bluuebunny/crossref_metadata_2025_split huggingface dataset:
Can 2 Different Fecal Calprotectin Assays be Used Interchangeably in IBD Treatment?
Authors: van Wassenaer Elsa A. , Diederen Kay , van Leeuwen Ester M.M. , D’Haens Geert R. , Benninga Marc A. , Koot Bart G.P. , Kindermann Angelika 
Published: October 2020

Background:Fecal calprotectin (FC) is a biomarker for inflammation in inflammatory bowel disease (IBD). Interpretation of results can be complicated because of the use of different assays to determine FC.Goals:To assess the agreement between 2 different assays for determining FC in patients with IBD.Methods:Samples from adults and children with IBD were tested with 2 assays: (1) EliA 2 Calprotectin and (2) EK-Cal. Samples were uniformly tested on the same day. Interassay variability was displayed in a Bland-Altman plot. The difference in categorization of the FC result (1: 0 to 250 mg/kg, 2: 250 to 500 mg/kg, 3: >500 mg/kg) was assessed with the linear weighted κ for adults and children separately.Results:A total of 171 patients [mean age: 33 (range: 7 to 81); 92 (54%) female; 117 (68%) Crohn’s disease; 53 (31%) ulcerative colitis] were included. Median (interquartile ranges) FC levels were 281 mg/kg (70 to 971) (EK-Cal) and 159 mg/kg (31 to 778) (EliA 2), and the mean delta FC was 89 mg/kg. In the adult population, there was substantial agreement between the 2 assays (κ: 0.72; SE: 0.06; 95% confidence interval, 0.60-0.83) and for pediatric patients, the agreement was almost perfect (κ: 0.83; SE: 0.06; 95% confidence interval: 0.70-0.95). Five of 171 patients (all aged ≥17 y and all with colonic disease) had a difference of 2 categories (1 vs. 3) between assays. Interassay variability was the highest in category 3.Conclusions:The agreement between the EliA 2 and EK-Cal assay in this cohort of IBD patients is substantial to almost perfect. Interassay variability is higher in the highest FC category.
Phenotypic Changes of PD-1 and GITR in T Cells Are Associated With Hepatitis B Surface Antigen Seroclearance
Authors: Liu Fen , Zhang Saisai , Wong Danny Ka-Ho , Huang Fung Yu , Cheung Ka-Shing , Mak Lung Yi , Fung James , Yuen Man-Fung , Seto Wai-Kay 
Published: October 2020

Background:
Regulatory T cells (Tregs) possess hepatitis B virus (HBV)-specific immunoregulatory effects in chronic HBV infection. The role of Tregs in spontaneous seroclearance of hepatitis B surface antigen (HBsAg) remains to be determined.

Methods:
We recruited treatment-naive chronic HBV patients achieving spontaneous HBsAg seroclearance (experimental group) and matched HBsAg-positive controls. Peripheral blood mononuclear cells were isolated using the Ficoll-Paque density gradient centrifugation method. The frequency of Tregs and inhibitory phenotypes and immunoregulatory cytokines of Tregs were detected by flow cytometry.

Results:
Twenty-seven patients with HBsAg seroclearance (mean age: 52.40±6.00 y, 55.6% male) and 27 matched controls were recruited. Median HBsAg and HBV DNA levels in the control group were 2.80 (1.24 to 3.43) and 3.16 (1.68 to 3.85) log IU/mL, respectively. Mean frequencies of Tregs and expressions of FoxP3+ Tregs were comparable in both groups (both P>0.05). The mean expression of programmed death 1 (PD-1) and glucocorticoid-induced TNFR family-related gene (GITR) in total CD4+ T cells were significantly downregulated in the experimental group when compared with the control group (10.62% vs. 13.85%, P=0.003; 16.20% vs. 27.02%, P=0.002, respectively). When compared with the control group, PD-1+CD4+ Tregs expression in the experimental group was significantly downregulated (13.85% vs. 10.62%, P=0.003). A similar phenomenon was noted for GITR+CD8+ Tregs (20.16% vs. 14.08%, P=0.049). Intracellular cytokine productions showed no significant differences (all P>0.05).

Conclusions:
The reduced expression of PD-1 and GITR might attenuate the immunosuppressive capability of Tregs. Decreased expression on CD4+ T cells might represent an enhanced antiviral function, playing a role in initiating the “functional cure” of chronic HBV infection.
Efficacy of DA-5204 (Stillen 2X) for patients with gastroesophageal reflux disease
Authors: Cho Jae Ho , Yoon Hyuk , Shin Cheol Min , Park Young Soo , Kim Nayoung , Lee Dong Ho 
Published: October 2020

Abstract

Background/Aim:
Proton pump inhibitor (PPI) alone is not satisfactory for the treatment of gastroesophageal reflux disease (GERD). Therefore, we investigated the efficacy of DA-5204 (Stillen 2X, 90 mg of Artemisia asiatica 95% ethanol extract per tablet) and PPI combination therapy on GERD in comparison to PPI alone.

Methods:
This randomized, double-blind, placebo-controlled study randomly assigned 70 patients with endoscopically proven esophageal mucosal injury (Los Angeles classification grade A or B) into 2 groups: pantoprazole 40 mg once daily with DA-5204 twice daily (DA-5204 group) or pantoprazole 40 mg once daily with placebo twice daily (placebo group) for 4 weeks. The primary endpoint was endoscopic healing rate. The secondary endpoint was sufficient relief (≥50% reduction) of symptoms using GERD Questionnaire.

Results:
Final analyses included 29 patients with the DA-5204 group and 30 patients with the placebo group. At weeks 4, there was no significant difference in the endoscopic healing rate between the 2 groups (DA-5204 vs placebo; 96.6% vs 93.3%; P = 1.000). However, the rate of residual minimal change was significantly lower in the DA-5204 group (5/28, 17.9%) than in the placebo group (17/28, 60.7%) (P
< .001). The rates of symptom relief were not different between the DA-5204 group and the placebo group (all P > .05).

Conclusion:
Combined therapy with PPI and DA-5204 has no additional effect on the endoscopic healing rate compared to PPI alone. However, it may be beneficial in resolving minimal change.
The efficacy of Qigong exercises for nonalcoholic fatty liver disease
Authors: Liu Yuqiao , Zou Jiaxi , Dan Lijuan , Zhang Renyan , Feng Quansheng 
Published: October 2020

Abstract

Background:
Nonalcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases in the world that represents an important public health challenge nowadays. Lifestyle changes and exercise can reduce the development of fatty liver. The aim of this systematic review and meta-analysis is to evaluate the treatment efficacy of Qigong for NAFLD.

Methods:
A detailed search for articles up to September 2020 will be performed to identify randomized controlled trials for Qigong in NAFLD. The following database will be used: PUBMED, Embase, Web of Science, Cochrane Library, Sino Med, Chinese National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodicals Database, and Wanfang Databas. Grey literature will be explored and the selection of studies, data extraction and validation will be performed independently by 2 reviewers using predefined selection criteria and quality indicators. Stata V.13.0 and Review manager 5.3 software will be used for data synthesis, sensitivity analysis, subgroup analysis, and risk of bias assessment. We will use the grading of recommendations assessment, development, and evaluation system to assess the quality of evidence.

Results:
This research will provide a quantitative and standardized assessment of the treatment efficacy of Qigong for NAFLD.

Conclusion:
This systematic review will generate the latest evidence for determining whether Qigong has a positive treatment effect for NAFLD.

Registration number:
INPLASY202090034
Bilious pleuritis due to hepatic microwave ablation
Authors: Wu Meimei , Zhu Qi , Chen Lingling , Yan Dong 
Published: October 2020

Abstract
Ultrasound guided percutaneous thermal ablation has been well acknowledged in treating hepatic malignancy. Although thermal ablation is safe for the treatment, it may induce some lethal complications such as diaphragmatic injury, bile-stained pleural fistula, and bilious pleuritis.
We presented 2 cancer patients in hepatic diaphragmatic dome showed diaphragmatic injury, bile-stained pleural fistula, and bilious pleuritis after microwave ablation (MVA). The symptoms were attenuated after chest drainage and anti-infection therapy. In the literature review, 17 articles published in the recent 10 years on diaphragmatic injury after MVA for treating hepatic cancer were available. Twenty-three cases were obtained, among which 2 showed bilious pleuritis after radiofrequency treatment. Most of the lesions were adjacent to the diaphragma. Among the articles reporting the localization of lesions, most of the cases showed lesions in S8, 2 in S7, 3 in S4, and 3 in S5, respectively. Surgical recovery was required for the patients with massive diaphragmatic injury. Only 2 cases underwent thorascopic surgery. After chest drainage and anti-infection, their symptoms were attenuated to some extent.
Radiofrequency or MVA may induce pleural effusion, and special attention should be paid to the diaphragmatic injury induced by thermal ablation.
Clinical implications and nomogram prediction of long noncoding RNA FRGCA as diagnostic and prognostic indicators in colon adenocarcinoma
Authors: Liao Cun , Guo Yun , Gong Yizhen , Huang Xue , Liao Xiwen , Wang Xiangkun , Ruan Guotian , Gao Feng 
Published: October 2020

Abstract
Colorectal cancer, especially colon adenocarcinoma (COAD), is associated with significant morbidity and mortality worldwide. Long noncoding RNA (lncRNA) has been implicated in tumorigenesis. The aim of the present study was to elucidate the potential diagnostic and prognostic values of lncRNA FRGCA in COAD.
The data of 438 COAD patients were retrieved for analysis. Diagnostic significance was evaluated using tumor and nontumor tissues. Prognostic significance was evaluated using a Cox proportional regression model. Stratified analysis was performed to identify associations between clinical factors and lncRNA FRGCA expression. A nomogram was constructed using the clinical factors and lncRNA FRGCA for survival prediction. Enrichment analysis identified gene ontologies and metabolic pathways of mRNAs with high Pearson correlation coefficients with lncRNA FRGCA.
lncRNA FRGCA was highly expressed in tumor tissues of COAD and demonstrated diagnostic value (area under curve = 0.763, P < .0001). Prognostic significance analysis indicated that lncRNA FRGCA had prognostic value in COAD [adjusted P < .001, hazard ratio (HR) = 0.444, 95% confidence interval (95% CI) = 0.288–0.685] and high expression of lncRNA FRGCA indicated better survival in COAD. A nomogram was evaluated for prediction of survival at 1, 3, and 5 years. Enrichment analysis revealed many mRNAs involved in the structural constituents of the mitochondrial inner membrane and translational termination, protein binding, translation, ribosome, oxidative phosphorylation, and metabolic pathways, especially the nucleoplasm.
Differentially expressed in tumor vs nontumor tissues, lncRNA FRGCA had both diagnostic and prognostic implications in COAD, which may be associated with ribosome metabolism, oxidative phosphorylation, and nucleoplasm-related metabolic pathways.
Acupuncture for “poor ovarian response” of women to controlled ovarian hyperstimulation
Authors: Wei Wei , Liu Li-Ying , Chen Ling , Su Meng-Hua , Hong Xiao-Juan 
Published: October 2020

Abstract

Background:
Poor ovarian response (POR) is a high-incidence disease of women, which cause in vitro fertilization failure. Various treatment options have been proposed for women with POR to improve their ovarian response, but with little effect. In recent years, there is a wide range of applications of acupuncture in the process of in vitro fertilization. The meta-analysis and systematic review are designed to analyze whether acupuncture is effective for patients with POR.

Methods:
The following databases will be searched from inception to March 2020: Electronic databases consist of MEDLINE, EMBASE, Allied and Complementary Medicine Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, the Chinese Scientific Journal Database, and Wanfang Database. Other literature resources will also be searched including clinical trial registries, key journals, and meeting records. The results of randomized controlled trials of acupuncture therapy on POR, which are published in Chinese or English, will be embedded. The primary outcome is the clinical pregnancy rate. Data identification, data selection, data extraction, and assessment of bias risk will be completed independently by 2 or more reviewers. STATA/IC 16 will be used to perform the meta-analysis. We will use the Grading of Recommendations Assessment, Development, and Evaluation system to evaluate the quality of our evidence. A systematic narrative synthesis will be provided if the quantitative analysis is not available.

Discussion:
This study will provide the first meta-analysis and systematic review to evaluate the efficacy of acupuncture in treating POR. This protocol provides details to guide this study.

Conclusions:
From this review may benefit POR patients or clinical decision-makers.

PROSPERO registration number:
PROSPERO CRD42020169560.
A phase I study of pharmacokinetics of trastuzumab emtansine in Chinese patients with locally advanced inoperable or metastatic human epidermal growth factor receptor 2-positive breast cancer who have received prior trastuzumab-based therapy
Authors: Ji Dongmei , Shen Weina , Zhang Jian , Cao Junning , Li Wenhua , Lam Lisa H. , Wu Fan , Wang Bei , Li Zao , Sun Guofang , Hu Xichun , Chen Shang-Chiung 
Published: October 2020

Abstract

Background:
Trastuzumab emtansine (T-DM1) is an antibody–drug conjugate that retains the antitumor effects of trastuzumab while also delivering the cytotoxic antimicrotubule agent, DM1, directly to tumor cells that overexpress human epidermal growth factor receptor 2. The pharmacokinetic (PK) profile of T-DM1 has been well characterized in Western, Asian, and Japanese patients; this single-center, phase I study (NCT03153163) examined the PK of T-DM1 and safety specifically in Chinese patients.

Methods:
Patients with locally advanced or metastatic breast cancer, previously treated with trastuzumab and a taxane, received open-label T-DM1 at 3.6 mg/kg every 3 weeks. Serum T-DM1 and total trastuzumab, and plasma DM1 were evaluated, and PK parameters were calculated using standard noncompartmental approaches. Adverse events (AEs) were assessed, and immunogenicity was evaluated by measuring antidrug antibodies to T-DM1.

Results:
Among 11 Chinese patients, mean (±standard deviation) PK parameters (maximum serum concentration, 77.6 ± 17.4 μg/mL; clearance 11.0 ± 2.6 mL/d/kg; terminal half-life 3.8 ± 1.0 days) were similar to those previously reported in Western and Japanese patients. One patient transiently developed antidrug antibodies, which did not appear to influence safety or PK. T-DM1 was generally well tolerated. Grade 3–4 AEs occurred in 7 patients (63.6%) and serious AEs occurred in 4 patients (36.4%). Platelet count decrease was the most common all-grade AE (10/11; 90.9%), grade 3–4 AE (5/11; 45.5%), and serious AE (3/11; 27.3%), but did not appear to be associated with any clinically significant bleeding events.

Conclusions:
T-DM1 PK in Chinese patients was consistent with those in global and Asian populations, supporting its use in patients with advanced human epidermal growth factor receptor 2-positive breast cancer following progression on trastuzumab and a taxane. The safety profile of T-DM1 was consistent with prior experience.
Efficacy of different forms of Guizhi Fuling Wan on reproduction and metabolism in women with polycystic ovary syndrome
Authors: Liu Min , Zhu Hongqiu , Hu Xiaodan , Zhu Ying , Chen Haiyan 
Published: October 2020

Abstract

Background:
Polycystic ovary syndrome (PCOS), is a common endocrine disorder in women characterized by increased androgen levels, ovulatory dysfunction, and polycystic ovaries. Western medicine is widely used for the treatment of PCOS, but patient satisfaction is low, largely due to its associated gastrointestinal symptoms of nausea and diarrhea. Guizhi Fuling Wan (GFW) is a traditional Chinese medicine used to remove blood stasis and dissipate phlegm for treating gynecological diseases that was invented by Zhang Zhongjing in the Eastern Han dynasty. In recent years, GFW has been widely used to treat patients with PCOS. This study aims to assess the efficacy and safety of GFW in the treatment of PCOS through a systematic review and meta-analysis.

Methods:
All randomized controlled trials connected with GFW targeting PCOS will be searched in the following electronic bibliographic databases from their earliest recorded publications to December 2020 without any language restrictions: MEDLINE, Embase, PubMed, Web of Science, China National Knowledge Infrastructure, Chinese Biological Medicine Database, Wan-fang data, Chinese Technical Periodicals, and other databases. The primary outcomes include Sex hormone levels, ovulation rate, pregnancy rate, and total effective rate. The secondary outcomes were Total cholesterol, triglyceride, low-density lipoprotein, high-density lipoprotein, fasting glucose, fasting insulin, insulin sensitivity index, body mass index, hypertrichosis score, acne score, adverse reactions, etc. Two reviewers will independently conduct cations retrieval, de-duplication, filtering, quality assessment, and data analysis by Endnote X9.1 and Review Manager software (RevMan V.5.3). Meta-analysis and/or subgroup analysis will be performed on the included data.

Discussion:
This study will investigate the application of GFW in the treatment or prevention of PCOS, and provide a high-quality synthesis to judge whether GFW is an effective and safe intervention for PCOS.

PROSPERO registration number:
CRD42020192405
The feasibility and effectiveness of internet-based rehabilitation for patients with knee osteoarthritis
Authors: Xie Su-Hang , Wang Qian , Wang Li-Qiong , Zhu Si-Yi , Li Yi , He Cheng-Qi 
Published: October 2020

AbstractBackground:Internet-based rehabilitation can ease the progression of chronic diseases. There had been studies on internet-based rehabilitation of knee osteoarthritis (OA), but them were conducted at home and ignored the potential benefits in the community setting. This study will explore the feasibility and effectiveness of internet-based rehabilitation accompanies wearable devices in the community setting for the patients with knee OA.Methods:An assessor-blinded randomized controlled feasibility trial will be performed to study the feasibility and effectiveness of internet-based rehabilitation program for the patients with knee OA in the community setting. Forty participants with knee OA will be recruited and randomly allocated into internet-based rehabilitation group (IRG) or control group (CG). The interventions of IRG will be performed in the community setting via web-based platform and wearable devices. The outcome measures will be conducted at baseline, and post-intervention 6 weeks, 12 weeks during the study. The feasibility will be tested by the proportion of participants who will complete the internet-based rehabilitation program within 12 weeks in IRG as well as the compliance and satisfaction. Additionally, the effectiveness of internet-based rehabilitation will be assessed by the Western Ontario and McMaster Universities Osteoarthritis Index, 11-point Numerical Rating Scale and Short Form-36 quality-of-life questionnaire.Conclusion:The internet-based rehabilitation program and community-based interventions is feasible and efficacy to ameliorate the osteoarthritic pain and promote the physical function and quality of life for the patients with knee OA in the community setting.Trial registration number:The study was registered in the clinical trial registry ChiCTR2000033397.
Cystatin C-based CKD-EPI estimated glomerular filtration rate equations as a better strategy for mortality stratification in acute heart failure
Authors: Cheang Iokfai , Liao Shengen , Yao Wenming , Lu Xinyi , Gao Rongrong , Zhou Yanli , Zhang Haifeng , Li Xinli 
Published: October 2020

Abstract
An increasing number of studies outline renal function as an important risk marker for mortality in acute heart failure (AHF). However, routine estimation of glomerular filtration rate (eGFR) based on serum creatinine is imprecise.
This study aims to compare the prognostic impact of CKD-EPI creatinine based equation (eGFRcr), cystatin C based equation (eGFRcyst), and creatinine–cystatin C equation (eGFRcrcyst) for the mortality stratification in AHF.
A total of 354 Patients with AHF were prospectively included between January 2012 and June 2016. Creatinine and cystatin C were measured using the same blood sample tube on admission. We quantified eGFR by the eGFRcr, eGFRcyst, and eGFRcrcyst equations. The continuous net reclassification improvement (cNRI) and integrated discrimination improvement (IDI) were calculated to compare the discriminative prognostic value of different CKD-EPI formula.
After a median follow-up of 35 months, 161 patients (45.5%) died. Reduced eGFRcyst and eGFRcrcyst remained significant association with death after adjustment. eGFRcyst showed the best area under the curve value (0.706) for the prediction of all-cause mortality. Considering mortality reclassification, both eGFRcyst (IDI = 7.3%, P < .001; cNRI = 19.6%, P = .012) and eGFRcrcyst (IDI = 4.3%, P < .001; cNRI = 8.7%, P = .138) showed its tendency in improving risk prediction compared to eGFRcr. Compared to eGFRcrcyst showed, eGFRcyst further improved mortality stratification (IDI = 3%, P = .049; cNRI = 11.1%, P = .036).
In patients with AHF, our study demonstrates the eGFR calculated by CKD-EPI cystatin C-based equation improved the risk stratification of mortality over both creatinine-based and creatinine/cystatin C-based equations.