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Foi avaliada as características do composto gerado no aterro sanitário do município de Goiânia - GO e sua aplicabilidade. Realizaram-se coletas de amostras do composto, para determinações dos seguintes parâmetros: nitrogênio, fósforo e potássio (macronutrientes). Com os resultados, se estabeleceu a aplicabilidade do composto nas mudas do viveiro localizado no aterro, que são encaminhadas para os canteiros e praças do município de Goiânia. Apesar dos problemas operacionais, como falta de maquinário, recursos e mão de obra, terem refletido nas características dos parâmetros avaliados, o composto gerado apresentou caráter satisfatório e eficácia em sua aplicabilidade.

The efficiency index (Eff

The Extended Salford Lung Study (Ext-SLS) is an extension of the Salford Lung Studies (SLS) in asthma and chronic obstructive pulmonary disease (COPD) through retrospective and prospective collection of patient-level electronic health record (EHR) data. We compared the Ext-SLS cohort with the SLS intention-to-treat populations using descriptive analyses to determine if the strengths (e.g. randomization) of the clinical trial were maintained in the new cohort. Historical and patient-reported outcome data were captured from asthma-/COPD-specific questionnaires (e.g., Asthma Control Test [ACT]/COPD Assessment Test [CAT]). The Ext-SLS included 1147 participants (n = 798, SLS asthma; n = 349, SLS COPD). Of participants answering the ACT, 39% scored

O conhecimento científico é fundamentado em registros de observações e experimentações, que são organizados e interpretados a partir de teorias e métodos próprios das várias áreas do conhecimento. Os dados precisam ser apresentados de maneira coerente para corroborar os achados, que são validados ou refutados por pares. Com o advento do Big Data e do movimento da Ciência Aberta, esforços para disseminar e reutilizar dados de distintas fontes ganharam força. Neste contexto, emergem questionamentos éticos, legais e analíticos em torno dos usos e reusos de dados, particularmente de dados pessoais. Estes são tradicionalmente utilizados por pesquisas científicas que envolvem seres humanos, como os estudos conduzidos na área da saúde, que necessitam de aprovação do Sistema CEP/Conep (Comitê de Ética em Pesquisa/Comissão Nacional de Ética em Pesquisa) para averiguar a aderência das atividades propostas aos princípios éticos e normativos com o intuito de proteger os direitos dos participantes da pesquisa. Em virtude da crescente produção e reutilização de dados nos diversos setores da sociedade e das lacunas regulatórias para proteger os direitos dos titulares destas informações, no Brasil, a Lei Geral de Proteção de Dados (LGPD) foi aprovada e sancionada em 2018,passando a vigorar a partir de agosto de 2020. Considerando que dados circulam e que são utilizados por uma ampla gama de atores com interesses distintos e para finalidades diversas, o presente artigo terá por foco refletir sobre o compartilhamento e abertura de dados para pesquisa científica na perspectiva da Ciência Aberta como também as especificidades da pesquisa científica e da saúde pública no âmbito da LGPD. Palavras-chave: Compartilhamento e abertura de dados. Pesquisa científica. Saúde pública. LGPD.

Jogos Sérios Imersivos são ferramentas úteis e eficazes para prover experiência para aprendizes. Nesses ambientes, são capazes de monitorar as práticas e experiências dos aprendizes rumo a personalização do aprendizado. Este trabalho criou uma abordagem educacional imersiva para que os professores recebam informações analíticas, tomem decisões sobre os melhores caminhos de aprendizagem e forneçam ensino personalizado. Apesar de estar em fase inicial, é possível visualizar o potencial de permitir: (i) feedback do perfil dos alunos por meio da análise de dados; (ii) quantidade de informações de um indivíduo ou de um grupo de indivíduos. O resultado deste trabalho é uma aula 3D em um laboratório de biologia em uma plataforma de realidade virtual, integrada a uma plataforma para gestão de ensino e registro das ações dos indivíduos.

Introduction The Salford Lung Studies (SLS) were real-world randomised controlled trials set within UK primary care that assessed the effectiveness and safety of initiating once-daily fluticasone furoate/vilanterol versus continuing usual care in patients with chronic obstructive pulmonary disease or asthma. Data were collected for a relatively short period, limiting the study of long-term outcomes. To broaden the capture of SLS patients’ data, we undertook the Extended SLS (Ext-SLS), aiming to better understand the patient disease journey and the effects of treatment in a real-world setting, through collection of patient-level data. Here, we present study design information and the challenges and learnings gathered in creating the Ext-SLS. Methods The Ext-SLS was intended to augment the SLS by collecting retrospective and prospective (up to 10 years from consent) primary and secondary care electronic health record (EHR) data and patient questionnaires. After ethics approval, general practitioners (GPs) obtained consent from SLS patients remotely (mean 3.2 years post-SLS completion). To facilitate GPs identifying eligible patients, a novel EHR-based approach flagged SLS patients who were alive and registered with their original GP. An automated system sent consent forms/questionnaires to patients. Medical data were collected via EHRs; primary care data were extracted from GPs’ systems whilst secondary care data were sourced from the UK NHS. Results Of the 75 GP sites from the SLS, 35 (47%) declined Ext-SLS participation leaving 4158 potentially eligible patients; 1169 (28%) patients were excluded as GPs could not confirm them as SLS participants or due to incapacity. Of 2989 patients invited, 1189 (40%) consented. Conclusions Developing an EHR-based trial extension was achieved, with reasonable consent rates amongst invited patients. The resulting Ext-SLS is a unique and valuable research resource. Leveraging EHRs and technology reduced GP burden, facilitating participation. Initiation of extension studies prior to study close-out may help increase GP and patient participation. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01827-2.

Belimumab is approved for active, autoantibody-positive systemic lupus erythematosus (SLE) and lupus nephritis, but limited data exist regarding its use in pregnancy. The Belimumab Pregnancy Registry (BPR, GSK Study BEL114256; NCT01532310) was created to evaluate pregnancy and infant outcomes following belimumab exposure.Individuals with SLE exposed to belimumab from 4 months before and/or during pregnancy can enroll into the BPR. The primary outcome is major birth defects; secondary outcomes include miscarriages, stillbirths, elective termination, pre-term birth, neonatal death, small for gestational age, and adverse infant outcomes during the first year of life. Belimumab exposure timing, concomitant medications, and other potential confounding factors are also collected. Data up to March 8, 2021, are reported descriptively.From an expected sample size target of 500 prospective pregnancies with a known outcome, only 55 were enrolled in the study. Among these, two pregnancy losses and 53 pregnancies with a live birth outcome were reported. Ten of the 53 live birth pregnancies resulted in a major birth defect. Ten pregnancies were enrolled after the pregnancy outcome occurred and were examined retrospectively (four live births with no defects, four miscarriages, and two elective terminations). There was no indication or pattern of birth defects associated with belimumab.Low recruitment numbers for the BPR and incomplete information limit the conclusions regarding belimumab exposure during pregnancy. There was no pattern or common mechanism of birth defects associated with belimumab within the BPR data.

The effects of selenium in rice grain composition depend on the soil nitrogen supply. Selenium and nitrogen have the potential to modify rice grain composition; however, it is unclear how the combined effect of Se and nitrogen affects the grain nutritional quality of rice. In our study, grain Se concentration was positively associated with the increased availability of nitrogen in soil. The accumulation of Se in grain of rice plants treated with Se combined with nitrogen was accompanied by an increase in expression of NRT1.1B, a rice nitrate transporter and sensor, in root. Moreover, Se potentiates the response of nitrogen supply in expression of sulfate transporter OsSULTR1.2, phosphate transporter OsPT2 and silicon transporter OsNIP2.1 in root, thereby increasing root Se uptake capacity. The combination of Se with high nitrogen increased the concentrations of protein, carbohydrates, Se, Mo and Mg, but decreased concentrations of Fe, Mn, Cu and Zn in grain. Overall, our results revealed that many of the effects of Se in rice grain composition are due to a shift in the nitrogen status of the plant.

Objetivo: Realizar uma revisão da literatura a fim de analisar as complicações mais frequentes da colelitíase, suas abordagens diagnósticas e terapêuticas. Método: Revisão sistemática e integrada de artigos originais e revisões que investigaram as complicações da colelitíase, abordando diagnóstico e tratamento. Foram incluídos artigos originais e revisões, publicados e indexados no MEDLINE, PubMed e Centro Latino-Americano e do Caribe de Informação em Ciências da Saúde (BIREME). Discussão: O melhor exame para detectar a presença de cálculos na vesícula biliar é a ultrassonografia (USG) abdominal com uma acurácia de mais de 95%. As principais complicações são decorrentes da migração de um ou mais cálculos ou para o ducto cístico, ou para o colédoco. Um único cálculo que migrar pode causar uma complicação. Ao migrar e impactar no ducto cístico pode resultar em colecistite aguda; hidropsia de vesícula; síndrome de Mirizzi. Se ele conseguir atravessar o cístico e passar para o colédoco, pode obstruí-lo total ou parcialmente, provocando: coledocolitíase, colangite e pancreatite biliar. Cerca de 10-20% dos pacientes com colecistite aguda evoluem com graves complicações, que indicam cirurgia de urgência. Cerca de 10% dos pacientes com colelitíase apresentam cálculo no colédoco. A incidência aumenta nos idosos em 20-25%. Conclusão: Existem pontos convergentes quanto aos métodos diagnósticos da colelitíase e suas complicações como a coledocolitíase e a colangite bacteriana aguda. Independente do caso, sempre de ser feita a busca dos fatores clínicos, laboratoriais e de USG que sugiram a obstrução da via biliar comum.

ObjectiveDescribe available data on birth defects and pregnancy loss in women with systemic lupus erythematosus (SLE) exposed to belimumab.MethodsData collected from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports up to 8 March 2020 were described. Belimumab exposure timing, concomitant medications and potential confounding factors were summarised descriptively.ResultsAmong 319 pregnancies with known outcomes (excluding elective terminations), 223 ended in live births from which birth defects were identified in 4/72 (5.6%) in belimumab-exposed pregnancies and 0/9 placebo-exposed pregnancies across 18 clinical trials, 10/46 (21.7%) belimumab-exposed pregnancies in the BPR prospective cohort (enrolled prior to pregnancy outcome) and 0/4 belimumab-exposed pregnancies in the BPR retrospective cohort (enrolled after pregnancy outcome), and 1/92 (1.1%) in belimumab-exposed pregnancies from postmarketing/spontaneous reports. There was no consistent pattern of birth defects across datasets. Out of pregnancies with known outcomes (excluding elective terminations), pregnancy loss occurred in 31.8% (35/110) of belimumab-exposed women and 43.8% (7/16) of placebo-exposed women in clinical trials; 4.2% (2/48) of women in the BPR prospective cohort and 50% (4/8) in the BPR retrospective cohort; and 31.4% (43/137) of belimumab-exposed women from postmarketing/spontaneous reports. All belimumab-exposed women in clinical trials and the BPR received concomitant medications and had confounding factors and/or missing data.ConclusionsObservations reported here add to limited data published on pregnancy outcomes following belimumab exposure. Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use.

Background Estimates for lung function decline in chronic obstructive pulmonary disease (COPD) have differed by study setting and have not been described in a UK primary care population. Purpose To describe rates of FEV1 and FVC decline in COPD and investigate characteristics associated with accelerated decline. Patients and Methods Current/ex-smoking COPD patients (35 years+) who had at least 2 FEV1 or FVC measurements ≥6 months apart were included using Clinical Practice Research Datalink. Patients were followed up for a maximum of 13 years. Accelerated rate of lung function decline was defined as the fastest quartile of decline using mixed linear regression, and association with baseline characteristics was investigated using logistic regression. Results A total of 72,683 and 50,649 COPD patients had at least 2 FEV1 or FVC measurements, respectively. Median rates of FEV1 and FVC changes or decline were −18.1mL/year (IQR: −31.6 to −6.0) and −22.7mL/year (IQR: −39.9 to −6.7), respectively. Older age, high socioeconomic status, being underweight, high mMRC dyspnoea and frequent AECOPD or severe AECOPD were associated with an accelerated rate of FEV1 and FVC decline. Current smoking, mild airflow obstruction and inhaled corticosteroid treatment were additionally associated with accelerated FEV1 decline whilst women, sputum production and severe airflow obstruction were associated with accelerated FVC decline. Conclusion Rate of FEV1 and FVC decline was similar and showed similar heterogeneity. Whilst FEV1 and FVC shared associations with baseline characteristics, a few differences highlighted the importance of both lung function measures in COPD progression. We identified important characteristics that should be monitored for disease progression.

The observation of very-high-energy γ-rays (VHE γ-rays, $E \gt 100\,$ GeV) has ledto the identification of extremely energetic processes and particle-acceleration sites both within our Galaxy and beyond. It is expected that VHE facilities, such as the Cherenkov Telescope Array, will explore these sources with an unprecedented level of detail. However, the transient and unpredictable nature of many important processes means that their observation requires the development of proper monitoring strategies. In this study, we estimate the properties of VHE transients that can be effectively detected by monitoring facilities. We use data collected by the Fermi-LAT instrument during its monitoring campaign to select events that are probably associated with VHE emission. We use this sample to estimate the frequency, the luminosity and the time-scales of various transients, focusing on blazar flares and gamma-ray bursts. We discuss how the balance between the field of view, sensitivity and duty cycle of an observatory affects the likelihood of detecting transients that occur at the inferred rates, and we conclude by describing the contribution that current and near-future monitoring facilities can make to the identification and study of VHE transient emission.

Marine resources are outstanding among renewable energy for their wide occurrence and diverse possibilities of exploitation. The tidal resource can be harnessed by the use of both potential (sea level) and kinetic energy (tidal currents). Maranhao coast presents one of the largest tidal ranges and strongest currents on Brazilian coastline, providing a good source of renewable energy. A 3D hydrodynamic model is implemented to numerically simulate the tidal circulation in the Maranhao Gulf so as to examine the tidal behavior and associated energy distribution. Amplitudes and current speeds are substantially increased by the estuary’s geomorphology and the shallow bathymetry. M2 tidal component presents the highest amplitudes among the tidal constituents, being the most energetic. Spring-neap cycle constitute an important factor in energy assessment due to their significant difference in power density and exchanged water volume between estuary and continental shelf. Maximum current velocities of 3 m s−1 are found around Medo Island, where tidal range can reach nearly 5.5 m. Three potential regions are located within the Sao Marcos Estuarine Complex, presenting surface velocities ranging from 1 to 2.15 m s−1 and power density as high as 5 kW m−2. The estuary is long and presents significant variations of tidal phase that allows a geographical disposition of turbines in order to lower the downtime.

Neurodegenerative diseases are characterized by a progressive loss of neuronal structures and functions. Although all biochemical and/or physiological processes are not completely understood, it is known that the main neurodegenerative diseases, like Alzheimer’s, Parkinson’s, Huntington’s, and prion diseases, and also amyotrophic lateral sclerosis (ALS) present certain obvious similarities. Biometal microelements, such as copper, iron, manganese, and zinc, are crucial for many physiological functions, especially in the CNS. Shifts in the amounts of these metals are essential for the development and maintenance of numerous enzymatic activities, mitochondrial functions, neurotransmission, and also for memorization and learning. However, with deregulations in their homeostasis, particularly in those connected with redox activity, there are consequent changes in the ion and microelement balance. This redox activity may contribute to the production of free radicals that can react with various organic substrates, thus generating increased levels of oxidative stress. There is growing evidence that metal microelements play significant roles in the pathogenesis of neurodegenerative diseases. The interaction between metals and CNS proteins is crucial in the development or absence of neurodegeneration. In this way, homeostasis of metal microelements represents a mechanism of extreme importance. Our paper aims at an updated and critical review of the role of the respective metals in neurodegenerative diseases and the main related pathogenic mechanisms.

Background The aim was to evaluate the distribution of ACE-I/D polymorphisms on Brazilian football players performance in aerobic capacity, strength, and speed tests. Methods The participants in this study were 212 Brazilian first division male football players genotyped in DD, ID. or II. Genotyping of DNA from leucocytes was performed using polymerase chain reaction and restriction fragment length polymorphism methods. We evaluated speed using a 30-m sprint test with speed measured at 10 m (V10), 20 m (V20), and 30 m (V30); muscular strength using counter-movement-jump and squat jump tests; and aerobic endurance using the Yo-Yo endurance test. The athletes were ranked in ascending order according to their performance in each test and divided into quartiles: first quartile (0-25%, Weak), second (25-50%, Normal), third (50-75%, Good), and fourth (75-100%, Excellent); these were clustered according to genotype frequency. Results We identified significant differences in the V20 test values and in the aerobic capacity test. Higher frequencies of the ACE-DD genotype were observed in the Excellent performance group in the V20. In the aerobic capacity test, higher frequencies of the ACE-II genotype were observed in Excellent and Good performance groups. Conclusions Players with higher performance in anaerobic and aerobic tests are ACE-DD and ACE-II genotypes, respectively.

Wind is a natural resource that has been explored widely in recent years in different regions around the world. In Brazil, the penetration of wind energy represents ~ 11 % of the country's generation capacity, currently explored in continental areas. Although offshore wind projects are in the environmental licensing phase, the country lacks coastal and offshore observations performed at height of modern wind turbines. Atmospheric models have been a valuable tool for the assessing the potential and distribution of offshore wind power. Some reanalysis present hourly datasets with long time record and global coverage. Here the ERA5 atmospheric reanalysis of ECMWF is compared to hub height wind observations of three locations in Brazil. The first is derived from a coastal meteorological tower located on Alcantara Launch Center in the state of Maranhao (MA- Tower). The second is derived from LIDAR observations of a coastal pier in Santa Catarina (SC-LIDAR). The last are tall tower observations performed by a Petrobras oil platform located in Santos Basin (Tower-PETRO). The temporal characteristics of the winds at these locations are explored and compared to ERA5. Power generation is simulated considering a 8 MW offshore wind turbine. Results demonstrate that ERA5 is well suited for daily to monthly scale analysis of wind speeds. The model spatial resolution, however, precludes a close representation of the diurnal variability in locations where the sea breeze is an important component of the circulation. Power simulations demonstrated good results for all ERA5 comparisons.

Introduction Congenital central hypoventilation syndrome (CCHS) is an autosomal dominant disorder characterized by alveolar hypoventilation and autonomic dysregulation secondary to mutations of the PHOX2B genes.The disorder results in ventilatory impairment characterized by alveolar hypoventilation which worsens in sleep and occurs in individuals with otherwise normal pulmonary mechanics.Diagnosis is based on identification of a pathologic variant in the PHOX2B gene in absence of primary pulmonary, cardiac or neuromuscular disease or a causative brainstem lesion. We present five cases from three generations within the same family with varying degrees of phenotypic expression of the PHOX2B gene mutation. Methods The identification of CCHS in the index case after birth prompted evaluation of other family members.Genetic testing and counselling were performed for all family members. All family members with a confirmed diagnosis of CCHS underwent a complete assessment. Discussion We report the unique occurrence of CCHS among five members of a single family in three generations with a varying degree of penetrance and expressivity resulting in diverse clinical manifestations.Early diagnosis and adequate ventilatory management can prevent associated neurologic morbidity and improve long-term outcomes. Providing positive pressure ventilation (PPV) in infants and children with CCHS poses many challenges.Consistency is important as patients with CCHS require lifelong assisted ventilation, at least during sleep, and weaning of ventilation is not advisable.These five cases not only highlight the challenges of managing CCHS, but also the importance of genetic counselling and screening among first-degree relatives and extended family members.

Wide field-of-view gamma-ray observatories must fight the overwhelming cosmic ray background to identify very-high-energy astrophysical gamma-ray events. This work introduces a novel gamma/hadron discriminating variable, LCm, which quantifies the azimuthal non-uniformity of the particle distributions at the ground. This non-uniformity, due to the presence of hadronic sub-showers, is higher in proton-induced showers than in gamma showers. The discrimination power of this new variable is then discussed, as a function of the air shower array fill factor, in the energy range 10TeV to 1PeV, and compared to the classical gamma/hadron discriminator based on the measurement of the number of muons at the ground. The results obtained are extremely encouraging, paving the way for the use of the proposed quantity in present and future large ground-array gamma-ray observatories.

Achondroplasia (ACH) is a rare, genetic condition and is the most common skeletal dysplasia resulting in disproportionate short stature and numerous multi-systemic comorbidities. As we enter an era of new treatment options which may impact comorbidities, it is important to understand the background rates of these events to aid evaluation of potential treatment effects. Thus, the aim of this literature review was to provide a comprehensive quantification of prevalence estimates of comorbidities in achondroplasia by age for use as a compiled reference to assist in quantifying the risk/benefit of new treatment options and informing timely management of ACH.PubMed and Embase databases were searched, complemented by manual bibliography searching, for peer-reviewed articles published between 1975 and 2021, guided by PRISMA principles. Number of patients and the prevalence of specific comorbidities by age were extracted. We calculated exact 95 %-confidence limits for the proportion of affected patients (prevalence) and data were presented visually using forest plots. An a priori decision was made not to utilise meta-analytic techniques to pool estimates as we intended to understand the variability in comorbidities by displaying each estimate separately.The literature search identified 206 articles of which 73 were eligible for inclusion. The majority of studies (n = 34) had been conducted in the USA or in Europe (n = 20). Study designs were mostly retrospective chart reviews (n = 33) or small cohort studies (n = 19). The availability of literature on particular conditions varied but trended towards a focus on assessment and prevention of severe conditions, such as respiratory conditions in children (21 studies), neurological manifestations (16 studies) and upper spine compression (15 studies). There was substantial heterogeneity in study design, type of clinical setting, populations and use of definitions in reporting comorbidities which need to be considered when interpreting study results. Despite the variability of the studies, comorbidity patterns by age were recognizable. In infants, a high prevalence (20 %) was found for kyphosis, a range of neurological manifestations and sleep apnea. There was also an excess mortality in infancy (4-7.8/100 person-years). Conditions identified in infancy continued to prevail in childhood. Genu varum was highly prevalent from the age children started to walk (9-75 %). Other conditions started to emerge in children; those with a high prevalence (20 %) were hearing loss and pain. In adolescence, neurological manifestations in the arm, neck or leg were reported (~15 %), consistent with symptomatic spinal stenosis or spinal compression. Fewer studies were available in older populations, especially in adults; however limited data suggest that pain and cardiovascular conditions, particularly excess weight and obesity, became more prevalent into adulthood. Mortality rates increased again in older age-groups.This review provides a reference base of current knowledge of the type and frequency of comorbidities in ACH. This not only allows future contextualisation of new treatment options but supports clinical decision-making on the timely medical management and intervention of ACH. This review also reflects the current medical priorities in the management of ACH, indicating a focus on pediatric care and the complex needs of individuals with ACH involving many different disciplines. Further studies into the natural history of this rare disease using more consistent definitions of comorbidities, especially into adulthood, are needed to elucidate the multi-systemic nature of this condition.

The Flora Neotropica treatment of Flaucourtiaceae s.l., by Sleumer, was a milestone in the study of the group and, consequently, of the families that were subsequently segregated from Flaucourtiaceae. Of these, Lacistemataceae comprise 16 tree-shrub species that usually occur in humid forests. However, specimens from campos rupestres in Bahia State, Brazil, were not analyzed by Sleumer so some morphological variation remained unnoticed. Here, we describe Lacistema ligiae, a new species from the campos rupestres of Bahia, and include notes on leaf venation and pollen morphology of related species. Lacistema ligiae can be recognized by leaf blades with sinuous secondary veins, which are covered by long and adpressed trichomes abaxially, hairy filament and ovary, and a distinct style not exceeding the height of the stamen.

Retosiban, an oxytocin receptor antagonist, was developed for treating spontaneous preterm labor (sPTL) in women with intact membranes. This ARIOS follow-up study aimed to characterize clinical safety, morbidity, and mortality of infants exposed to retosiban or comparator over 2 years. ARIOS prospectively assessed outcomes in infants whose mothers received at least one dose of retosiban or comparator (placebo/atosiban) in two Phase 3 sPTL trials. Both trials were terminated prematurely owing to poor enrolment. Infants could be enrolled into ARIOS from 28 days after estimated due date until hospital discharge or up to 9 months (corrected age). An internally developed questionnaire detailing medical conditions, mortality and resource use (Child Health Inventory; CHI), Ages and Stages Questionnaire-3 (ASQ-3), Modified Checklist for Autism in Toddlers-Revised with Follow-Up, and Child Behavior Checklist for Ages 1.5 to 5 were completed remotely by parents or legal guardians at prespecified intervals. Serious adverse events (SAEs) were primarily captured via CHI. No comparative statistical analysis was conducted between treatment arms. A total of 49 (86%) infants who had received retosiban and 49 (78%) infants who had received a comparator were enrolled in ARIOS. No deaths occurred during the study. Nine infants experienced SAEs: 6/49 (12.2%) infants in the comparators group and 3/49 (6.1%) in the retosiban group. Of the nine SAEs, seven were due to infections, three, and four in the retosiban and comparators groups, respectively. Based on ASQ-3 score, the incidence of neurodevelopmental delay at 18 and 24 months were 0/18 (0%) and 2/25 (8%) with retosiban and 7/22 (31.8%) and 3/21 (14.3%) with comparator, respectively. The current study showed no unexpected adverse outcome or impairment with retosiban based on safety monitoring and neurodevelopment assessments. No further follow-up is intended owing to the discontinuation of clinical development of retosiban.· There is a need for an effective and safe treatment for sPTL.. · ARIOS was a follow-up study of two Phase 3 trials in sPTL.. · There were no safety concerns with retosiban treatment.. · Slow recruitment led to termination of the Phase 3 trials..

Cancer is associated with muscle wasting. However, optimal protein intake has not been determined, limiting the efficacy of nutritional interventions. This systematic review aims to assess the effect of protein intake on muscle mass of patients with cancer types with high prevalence of sarcopenia during treatment, in longitudinal studies.MEDLINE, CINAHL, and Scopus databases were searched following PRISMA guidelines. Longitudinal studies written in English, including adults with high sarcopenia prevalence cancer diagnosis, submitted to (chemo)radiotherapy, with assessment of protein intake and muscle changes during treatment, published until 4 October 2020 were included. Studies including supplementation with substances, such as n-3 fatty acids, specific amino acids, or proteins, were excluded. Study appraisal was independently conducted by two reviewers, and a qualitative research synthesis was performed.Overall, 575 records were identified, of which, eight studies were included (one randomized clinical trial and seven uncontrolled before and after studies). Patients with head and neck (n = 5), lung (n = 2), and esophageal cancer (n = 1) were included, comprising a total of 554 participants. The studies presented heterogeneous methodologies, objectives, and methods to assess body composition. Overall, participant groups with a mean protein intake below 1.2 g/kg presented muscle wasting, with one exception, while those reporting a mean intake above 1.4 g/kg, maintained muscle during treatment.Our findings show that protein intakes below 1.2 g/kg, even when within the recommendations, have been associated with muscle wasting during treatment. Only intakes above 1.4 g/kg have been associated with muscle maintenance. High-quality research is needed to establish an optimal dose response.

The aim of the study was to compare the levels and relative responses of C-Reactive Protein (CRP) and Skin Temperature (Tsk) of the lower limbs (LLs) of elite soccer players following three consecutive games with short intervals (4 days). Eleven male professional athletes (age, 29.26 ± 4.52 years) from an Brazil elite team were evaluated, with measurements obtained before (Baseline), and at Post-Games times (24, 48 and 72h). CRP and Tsk levels at 24 h and 48 h Post-Games times were higher than Baseline levels (CRP, p 0.001, d 0.9; Tsk, p 0.04, d 0.58), additionally, the levels of these variables (CRP vs. Tsk) showed positive correlations (p 0.05, r

Intelligent transportation systems (ITSs) are comprised of multiple technologies that are applied to improve the quality of transport, offering services and applications that will monitor, manage the transportation systems, and increase the level of comfort and safety for passengers and drivers. ITSs services are available for vehicular users through the infrastructure, based on the vehicular network. Furthermore, they can use a vehicular cloud to take advantage of all the resources that a cloud can provide. To achieve this, the ITSs require a mechanism that will aggregate and manage all the available resources provided by the vehicles. Moreover, the aggregation and allocation resource schemes must address the characteristics of the vehicular network to attempt all the quality of service requirements. Therefore, one of the greatest challenges lies in managing the allocation and aggregation of vehicle resources when there is no external infrastructure that will support the system. Hence, we propose an aggregate and allocate resource approach to maximize the availability of service. For this, we formulate the problem through the semi-Markov decision process (SMDP) that will provide an optimal solution for the aggregation and allocation problem. Moreover, we use an average reward function and iterative algorithm to solve the SMDP. The results show that the proposed approach showed stable behavior regardless of the frequency of receiving requests for service. Furthermore, the proposed solution has high average reward when compared to other work in the paper.

Introduction : PARP inhibitors are a new class of drugs that are currently being studied in several malignancies. Olaparib is FDA-approved for advanced breast cancer and advanced ovarian cancer patients. Fatigue and anemia are among the most common cancer and treatment-related symptoms. Therefore, we conducted a meta-analysis of randomized controlled trials (RCT) to characterize the incidence and relative risks (RRs) of fatigue and anemia associated with olaparib. Methods : PubMed, Cohrane, Embase and abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO) were searched for articles published from 2000 to June 2018. The eligible studies were phase II and III RCT of olaparib. Safety profile from each selected study was evaluated for all-grade and high-grade fatigue and anemia adverse events. Summary incidences and the RR, with 95% confidence intervals, of all-grade and high-grade events were calculated using random-effects or fixed-effects model based on the heterogeneity of selected studies. Results : A total of 9 trials were selected, and included 2074 patients with advanced ovarian, gastric, prostate, lung or breast cancer. 908 patients received placebo/control treatments and 1166 received olaparib alone or combination with other active cancer treatments. The RR of all-grade and high fatigue was 1.24 (95% CI, 1.10–1.39) and 1.71 (95% CI, 1.06–2.77), respectively. The RR of all-grade and high-grade anemia was 2.10 (95% CI, 1.48–2.98) and 3.15 (95% CI, 1.73–5.71), respectively. Conclusion : Our findings suggest that the olaparib treatment is associated with an increased risk of fatigue and anemia. Since fatigue and anemia are very common treatment related adverse events, and both can impair the quality of life of patients, it is important to identify them early and manage it accordingly in order to optimize the overall treatment.

To analyze the impact of ≥1 major congenital anomaly (CA) on risk and hospitalization for common neonatal morbidities. Retrospective infant cohort: 241,033 preterm and 3,446,156 term singletons in the US Premier Healthcare database (2006–2013) with up to 1-year follow-up. Discharge records were searched for ≥1 CA and neonatal morbidities. Five morbidities demonstrated strong increasing rates as GA decreased. RRs in preterm infants with CAs relative to those without CAs were: RDS (2.17, 95% CI 2.14–2.21), sepsis (2.42, 95% CI 2.37–2.46), apnea (2.04, 95% CI 2.01–2.07), infectious diseases (2.37, 95% CI 2.34–2.41), and hyperbilirubinemia (1.25, 95% CI 1.24–1.26). Median length of NICU stay (days) was consistently longer in infants with ≥1 CA relative to infants without CA during each GA period. Preterm infants with ≥1 major CA have increased risk of hospitalization for common morbidities, implying compromised neonatal health regardless of CA type.

PURPOSE: To validate an algorithm for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) episodes derived in an electronic health record (EHR) database, against AECOPD episodes collected in a randomized clinical trial using an electronic case report form (eCRF).METHODS: We analyzed two data sources from the Salford Lung Study in COPD: trial eCRF and the Salford Integrated Record, a linked primary-secondary routine care EHR database of all patients in Salford. For trial participants, AECOPD episodes reported in eCRF were compared with algorithmically derived moderate/severe AECOPD episodes identified in EHR. Episode characteristics (frequency, duration), sensitivity, and positive predictive value (PPV) were calculated. A match between eCRF and EHR episodes was defined as at least 1-day overlap.RESULTS: In the primary effectiveness analysis population (n = 2269), 3791 EHR episodes (mean [SD] length: 15.1 [3.59] days; range: 14-54) and 4403 moderate/severe AECOPD eCRF episodes (mean length: 13.8 [16.20] days; range: 1-372) were identified. eCRF episodes exceeding 28 days were usually broken up into shorter episodes in the EHR. Sensitivity was 63.6% and PPV 71.1%, where concordance was defined as at least 1-day overlap.CONCLUSIONS: The EHR algorithm performance was acceptable, indicating that EHR-derived AECOPD episodes may provide an efficient, valid method of data collection. Comparing EHR-derived AECOPD episodes with those collected by eCRF resulted in slightly fewer episodes, and eCRF episodes of extreme lengths were poorly captured in EHR. Analysis of routinely collected EHR data may be reasonable when relative, rather than absolute, rates of AECOPD are relevant for stakeholders' decision making.

The effect of elevated [CO2] on the growth of tomato plants with reduced gibberellin content is influenced by developmental stage. The impact of increased atmospheric carbon dioxide (CO2) on plants has aroused interest in the last decades. Signaling molecules known as plant hormones are fundamental controllers of plant growth and development. Elevated CO2 concentration ([CO2]) increases plant growth; however, whether plant hormones act as mediators of this effect is still an open question. Here, we show the response to elevated [CO2] in tomato does not require a functional gibberellin (GA) biosynthesis pathway. We compared growth and primary metabolism between wild-type (WT) and GA-deficient mutant (gib-1) plants transferred from ambient (400 ppm) to elevated (750 ppm) [CO2] at two different growth stages (either 21 or 35 days after germination, DAG). Growth, photosynthetic parameters and primary metabolism in the stunted gib-1 plants were restored when they were transferred to elevated [CO2] at 21 DAG. Elevated [CO2] also stimulated growth and photosynthetic parameters in WT plants at 21 DAG; however, only minor changes were observed in the level of primary metabolites. At 35 DAG, on the other hand, elevated [CO2] did not stimulate growth in WT plants and gib-1 mutants showed their characteristic stunted growth phenotype. Taken together, our results reveal that elevated [CO2] enhances growth only within a narrow developmental window, in which GA biosynthesis is dispensable. This finding could be relevant for breeding crops in the face of the expected increases in atmospheric CO2 over the next century.

Selenium modulates the formation of primary and lateral roots through alterations in auxin and ethylene, leading to new patterns of root architecture in rice seedlings. Selenium (Se) at low concentrations can control root growth through interaction with hormone biosynthesis. Auxin and ethylene have been shown to control the root architecture, with most of the information obtained from the eudicots such Arabidopsis and Nicotiana tabacum. Here, we presented the effects of Se on auxin and ethylene pathways and examined their impact on primary metabolism and root system architecture in rice (Oryza sativa L.) seedlings. Se treatment increased elongation of primary root, but decreased the number and length of lateral roots. Se led to decreased expression of genes associated with the biosynthesis of auxin and ethylene, concomitantly with reduced production of these hormones by the roots. Moreover, Se decreased the abundance of transcripts encoding auxin transport proteins. Indole-3-acetic acid (IAA) treatment overrode the repressive effect of Se on lateral root growth. The ethylene synthesis inhibitor L-α-(2-aminoethoxyvinyl)-glycine (AVG) increased elongation of primary root, whereas the ethylene precursor 1-aminocyclopropane-1-carboxylic acid (ACC) resulted in the opposite effect. Soluble sugars accumulate in roots of rice seedlings under Se treatment. Thus, Se modulates the formation of primary and lateral roots through alterations in auxin and ethylene, leading to new patterns of root architecture in rice seedlings.

BACKGROUND Enrollment in pregnancy registries is challenging despite substantial awareness-raising activities, generally resulting in low recruitment owing to limited safety data. Understanding patient and physician awareness of and attitudes toward pregnancy registries is needed to facilitate enrollment. Crowdsourcing, in which services, ideas, or content are obtained by soliciting contributions from a large group of people using web-based platforms, has shown promise for improving patient engagement and obtaining patient insights. OBJECTIVE This study aimed to use web-based crowdsourcing platforms to evaluate Belimumab Pregnancy Registry (BPR) awareness among patients and physicians and to identify potential barriers to pregnancy registry enrollment with the BPR as a case study. METHODS We conducted 2 surveys using separate web-based crowdsourcing platforms: Amazon Mechanical Turk (a 14-question patient survey) and Sermo RealTime (a 11-question rheumatologist survey). Eligible patients were women, aged 18-55 years; diagnosed with systemic lupus erythematosus (SLE); and pregnant, recently pregnant (within 2 years), or planning pregnancy. Eligible rheumatologists had prescribed belimumab and treated pregnant women. Responses were descriptively analyzed. RESULTS Of 151 patient respondents over a 3-month period (n=88, 58.3% aged 26-35 years; n=149, 98.7% with mild or moderate SLE; and n=148, 98% from the United States), 51% (77/151) were currently or recently pregnant. Overall, 169 rheumatologists completed the survey within 48 hours, and 59.2% (100/169) were based in the United States. Belimumab exposure was reported by 41.7% (63/151) patients, whereas 51.7% (75/145) rheumatologists had prescribed belimumab to 10 patients who were pregnant or trying to conceive. Of the patients exposed to belimumab, 51% (32/63) were BPR-aware, and 45.5% (77/169) of the rheumatologists were BPR-aware. Overall, 60% (38/63) of patients reported belimumab discontinuation because of pregnancy or planned pregnancy. Among the 77 BPR-aware rheumatologists, 70 (91%) referred patients to the registry. Concerns among rheumatologists who did not prescribe belimumab during pregnancy included unknown pregnancy safety profile (119/169, 70.4%), and 61.5% (104/169) reported their patients’ concerns about the unknown pregnancy safety profile. Belimumab exposure during or recently after pregnancy or while trying to conceive was reported in patients with mild (6/64, 9%), moderate (22/85, 26%), or severe (1/2, 50%) SLE. Rheumatologists more commonly recommended belimumab for moderate (84/169, 49.7%) and severe (123/169, 72.8%) SLE than for mild SLE (36/169, 21.3%) for patients trying to conceive recently or currently pregnant. Overall, 81.6% (138/169) of the rheumatologists suggested a belimumab washout period before pregnancy of 0-30 days (44/138, 31.9%), 30-60 days (64/138, 46.4%), or >60 days (30/138, 21.7%). CONCLUSIONS In this case, crowdsourcing efficiently obtained patient and rheumatologist input, with some patients with SLE continuing to use belimumab during or while planning a pregnancy. There was moderate awareness of the BPR among patients and physicians.