates for the SD NRS score in both adolescents and adults with moderate-to-severe AD using an explanatory sequential mixed-methods design. This mixed-methods design provides interesting insights for establishing MWIC thresholds of a PRO score in the context of a drug development program.
Assuntos
Dermatite Atópica , Transtornos do Sono-Vigília , Adulto , Adolescente , Humanos , Índice de Gravidade de Doença , Qualidade de Vida/psicologia , Projetos de Pesquisa , SonoRESUMO
To reduce the microbial load in goat's milk, which is less thermally stable than cow's milk, an alternative processing method was used in this study. This involved treating the milk with pulsed electric fields (PEFs) (at 10 kV·cm-1, with 50 µs pulses for 3 Hz) and then heat-treating it at 63 °C for 6.0 s, as well as using heat treatment alone at 75 °C for 3.4 s. Cheeses were made using both types of milk treatment, and samples were collected after 5, 15, and 25 days of ripening for DNA extraction and purification, followed by high-throughput sequencing on the MiSeq Illumina sequencing platform. Analysis of the bacterial populations in the two types of cheese using various diversity indices revealed no significant differences in species richness and abundance, although there was a trend for the PEF-treated cheese to have a less diverse set of species with an uneven distribution of relative abundance. However, when examining the composition of the microbial communities in the two types of cheese using Weighted UniFrac analysis and Analysis of Similarities, there were significant differences in the presence and abundance of various species, which could have implications for the development of starter cultures. Concerning physicochemical properties (pH, aw, moisture content, total acidity and L, and a and b color parameters), the results also reveal that, generally, no significant differences were found, except for the color parameter, where cheeses treated with PEF demonstrated more whiteness (L) and yellowness (b) during ripening. Sensory scores for typicity (caprylic, goaty, and acetic) increased over time, but between treatments, only small differences were perceived by panellists in cheese with 5 days of ripening. Concerning texture firmness and cohesiveness, the PEF+HT samples presented lower values than the HT samples, even over storage time. In general, concerning quality parameters, similar behavior was observed between the treatments during the ripening period.