bluuebunny/crossref_metadata_2025_split huggingface dataset:
An audit of questions asked by participants during the informed consent process for regulatory studies at a tertiary referral centre – An analysis of consent narratives
Authors: Saxena Unnati , Bose Debdipta , Maurya Mitesh Kumar , Gogtay Nithya Jaideep , Thatte Urmila Mukund 
Published: September 2020

Objective To evaluate the questions asked during the informed consent process by adult and adolescent participants as well as their parents in five interventional regulatory studies conducted at our center from 2018 to 2019. Methods The study protocol was approved by Institutional Ethics Committee [EC/OA-116/2019]. Consent narratives in the source documents for the studies were evaluated. Questions asked were classified as per Indian Council of Medical Research’s (ICMR) guidelines (2017). We evaluated total number of questions, nature of questions and whether there was an association between education, gender, phase of trials, physician taking consent and number questions being asked. Results A total of five studies that had N = 297 consent narratives were evaluated. Narratives of n = 284 adult participants/Guardians and of n = 13 children were analysed. A total of 374 questions were asked of which children asked only 10 questions. A total of 131/284 (40%) of the participants did not ask any question. Among the participants who asked questions, the majority132/171 (77%) participants asked about risks related to investigational products followed by questions related to study procedures 83/171 (49%). Participants/guardians with higher education (relative to those who were educated upto the secondary school and primary school) and those who consented for Phase III studies (relative to Phase I studies) asked significantly more questions (p < 0.0001). Conclusion A majority of the queries were related to the risks associated with the investigational products. Educational status and the Phase of the trial were found to be significantly associated with the number of questions being asked.
Olfactory Function After Surgical Treatment of CRS: A Comparison of CRS Patients to Healthy Controls
Authors: Mattos Jose L. , Soler Zachary M. , Schlosser Rodney J. , Mace Jess C. , Alt Jeremiah A. , Ramakrishnan Vijay R. , Payne Spencer C. , Smith Timothy L. , Beswick Daniel M. 
Published: September 2020

Background Many patients with chronic rhinosinusitis (CRS) have persistent olfactory dysfunction (OD) following endoscopic sinus surgery (ESS). Few studies compare outcomes to control subjects so it is unknown if residual OD is due to persistent CRS. Objective Compare postoperative measures of OD in case patients with CRS to healthy controls without sinonasal disease. Methods Prospective, observational, multicenter cohort study between October, 2016 and May, 2019. Case participants were selected from referred adult patients diagnosed with CRS, with or without nasal polyposis (NP), electing ESS as subsequent treatment modality. Controls voluntarily enrolled from a community-based sample without a history of CRS. Primary outcomes included measures of preoperative and postoperative OD using “Sniffin’ Stick” pens which summarize odorant threshold (T), discrimination (D), and identification (I) scores. Secondary outcomes included the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) survey and olfactory cleft endoscopy scores (OCES). Results Outcomes were compared between 113 cases and 164 controls of similar average age and gender. Cases reported significantly worse baseline Sniffin’ Sticks TDI total scores (−6.8[SE ± 1.0]; 95% CI: −4.9 to −8.7), QOD-NS (8.9[SE ± 1.1]; 95% CI: 6.8–10.9), and OCES (3.5[SE ± 0.4]; 95% CI: 2.9–4.2) on average. Cases reported significant postoperative improvement in TDI total score (3.7[SD ± 8.2]; 95% CI: 2.2–5.2), QOD-NS (−5.9[SD ± 8.7]; 95% CI: −7.6 to −4.3), and OCES (−1.7[SD ± 3.8]; 95% CI: −2.7 to −0.8) on average, while 63% of anosmics reported improved postoperative olfaction. Multivariate regression identified that NP (OR = 0.4; 95% CI: 0.2–1.0) and previous ESS (OR = 0.3; 95% CI: 0.1–0.8) decreased the odds of postoperative improvement equal to mean TDI scores of controls, while septoplasty increased those odds (OR = 4.5; 95% CI: 1.5–13.7). Conclusion ESS improved olfactory metrics and restored olfactory function in approximately 50% of patients with CRS to that of healthy controls. Concurrent septoplasty increased the likelihood of achieving normal olfaction, while NP and previous ESS decreased those odds.
Extracellular vesicles released from p18 overexpressing pulmonary endothelial cells are barrier protective – potential implications for acute respiratory distress syndrome
Authors: Harrington Elizabeth O. , Braza Julie , Shil Aparna , Chichger Havovi 
Published: September 2020

The novel endosome protein, p18, and the early endosome GTPase, Rab4, play a significant role in protecting the pulmonary vasculature against permeability associated with acute respiratory distress syndrome. Recently, endothelial‐derived extracellular vesicles have been identified to play a key role in the endothelial permeability associated with acute respiratory distress syndrome. Therefore, we investigated the effect of these microparticles, released from endothelial cells overexpressing p18 and Rab4, on pulmonary endothelial barrier function. Endothelial‐derived extracellular vesicles isolated from lung microvascular endothelial cells which overexpressed cDNA for wild‐type p18 protected a naïve monolayer against lipopolysaccharide‐induced permeability. In contrast, endothelial‐derived extracellular vesicles from cells overexpressing the non‐endosomal binding p18 mutant (p18N39) exerted no protective effect on the endothelial monolayer. Cells overexpressing either dominant active or inactive Rab4 released endothelial‐derived extracellular vesicles which had no effect on lipopolysaccharide‐induced permeability. miRNA analysis and permeability studies of endothelial‐derived extracellular vesicle isolated from wild‐type p18‐overexpressing cells demonstrates that let‐7i‐5p, miR‐96‐5p, and miR‐137‐3p are endothelial‐derived extracellular vesicle cargo which exert protective effects on the pulmonary endothelium. Finally, we observed down‐regulation of p18 protein expression in both the lung and endothelium in an in vivo and in vitro model of acute respiratory distress syndrome. These results demonstrate that endothelial‐derived extracellular vesicle released from cells overexpressing p18, but not Rab4, contain miRNA cargo which likely promote a barrier‐protective effect on the pulmonary endothelium in settings of acute respiratory distress syndrome. Findings indicate the importance of p18 in the pulmonary vasculature and demonstrate that targeting this protein may provide a novel therapeutic strategy to reduce endothelial permeability associated with acute respiratory distress syndrome.
Identifying the challenges to successfully teaching about genetic diversity among Japanese junior high school students
Authors: Kohama Natsu , Kawasaki Hiromi , Kukinaka Chieko , Goda Hiromi , Rahman Md Moshiur 
Published: September 2020

Objectives: Creating a diverse and inclusive symbiotic society is specified in the sustainable development goals. In a symbiotic society, support for those who need, it is called “reasonable support.” However, it is unclear in the classroom that many children understand “reasonable” as a consideration to support children with special needs. The aim of this study is to identify the actual understanding of junior high school students and the challenges related to genetic diversity through school health teachers in readiness for developing a symbiotic society. Methods: A focus group interview was conducted for five school health teachers working in public junior high schools to identify the perspectives of their feeling about the current understanding of children in regard to genetics and diversity. Participants were recruited who agreed to engage voluntarily in this research. A qualitative descriptive design was used in this study. Results: The results of the analysis revealed three categories consisting of 67 codes and 10 subcategories. Three categories were identified: I—understanding the heterogeneity and diversity of children’s ambivalent minds; II—limitation of school health teachers’ involvement in genetics and diversity-related issues; and III—importance for children to understand heterogeneity and diversity to build life skills. Conclusions: School health teachers remarked on the limitations of learning and teaching genetics and diversity. They paid attention to the flexibility of a child. It suggests that the purpose of genetic education is to develop children’s life skills with the flexibility to live in the future. There is a need to consider new genetic education for school health teachers and students to learn about diversity.
Dignity therapy online: Piloting an online psychosocial intervention for people with terminal illness
Authors: Bentley Brenda , O’Connor Moira , Williams Anne , Breen Lauren J 
Published: September 2020

Objective Dignity therapy is a life review intervention shown to reduce distress and enhance the quality of life for people with a terminal illness and their families. Dignity therapy is not widely used in clinical practice because it is time and cost prohibitive. This pilot study examined the feasibility and acceptability of dignity therapy delivered through therapist-supported web-based delivery to reduce costs, increase time efficiency, and promote access to treatment. Methods This study employed a one-group pre-test post-test design to pilot methods. Australian adults diagnosed with a terminal illness with a prognosis of six months or less were recruited for the study. The primary outcome measure was a Participant Feedback Questionnaire used in previous face-to-face dignity therapy studies. Data regarding therapist time and details about final documents were recorded. Results Six people were recruited; four chose to complete the intervention via videoconference and two chose email. Participants reported high levels of acceptability and efficacy comparable to face-to-face delivery; meanwhile therapist time was about 40% less and legacy documents were longer. Participants described dignity therapy online as convenient, but technological issues may create challenges. Conclusions Online delivery of dignity therapy is feasible and acceptable, reduces therapist time and clinical cost, and appears to reach people who would not otherwise receive the therapy. Dignity therapy via email may have the greatest potential to reduce time and cost barriers. This pilot study demonstrates a need for further research to determine the full benefits of online delivery of dignity therapy.
Comparison of image quality of head and neck lesions between 3D gradient echo sequences with compressed sensing and the multi-slice spin echo sequence
Authors: Kami Yukiko , Chikui Toru , Togao Osamu , Ooga Masahiro , Yoshiura Kazunori 
Published: September 2020

Background Although magnetic resonance imaging (MRI) provides excellent soft-tissue contrast, long acquisition times are major disadvantages. Purpose To evaluate the usefulness of compressed sensing (CS) for contrast-enhanced oral and maxillofacial MRI by comparing the 3D T1 turbo field echo with compressed SENSE (CS-3D-T1TFE) sequence with the multi-slice spin echo (MS-SE) sequence as the reference standard. Material and Methods Thirty patients with orofacial lesions participated in this study. The scan times for MS-SE and CS-3D-T1TFE were 5 min 56 s and 1 min 43 s, respectively. The signal-to-noise ratio (SNR) was calculated for quantitative analysis and seven parameters (degree of lesion conspicuity, motion artifacts, metal artifacts, pulsation artifacts, quality of fat suppression, homogeneity of blood vessel signal intensity, and overall image quality) were evaluated using a 5-point scale (5 = excellent, 1 = unacceptable) by two observers for qualitative analysis. For comparisons between MS-SE and CS-3D-T1TFE, the paired t-test was used. Results The SNR of CS-3D-T1TFE was higher than or equal to that of MS-SE. The CS-3D-T1TFE scores for motion artifacts, pulsation artifacts, and homogeneity of blood vessel signal intensity were higher than the corresponding MS-SE scores in assessments by both observers. The MS-SE scores for fat suppression were higher than or equal to the CS-3D-T1TFE scores. There were no significant differences in lesion conspicuity, metal artifacts, and overall image quality between the two sequences. Conclusion CS-3D-T1TFE imaging, less than 30% of the scan time for MS-SE, showed no image degradation while retaining equal or higher SNR and image quality.
Comparative genomics of CXCR4MUT and CXCR4WT single cells in Waldenström’s macroglobulinemia
Authors: Jiménez Cristina , Xu Lian , Tsakmaklis Nickolas , Demos Maria G. , Kofides Amanda , Chan Gloria G. , Guerrera Maria Luisa , Chen Jiaji G. , Liu Xia , Munshi Manit , Patterson Christopher J. , Yang Guang , Castillo Jorge J. , Treon Steven P. , Hunter Zachary R. 
Published: September 2020

Key PointsSingle-cell whole-genome amplification can be used to interrogate the genomic architecture of Waldenström’s macroglobulinemia. The mutational signature of CXCR4MUT cells may be associated with alterations in DNA repairing genes and tumor suppressors.
The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study
Authors: Silberstein Stephen D. , Cohen Joshua M. , Seminerio Michael J. , Yang Ronghua , Ashina Sait , Katsarava Zaza 
Published: September 2020

Abstract
Background
We evaluated the efficacy of fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, in patients with chronic migraine (CM) with and without medication overuse (MO).

Methods
In a 12-week, phase 3 trial, patients with CM were randomized to fremanezumab quarterly (675 mg/placebo/placebo), monthly (675 mg/225 mg/225 mg), or placebo. Post hoc analyses assessed the impact of fremanezumab in patients with and without MO (monthly use of acute headache medication ≥15 days, migraine-specific acute medication ≥10 days, or combination medication ≥10 days) on efficacy outcomes, including headache days of at least moderate severity (HDs), and six-item Headache Impact Test (HIT-6) and Migraine-Specific Quality of Life (MSQoL) questionnaire scores.

Results
Of 1130 patients enrolled, 587 (51.9%) had baseline MO. Fremanezumab reduced placebo-adjusted least-squares mean (95% confidence interval) monthly HDs (− 2.2 [− 3.1 to − 1.2] and − 2.7 [− 3.7 to − 1.8]; P < 0.0001) in patients with MO and without MO (quarterly − 1.4 [− 2.3 to − 0.5], P = 0.0026; monthly − 1.4 [− 2.3 to − 0.6], P = 0.0017). Significantly more fremanezumab-treated patients had ≥ 50% reduction in HDs versus placebo, regardless of baseline MO (with: quarterly 70/201 [34.8%], monthly 78/198 [39.4%] vs placebo 26/188 [13.8%]; without: quarterly 71/174 [40.8%], monthly 75/177 [42.4%] vs placebo 41/183 [22.4%]). Fremanezumab improved HIT-6 and MSQoL scores. Significantly more fremanezumab-treated patients reverted to no MO (quarterly 111/201 [55.2%], monthly 120/198 [60.6%]) versus placebo (87/188 [46.3%]).

Conclusions
Fremanezumab is effective for prevention of migraine in patients with CM, regardless of MO, and demonstrated a benefit over placebo in reducing MO.

Trial registration
ClinicalTrials.gov NCT02621931 (HALO CM), registered December 12, 2012.
Barriers and facilitators to adherence to walking group exercise in older people living with dementia in the community: a systematic review
Authors: Vseteckova J. , Dadova K. , Gracia R. , Ryan G. , Borgstrom E. , Abington J. , Gopinath M. , Pappas Y. 
Published: September 2020

Summary
Background & Aims
Evidence suggests that targeted exercise is important for people living with dementia. The aim of this review was to collect and synthesize evidence on the known barriers and facilitators to adherence to walking group exercise of older people living with dementia in the community.

Methods
We have searched appropriate electronic databases between January 1990 until September 2019, in any language. Additionally, we searched trial registries (clinicaltrial.gov and WHO ICTRP) for ongoing studies. We included all study designs. Studies were excluded when participants were either healthy older people or people suffering from dementia but living in residential care. Narrative synthesis was used.

Findings
10 papers met the inclusion criteria. The narrative analysis focused on barriers, facilitators, and adherence. All studies reported on barriers and facilitators. Barriers included: bio-medical reasons (including mental wellbeing and physical ability); relationship dynamics; and socio-economic reasons and environmental issues. Facilitators included: bio-medical benefits & benefits related to physical ability; staff, group relationship dynamics and social aspect of walking group; environmental issues and individual tailoring; and participants perceptions about the walks & the program. Most studies did not provide data about adherence or attendance; where reported, adherence ranged from 47 to 89%.

Conclusions
This systematic review of literature has highlighted known barriers and facilitators to adherence to walking groups type of exercise for people living with dementia in community. Carers’ willingness to engage, their circumstances, perspectives and previous experiences of exercise seem to play a key role in facilitating adherence but there is little research that explores these. Also, the design, location and organisation of walking groups facilitate adherence. This reflects the need for such activities to be part of a wider ‘program of care’, tailored to the needs of the individual, flexible and convenient. Knowledgeable and well-trained instructors or healthcare professionals are recommended as group exercise leaders.
Management of cryptorchidism in adolescent and adult males
Authors: Viljoen J. T. , Zarrabi A. , Van der Merwe A. 
Published: September 2020

Abstract
Background
In developing countries, it is not unusual for patients with undescended testes (UDT) to present in adulthood and the late detection of UDT can be problematic. The limited contribution to fertility and increased potential of malignancy seen in UDT have swayed many authors towards recommending orchidectomy, rather than orchidopexy, for the adult patient presenting with cryptorchidism. With conflicting data, and most guidelines aimed at first world countries with pre-pubertal patients as their focus group, a lot of uncertainty exists regarding the management of adults who present with cryptorchidism. This may result in variation in the approach to management of this patient population.

Methods
A retrospective review was conducted of patients with cryptorchidism, aged 12 years or older at the time of surgery. The following data were retrieved: patient’s age, medical and previous surgical history, clinical features of UDT (laterality, position and size), date of surgery, intra-operative findings and procedure performed. Management decisions were compared to the most recent guidelines.

Results
The mean age of the 106 subjects was 25.4 years. An orchidectomy was performed in a total of 30 (24.2%) of the 124 testicular units. The majority of testes, 91 (73.4%), in this group were preserved. Of these, 43 (47.3%) were older than 18 years of age, 33 (36.2%) were reported as having unilateral UDT with a normal contralateral testis and in 9 (9.8%) of these cases, the preserved testes were described as being atrophic. The majority (59.7%) of UDT in the post-pubertal group (> 18 years) were managed by orchidopexy.

Conclusion
Contrary to the recommended treatment for this group of patients, there was a general tendency towards testicular preservation. The decision on surgical management was made by the attending surgical team. This not only demonstrates variation in the management of UDT, but could also be a reflection of the lack of sufficient guidelines as to the management of the post-pubertal patient presenting with UDT. Further studies, following cryptorchidism through adulthood, are needed to refine guidelines for the optimal management of this group of patients.
Monitoring sustainable development by means of earth observation data and machine learning: a review
Authors: Ferreira Bruno , Iten Muriel , Silva Rui G. 
Published: September 2020

AbstractThis paper presents and explores the different Earth Observation approaches and their contribution to the achievement of United Nations Sustainable Development Goals. A review on the Sustainable Development concept and its goals is presented followed by Earth Observation approaches relevant to this field, giving special attention to the contribution of Machine Learning methods and algorithms as well as their potential and capabilities to support the achievement of Sustainable Development Goals. Overall, it is observed that Earth Observation plays a key role in monitoring the Sustainable Development Goals given its cost-effectiveness pertaining to data acquisition on all scales and information richness. Despite the success of Machine Learning upon Earth Observation data analysis, it is observed that performance is heavily dependent on the ability to extract and synthesise characteristics from data. Hence, a deeper and effective analysis of the available data is required to identify the strongest features and, hence, the key factors pertaining to Sustainable Development. Overall, this research provides a deeper understanding on the relation between Sustainable Development, Earth Observation and Machine Learning, and how these can support the Sustainable Development of countries and the means to find their correlations. In pursuing the Sustainable Development Goals, given the relevance and growing amount of data generated through Earth Observation, it is concluded that there is an increased need for new methods and techniques strongly suggesting the use of new Machine Learning techniques.
Keeping up with the genomes: efficient learning of our increasing knowledge of the tree of life
Authors: Zhao Zhengqiao , Cristian Alexandru , Rosen Gail 
Published: September 2020

AbstractBackgroundIt is a computational challenge for current metagenomic classifiers to keep up with the pace of training data generated from genome sequencing projects, such as the exponentially-growing NCBI RefSeq bacterial genome database. When new reference sequences are added to training data, statically trained classifiers must be rerun on all data, resulting in a highly inefficient process. The rich literature of “incremental learning” addresses the need to update an existing classifier to accommodate new data without sacrificing much accuracy compared to retraining the classifier with all data.ResultsWe demonstrate how classification improves over time by incrementally training a classifier on progressive RefSeq snapshots and testing it on: (a) all known current genomes (as a ground truth set) and (b) a real experimental metagenomic gut sample. We demonstrate that as a classifier model’s knowledge of genomes grows, classification accuracy increases. The proof-of-concept naïve Bayes implementation, when updated yearly, now runs in 1/4thof the non-incremental time with no accuracy loss.ConclusionsIt is evident that classification improves by having the most current knowledge at its disposal. Therefore, it is of utmost importance to make classifiers computationally tractable to keep up with the data deluge. The incremental learning classifier can be efficiently updated without the cost of reprocessing nor the access to the existing database and therefore save storage as well as computation resources.