bluuebunny/crossref_metadata_2025_split huggingface dataset:
Quality of adverse event reporting in phase III randomized controlled trials of breast and colorectal cancer: A systematic review
Authors: Komorowski Adam S. , MacKay Helen J. , Pezo Rossanna C. 
Published: May 2020

AbstractBackgroundClinical trial reports often emphasize efficacy over harms, leading to misinterpretation of the risk‐to‐benefit ratio of new therapies. Clear and sufficiently detailed reporting of methods and results is especially important in the abstracts of trial reports, as readers often base their assessment of a trial on such information. In this study, we evaluated the quality of adverse event (AE) reporting and abstract quality in phase III randomized controlled trials (RCTs) of systemic therapies in breast and colorectal cancer.MethodsMedline, EMBASE, Cochrane Database of RCTs, and Cochrane Database of Systematic Reviews were searched from November 2005 to September 2018. Phase III RCTs evaluating systemic therapies in breast or colorectal cancer were included. Each article was independently reviewed by two investigators using a standardized data extraction form based on guidelines developed by the Consolidated Standards of Reporting Trials (CONSORT) group. Descriptive statistics, bivariate analysis, and multivariable linear regression were used to analyze data. All statistical tests were two‐sided.ResultsOf 166 RCTs identified, 99.4% reported harms in the manuscript body, and 59.6% reported harms in the abstract. Reporting was restricted to severe harms in 15.6% of RCTs. Statistical comparison of AE rates went unreported in 59.0% of studies. Information regarding AEs leading to dose reductions, treatment discontinuations, or study withdrawals went unreported in 59.3%, 18.7%, and 86.8% of studies, respectively. Recently published RCTs (P = .009) and those sponsored at least partially by for‐profit companies (P = .003) had higher abstract quality scores.ConclusionsBreast and colorectal cancer phase III RCTs inadequately report CONSORT‐compliant AE data. Improved guideline adherence and abstract reporting is required to properly weigh benefits and harms of new oncologic therapies.Systematic Review Registration NumberCRD42019140673.
Association between lactate dehydrogenase levels and oncologic outcomes in metastatic prostate cancer: A meta‐analysis
Authors: Li Fan , Xiang Hui , Pang Zisen , Chen Zejia , Dai Jinlong , Chen Shu , Xu Bin , Zhang Tianyu 
Published: May 2020

AbstractPurposePrevious studies have provided evidence of the high expression of lactate dehydrogenase (LDH) in multiple solid tumors; however, its prognostic relationship with metastatic prostate cancer (mPCa) remains controversial. We performed a meta‐analysis to better understand the prognostic potential of LDH in mPCa.MethodsIn our investigation, we included PubMed, Embase, Web of Science, and Cochrane Library as web‐based resources, as well as studies published before January 2020 on the predictive value of LDH in mPCa. We independently screened the studies according to the inclusion and exclusion criteria, evaluated the quality of the literature, extracted the data, and used RevMan 5.3 and STATA12.0 software for analysis.ResultFrom the 38 published studies, the records of 9813 patients with mPCa were included in this meta‐analysis. We observed that higher levels of LDH in patients with mPCa were significantly associated with poorer overall survival (OS) (HR = 2.17, 95% CI: 1.91‐2.47, P < .00001) and progression‐free survival (PFS) (HR = 1.60, 95% CI: 1.20‐2.13, P = .001). The subgroup analyses indicated that the negative prognostic impact of higher levels of LDH on the oncologic outcomes of mPCa was significant regardless of ethnicity, publication year, sample size, analysis type, treatment type, age, and disease state.ConclusionOur analysis suggested the association between a higher level of LDH and poorer OS and PFS in patients with mPCa. As a parameter that can be conveniently evaluated, the LDH levels should be included as a valuable biomarker in the management of mPCa.
Why disadvantaged older adults engage in community consultation: A world café study
Authors: Wright‐Bevans Katie , Walker Alison , Vosper Emma 
Published: May 2020

AbstractCommunity consultation is increasingly favoured as a means of ensuring that health services adequately meet population needs, yet research, has highlighted the frequency of inadequate and tokenistic consultation. Our aim was to address the gap in understanding of the mechanisms of successful community consultation by being the first study to examine consultation events for older adults in one of the most deprived local authority areas in the UK. A naturalistic world café was co‐designed with a community engagement service. Adults aged 68–91 years (n = 103) participated in one of two world café discussions. Qualitative findings demonstrated the mechanisms behind and the added value of consultation with disadvantaged older adults. Forums were found to not only offer space within which opinions could be voiced, they also supported information gathering, the adoption of civic responsibilities and social activities. Understanding of the added value of consultation forums may incentivise service providers to facilitate more meaningful consultation and encourage scholars to examine think more critically about social mechanisms that promote active ageing.
Highly Sensitive Electrochemical Detection of Reactive Oxygen Species in Living Cancer Cells Using Monolithic Metallic Foam Electrodes
Authors: Yang Yang , Zhang Heng , Wang Zhe , Li Xuepeng , Abdelsamie Abdelrahim Abdelsamie Abdalla , Yuan Xichen , Fan Xiaomeng , Zhang Ruirong , Chang Honglong 
Published: May 2020

AbstractReactive oxygen species (ROS) distribute in most mammalian cells in living organisms, and play a necessary role in signaling molecule to regulate various biological processes. To quantitatively and accurately monitor the ROS level releasing from living cells, electrochemical techniques have drawn great attention and ubiquitous innovations. However, its practicability is hindered by the sluggish electron transfer and poor mass transport efficiency between functional catalysts and their supports. Herein, we develop a three‐dimensional monolithic and metallic foam (Ag‐wire foam) to detect one typical ROS, i. e. hydrogen peroxide (H2O2) in three cancer cells. The high electrical conductivity of Ag and the substrate‐free configuration guarantee the rapid electron flow within the metal scaffolds. The numerical model is established to depict the concentration distributions of H2O2 and reaction products. It shows the inter‐fiber voids throughout the foam can provide fast reactant diffusion channels and further facilitate the mass transport. We fabricate a microfluidic chip‐based three‐electrode system to detect the trace H2O2 concentration. A low detection limit of 15 nM H2O2 in human leukemia K562 cancer cells and less than 20 s response time 0is observed, outperforming many previous reports. Importantly, the concept of building three‐dimensional metal wire foams demonstrated herein is hopeful to guide the designing and promote high‐performance ROS‐detection in living cells.
Procedural outcomes and learning curve of cardiac arrhythmias catheter ablation using remote magnetic navigation: Experience from a large‐scale single‐center study
Authors: Li Xiang , Jin Qi , Zhang Ning , Ling Tianyou , Lin Changjian , Jia Kangni , Bao Yangyang , Xie Yun , Wei Yue , Chen Kang , Pan Wenqi , Xie Yucai , Wu Liqun 
Published: May 2020

AbstractBackgroundRemote magnetic navigation (RMN)‐guided ablation has become an inspiring method of catheter ablation for tachyarrhythmias.HypothesisData from a large‐scale single center may provide further insight into the safety of and the learning curve for RMN‐guided ablation.MethodsA total of 1003 catheter ablation procedures using RMN for conditions including supraventricular ventricular tachycardia, atrial tachyarrhythmias, and premature ventricular contraction/ventricular tachycardia (PVC/VT) were retrospectively analyzed from an ablation registry. Procedural outcomes, including procedure time, mapping time, X‐ray time, and RF time, were assessed. The complications were classified into two categories: major and minor. A subanalysis was used to illustrate the learning curve of RMN‐guided ablation by assessing procedure time and total X‐ray time of 502 atrial fibrillation (AF) ablation procedures.ResultsAmong these procedures, 556 (55.4%) were AF and 290 (28.9%) were PVC/VT. Electrical pulmonary vein isolation was achieved in 99.0% of AF procedures, and acute success reached 90.3% in PVC/VT procedures. The overall complication rate was 0.5%. In the subanalysis of AF procedures, the overall procedure time and X‐ray time of procedures were short (125.9 ± 54.6 and 5.3 ± 3.9 minutes, respectively) and proceeded to decrease from the initial 30 procedures to about 300 procedures, where the learning curve reached plateau, demonstrating maximum procedure efficiency.ConclusionsRMN‐guided ablation is safe, as verified by very low overall complication rate and reduced X‐ray time. In our study, even the first AF procedures had a relatively low procedure time and total X‐ray time, and procedure efficiency improved during the learning curve.
Patterns of metastases of prostatic ductal adenocarcinoma
Authors: Ranasinghe Weranja K. B. , Brooks Nathan A. , Elsheshtawi Mohamed A. , Davis John W. , Bathala Tharakeswara K. , Tang Chad , Troncoso Patricia , Aparicio Ana , Tu Shi‐Ming , Pisters Louis L. , Chapin Brian F. 
Published: May 2020

BackgroundThe current study was conducted to investigate the patterns of metastases in men with metastatic prostatic ductal adenocarcinoma (DAC) and recurrence patterns after therapy.MethodsAll patients with a new diagnosis of DAC with de novo metastases and those with localized disease who developed metastases after treatment and were treated at the study institution from January 2005 to November 2018 were included. All patient and tumor characteristics and outcome data were collected.ResultsA total of 164 patients (37.7%) had metastatic DAC, including 112 with de novo metastases and 52 who developed metastases after treatment. Men with de novo metastases were found to have a significantly higher median prostate‐specific antigen level and International Society of Urological Pathology grade but a lower cT3 and/or T4 classification compared with those with metastases that developed after treatment (all P < .05). Approximately 87% of men with de novo metastases progressed despite multiple systemic therapies, 37.6% required intervention for the palliation of symptoms, and 10.1% responded to systemic therapy and underwent treatment of the primary tumor. Men with de novo metastatic DAC and those who developed metastases after treatment had multiple metastatic sites (including bone and viscera), with higher rates of lung metastases noted in the posttreatment group (23.2% vs 44.2%; P = .01). A total of 45 patients who were treated with curative intent developed metastases at a median of 22 months (range, 0.9‐74.8 months) after treatment, at low prostate‐specific antigen levels (median, 4.4 ng/mL [interquartile range, 1.7‐11.1 ng/mL]).ConclusionsThe current study described the metastatic patterns of DAC in both patients with de novo metastatic disease and those who later progress to metastases. Men receiving treatment for DAC with curative intent require stringent long‐term follow‐up with imaging modalities, including chest imaging given the predilection toward lung metastases noted among these patients.
A multi‐institutional phase 2 trial of regorafenib in refractory advanced biliary tract cancer
Authors: Kim Richard D. , Sanoff Hanna K. , Poklepovic Andrew S. , Soares Heloisa , Kim Jongphil , Lyu Jing , Liu Yingmiao , Nixon Andrew B. , Kim Dae Won 
Published: May 2020

BackgroundRegorafenib is an oral multikinase inhibitor targeting angiogenesis, oncogenesis, and cancer proliferation/metastasis. This study evaluated the efficacy of regorafenib in refractory biliary tract cancer (BTC) in a multi‐institutional phase 2 study.MethodsPatients with BTC who progressed on at least 1 line of systemic therapy received regorafenib at 160 mg daily for 21 days on and 7 days off. The primary endpoint was 6‐month overall survival (OS), and the secondary endpoints were median OS, progression‐free survival (PFS), and objective response rates. Pretreatment plasma was collected for cytokine evaluation.ResultsA total of 39 patients were enrolled, and 33 were evaluable for efficacy. The median PFS and OS were 3.7 and 5.4 months, respectively, with survival rates of 46.2% at 6 months, 35.9% at 12 months, and 25.6% at 18 months for the intention‐to‐treat population. For the 33 evaluable patients who received regorafenib for at least 3 weeks, the median PFS and OS were 3.9 and 6.7 months, respectively, with survival rates of 51.5% at 6 months, 39.4% at 12 months, and 27.3% at 18 months. The objective response rate was 9.1%, and the disease control rate was 63.6%. Twenty‐eight patients (71.8%) experienced grade 3/4 adverse events. Among the 23 cytokines analyzed, elevated baseline vascular endothelial growth factor D (VEGF‐D) was associated with shorter PFS, whereas elevated baseline interleukin 6 (IL‐6) and glycoprotein 130 (GP130) were associated with shorter OS.ConclusionsRegorafenib demonstrated modest clinical efficacy in heavily pretreated patients with BTC. Further exploration of biomarkers is warranted to identify a group of patients with BTC who may benefit from regorafenib.
Cancer classification from microarray data for genomic disorder research using optimal discriminant independent component analysis and kernel extreme learning machine
Authors: Nguyen Tram Thi Huyen , Nguyen Pol Van , Tran Quang Vinh , Vo Nam Xuan , Vo Trung Quang 
Published: May 2020

AbstractOne of the challenging tasks in the medicinal field is genomic disorder investigation and its classification from the microarray dataset. The microarray dataset reorganization and its classification is more complex and expensive in the biomedical research area due to the larger number of features in the microarray dataset. In this paper, we construct a hybrid feature selection method such as t test, Fisher ration, and Bayesian logistic regression to select genes and that reduce the time cost. Based on the features, the top‐ranked features are selected via the best hybrid rank method. Thereafter, the features are extracted using the modified firefly optimization‐based discriminant independent component analysis (MF‐DICA). Especially, the modified firefly optimization algorithm is capable of improving the search efficiency of DICA. From the high dimensional microarray dataset, MF‐DICA is used to obtain the best features within the entire search space. The kernel extreme learning machine classifies the gene features depending upon the most relevant class. Experimentally, six datasets namely Leukemia dataset, Diffuse Larger B‐cell Lymphomas, Lung cancer, Breast cancer, Prostate tumor, and Colon dataset are chosen to evaluate the performance of proposed approaches. Finally, the experimental data demonstrate that the proposed method is well suitable to classify the microarray data.
Pharmacokinetics and Bioequivalence of Clopidogrel Hydrogen Sulfate Tablets in Fed and Fasted Conditions: An Open‐Label, Randomized, Semireplicated Crossover Study in Healthy Chinese Volunteers
Authors: Pei Tong , Yang Jing , Hu Chaoying , Chen Xiaoping , Gong Shili , Hu Xiao , Li Lin , Zhang Lan 
Published: May 2020

AbstractClopidogrel is an antiplatelet drug with high intraindividual variability in systemic exposure and efficacy. It has been used for treating atherosclerosis and acute coronary syndrome and in preventing stent restenosis and thrombotic complications after stent implantation in clinical practice for nearly 20 years. In this study we aimed to evaluate the bioequivalence of 2 clopidogrel hydrogen sulfate formulations (75‐mg tablets) under fed (n = 66) and fasted (n = 66) conditions by using the reference‐scaled average bioequivalence method. An open‐label, randomized, 3‐sequence and 3‐period crossover (3×3), semireplicated study was designed and conducted. Clopidogrel concentration of plasma samples was measured by high‐precision liquid chromatography and tandem mass spectrometry. The pharmacokinetic parameters were derived by a noncompartmental model. In the fed condition the geometric least‐squares mean ratios of peak concentration (Cmax) and area under the concentration‐time curve (AUC0‐t) were, respectively, 103.38% and 98.97%, and the corresponding 90%CIs were 95.68% to 111.70% and 94.67% to 103.47%. In the fasted condition the geometric least squares mean ratios of Cmax and AUC0‐t were, respectively, 106.53% and 105.77%, and the corresponding 90%CIs were 97.62% to 116.25% and 96.96% to 115.38%. According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.
A robust interclass and intraclass loss function for deep learning based tongue segmentation
Authors: Cai Yuanzheng , Wang Tao , Liu Wei , Luo Zhiming 
Published: May 2020

SummaryThe fast and robust segmentation of tongue images is a prerequisite to achieve automatic tongue diagnosis in traditional Chinese medicine. In order to assist tongue diagnosis in real‐life scenarios, an ideal tongue segmentation method would need to obtain the entire tongue body as well as its precise contours. However, the similar appearance among the tongue body, the coating, and the lips hinders the performance for most unsupervised learning methods that primarily utilize low‐level visual features. On the other hand, although the supervised deep convolutional neural networks (DCNNs) that typically depend on the widely used crossentropy loss can achieve better accuracy, they are very prone to segment image to multiple trivially areas. To address both of the above issues, we make an attempt to boost the segmentation performance of DCNNs with a novel auxiliary loss function that seeks to exploit large margin learning for end‐to‐end tongue segmentation models. Specifically, we first propose a loss function that involves interclass and intraclass costs to directly measure the distance among pixels that belong to different connected regions. Then, we explore the potential ability of this loss function as a regularization for different segmentation networks such as those with attention modules and the deeply supervised network. Finally, a theoretical analysis for this learning scheme is presented. Through experiments on challenging datasets, we show that the proposed approach can be easily integrated into state‐of‐the‐art networks to boost their performance at the tongue segmentation task without bells and whistles.
How do you define recovery? A qualitative study of patients with eating disorders, their parents, and clinicians
Authors: Richmond Tracy K. , Woolverton G. Alice , Mammel Kathy , Ornstein Rollyn M. , Spalding Allegra , Woods Elizabeth R. , Forman Sara F. 
Published: May 2020

AbstractObjectiveRecovery from an eating disorder (ED) may be defined differently by different stakeholders. We set out to understand the definition of ED recovery from the perspective of patients, their parents, and clinicians.MethodWe recruited patients with EDs (n = 24, ages 12–23 years) representing different diagnoses (anorexia nervosa n = 17, bulimia nervosa n = 4, binge‐ED n = 2, avoidant/restrictive food intake disorder n = 1), along with their parents (n = 20), dietitians (n = 11), therapists (n = 14), and primary care providers (n = 9) from three sites: Boston Children's Hospital, University of Michigan C. S. Mott Children's Hospital, and Penn State Hershey Children's Hospital. In‐depth, semi‐structured, qualitative interviews explored participants' definitions of recovery. Interviews were analyzed using inductive data‐driven thematic analysis. Statistical analyses followed to examine the distribution within each theme by respondent type.ResultsQualitative analysis resulted in the emergence of four overarching themes of ED recovery: (a) psychological well‐being, (b) eating‐related behaviors/attitudes, (c) physical markers, and (d) self‐acceptance of body image. Endorsement of themes two and four did not significantly differ between patients, parents, and clinicians. Clinicians were significantly more likely to endorse theme one (χ2 = 9.90, df = 2, p = .007, φc = 0.356) and theme three (χ2 = 6.42, df = 2, p = .04, φc = 0.287) than patients and parents.DiscussionOur study demonstrates overwhelming support for psychological markers as indicators of ED recovery by all three groups. Clinicians should remain open to additional markers of recovery such as body acceptance and eating‐related behaviors/emotions that may be of critical importance to patients and their caregivers.
Trait‐based life strategies, ecological niches, and niche overlap in the nekton of the data‐poor Mediterranean Sea
Authors: Koutsidi Martha , Moukas Catherine , Tzanatos Evangelos 
Published: May 2020

AbstractBiological traits can determine species ecological niches and define species responses to environmental variation. Species have a specific functional position in the biological community, resulting in interactions like interspecific competition. In this study, we used biological traits in order to define the life strategies of 205 nektonic species of the Mediterranean Sea. Furthermore, traits related to resource use were analyzed to determine the level of trait and niche overlap and their relationship to life strategies. Focusing on habitats of importance (Posidonia beds, coralligène formations, and lagoons), we investigated strategies and niches of the species present there. Finally, we examined the life strategy of Lessepsian species and investigated the niche overlap between them and indigenous species. Archetypal analysis indicated the existence of three life histories corresponding to strategies already documented for fish (equilibrium, periodic, and opportunistic), with some species also placed in intermediate positions. Niche overlap was evaluated by multiple correspondence analysis and the generation of a single distance metric between all species pairs. This identified species occupying relatively empty (underexploited) ecological niches, like the Lessepsian species Siganus luridus and S. rivulatus, a finding that can also be associated with their establishment in the Mediterranean. Most Lessepsian species were associated with the opportunistic life history strategy, again an important aspect related to their establishment. Also, we documented that most species occurring in important habitats have a relatively high overlap of niches. No significant differences were found in the life strategies across Mediterranean habitats; however, variation in niche overlap and traits related to habitat use was detected. The findings can be useful to determine theoretical competition between species and to identify empty ecological niches. Fisheries science can also benefit from comprehending the dynamics of competing stocks or predict the responses of data‐poor stocks to anthropogenic stressors from known examples of species with shared life strategies.