bluuebunny/crossref_metadata_2025_split huggingface dataset:
A standardised model for stool banking for faecal microbiota transplantation: a consensus report from a multidisciplinary UEG working group
Authors: Keller Josbert J. , Ooijevaar Rogier E. , Hvas Christian L. , Terveer Elisabeth M. , Lieberknecht Simone C. , Högenauer Christoph , Arkkila Perttu , Sokol Harry , Gridnyev Oleksiy , Mégraud Francis , Kump Patrizia K. , Nakov Radislav , Goldenberg Simon D. , Satokari Reetta , Tkatch Sergiy , Sanguinetti Maurizio , Cammarota Giovanni , Dorofeev Andrey , Gubska Olena , Ianiro Gianluca , Mattila Eero , Arasaradnam Ramesh P. , Sarin Shiv K. , Sood Ajit , Putignani Lorenza , Alric Laurent , Baunwall Simon M. D. , Kupcinskas Juozas , Link Alexander , Goorhuis Abraham G. , Verspaget Hein W. , Ponsioen Cyriel , Hold Georgina L. , Tilg Herbert , Kassam Zain , Kuijper Ed J. , Gasbarrini Antonio , Mulder Chris J. J. , Williams Horace R. T. , Vehreschild Maria J. G. T. 
Published: November 2020

AbstractBackgroundFaecal microbiota transplantation is an emerging therapeutic option, particularly for the treatment of recurrent Clostridioides difficile infection. Stool banks that organise recruitment and screening of faeces donors are being embedded within the regulatory frameworks described in the European Union Tissue and Cells Directive and the technical guide to the quality and safety of tissue and cells for human application, published by the European Council.ObjectiveSeveral European and international consensus statements concerning faecal microbiota transplantation have been issued. While these documents provide overall guidance, we aim to provide a detailed description of all processes that relate to the collection, handling and clinical application of human donor stool in this document.MethodsCollaborative subgroups of experts on stool banking drafted concepts for all domains pertaining to stool banking. During a working group meeting in the United European Gastroenterology Week 2019 in Barcelona, these concepts were discussed and finalised to be included in our overall guidance document about faecal microbiota transplantation.ResultsA guidance document for all domains pertaining to stool banking was created. This document includes standard operating manuals for several processes involved with stool banking, such as handling of donor material, storage and donor screening.ConclusionThe implementation of faecal microbiota transplantation by stool banks in concordance with our guidance document will enable quality assurance and guarantee the availability of donor faeces preparations for patients.
CRS Adds a Human Feel to Pharmaceutical Automation
Authors: Lenz Steven , Reichman Mel 
Published: November 2020

Ligand Pharmaceuticals' New Leads Discovery department adopted a workstation approach to automating its screening assays in order to increase productivity. This approach stressed optimizing assay work flow and implementing stacking workstations, which allowed capacity to increase tremendously. However, this approach required operator intervention, therefore ultimate capacity was limited by head count and available hours for operating the equipment. A fully automated robotics system for performing the cell-based screening assays would allow for increased capacity without an increase in labor. In effect, the new system provides an operator-less second shift. System requirements included modularity and flexible scheduling software so that the system would complement the existing work flow in the lab, as well as afford rapid assay development and deployment. Ligand's cell-based screening assays require assay cell plates to be incubated at a constant temperature, relative humidity and CO2 (37° C, 95%, 5%, respectively). The robot must be able to rapidly access the cell plates without perturbing the incubator environment.
The design of a Bayesian platform trial to prevent and eradicate inhibitors in patients with hemophilia
Authors: Bertolet Marnie , Brooks Maria M. , Ragni Margaret V. 
Published: November 2020

AbstractAmong individuals with the rare congenital bleeding disorder hemophilia A, the major challenge is inhibitor formation, which is associated with significant morbidity and cost. Yet, as the optimal approach to prevent and eradicate inhibitors is not known, we are at equipoise. Because classic trial design is not practical in a rare disease setting, we designed 2 48-week randomized trials comparing ELOCTATE and emicizumab to prevent and eradicate inhibitors. To achieve statistical efficiency, we incorporated historic data (Bayesian priors) on inhibitor formation to allow preferential randomization to emicizumab, piecewise exponential survival models to determine mean and 95% confidence interval for inhibitor formation in each arm, and simulations to determine the best model design to optimize power. To achieve administrative efficiency, the trials will be performed with the same sites, staff, visit frequency, blood sampling, laboratories, and laboratory assays, with streamlined enrollment so patients developing inhibitors in the first trial may be enrolled on the second trial. The primary end point is the probability of inhibitor formation or inhibitor eradication, respectively. The design indicates early stopping rules for overwhelming evidence of superiority of the emicizumab arms. Simulations indicate that, with 66 subjects, the Prevention Trial will have 84% power to detect noninferiority of emicizumab to ELOCTATE with a margin of 10% if emicizumab is truly 10% superior to ELOCTATE; with 90 subjects, the Eradication Trial will have 80% power to detect 15% superiority of ELOCTATE immune tolerance induction with vs without emicizumab. Thus, a platform design provides statistical and administrative efficiency to conduct INHIBIT trials.
Predicted values for the forced expiratory flow adjusted for forced vital capacity, a descriptive study
Authors: Cox Claire A. , Vonk Judith M. , Kerstjens Huib A.M. , van den Berge Maarten , ten Hacken Nick H.T. 
Published: November 2020

BackgroundThe forced expiratory flows (FEFs) towards the end of the expiration may be more sensitive in detecting peripheral airways obstruction compared to the forced expiratory volume in 1 s and forced vital capacity (FVC). However, they are highly variable. A partial solution is to adjust the FEFs for FVC (FEF/FVC). Here we provide reference equations for these adjusted FEFs at 25%, 50%, 75% and 25–75% of FVC, which are currently lacking.MethodsWe included pulmonary healthy, never-smoker adults; 14 472 subjects from Lifelines, a biobank for health research, and 338 subjects from the department's control cohorts (NORM and Fiddle). Reference equations were obtained by linear regression on 80% of the Lifelines dataset and validated on the remaining data. The best model was defined as the one with the highest adjusted R2-value. The difference in variability between adjusted and unadjusted FEFs was evaluated using the coefficient of variation.ResultsFor all adjusted FEFs, the best model contained age, height and weight. The adjustment improved the coefficient of variation of the FEF75from 39% to 36% and from 43% to 40%, respectively, in males and females. The highest percentage of explained variance by the reference equation was obtained for FEF75/FVC, 32%–38% for males, and 41%–46% for females, depending on the validation set.ConclusionWe developed reference equations for FVC-adjusted FEF values. We demonstrated minimally yet significantly improved variability. Future studies in obstructive airway diseases should demonstrate whether it is worthwhile to use these (predicted) adjusted FEF values.
Inclusion of medication-related fall risk in fall risk assessment tool in geriatric care units
Authors: Michalcova Jana , Vasut Karel , Airaksinen Marja , Bielakova Katarina 
Published: November 2020

AbstractBackgroundFalls are common undesirable events for older adults in institutions. Even though the patient’s fall risk may be scored on admission, the medication-induced fall risk may be ignored. This study developed a preliminary categorization of fall-risk-increasing drugs (FRIDs) to be added as a risk factor to the existing fall risk assessment tool routinely used in geriatric care units.MethodsMedication use data of older adults who had experienced at least one fall during a hospital ward or a nursing home stay within a 2-year study period were retrospectively collected from patient records. Medicines used were classified into three risk categories (high, moderate and none) according to the fall risk information in statutory summaries of product characteristics (SmPCs). The fall risk categorization incorporated the relative frequency of such adverse drug effects (ADEs) in SmPCs that were known to be connected to fall risk (sedation, orthostatic hypotension, syncope, dizziness, drowsiness, changes in blood pressure or impaired balance). Also, distribution of fall risk scores assessed on admission without considering medications was counted.ResultsThe fall-experienced patients (n = 188, 128 from the hospital and 60 from nursing home records) used altogether 1748 medicaments, including 216 different active substances. Of the active substances, 102 (47%) were categorized as high risk (category A) for increasing fall risk. Fall-experienced patients (n = 188) received a mean of 3.8 category A medicines (n = 710), 53% (n = 375) of which affected the nervous and 40% (n = 281) the cardiovascular system. Without considering medication-related fall risk, 53% (n = 100) of the patients were scored having a high fall risk (3 or 4 risk scores).ConclusionIt was possible to develop a preliminary categorization of FRIDs basing on their adverse drug effect profile in SmPCs and frequency of use in older patients who had experienced at least one documented fall in a geriatric care unit. Even though more than half of the fall-experienced study participants had high fall risk scores on admission, their fall risk might have been underestimated as use of high fall risk medicines was common, even concomitant use. Further studies are needed to develop the FRID categorization and assess its impact on fall risk.
Phase II study of sequential S-1 and cyclophosphamide therapy in patients with metastatic breast cancer
Authors: Yanai Keiko , Fujii Takaaki , Horiguchi Jun , Nakazawa Yuko , Kurozumi Sasagu , Obayashi Sayaka , Yajima Reina , Shirabe Ken 
Published: November 2020

Abstract

Background
S-1 and cyclophosphamide (CPA) can be given orally, and their combination may have great potential for treating metastatic breast cancer (MBC). A phase I study of sequential S-1 and CPA therapy was conducted in patients with MBC; the recommended doses that were determined for this regimen were 80 mg/m2/day for S-1 and 100 mg/m2/day for CPA. We then conducted a phase II study of this oral S-1 and CPA regimen.

Methods
This was a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy of a sequential S-1 and CPA regimen for MBC. S-1 was administered orally 2×/day for 14 consecutive days, and then CPA was administered orally 2×/day for 14 consecutive days in a repeating 4-week cycle (S-1 for 2 weeks, CPA for 2 weeks). The primary endpoint was the overall response rate (ORR). Secondary endpoints included the overall survival (OS), progression-free survival (PFS), clinical benefit rate (CBR) and safety.

Results
Thirty-six patients were enrolled in this study. The overall response was complete response in 0 (0%), partial response in 12 (33.3%), stable disease in 12 (33.3%), and progressive disease in 11 (30.1%) patients. The ORR was 33.3% (12/36). The CBR was 66.7% (24/36). The median PFS was 9.5 months (95%CI: 7.8–12.6 months). The median OS was 20.2 months (95%CI: 15.0–25.4 months) Grade 3/4 adverse events included leukopenia in seven patients (19.4%). Dose reductions because of adverse events occurred in 12 patients (33.3%). There was no treatment-related mortality.

Conclusion
The combination of sequential therapy with S-1 and CPA was tolerable and had efficacy with good disease control. Sequential therapy with S-1 and CPA may be a feasible new treatment option for patients with MBC; however, further study is warranted to explore the efficacy of this therapy.

Trial registration
JRCT, JRCTs031180296. Registered 2 December 2019 – Retrospectively registered.
Child health nurse perceptions of using confident body, confident child in community health: a qualitative descriptive study
Authors: Norton Lyza N. , Hart Laura M. , Butel Francoise E. , Roberts Shelley 
Published: November 2020

Abstract

Background
Confident Body, Confident Child (CBCC) is an innovative, evidence-based program providing parenting strategies to promote healthy eating, physical activity and body satisfaction in children aged 2–6 years. This study aimed to explore Child Health Nurse (CHN) experiences with using CBCC in their community health clinics with parents of young children. This work is part of a larger study involving tailoring, implementing and evaluating CBCC in a community child health setting.

Methods
This qualitative descriptive study was conducted within community child health centres at a public health service in Queensland, Australia. Participants included CHNs who had recently attended a tailored CBCC training workshop providing training/education, group activities/discussions and CBCC resources for CHN use in clinical practice. Semi-structured interviews were conducted to explore CHN perceptions of CBCC training, content and resources; and how CBCC was used in practice. Interviews were recorded and transcribed verbatim and analysed thematically.

Results
Eleven CHNs participated in interviews, with three themes emerging from the data. In Theme 1, High CHN satisfaction with CBCC messages, resources and utility, nurses expressed CBCC was highly valuable, useful and easy to enact in their practice. In Theme 2, Effects of CBCC on CHN knowledge, behaviour and practice, CHNs said they experienced increased awareness around body image, improved confidence in addressing issues with clients, and positive changes in their own behaviour and practice after attending CBCC training. In Theme 3, CHNs discussed Ideas for future implementation of CBCC, including challenges and considerations for practice, ongoing education/training for CHNs and broadening the target audience for wider CBCC dissemination.

Conclusions
This study found CHNs were highly accepting of CBCC as it was useful and valuable in practice, increased their awareness and confidence around body image issues, and positively affected their attitudes and behaviours. CHNs’ suggestions for making CBCC delivery more efficient and broadening its reach in the community were valuable and will likely inform local policy and future research. Further research is required on the wider dissemination of CBCC to parents of young children for promoting positive body image and healthy eating, ultimately for the long-term prevention of eating disorders.
Assessing intake and consumption level of spices among urban and rural households of Ludhiana district of Punjab, India
Authors: Bhathal Simranpreet Kaur , Kaur Harpreet , Bains Kiran , Mahal Amrit Kaur 
Published: November 2020

Abstract

Background
Spices are the esoteric food adjuncts that are used for enhancing the sensory quality of the food in Punjabi diets and add many health benefits. Estimating the intake of spices at the individual level is a challenging task as they are consumed in very small quantities as compared to other foods. The present study aimed to assess the intake and spices consumption level of spices among urban and rural households.

Methods
A study was carried out among 100 households each from urban and rural areas from Ludhiana district of Punjab, India to collect the information regarding frequency of spice usage and portion sizes using a questionnaire. The information pertaining to sociodemographic characteristics of female respondents from urban and rural households were also collected. The commonly used 25 spices in Punjabi diets were selected to assess their dietary intake at the individual level among households.

Results
Spice consumption frequency was more in urban households in comparison to rural households. The maximum mean consumption frequency score among urban and rural households was observed for red chilli powder (5.00) and turmeric powder (5.00). Maximum percentage (76 and 72%) of urban and rural households preferred to use the unroasted form of spices, respectively. The highest mean intake and range was observed for red chilli powder (3.19 g with range 0.35–5.23 g) among urban women and (2.41 g with range 0.25–3.75 g) for rural women. Spice intake from individual dishes showed the maximum number of portion sizes for red chilli powder that were from vegetable>dhal > curry preparations among urban and dhal > vegetable>curry preparation among rural households. Average amount of spices consumed by urban adult women was 10.04 g per day which was higher as compared to spices consumed by rural adult women per day (7.68 g).

Conclusions
The study concluded that the urban households showed higher consumption of spices as compared to rural households thus assessing the quantifying intake of spices. Urban adult women consumed more spices per day as compared to rural women. Therefore, more encouragement for increased use of spices is required to reap various health benefits of spices in combating metabolic disorders.
Recommendation for response to the COVID-19 pandemic: Korean context of “distancing in daily life,” considering vulnerable population
Authors: Kim Ja Young , Han Jin-Ok , Lee Heeyoung 
Published: November 2020

Abstract
While the coronavirus disease 2019 (COVID-19) pandemic is an ongoing worldwide, including South Korea (hereinafter Korea), it is impossible to predict the duration of the pandemic. To stop the spread of COVID-19, “social distancing,” which included mandatory lockdown, and attention to personal hygiene are being adopted globally as non-pharmaceutical preventive strategies. In Korea, after maintaining strong social distancing rules for a while, the government transitioned to implementing “distancing in daily life” since May 6, 2020. The distancing in daily life was combined with infection prevention activities to stop the COVID-19 pandemic, while guaranteeing one’s daily life and economic activities.
In this regard, the Ministry of Health and Welfare in Korea disclosed key rules for personal quarantine. The five key rules for individual infection control are as follows: to stay at home for 3–4 days if you feel unwell, keep a distance of two arms’ length from others, to wash your hands for 30 s and cough or sneeze into your sleeves, ventilate at least twice a day and disinfect regularly, and stay connected while physically distancing. However, for vulnerable populations, it is very difficult to follow such rules.
Thus, we attempted to recommend how the society could support such vulnerable populations who may face difficulties in following these individual infection control rules. Through our recommendations for the weakest part of our society, we expect to strengthen the overall social structure.
Impacts of peat on nitrogen conservation and fungal community composition dynamics during food waste composting
Authors: He Zaihua , Li Qiang , Zeng Xiaoyi , Tian Kai , Kong Xiangshi , Tian Xingjun 
Published: November 2020

AbstractPeat, as a heterogeneous mixture of decaying plant debris and microbial residues, has been widely used in many fields. However, little research focused on the impact of peat addition on food waste composting. To fill this gap, a composting experiment of food waste mixed with five varying percent peat 0, 5, 10, 15, and 20% (w/w, dry weight) was designed to investigate the effect of different dosages of peat on nitrogen conservation, physiochemical parameters, and fungal community dynamics during composting. The results showed that adding peat elevated the peak temperature of composting, lowered final pH, reduced ammonia emissions and increased the final total nitrogen content. Compared to control, adding 5, 10, 15, and 20% peat decreased ammonia emissions by 1.91, 10.79, 23.73, and 18.26%, respectively, during 42 days of composting. Moreover, peat addition increased fungal community diversity especially during maturation phase. The most two abundant phyla were Basidiomycota and Ascomycota in all treatments throughout the composting process. At the end of composting, in treatments with adding 10 and 15% peat, the richest fungi were Scedosporium spp. and Coprinopsis spp., respectively. Simultaneously, canonical correlation analyses showed that pH, moisture content, and seed germination index had significant association with fungal community composition. The study also showed that fungal community and nitrogen conservation had no direct obvious relation during composting. Overall, the results suggest that the addition of peat could efficiently enhance nitrogen conservation through reduction of ammonia emissions and 15% peat addition is the optimal formula for food waste composting.
Eating disorders in the Arab world: a literature review
Authors: Melisse Bernou , de Beurs Edwin , van Furth Eric F. 
Published: November 2020

AbstractBackgroundThe prevalence of eating disorders has been assumed to be low in the Arab world, due to the alleged absence of the thin ideal. However, the Arab world is undergoing rapid sociocultural changes, and there are reports of an increase of the desire to be thin. This literature review therefore provides point-prevalence of Arabs at high risk for eating disorders, and a comprehensive synthesis of correlates of eating disorder symptoms, eating disorder-related variables and of a high risk for eating disorders.MethodSeveral electronic databases were searched for published, peer-reviewed studies between 1986 and 2019 involving several key terms. From 317 screened studies, 81, mainly cross-sectional, were included. Preferred Reporting Items for Systematic reviews and meta-analyses was used as guidance and the quality of studies were assessed using the Newcastle-Ottawa scale.ResultsEstimates of individuals at high risk for eating disorders ranged from 2 to 54.8%. The eating disorder-related variables identified were desire to be thin, body dissatisfaction, disturbed-, and dieting- eating behavior. Identified correlates were increased affluence, media use, western influences, and obesity. An additional finding was that in some cases eating disorders were expressed somatically rather than psychiatrically.DiscussionIn the Arab world, females were most at risk for eating disorders and eating disorder symptoms. Sociocultural changes gave rise to the thin ideal and the prevalence of obesity, increasing the risk for the development of eating disorder-related variables and eating disorders. The literature on eating disorders in the Arab world suffers from potential limitations due to the use of non-validated assessment tools. Further research is necessary, particularly on the development and validation of a culturally sensitive assessment tool. Improved knowledge is likely to increase the number of people seeking treatment and decrease the stigma of psychotherapy.