bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety and Efficacy of Adding Dapagliflozin to Furosemide in Type 2 Diabetic Patients With Decompensated Heart Failure and Reduced Ejection Fraction
Authors: Ibrahim Ayman , Ghaleb Ramadan , Mansour Hossam , Hanafy Amr , Mahmoud Naggeh M. , Abdelfatah Elsharef Mohamed , Kamal Salama Mohamed , Elsaughier Saud M. , Abdel-Wahid Lobna , Embarek Mohamed Mona , Ibrahim Ahmed K. , Abdel-Galeel Ahmed 
Published: December 2020

Background:Heart failure is the most common cause of hospitalization in elderly patients. It is likely that many of the mechanisms that contribute to reductions in systolic and diastolic function, seen in diabetic patients, place them at an increased risk of heart failure. Diuretic therapy, especially loop diuretics, is the usual way of managing congestion, particularly in volume-overloaded patients. Little is known about the beneficial effect of dapagliflozin when added to loop diuretics in managing patients with decompensated heart failure.Aim:To assess the effect of the addition of dapagliflozin to furosemide in managing decompensated patient with heart failure and reduced left ventricular ejection fraction in terms of weight loss and dyspnea improvement.Patients and Methods:The study included 100 type 2 diabetic patients who were admitted with decompensated heart failure. The study population was randomly divided into two arms. Serum electrolytes and kidney functions were followed up during their hospital stay.Results:With dapagliflozin, there was a statistically significant difference between the two groups regarding the change in body weight and body mass index. The diuresis parameters including urine output, total fluid loss, and fluid balance also showed a statistically significant difference in favor of the use of dapagliflozin, with no significant change in serum potassium or kidney functions. There was significant improvement in patient-reported dyspnea scores with the use of dapagliflozin.Conclusions:Dapagliflozin may provide a new drug option in the treatment of heart failure especially among vulnerable group of diabetics. It had no remarkable effects on serum potassium level and kidney functions.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT04385589.
The Use of Synthetic Electronic Health Record Data and Deep Learning to Improve Timing of High-Risk Heart Failure Surgical Intervention by Predicting Proximity to Catastrophic Decompensation
Authors: Guo Aixia , Foraker Randi E. , MacGregor Robert M. , Masood Faraz M. , Cupps Brian P. , Pasque Michael K. 
Published: December 2020

Objective: Although many clinical metrics are associated with proximity to decompensation in heart failure (HF), none are individually accurate enough to risk-stratify HF patients on a patient-by-patient basis. The dire consequences of this inaccuracy in risk stratification have profoundly lowered the clinical threshold for application of high-risk surgical intervention, such as ventricular assist device placement. Machine learning can detect non-intuitive classifier patterns that allow for innovative combination of patient feature predictive capability. A machine learning-based clinical tool to identify proximity to catastrophic HF deterioration on a patient-specific basis would enable more efficient direction of high-risk surgical intervention to those patients who have the most to gain from it, while sparing others. Synthetic electronic health record (EHR) data are statistically indistinguishable from the original protected health information, and can be analyzed as if they were original data but without any privacy concerns. We demonstrate that synthetic EHR data can be easily accessed and analyzed and are amenable to machine learning analyses.Methods: We developed synthetic data from EHR data of 26,575 HF patients admitted to a single institution during the decade ending on 12/31/2018. Twenty-seven clinically-relevant features were synthesized and utilized in supervised deep learning and machine learning algorithms (i.e., deep neural networks [DNN], random forest [RF], and logistic regression [LR]) to explore their ability to predict 1-year mortality by five-fold cross validation methods. We conducted analyses leveraging features from prior to/at and after/at the time of HF diagnosis.Results: The area under the receiver operating curve (AUC) was used to evaluate the performance of the three models: the mean AUC was 0.80 for DNN, 0.72 for RF, and 0.74 for LR. Age, creatinine, body mass index, and blood pressure levels were especially important features in predicting death within 1-year among HF patients.Conclusions: Machine learning models have considerable potential to improve accuracy in mortality prediction, such that high-risk surgical intervention can be applied only in those patients who stand to benefit from it. Access to EHR-based synthetic data derivatives eliminates risk of exposure of EHR data, speeds time-to-insight, and facilitates data sharing. As more clinical, imaging, and contractile features with proven predictive capability are added to these models, the development of a clinical tool to assist in timing of intervention in surgical candidates may be possible.
Thyroid Hormone Changes in Early Pregnancy Along With the COVID-19 Pandemic
Authors: Lin Ting-Ting , Zhang Chen , Zhang Han-Qiu , Wang Yu , Chen Lei , Dennis Cindy-Lee , Huang Hefeng , Wu Yan-Ting 
Published: December 2020

PurposeCOVID-19 (Coronavirus Disease 2019) was first reported in December 2019 and quickly swept across China and around the world. Levels of anxiety and depression were increased among pregnant women during this infectious pandemic. Thyroid function is altered during stressful experiences, and any abnormality during early pregnancy may significantly affect fetal development and pregnancy outcomes. This study aimed to determine whether the COVID-19 pandemic induces thyroid hormone changes in early pregnant women.MethodsThis study comprised two groups of pregnant women in Shanghai in their first trimester – those pregnant women before the COVID-19 outbreak from January 20, 2019, to March 31, 2019 (Group 1) and those pregnant during the COVID-19 outbreak from January 20, 2020, to March 31, 2020 (Group 2). All women were included if they had early pregnancy thyrotropin (TSH), free triiodothyronine (FT3), free thyroxine (FT4), total triiodothyronine (TT3), and total thyroxine (TT4) concentrations, thyroid peroxidase (TPO) antibody or thyroglobulin antibody (TgAb) available and did not have a history of thyroid diseases or received thyroid treatment before or during pregnancy. We used propensity score matching to form a cohort in which patients had similar baseline characteristics.ResultsAmong 3338 eligible pregnant women, 727 women in Group 1 and 727 in Group 2 had similar propensity scores and were included in the analyses. Pregnant women in Group 2 had significantly higher FT3 (5.7 vs. 5.2 pmol/L, P&lt;0.001) and lower FT4 (12.8 vs. 13.2 pmol/L, P&lt;0.001) concentrations compared with those in Group 1. Pregnant women in Group 2 were more likely to develop isolated hypothyroxinemia (11.6% vs. 6.9%, OR, 1.75 [95% CI, 1.20–2.53], P=0.003) than those in Group 1 but had a significantly lower risk of TgAb positivity (12.0% vs. 19.0%, OR, 0.58 [95% CI, 0.43–0.78], P&lt;0.001).ConclusionPregnant women in their first trimester in Shanghai during the COVID-19 outbreak were at an increased risk of having higher FT3 concentrations, lower FT4 concentrations, and isolated hypothyroxinemia. The association between thyroid hormones, pregnancy outcomes, and the COVID-19 outbreak should be explored further.
Quality of Stroke Patient Information Applied in Randomized Controlled Trials—Literature Review
Authors: Alegiani Anna C. , Rahn Anne C. , Steckelberg Anke , Thomalla Götz , Heesen Christoph , Köpke Sascha 
Published: December 2020

Background: Strokes have a huge impact on patients' quality of life. Although there are potentially effective secondary preventions and treatment options for stroke patients, adherence is mostly low. Low disease and treatment-related knowledge and, consequently, a lack of informed decision-making in stroke patients may contribute to this problem. However, stroke patient information did not seem to have relevant effects on patients' knowledge in randomized controlled trials. One contributing factor may be the lack of thoroughly developed patient information materials.Methods: We aimed to evaluate the quality of patient information materials for stroke patients by using randomized controlled trials, applying quality criteria for evidence-based patient information (EBPI). We conducted a literature search (MEDLINE, Embase, CINAHL, PsycINFO, and CENTRAL). To be included in the review, research had to be randomized controlled trials that provided stroke patient information, were published in English, and had knowledge assessed as the primary endpoint. Authors of primary studies were contacted and asked for information materials applied.Results: We screened 15,507 hits and identified 30 eligible studies. Information materials were available for only eight studies. Analyses revealed that all available materials had important shortcomings concerning EBPI quality criteria [concerning, for example, structural information (e.g., reporting conflicts of interest), content information (e.g., reporting sources of information), or comprehensive descriptions of treatment effects and side effects]. Frequently, treatment effects were reported only narratively without providing absolute numbers, values, or frequencies.Conclusion: Quality of materials differed, but none sufficiently fulfilled EBPI quality criteria. Unsatisfactory trial results concerning patient knowledge and patient involvement in decision-making may at least partially be explained by limitations of the provided materials. Future patient information should consider EBPI quality criteria.
Nocebo-Hypothesis Cognitive Behavioral Therapy (NH-CBT) for Persons With Functional Neurological Symptoms (Motor Type): Design and Implementation of a Randomized Active-Controlled Trial
Authors: Richardson Matt , Kleinstäuber Maria , Wong Dana 
Published: December 2020

Introduction: Functional Neurological Symptom Disorders (FNSD) are associated with high levels of disability and immense direct and indirect health costs. An innovative interdisciplinary rehabilitation approach for individuals with functional neurological symptoms of motor type–Nocebo-Hypothesis Cognitive Behavioral Therapy (NH-CBT)—combines CBT and movement retraining with video feedback embedded in a comprehensive explanatory model of the etiology of FNSD.Methods: This protocol describes the development and implementation of a phase II, parallel group, randomized controlled trial with blinded outcome assessors to compare the efficacy of NH-CBT with an active control condition (supportive counseling and movement retraining). Individuals meeting diagnostic criteria of an FNSD or psychogenic movement disorder will be randomly assigned to one of the 8-week interventions. Self-report scales of motor and other physical symptoms, symptom-related psychological variables, and assessor ratings of participants' mobility will be administered at baseline, and at 8- and 16-week follow-up. Adverse events will be monitored across all sessions and therapeutic alliance will be measured at the end of therapy. The primary statistical analysis will test the hypothesis that NH-CBT is more effective than the control intervention at the 8-week follow-up.Discussion: The therapeutic strategies of NH-CBT are theory-driven by assumptions of the predictive coding model of the etiology of FNSD. Strengths and limitations of this trial will be discussed.Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR; identifier: ACTRN12620000550909).
A Prognostic Microenvironment-Related Immune Signature via ESTIMATE (PROMISE Model) Predicts Overall Survival of Patients With Glioma
Authors: Qiu Huaide , Li Yongqiang , Cheng Shupeng , Li Jiahui , He Chuan , Li Jianan 
Published: December 2020

ObjectiveIn the development of immunotherapies in gliomas, the tumor microenvironment (TME) needs to be investigated. We aimed to construct a prognostic microenvironment-related immune signature via ESTIMATE (PROMISE model) for glioma.MethodsStromal score (SS) and immune score (IS) were calculated via ESTIMATE for each glioma sample in the cancer genome atlas (TCGA), and differentially expressed genes (DEGs) were identified between high-score and low-score groups. Prognostic DEGs were selected via univariate Cox regression analysis. Using the lower-grcade glioma (LGG) data set in TCGA, we performed LASSO regression based on the prognostic DEGs and constructed a PROMISE model for glioma. The model was validated with survival analysis and the receiver operating characteristic (ROC) in TCGA glioma data sets (LGG, glioblastoma multiforme [GBM] and LGG+GBM) and Chinese glioma genome atlas (CGGA). A nomogram was developed to predict individual survival chances. Further, we explored the underlying mechanisms using gene set enrichment analysis (GSEA) and Cibersort analysis of tumor-infiltrating immune cells between risk groups as defined by the PROMISE model.ResultsWe obtained 220 upregulated DEGs and 42 downregulated DEGs in both high-IS and high-SS groups. The Cox regression highlighted 155 prognostic DEGs, out of which we selected 4 genes (CD86, ANXA1, C5AR1, and CD5) to construct a PROMISE model. The model stratifies glioma patients in TCGA as well as in CGGA with distinct survival outcome (P&lt;0.05, Hazard ratio [HR]&gt;1) and acceptable predictive accuracy (AUCs&gt;0.6). With the nomogram, an individualized survival chance could be predicted intuitively with specific age, tumor grade, Isocitrate dehydrogenase (IDH) status, and the PROMISE risk score. ROC showed significant discrimination with the area under curves (AUCs) of 0.917 and 0.817 in TCGA and CGGA, respectively. GSEA between risk groups in both data sets were significantly enriched in multiple immune-related pathways. The Cibersort analysis highlighted four immune cells, i.e., CD 8 T cells, neutrophils, follicular helper T (Tfh) cells, and Natural killer (NK) cells.ConclusionsThe PROMISE model can further stratify both LGG and GBM patients with distinct survival outcomes.These findings may help further our understanding of TME in gliomas and shed light on immunotherapies.
Apatinib Mesylate Inhibits the Proliferation and Metastasis of Epithelioid Malignant Peritoneal Mesothelioma In Vitro and In Vivo
Authors: Yang Zhi-Ran , Chen Zhi-Gao , Du Xue-Mei , Li Yan 
Published: December 2020

ObjectiveMalignant peritoneal mesothelioma (MPM) is a rare malignancy with few effective molecular therapies. In this study, we evaluated the anti-tumor activity and safety of apatinib, a vascular endothelial growth factor receptor 2 inhibitor, in MPM in vitro and in vivo.MethodsWe established several patient-derived xenograft (PDX) models and primary cell lines of MPM. The cell lines were used to study the effects of apatinib on proliferation, cell cycle, migration, and apoptosis by CCK8, flow cytometry, wound-healing, Transwell, DAPI staining, and caspase-3 assays, respectively. For in vivo study, apatinib was delivered by gastric gavage into PDX models, and then efficacy and toxicity were determined by experimental peritoneal cancer index (ePCI) score and pathological examinations.ResultsOur results showed that apatinib significantly inhibited the proliferation and migration of MPM cells in vitro and induced cell cycle arrest. Studies on PDX models concurred that apatinib effectively suppressed subphrenic and liver invasions of nude mice. Moreover, histopathological analysis found that lymphocyte infiltration, coagulation necrosis and eosinophilic cell fragments were detected in tumor tissues after apatinib treatment. Apatinib showed no obvious effects on body mass of models and did not affect function of important organs, except for occasional focal lymphoid infiltration of liver (16.7%) and cardiac muscle (16.7%).ConclusionsWe successfully established MPM PDX models and primary cell lines, and confirmed that apatinib effectively inhibited proliferation and metastasis of MPM in vitro and in vivo study.
Paclitaxel Plus Platinum Neoadjuvant Chemotherapy Followed by Surgery Versus Primary Surgery in Locally Advanced Cervical Cancer—A Propensity Score Matching Analysis
Authors: Zhang Yanan , Li Bin , Wang Yating , Liu Shuanghuan , Wang Haibo 
Published: December 2020

ObjectiveTo compare the efficacy and safety of neoadjuvant chemotherapy followed by surgery (NACTS) and primary surgery (PS) in locally advanced cervical cancer (LACC).MethodsLACC (stage IB2/IIA2, FIGO 2009) patients who accepted NACTS or PS in the Cancer Hospital of the Chinese Academy of Medical Sciences from 2007 to 2017 were enrolled, and a database was established. A 1:1 ratio propensity score matching (PSM) was performed for the NACTS group and PS group according to pretreatment characteristics. After PSM, the clinicopathological features and prognosis between the matched groups were compared.ResultsOf 802 cases in the database, 639 met the inclusion criteria, with 428 received paclitaxel plus platinum NACTS, and 211 received PS. After PSM, the two groups had comparable pretreatment characteristics, with 190 cases in each group. In the NACTS group, the operation parameters were similar to the PS group except for the longer operation time (median 255 min vs. 239 min, P = 0.007); pathological intermediate-risk factors including tumor diameter (P &lt; 0.001) and LVSI(+) (P &lt; 0.001) were significantly decreased; fewer patients were with ≥2 intermediate-risk factors (10.5 vs. 53.2%, P &lt; 0.001) so that the rate of adjuvant radiotherapy was reduced (54.2 vs. 70.0%, P = 0.002). DFS and OS were similar between the NACTS group and PS group (P &gt; 0.05). However, for patients with tumor diameter ≥5 cm or SCC ≥5 ng/ml, DFS of the NACTS group was significantly prolonged (P = 0.016, P = 0.007).ConclusionPaclitaxel plus platinum neoadjuvant chemotherapy can reduce adjuvant radiotherapy by decreasing pathological risk factors. Patients with tumor diameter ≥5 cm or SCC ≥5 ng/ml may obtain survival benefits.
Prevalence of Therapeutic use of Opioids in Chronic non-Cancer Pain Patients and Associated Factors: A Systematic Review and Meta-Analysis
Authors: De Sola Helena , Dueñas María , Salazar Alejandro , Ortega-Jiménez Patricia , Failde Inmaculada 
Published: December 2020

Objectives:To determine the prevalence and factors associated with the use of opioids among patients with chronic non-cancer pain (CNCP).Methods:A systematic review and meta-analysis. Comprehensive literature searches in Medline-PubMed, Embase and SCOPUS databases. Original studies published between 2009 and 2019 with a cross-sectional design were included. The quality of the studies was assessed with Critical Appraisal Checklist for Studies Reporting Prevalence Data from the Joanna Briggs Institute. Protocol registered in the International Prospective Register of Systematic Reviews with reference number: CRD42019137990.Results:Out of the 1,310 potential studies found, 25 studies fulfilled the inclusion criteria. Most of the studies were of high quality. High levels of heterogeneity were found in the studies included. In the general population, the prevalence of long-term opioid use was 2.3% (95% CI: 1.5–3.6%), the prevalence of short-term opioid use was 8.1% (95% CI: 5.6–11.6%), and among people with chronic low back pain it was 5.8% (95% CI: 0.5–45.5%). The prevalence of opioid use among patients from the health records or medical surveys was 41% (95% CI: 23.3–61.3%). Finally, in patients with musculoskeletal pain, the prevalence was 20.5% (95% CI: 12.9–30.9%) and in patients with fibromyalgia, 24.5% (95% CI: 22.9–26.2%). A higher prevalence of opioid use was observed among men, younger people, patients receiving prescriptions of different types of drugs, smokers and patients without insurance or with noncommercial insurance. In addition, non-white and Asian patients were less likely to receive opioids than non-Hispanic white patients.Conclusions:The prevalence of opioid use among patients with CNCP was higher in subjects with short or occasional use compared to those with long-term use. Men, younger people, more chronic pain conditions, and patients without insurance or with noncommercial insurance were most related to opioid use. However, non-white and Asian patients, and those treated by a physician trained in complementary medicine were less likely to use opioids.
Capsular Polysaccharide From Bacteroides fragilis Protects Against Ulcerative Colitis in an Undegraded Form
Authors: Zheng Lijun , Luo Meihua , Kuang Gaobo , Liu Yangyang , Liang Debao , Huang Haiqing , Yi Xiaomin , Wang Congfeng , Wang Ye , Xie Qiuling , Zhi Fachao 
Published: December 2020

The prominent human symbiont Bacteroides fragilis protects animals from intestinal diseases, such as ulcerative colitis, and its capsular polysaccharide plays a key role in reducing inflammation. B. fragilis strain ZY-312 was isolated from the feces of a healthy breast-fed infant, and the zwitterionic capsular polysaccharide zwitterionic polysaccharide, TP2, was extracted. In rats with 2,4-dinitrobenzenesulfonic acid (DNBS)-induced enteritis, TP2 at an optimal dose of 2.5 mg/kg could significantly alleviate enteritis and reduced the degree of intestinal adhesions, the intestinal ulcer area, and the incidence of ulcers in rats. To understand the underlying mechanism, TP2 was labeled with Fluorescein isothiocyanate and orally administered at a dose of 2.5 mg/kg in rats. TP2 was mainly distributed in the cecum and colorectum, but it was not detected in the blood and other organs except that a compound with a molecular weight greater than that of TP2-FITC was found in liver tissue. During the absorption, distribution, metabolism, and excretion, TP2 was indigestible. These results were further confirmed by investigation in the simulated gastric, intestinal fluid, and colonic fluid with fecal microbiota in vitro, where TP2 remained unaltered at different time points. Furthermore, flora composition was analyzed in simulated colonic fluid with TP2 added and it was found that TP2 increased the abundance of Faecalibacterium, Enterococcus romboutsia, and Ruminococcaceae, whereas the abundance of the phylum Proteobacteria represented by Sutterella, Desulfovibrio, and Enterobacteriaceae was decreased. However, the amount of short-chain fatty acids in the simulated colonic fluid was not changed by intestinal flora post-TP2 addition. In conclusion, these findings confirmed that TP2, a capsular polysaccharide of B. fragilis, protects against ulcerative colitis in an undegraded form.