bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of cumulative fluid balance on the pharmacokinetics of extended infusion meropenem in critically ill patients with sepsis
Authors: Pařízková Renata Černá , Martínková Jiřina , Havel Eduard , Šafránek Petr , Kaška Milan , Astapenko David , Bezouška Jan , Chládek Jaroslav , Černý Vladimír 
Published: July 2021

Abstract
Background
Meropenem dosing for septic critically patients is difficult due to pathophysiological changes associated with sepsis as well as supportive symptomatic therapies. A prospective single-center study assessed whether fluid retention alters meropenem pharmacokinetics and the achievement of the pharmacokinetic/pharmacodynamic (PK/PD) targets for efficacy.

Methods
Twenty-five septic ICU patients (19 m, 6f) aged 32–86 years with the mean APACHE II score of 20.2 (range 11–33), suffering mainly from perioperative intra-abdominal or respiratory infections and septic shock (n = 18), were investigated over three days after the start of extended 3-h i.v. infusions of meropenem q8h. Urinary creatinine clearance (CLcr) and cumulative fluid balance (CFB) were measured daily. Plasma meropenem was measured, and Bayesian estimates of PK parameters were calculated.

Results
Eleven patients (9 with peritonitis) were classified as fluid overload (FO) based on a positive day 1 CFB of more than 10% body weight. Compared to NoFO patients (n = 14, 11 with pneumonia), the FO patients had a lower meropenem clearance (CLme 8.5 ± 3.2 vs 11.5 ± 3.5 L/h), higher volume of distribution (V1 14.9 ± 3.5 vs 13.5 ± 4.1 L) and longer half-life (t1/2 1.4 ± 0.63 vs 0.92 ± 0.54 h) (p < 0.05). Over three days, the CFB of the FO patients decreased (11.7 ± 3.3 vs 6.7 ± 4.3 L, p < 0.05) and the PK parameters reached the values comparable with NoFO patients (CLme 12.4 ± 3.8 vs 11.5 ± 2.0 L/h, V1 13.7 ± 2.0 vs 14.0 ± 5.1 L, t1/2 0.81 ± 0.23 vs 0.87 ± 0.40 h). The CLcr and Cockroft–Gault CLcr were stable in time and comparable. The correlation with CLme was weak to moderate (CLcr, day 3 CGCLcr) or absent (day 1 and 2 CGCLcr). Dosing with 2 g meropenem q8h ensured adequate concentrations to treat infections with sensitive pathogens (MIC 2 mg/L). The proportion of pre-dose concentrations exceeding the MIC 8 mg/L and the fraction time with a target-exceeding concentration were higher in the FO group (day 1–3 f Cmin > MIC: 67 vs 27%, p < 0.001; day 1%f T > MIC: 79 ± 17 vs 58 ± 17, p < 0.05).

Conclusions
These findings emphasize the importance of TDM and a cautious approach to augmented maintenance dosing of meropenem to patients with FO infected with less susceptible pathogens, if guided by population covariate relationships between CLme and creatinine clearance.
Altered cholesterol homeostasis in critical illness-induced muscle weakness: effect of exogenous 3-hydroxybutyrate
Authors: Goossens Chloë , Weckx Ruben , Derde Sarah , Vander Perre Sarah , Derese Inge , Van Veldhoven Paul P. , Ghesquière Bart , Van den Berghe Greet , Langouche Lies 
Published: July 2021

Abstract
Background
Muscle weakness is a complication of critical illness which hampers recovery. In critically ill mice, supplementation with the ketone body 3-hydroxybutyrate has been shown to improve muscle force and to normalize illness-induced hypocholesterolemia. We hypothesized that altered cholesterol homeostasis is involved in development of critical illness-induced muscle weakness and that this pathway can be affected by 3-hydroxybutyrate.

Methods
In both human critically ill patients and septic mice, the association between circulating cholesterol concentrations and muscle weakness was assessed. In septic mice, the impact of 3-hydroxybutyrate supplementation on cholesterol homeostasis was evaluated with use of tracer technology and through analysis of markers of cholesterol metabolism and downstream pathways.

Results
Serum cholesterol concentrations were lower in weak than in non-weak critically ill patients, and in multivariable analysis adjusting for baseline risk factors, serum cholesterol was inversely correlated with weakness. In septic mice, plasma cholesterol correlated positively with muscle force. In septic mice, exogenous 3-hydroxybutyrate increased plasma cholesterol and altered cholesterol homeostasis, by normalization of plasma mevalonate and elevation of muscular, but not hepatic, expression of cholesterol synthesis genes. In septic mice, tracer technology revealed that 3-hydroxybutyrate was preferentially taken up by muscle and metabolized into cholesterol precursor mevalonate, rather than TCA metabolites. The 3-hydroxybutyrate protection against weakness was not related to ubiquinone or downstream myofiber mitochondrial function, whereas cholesterol content in myofibers was increased.

Conclusions
These findings point to a role for low cholesterol in critical illness-induced muscle weakness and to a protective mechanism-of-action for 3-hydroxybutyrate supplementation.
Impact of Oncotype DX testing on ER+ breast cancer treatment and survival in the first decade of use
Authors: Schaafsma Evelien , Zhang Baoyi , Schaafsma Merit , Tong Chun-Yip , Zhang Lanjing , Cheng Chao 
Published: July 2021

AbstractBackgroundThe Oncotype DX breast recurrence score has been introduced more than a decade ago to aid physicians in determining the need for systemic adjuvant chemotherapy in patients with early-stage, estrogen receptor (ER)+, lymph node-negative breast cancer.MethodsIn this study, we utilized data from The Surveillance, Epidemiology, and End Results (SEER) Program to investigate temporal trends in Oncotype DX usage among US breast cancer patients in the first decade after the introduction of the Oncotype DX assay.ResultsWe found that the use of Oncotype DX has steadily increased in the first decade of use and that this increase is associated with a decreased usage of chemotherapy. Patients who utilized the Oncotype DX test tended to have improved survival compared to patients who did not use the assay even after adjusting for clinical variables associated with prognosis. In addition, chemotherapy usage in patients with high-risk scores is associated with significantly longer overall and breast cancer-specific survival compared to high-risk patients who did not receive chemotherapy. On the contrary, patients with low-risk scores who were treated with chemotherapy tended to have shorter overall survival compared to low-risk patients who forwent chemotherapy.ConclusionWe have provided a comprehensive temporal overview of the use of Oncotype DX in breast cancer patients in the first decade after Oncotype DX was introduced. Our results suggest that the use of Oncotype DX is increasing in ER+ breast cancer and that the Oncotype DX test results provide valuable information for patient treatment and prognosis.
Can bag-valve mask ventilation with positive end-expiratory pressure reduce hypoxia during intubation? A prospective, randomized, double-blind trial
Authors: Dai Yili , Dai Jiayuan , Walline Joseph Harold , Fu Yangyang , Zhu Huadong , Xu Jun , Yu Xuezhong 
Published: July 2021

Abstract
Background
Hypoxia is one of the life-threatening complications of endotracheal intubation. Supplemental oxygen and ventilation play a vital role in preventing hypoxia. Bag-valve mask (BVM) ventilation is frequently used before intubation, and its ability to improve oxygenation was recently confirmed. It is still unclear if positive end-expiratory pressure (PEEP) added to BVM ventilation can further reduce hypoxia during intubation.

Methods
This will be a prospective, randomized, double-blind trial to determine if PEEP combined with BVM ventilation can reduce the incidence of hypoxia during intubation compared with conventional BVM ventilation. The lowest oxygen saturation and incidence of complications will be compiled to verify the comparative effectiveness and safety of the two groups.

Discussion
BMV ventilation with PEEP is hoped to further reduce the incidence of hypoxia during intubation.

Trial registration
Chinese Clinical Trial Registry ChiCTR2000035156. Registered on August 2, 2020. It had begun enrollment after passing ethical review but before registration.
Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials
Authors: Scantlebury Arabella , McDaid Catriona , Brealey Stephen , Cook Elizabeth , Sharma Hemant , Ranganathan Arun , Adamson Joy ,   on behalf of the ACTIVE and PRESTO study teams
Published: July 2021

Abstract
Background
Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research.

Design
Two qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically.

Setting
NHS secondary care organisations throughout the UK. Interviews were undertaken via telephone.

Participants
Thirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed.

Results
We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient’s circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients’ treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated.

Conclusions
A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials.

Trial registration
ACTIVE: (ISRCTN98152560). Registered on 06/03/2018. PRESTO: (ISRCTN12094890). Registered on 22/02/2018,
Design and validation of a food frequency questionnaire to assess the dietary intake for adults in pastoral settings in Northern Tanzania
Authors: Khamis Ahmed Gharib , Mwanri Akwilina Wendelin , Ntwenya Julius Edward , Senkoro Mbazi , Kreppel Katharina , Bonfoh Bassirou , Mfinanga Sayoki Godfrey , Kwesigabo Gideon 
Published: July 2021

AbstractObjectiveFood frequency questionnaires are widely used as a dietary assessment tool in nutritional epidemiology to determine the relationship between diet and diseases. In Tanzania, there are several cultural variations in food intake which makes it necessary to design and validate a culture-specific food frequency questionnaire (CFFQ). Therefore, we designed a 27-items CFFQ and examine its validity in pastoral communities. Validity of CFFQ was assessed by comparing nutrient intake estimated from the CFFQ against the average from two 24-h diet recall (2R24). Spearman’s correlation coefficients, cross classification and Bland–Altman’s methods were used to assess the validity of CFFQ.ResultsA total of 130 adults aged 18 years and above completed both CFFQ and 2R24. Correlation coefficients between CFFQ and 2R24 ranged from low (r = − 0.07) to moderate (r = 0.37). The correlation coefficients were moderately significant for kilocalories (r = 0.31,p < 0.001), carbohydrate (r = 0.33,p < 0.001), magnesium (r = 0.37,p < 0.001), and iron (r = 0.34,p < 0.001). On average, about 69% of participants were correctly classified into the same or adjacent quartile of energy and nutrient intake, while 9% were misclassified by the CFFQ. Bland–Altman’s plot demonstrated that the CFFQ had acceptable agreement with the 2R24.
Impact of Bacillus in fermented soybean foods on human health
Authors: Gopikrishna Trishala , Suresh Kumar Harini Keerthana , Perumal Kumar , Elangovan Elavarashi 
Published: July 2021

Abstract
Purpose
Fermented soybean foods (FSF) is popularly consumed in the South-East Asian countries. Bacillus species, a predominant microorganism present in these foods, have demonstrated beneficial and deleterious impacts on human health. These microorganisms produce bioactive compounds during fermentation that have beneficial impacts in improving human health. However, the health risks associated with FSF, food pathogens, biogenic amines (BAs) production, and late-onset anaphylaxis, remain a concern. The purpose of this review is to present an in-depth analysis of positive and negative impacts as a result of consumption of FSF along with the measures to alleviate health risks for human consumption.

Methods
This review was composed by scrutinizing contemporary literature of peer-reviewed publications related to Bacillus and FSF. Based on the results from academic journals, this review paper was categorized into FSF, role of Bacillus species in these foods, process of fermentation, beneficial, and adverse influence of these foods along with methods to improve food safety. Special emphasis was given to the potential benefits of bioactive compounds released during fermentation of soybean by Bacillus species.

Results
The nutritional and functional properties of FSF are well-appreciated, due to the release of peptides and mucilage, which have shown health benefits: in managing cardiac disease, gastric disease, cancer, allergies, hepatic disease, obesity, immune disorders, and especially microbial infections due to the presence of probiotic property, which is a potential alternative to antibiotics. Efficient interventions were established to mitigate pitfalls like the techniques to reduce BAs and food pathogens and by using a defined starter culture to improve the safety and quality of these foods.

Conclusion
Despite some of the detrimental effects produced by these foods, potential health benefits have been observed. Therefore, soybean foods fermented by Bacillus can be a promising food by integrating effective measures for maintaining safety and quality for human consumption. Further, in vivo analysis on the activity and dietary interventions of bioactive compounds among animal models and human volunteers are yet to be achieved which is essential to commercialize them for safe consumption by humans, especially immunocompromised patients.
Demographic characteristics associated with food allergy in a Nationwide Canadian Study
Authors: Clarke Ann E. , Elliott Susan J. , St. Pierre Yvan , Soller Lianne , La Vieille Sebastien , Ben-Shoshan Moshe 
Published: July 2021

Abstract
Introduction
We conducted a nationwide Canadian telephone survey on food allergy prevalence between February 2016 and January 2017, targeting vulnerable populations (New, Indigenous, and lower-income Canadians).

Objective
To examine the independent effect of demographic characteristics on food allergy.

Methods
Canadian households with vulnerable populations were targeted using Canadian Census data and the household respondent reported whether each household member had a perceived (self-reported) or probable (self-report of a convincing history or physician diagnosis) food allergy. The association between perceived and probable food allergy and demographic characteristics was assessed through weighted multivariable random effects logistic regressions.

Results
Children, females, Canadian-born participants, adults with post-secondary education, and those residing in smaller households were more likely to report perceived or probable food allergy. Although immigrant parents self-reported less food allergy, Canadian-born children of Southeast/East Asian immigrant versus other immigrant or Canadian-born parents reported more food allergy.

Conclusion
We have demonstrated clear associations between demographic characteristics and food allergy, which may provide important clues to the environmental determinants of food allergy.
Phlebosclerotic colitis in a non-Asian patient: a case report
Authors: Mohigefer J. , Gómez-Millán P. , Borrero J. J. 
Published: July 2021

Abstract
Background
Phlebosclerotic colitis is a rare condition with a high mortality. It has been seen almost exclusively in Asian patients who are ≥ 60 years old, with a slight male predominance. Although it predominantly affects the right colon and seems to be related in some cases to using natural herbal medicines, neither its etiology nor its pathogenesis are known.

Case presentation
We present an extremely rare case of a 62-year-old Spanish white man patient of non-Asian ethnicity with no history of using natural medications, who was diagnosed with phlebosclerotic colitis of submucosal veins.

Conclusion
To date, this is the only case reported in Spain, and only the second reported for Europe, in the literature. Due to the nonspecific symptoms and insidious radiological findings of this disease (both in early and mild stages) as well as exclusive submucosal involvement presented here, it is necessary that the treating physician has a high level of suspicion for its diagnosis.
Noise reduction for radio map crowdsourcing building in WLAN indoor localization system
Authors: Zhang Liye , Wang Zhuang , Meng Xiaoliang , Fang Chao , Liu Cong 
Published: July 2021

AbstractRecent years have witnessed a growing interest in using WLAN fingerprint-based method for indoor localization system because of its cost-effectiveness and availability compared to other localization systems. In order to rapidly deploy WLAN indoor localization system, the crowdsourcing method is applied to alternate the traditional deployment method. In this paper, we proposed a fast radio map building method utilizing the sensors inside the mobile device and the Multidimensional Scaling (MDS) method. The crowdsourcing method collects RSS and sensor data while the user is walking along a straight line and computes the position information using the sensor data. In order to reduce the noise in the location space of the radio map, the short-term Fourier transform (STFT) method is used to detect the usage mode switching to improve the step determination accuracy. When building a radio map, much fewer RSS values are needed using the crowdsourcing method compared to conventional methods, which lends greater influence to noises and erroneous measurements in RSS values. Accordingly, an imprecise radio map is built based on these imprecise RSS values. In order to acquire a smoother radio map and improve the localization accuracy, the MDS method is used to infer an optimal RSS value at each location by exploiting the correlation of RSS values at nearby locations. Experimental results show that the expected goal is achieved by the proposed method.
Spatial and temporal learning representation for end-to-end recording device identification
Authors: Zeng Chunyan , Zhu Dongliang , Wang Zhifeng , Wu Minghu , Xiong Wei , Zhao Nan 
Published: July 2021

AbstractDeep learning techniques have achieved specific results in recording device source identification. The recording device source features include spatial information and certain temporal information. However, most recording device source identification methods based on deep learning only use spatial representation learning from recording device source features, which cannot make full use of recording device source information. Therefore, in this paper, to fully explore the spatial information and temporal information of recording device source, we propose a new method for recording device source identification based on the fusion of spatial feature information and temporal feature information by using an end-to-end framework. From a feature perspective, we designed two kinds of networks to extract recording device source spatial and temporal information. Afterward, we use the attention mechanism to adaptively assign the weight of spatial information and temporal information to obtain fusion features. From a model perspective, our model uses an end-to-end framework to learn the deep representation from spatial feature and temporal feature and train using deep and shallow loss to joint optimize our network. This method is compared with our previous work and baseline system. The results show that the proposed method is better than our previous work and baseline system under general conditions.
Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for a systematic review and meta-analysis
Authors: Ascef Bruna O. , Almeida Matheus O. , de Medeiros Ribeiro Ana Cristina , Andrade Danieli C. O. , de Oliveira Júnior Haliton A. , Pereira Tiago V. , de Soárez Patrícia C. 
Published: July 2021

Abstract
Background
Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide. The expiration of patents for these biologics has driven the production of biosimilar drugs, which are potentially less costly and remarkably similar, albeit not identical to the reference molecules. This paper aims to outline the protocol of a systematic review that will investigate the efficacy and safety profile of biosimilars compared to biologics (objective 1) and the impact of switching between biosimilar drugs and reference biologics on the management of RA patients (objective 2).

Methods
We will investigate the effects of any biosimilars of adalimumab, etanercept, and infliximab on RA patients. We will include randomized controlled trials (RCTs) or quasi-RCTs to assess efficacy and safety outcomes and RCTs with two- or multiple-part designs to evaluate the consequences of switching from reference biologics to biosimilar drugs (and vice-versa). Electronic searches will be performed through MEDLINE (via PubMed), EMBASE, LILACS, and CENTRAL (from inception to April 2021). Two independent reviewers will screen studies, extract data, and evaluate the risk of bias. The latter will be carried out considering specific domains from equivalence trials and switching studies. Random-effects models will be fitted to obtain summary estimates using either relative risk or standardized mean difference as a metric. The primary outcome will be the rate of treatment success according to the American College of Rheumatology 20 (ACR20), and the co-primary outcome will be the Health Assessment Questionnaire—Disability Index (HAQ-DI). Conclusions will be based on equivalence hypothesis testing using predefined margins of equivalence elicited from a group of experienced rheumatologists and prior studies. The overall certainty of the evidence will be assessed based on the GRADE system.

Discussion
The present investigation proposes a comprehensive, clinician-oriented approach to assess the equivalence and the impact of switching between biosimilars and biologics on the management of patients with RA. Our results will elucidate the efficacy, safety, immunogenicity of biosimilars, and the clinical consequences of substituting biologics with biosimilars in the management of RA.

Systematic review registration
PROSPERO CRD42019137152 and CRD42019137155