bluuebunny/crossref_metadata_2025_split huggingface dataset:
Media scandals, rumour and gossip: A study with an ear close to the ground
Authors: Hammarlin Mia-Marie 
Published: August 2019

The abiding interest of researchers in the nature of mediated scandals continues to provoke discussions of what this phenomenon actually is, and how it is best researched empirically. This article argues that despite the claims that a modern scandal is manifested mainly through traditional and digital media, a careful analysis of the lived experience of this phenomenon – using in-depth qualitative interviews with the subjects of scandal – demonstrates that to fully understand it, we must take into account other forms of direct human communication, such as gossip and rumours, which flourish among the audiences as a response to the transgressional acts that started the scandal. The results of this study challenge the idea of ‘mediated scandals’ as a typically modern conjuncture that can be separated from ‘localized scandals’ or ‘classic scandals’. Instead, I consider the mediated scandal to be above all a cultural phenomenon, which audiences use to debate and negotiate transgressional acts and norms. They also reflect the historical staying power of this phenomenon, and the urgent need to analytically transgress the alleged border between the ‘mediated’ dimension of communication with the word-of-mouth dimension, which may very well be one of the most influential news media in every society.
Categorization for occasioned semantics: Reanalysis of a Japanese Yamagata 119 emergency call
Authors: Hayashi Reiko 
Published: August 2019

Without making any reference to traditional linguistic disciplines such as presupposition, implicature and indirect speech acts, this article analyzes how and what implicit meanings were constructed, structured and negotiated through an ambulance request call to the119 call center in Yamagata, Japan in 2011, while enhancing the cogency of the empirical approach independent from analytical theories. Through the occasioned taxonomic analysis of the occasioned semantics of the caller and the call-taker regarding the dispatch, the analysis captured definitive evidence on how a negative response was created from the call-taker’s categorization process. It reveals the process in which the rejection was determined from the talk by the call-taker that was oriented toward and constructed by the conceptual knowledge of motion, which was formulated as ‘walk’. A three-part-list structure was created, which formulated ‘emesis’ into the category of a symptom, but not into that of an illness. The analysis reports that the call-taker’s method of occasioned semantics was operative and systematically patterned. Based on the results of the analysis, with linguistic evidence, the article critically argues that the rejection of an ambulance request was due in large part to the call-taker’s method of categorization when asking questions, which provides an alternative account to that of a previously reported analysis.
Identification of serum exosomal microRNAs in acute spinal cord injured rats
Authors: Ding Shu-Qin , Chen Jing , Wang Sai-Nan , Duan Fei-Xiang , Chen Yu-Qing , Shi Yu-Jiao , Hu Jian-Guo , Lü He-Zuo 
Published: August 2019

It is important to find specific and easily detectable diagnostic markers in acute stage of spinal cord injury for guiding treatment and estimating prognosis. Although, microRNAs are attractive biomarkers, there is still no uniform standard for clinical evaluation of spinal cord injury based on “free circulation” miRNA spectrum. The reason may be that miRNA analysis from biological fluids is influenced by many pre-analysis variables. Exosome miRNAs are widely distributed in body fluids and have many advantages comparing with free miRNAs. The specific miRNAs in the central nervous system can be transported to the peripheral circulation and concentrated in exosomes. Therefore, we hypothesized that there might be some physiological changes associated with spinal cord injury in serum exosomal miRNAs. Using next-generation sequencing, miRNA profiles in serum exosomes of sham and acute spinal cord injury rats were analyzed, and integrative bioinformatics were used to analyze the function and regulation of putative target genes. The results showed that acute spinal cord injury can lead to changes in miRNA expression in the circulating exosomes. The changed miRNAs and their associated pathways may explain the pathology of acute spinal cord injury. More importantly, we determined serum exosomal miR-125b-5p, miR-152-3p, and miR-130a-3p are specific and easily detectable diagnostic markers in acute spinal cord injury. More interestingly, we also found some valuable known and novel miRNAs. Further bioinformatics analysis and functional research will be of great help to make clear their role in the pathological process of spinal cord injury and judging whether they can be used as diagnostic markers. Impact statement This research hypothesized that there might be some physiological changes associated with SCI in serum exosomal miRNAs. Using next-generation sequencing, miRNA profiles in serum exosomes of sham and acute SCI rats were analyzed, and integrative bioinformatics were used to analyze the function and regulation of putative target genes. The results showed that acute SCI can lead to changes in miRNA expression in the circulating exosomes. The changed miRNAs and their associated pathways may explain the pathology of acute SCI. More importantly, we determined serum exosomal miR-125b-5p, miR-152-3p, and miR-130a-3p are specific and easily detectable diagnostic markers in acute SCI.
Availability of study protocols for randomized trials published in high-impact medical journals: A cross-sectional analysis
Authors: Spence O’Mareen , Hong Kyungwan , Onwuchekwa Uba Richie , Doshi Peter 
Published: August 2019

Background: To improve reporting transparency and research integrity, some journals have begun publishing study protocols and statistical analysis plans alongside trial publications. We sought to assess the overall availability and characteristics of protocols and statistical analysis plans of randomized clinical trials published in the top five (by impact factor) general medicine journals. Methods: All randomized clinical trials published in Annals of Internal Medicine, BMJ, JAMA, Lancet, and NEJM in 2016 were identified. For each randomized clinical trial, we searched for protocols and statistical analysis plans on journal websites (including supplementary material) and in the article, for example, a referenced publication or link to trial or institutional website. Characteristics of randomized clinical trials were extracted from the publication and clinical trial registry. A detailed assessment of protocols and statistical analysis plans was conducted in a 20% random sample of randomized clinical trials. Results: Protocols were available for 299 (82%) trials, ranging from 50% in BMJ to >95% in NEJM and JAMA. Statistical analysis plans were available for 182 (50%) trials and varied from <10% for Annals of Internal Medicine, BMJ, and Lancet to 92% for NEJM. Of the 76 randomized clinical trials in the 20% random sample, 63 (83%) had a protocol but less than half (31; 44%) included an a priori (dated prior to patient enrollment) version of the protocol. Statistical analysis plans were available for 35 (46%) trials, and only 5 (7%) included an a priori version. Conclusion: Protocols and statistical analysis plans are publicly available for the majority of trials. However, the a priori versions of these documents are only available for a minority of trials. More attention must be paid to ensuring the public availability of a priori versions.
Design and monitoring of survival trials based on restricted mean survival times
Authors: Luo Xiaodong , Huang Bo , Quan Hui 
Published: August 2019

Background/Aims: Restricted mean survival time has become a popular treatment effect measurement because of its nice interpretability. However, study design based on restricted mean survival times often requires extensive simulation studies as the variance structure is hard to obtain analytically. This article aims to provide a flexible approach to conduct study design and monitoring based on the restricted mean survival times without resorting to simulation. Methods: We assume that both the event time and censoring time distributions are piecewise exponential, and the accrual distribution is piecewise uniform, with which the restricted mean survival times and their variance–covariance structure can be conveniently computed. Results: Since we allow arbitrary number of pieces in the piecewise exponential and uniform distributions, the resulting model can handle a wide range of scenarios. The usefulness of the approach is demonstrated via an example. Conclusion: The proposed approach is flexible and useful in the design and monitoring of survival trials based on restricted mean survival times.
Bayesian clinical trials at The University of Texas MD Anderson Cancer Center: An update
Authors: Tidwell Rebecca S Slack , Peng S Andrew , Chen Minxing , Liu Diane D , Yuan Ying , Lee J Jack 
Published: August 2019

Background/aims In our 2009 article, we showed that Bayesian methods had established a foothold in developing therapies in our institutional oncology trials. In this article, we will document what has happened since that time. In addition, we will describe barriers to implementing Bayesian clinical trials, as well as our experience overcoming them. Methods We reviewed MD Anderson Cancer Center clinical trials submitted to the institutional protocol office for scientific and ethical review between January 2009 and December 2013, the same length time period as the previous article. We tabulated Bayesian methods implemented for design or analyses for each trial and then compared these to our previous findings. Results Overall, we identified 1020 trials and found that 283 (28%) had Bayesian components so we designated them as Bayesian trials. Among MD Anderson–only and multicenter trials, 56% and 14%, respectively, were Bayesian, higher rates than our previous study. Bayesian trials were more common in phase I/II trials (34%) than in phase III/IV (6%) trials. Among Bayesian trials, the most commonly used features were for toxicity monitoring (65%), efficacy monitoring (36%), and dose finding (22%). The majority (86%) of Bayesian trials used non-informative priors. A total of 75 (27%) trials applied Bayesian methods for trial design and primary endpoint analysis. Among this latter group, the most commonly used methods were the Bayesian logistic regression model (N = 22), the continual reassessment method (N = 20), and adaptive randomization (N = 16). Median institutional review board approval time from protocol submission was the same 1.4 months for Bayesian and non-Bayesian trials. Since the previous publication, the Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) trial was the first large-scale decision trial combining multiple treatments in a single trial. Since then, two regimens in breast cancer therapy have been identified and published from the cooperative Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis (I-SPY 2), enhancing cooperation among investigators and drug developers across the nation, as well as advancing information needed for personalized medicine. Many software programs and Shiny applications for Bayesian trial design and calculations are available from our website which has had more than 21,000 downloads worldwide since 2004. Conclusion Bayesian trials have the increased flexibility in trial design needed for personalized medicine, resulting in more cooperation among researchers working to fight against cancer. Some disadvantages of Bayesian trials remain, but new methods and software are available to improve their function and incorporation into cancer clinical research.
Accrual Prediction Program: A web-based clinical trials tool for monitoring and predicting accrual for early-phase cancer studies
Authors: Liu Junhao , Wick Jo A , Mudaranthakam Dinesh Pal , Jiang Yu , Mayo Matthew S , Gajewski Byron J 
Published: August 2019

Background Monitoring subject recruitment is key to the success of a clinical trial. Accordingly, researchers have developed accrual-monitoring tools to support the design and conduct of trials. At an institutional level, delays in identifying studies with high risk of accrual failure can lead to inefficient and costly trials with little chances of meeting study objectives. Comprehensive accrual monitoring is necessary to the success of the research enterprise. Methods This article describes the design and implementation of the University of Kansas Cancer Center Accrual Prediction Program, a web-based platform was developed to support comprehensive accrual monitoring and prediction for all active clinical trials. The Accrual Prediction Program provides information on accrual, including the predicted completion date, predicted number of accrued subjects during the pre-specified accrual period, and the probability of achieving accrual targets. It relies on a Bayesian accrual prediction model to combine protocol information with real-time trial enrollment data and disseminates results via web application. Results First released in 2016, the Accrual Prediction Program summarizes enrollment information for active studies categorized by various trial attributes. The web application supports real-time evidence-based decision making for strategic resource allocation and study management of over 120 ongoing clinical trials at the University of Kansas Cancer Center. Conclusion The Accrual Prediction Program makes accessing comprehensive accrual information manageable at an institutional level. Cancer centers or even entire institutions can reproduce the Accrual Prediction Program to achieve real-time comprehensive monitoring and prediction of subject accrual to aid investigators and administrators in the design, conduct, and management of clinical trials.
Food store environment examination – FoodSee: a new method to study the food store environment using wearable cameras
Authors: McKerchar Christina , Smith Moira , Stanley James , Barr Michelle , Chambers Tim , Abel Gillian , Lacey Cameron , Gage Ryan , Ni Mhurchu Cliona , Signal Louise 
Published: August 2019

Introduction: Food environments shape food behaviours and are implicated in rising rates of obesity worldwide. Measurement of people’s interactions with food stores is important to advance understanding of the associations between the food environment and in-store behaviour. This paper describes a new method, Food Store Environment Examination (FoodSee) to measure people’s interaction with the food store environment in a feasibility study focused on convenience stores and children. Methods: One hundred and sixty-eight randomly selected children (aged 11–13 years) recruited from 16 randomly selected schools in Wellington, New Zealand, used wearable cameras for 4 days that recorded images every 7 s. The study was conducted from July 2014 to June 2015. All images of convenience stores and service stations, and a sample of images from supermarkets, were evaluated to determine the feasibility of assessing food availability and marketing. The outcomes of interest assessed were: food product availability, placement, packaging, branding, price promotion, purchases and consumption. Results: Thirty-seven children (22%) visited a convenience store or service station at least once during the study period. In total, there were 65 visits to 34 different stores. Seven hundred and nineteen images revealed the in-store environment. Of those, 86.1% were usable and able to be analysed for the outcomes of interest. Conclusions: The FoodSee methodology provides a promising new method to study people’s interaction with the in-store food environment. The evidence generated will be valuable in understanding and improving the food store environment within which people shop, and will contribute to efforts to address obesity globally.
Cutaneous Complications With Continuous or Flash Glucose Monitoring Use: Systematic Review of Trials and Observational Studies
Authors: Asarani Nurul A. Mohd , Reynolds Andrew N. , Boucher Sara E. , de Bock Martin , Wheeler Benjamin J. 
Published: August 2019

Background: Continuous glucose monitoring (CGM)/flash glucose monitoring (FGM) use in diabetes management is increasing. Cutaneous complications associated with these devices were reported. We conducted a systematic review to provide an overview of cutaneous complications with CGM/FGM use. Methods: We identified observational studies and intervention trials that report on cutaneous complications with CGM/FGM use up to January 14, 2019. Studies were identified through Medline, Embase, and PubMed, or with hand searching of the previous publications. Screening was duplicated and data extracted to consider four main themes: incidence rate and severity, participant perspectives of cutaneous complications, potential solutions, and future directions in diabetic technology relevant to reducing cutaneous complications. Results: A total of 54 eligible studies were identified. The overall event rate of cutaneous complications reported from 19 trials was one event per eight weeks of sensor wear-time of which 1.5% were considered severe. The most common cutaneous complications were wear-related erythema, itching, and induration. Although skin irritations were the most common cause of CGM/FGM discontinuation, most users experienced less pain or discomfort with CGM/FGM than capillary blood glucose testing. Future technological advances may reduce, but not eliminate cutaneous complications. Conclusion: The incidence rate of reported cutaneous complications with CGM/FGM use from the available literature is low, with one event per eight weeks of sensor wear-time. Reported complication severity was also low, leading to low rates of CGM/FGM discontinuation. However, there appear to be discrepancies between reporting in trial and observational data. Greater constancy in reporting is necessary to understand the frequency of this issue.
Infrared Thermography and Vascular Disorders in Diabetic Feet
Authors: Ilo Arjaleena , Romsi Pekka , Mäkelä Jussi 
Published: August 2019

Aim: Diabetes mellitus (DM) and related foot complications constitute a growing healthcare burden. Diabetes mellitus is associated with lower-limb amputation, but diabetic foot assessment is challenging. Here, we evaluated a novel noninvasive diagnostic method—infrared thermography (IRT) —assessing its diagnostic potential compared to conventional noninvasive measurements. Methods: This study included patients with DM ( n = 118) and healthy controls ( n = 93). All participants underwent ankle brachial index and toe pressure (TP) measurements, and IRT using a standardized protocol with temperature measurement at five foot areas. Results: Compared to controls, patients with DM generally had warmer feet and exhibited a significantly greater temperature difference between feet ( P < .001). Mean temperatures were highest in patients with DM with neuroischemia, followed by neuropathy. Patients with DM with angiopathy showed the lowest mean temperature—similar to controls and noncomplicated diabetics. Mean temperatures at all measurement sites were significantly higher with abnormal TP (<50 mmHg) than normal TP (≥50 mmHg) ( P < .001). Infrared thermography revealed differences between angiosome areas, subclinical infections, and plantar high-pressure areas. Conclusion: Infrared thermography revealed local temperature differences in high-risk diabetic feet. Normal skin surface temperature varies between individuals, but in combination with other tools, IRT might be useful in clinical screening. ClinicalTrials ID: 14212016
Microarray Assay Reveals Ciliary Abnormalities of the Allergic Nasal Mucosa
Authors: Peng Yang , Guan Wei-jie , Zhu Zhen-chao , Tan Kai Sen , Chen Zhuo , Hong Hai-yu , Zi Xiao-xue , Andiappan Anand Kumar , Shi Li , Yang Qin-tai , Wang De-Yun , Qiu Qian-hui 
Published: August 2019

Background Gene expression patterns (particularly, cilia-associated genes) of nasal mucosa, the first-line defense system, in allergic rhinitis (AR) are not well understood. Objective We sought to screen for AR-associated genes in inferior turbinate (IT) from patients with AR, and to validate the expression of common cilia-related genes and ciliary shedding. Methods Prime View™ Human Gene Expression Array, which consisted of more than 530 000 probes covering more than 36 000 transcripts and variants, was employed to compare individual gene expression of ITs from control subjects (n = 11) and patients with AR (n = 19). Gene ontology (GO) analysis was performed with Cytoscape software. Eight of the common cilia-related genes were validated with quantitative polymerase chain reaction. We applied a semiquantitative scoring system for immunofluorescence assay to demonstrate ciliary shedding in 5 areas per paraffin section, with individual sections being scored between 0 (normal ciliary distribution) and 1 (ciliary shedding). Results Compared with control subjects, 160 (38 upregulated and 122 downregulated) genes were differentially expressed for at least 2 folds (all P < .05) in AR. Seven GO categories were significantly enriched, 4 of which were related to cilium assembly and motility. Quantitative polymerase chain reaction validated the predicted direction of change for common cilia-related gene expression. The ciliary distribution score was significantly higher (more prominent ciliary shedding) in AR than in controls ( P < .05). Conclusion The significant aberrant cilia-related gene expression, revealed by microarray assays, might be the critical driver of AR where ciliary shedding is prominent.
Pain control for interstitial cystitis/bladder pain syndrome patients undergoing pelvic reconstructive surgery
Authors: Crouss Tess , Mancenido Briana , Rana Neha , Jia Xibei , Whitmore Kristene 
Published: August 2019

Introduction: Scant research exists on pain control for interstitial cystitis patients undergoing pelvic reconstructive surgery. Our aim was to compare the perioperative courses in patients with and without interstitial cystitis undergoing pelvic reconstructive surgery performed using primarily monitored anesthesia care with local anesthesia. Methods: A retrospective chart review of surgical cases performed at a single site from November 2015 to July 2018 was performed. Joint non-gynecologic cases were excluded. Data including demographics, intraoperative variables, medication requirements, and postoperative courses were abstracted. Chi-square, independent t, and Mann–Whitney U tests were used to compare interstitial cystitis with non-interstitial cystitis patients. Results: In total, 65 separate cases met inclusion criteria and were analyzed, with 57 individual subjects. Out of the 65 cases, 33 cases were performed on interstitial cystitis patients. Only 2 of the 33 interstitial cystitis patient cases required general anesthesia. Interstitial cystitis patients did not require higher concentrations of 1% lidocaine with epinephrine (average of 3.8 mg/kg) compared to patients without (2.8 mg/kg). There was no difference between groups in perioperative complications, length of recovery, or postoperative narcotic consumption. Conclusion: Perioperative outcomes and pain control do not differ in those with and without interstitial cystitis undergoing pelvic reconstructive surgery. Prolapse surgery can be safely performed on a patient population with a high proportion of chronic pelvic pain using monitored anesthesia care with local anesthesia, without increased morbidity or difficultly with perioperative pain control.