bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation of titanium cranioplasty and polyetheretherketone cranioplasty after decompressive craniectomy for traumatic brain injury
Authors: Yang Jingguo , Sun Tong , Yuan Yikai , Li Xuepei , Yu Hang , Guan Junwen 
Published: July 2020

Abstract

Introduction:
Cranioplasty following decompressive craniectomy is routinely performed to restore integrity of skull and improve neurological function. However, reconstructing the cranial defect brings many challenges to neurosurgeons and search for ideal implant materials is one of the most controversial issues. Although many studies have compared the outcomes of titanium and polyetheretherketone (PEEK) cranioplasty, yet no prospective study exists to guide the choice of titanium and PEEK materials.

Methods/design:
A non-randomized, partially blinded, prospective cohort study is described that comprehensively compares the long-term outcomes of titanium cranioplasty versus PEEK cranioplasty. One hundred forty-five patients for each group will be recruited. Eligible patients are those with cranial defect due to traumatic brain injury (≥ 16 years), defect size is over 25 cm2 and they must agree to participate in the trial. Each participant is evaluated before surgery, on discharge, 3, 6, and 12 months after cranioplasty. The primary outcome is the infection, implant failure and implant deformation requiring revision surgery within 12 months. Secondary outcomes include postoperative complication rate, neurological outcomes, motor function, and cosmetic outcome over a 6-month period.

Discussion:
Search for ideal implant materials is throughout the history of cranioplasty. This study will provide robust evidence for the choice of cranioplasty materials.

Trial registration number:
ChiCTR2000033406
Evaluation of efficacy and safety of single and multiple therapy of herbal medicine/Chuna therapy on non-specific chronic low back pain
Authors: Ko Youme , Jang Bo-Hyoung , Oh Min-Seok , Kim Sun Joong , Ko Yeon-seok , Ha In-Hyuk , Lee Eun Jung , Kim Me-riong , Song Yun-Kyung , Ko Seong-Gyu 
Published: July 2020

Abstract

Introduction
Chronic non-specific low back pain is one of the common health issues which reduce the quality of life and in working population. While combined therapeutic treatment method is widely used for musculoskeletal related disorders in Korea, well-developed trials on the efficacy of single or combine therapy on herbal medicine and Chuna manual therapy (CMT) are scarce.

Objective
This study aims to evaluate the clinical efficacy and safety of herbal medicine, Sogyeonghwalhyeol-tang (SGHH) on work related chronic low back pain patients. The primary aim is to determine the efficacy of a combined multidisciplinary approach using SGHH with CMT compared to SGHH alone. The secondary aim is to examine the naïve direct comparison between SGHH and placebo.

Method
This trial is designed as a multicenter, randomized, controlled, clinical trial. A total of 150 participants who have with chief complaint of low back pain in Korean medicine rehabilitation center will be randomly assigned to 1 of 3 treatments with a ratio of 1:1:1. Eligible participant will be randomized to treatment arm A receive single treatment of Sogyeonghwalhyeol-tang, in treatment Arm B Sogyeonghwalhyeol-tang and Chuna manual therapy are administered concurrently, in treatment arm C, where individuals receive placebo with Chuna manual therapy. They will receive assigned treatment in 4 weeks and follow-up for 4 weeks. The primary endpoint is to assess the change in severity of low back pain from baseline. The secondary endpoints are the following: the changes in disability and health related quality of life. Adverse events will also be reported.

Discussion
The study result will provide the valuable information for efficacy and safety of monotherapy and multiple therapy of herbal medicinal extract and Chuna manual therapy on chronic non-specific low back pain.

Trial registration:
ClinicalTrials.gov Identifier: NCT03132974.
Comparison of clinicopathologic profiles and prognosis of gastric cancer in the upper, middle and lower third of the stomach
Authors: Ma Xiaoming , Zhang Chengwu , Wang Cheng , Miao Wei , Zhou Wei , An Juan , Qiao Wenjie , Li Mingzheng , Lai Minggui , Yu Pengjie 
Published: July 2020

Abstract
Gastric cancer (GC) is the fourth most common cancer in the world and the second most common cancer in China. The aim of this study was to investigate the clinicopathologic profiles and prognosis of GC in the upper third (UT), middle third (MT) and low third (LT) of the stomach.
Five hundred and forty-two patients with GC resected between January 2010 and January 2014 were retrospectively studied and divided in 3 groups according to cancer location: upper third gastric cancer (UTGC) (n = 62); MTGC (n = 131) and LTGC (n = 349). Clinical and pathological parameters including gender, age, tumor size, macroscopic types, histological types, depth of invasion, lymph node metastasis, venous infiltration and lymph embolism were compared among groups. Overall survival (OS) was calculated based on the aforementioned parameters. Univariate and multivariate survival was analyzed and Cox regression was conducted for each location. The prognostic accuracy was determined using receiver operating characteristic curve analysis.
Patients with UTGC was similar to those with MTGC and both were distinct from those with LTGC based on the tumor size, macroscopic types, depth of invasion and 5-year OS. Patients with MTGC were similar to those with LTGC and distinct from UTGC patients based on gender. 5-year OS were lower for patients with UTGC than those with LTGC (P = .001) and were comparable between MTGC and LTGC. No significant differences in 5-year OS were observed between UTGC and MTGC. Cox regression revealed that macroscopic types, depth of invasion and lymph node metastasis were the independent prognostic factors for GC patients regardless of locations. Receiver operating characteristic curve analysis revealed that macroscopic types, depth of invasion and lymph node metastasis were the significantly effective prognosis for the 5-year OS in GC patients regardless of locations.
Our results showed that UTGC is distinct from LTGC whereas MTGC shares some characteristics from both UTGC and LTGC.
Survival after in-hospital cardiopulmonary resuscitation from 2003 to 2013
Authors: Park In Young , Ju Young-Su , Lee Sung Yeon , Cho Hyun Sun , Hong Jeong-Im , Kim Hyun Ah 
Published: July 2020

Abstract
We analyzed cardiopulmonary resuscitation (CPR) rates, deaths preceded by CPR, and survival trends after in-hospital CPR, using a sample of nationwide Korean claims data for the period 2003 to 2013.
The Korean National Health Insurance Service–National Sample Cohort is a stratified random sample of 1,025,340 subjects selected from among approximately 46 million Koreans. We evaluated the annual incidence of CPR per 1000 admissions in various age groups, hospital deaths preceded by CPR, and survival rate following in-hospital CPR. Analyses of the relationships between survival and patient and hospital characteristics were performed using logistic regression analysis.
A total of 5918 in-hospital CPR cases from 2003 to 2013 were identified among eligible patients. The cumulative incidence of in-hospital CPR was 3.71 events per 1000 admissions (95% confidence interval 3.62–3.80). The CPR rate per 1000 admissions was highest among the oldest age group, and the rate decreased throughout the study period in all groups except the youngest age group. Hospital deaths were preceded by in-hospital CPR in 18.1% of cases, and the rate decreased in the oldest age group. The survival-to-discharge rate in all study subjects was 11.7% during study period, while the 6-month and 1-year survival rates were 8.0% and 7.2%, respectively. Survival tended to increase throughout the study period; however, this was not the case in the oldest age group. Age and malignancy were associated with lower survival rates, whereas myocardial infarction and diabetes mellitus were associated with higher survival rates.
Our result shows that hospital deaths were preceded by in-hospital CPR in 18.1% of case, and the survival-to-discharge rate in all study subjects was 11.7% during the study period. Survival tended to increase throughout the study period except for the oldest age group. Our results provide reliable data that can be used to inform judicious decisions on the implementation of CPR, with the ultimate goal of optimizing survival rates and resource utilization.
Impacts of renin–angiotensin system inhibitors on two-year clinical outcomes in diabetic and dyslipidemic acute myocardial infarction patients after a successful percutaneous coronary intervention using newer-generation drug-eluting stents
Authors: Kim Yong Hoon , Her Ae-Young , Jeong Myung Ho , Kim Byeong-Keuk , Hong Sung-Jin , Kim Seunghwan , Ahn Chul-Min , Kim Jung-Sun , Ko Young-Guk , Choi Donghoon , Hong Myeong-Ki , Jang Yangsoo 
Published: July 2020

Abstract
This study investigated the impacts of renin–angiotensin system inhibitors (RASIs) on 2-year clinical outcomes in diabetes and dyslipidemic acute myocardial infarction (AMI) patients after a successful percutaneous coronary intervention (PCI) using newer-generation drug-eluting stents (DESs).
A total of 16,997 AMI patients were enrolled, and divided into four groups based on the presence or absence of diabetes and dyslipidemia as follows: diabetes –/dyslipidemia –(group A, 11,132 patients), diabetes +/dyslipidemia – (group B, 3,860 patients), diabetes –/dyslipidemia + (group C, 1,328 patients), and diabetes +/dyslipidemia + (group D, 677 patients). The clinical endpoint was the occurrence of major adverse cardiac events (MACEs), the composite of total death, recurrent myocardial infarction (re-MI), and any repeat revascularization, including target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target vessel revascularization (non-TVR).
After RASIs therapy, the cumulative incidences of MACEs (adjusted hazard ratio [aHR], 1.330; 95% confidence interval [CI], 1.022–1.732; P = .034), any repeat revascularization (aHR, 1.584; 95% CI, 1.092–2.298; P = .015), TLR, and TVR were significantly higher in group B than group C. However, the cumulative incidences of all-cause death, cardiac death, re-MI, and non-TVR were similar in groups B and C.
In this study, under the newer-generation DESs era, repeat revascularization rate reduction benefit of RASIs therapy in diabetic AMI patients was lesser than that in dyslipidemic AMI patients. However, larger randomized controlled studies are needed to confirm these results in the future.
Effect of low frequency repetitive magnetic stimulation at Shenmen (HT7) on sleep quality in patients with chronic insomnia
Authors: Yuan Jie , Wang Hui , Chen Jie , Lei Yaling , Wan Zhaoxin , Zhao Yuan , Han Zucheng , Liu Dongling , Wang Pei , Luo Fan , Wang Yuan , Cao Yue 
Published: July 2020

Abstract

Background:
Insomnia is a common, recurrent, and tenacious sleep problem, especially the chronic insomnia. Repetitive transcranial magnetic stimulation (rTMS) at right dorsolateral prefrontal cortex (r-DLPFC) is used in chronic insomnia, and repetitive magnetic stimulation (rMS) at Shenmen (HT7) acupoint may be an alternative approach. However, the efficacy and mechanism of rMS at HT7 acupoint for chronic insomnia has not been confirmed.

Methods/design:
This is a 3-armed randomized positive-controlled noninferiority clinical trial. We will allocate 45 subjects aged between 18 and 65 years old, diagnosed with initial chronic insomnia over 3 months to 3 groups randomly in a ratio of 1:1:1. Patients in the experimental group will be treated with rMS at HT7 acupoint while the others in the control group will be treated with rTMS at r-DLPFC or waiting treatment. All will be given rMS at HT7 or rTMS at r-DLPFC or no treatment for 10 days, and then received 20-day follow-up. Patients will be evaluated with the insomnia severity index and Pittsburgh sleep quality index for sleep state, Beck Depression Inventory-2nd edition scores for the depression state, Beck anxiety inventory scores for the anxiety state, and Montreal Cognitive Assessment scores for the cognition state before and the 10th day of treatment, 30th day of follow-up; study on mechanisms of rMS will be revealed through the resting motor threshold diversity of the motor cortex before and the 10th day of treatment, 30th day of follow-up. Baseline characteristics of patients will be summarized by groups and compared with Chi-squared for categorical variables, and analysis of variance or Kruskal–Wallis test for the continuous variables. Primary and secondary outcomes according to the measurement times are applicable to univariate repetitive measurement deviation analysis or analysis of variance, or Kruskal–Wallis test.

Conclusion:
The present study is designed to preliminarily investigate short-term efficacy and mechanism of rMS at HT7 acupoint therapy on chronic insomnia, also to explore the correlation between motor cortex excitability and chronic insomnia. With this research, we are looking forward to find out an appropriate alternative and easy therapy for chronic insomnia individuals compared with rTMS at r-DLPFC.

Trial Registration:
The trial was registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) with the ID ChiCTR1900026844 on October 24, 2019.
Effect of acupuncture versus artificial tears for dry eye disease
Authors: Fu Hongjuan , Wang Junxiang , Zhang Feng , Tang Yong , Zhou Hao , Wang Chao 
Published: July 2020

Abstract

Background:
The global prevalence of dry eye disease (DED) ranged from 5% to 50%, accompanied by the yearly increasing trend and younger onset. To date artificial tear serves as a mainstay therapy for DED management. It is noteworthy that, acupuncture has been accepted for treating DED with a time-honored history in China. However, no systematic review has been updated till now, which is focusing on comparing acupuncture vs. artificial tears for DED management.

Methods:
Eight databases will be searched with the language restrictions of English and Chinese from their inception to July 1, 2020. Randomized controlled trials comparing acupuncture versus artificial tears for DED treatment were enrolled. Identification, research inclusion, data extraction and assessment of the risk of bias were conducted independently by 2 or more reviewers. The primary outcomes were Schirmer I test and tear break-up time. We used Review Manager Software (v.5.3) for assessing the risk of bias and all statistical analyses.

Results:
Based on the evidence obtained, whether the effect of acupuncture was equal to or even better than that of artificial tear therapy in the treatment of DED would be elaborated.

Conclusion:
In summary, this review would provide a relatively convincing conclusion on whether acupuncture deserves to be recommended as an adjunct treatment for DED, so as to propose some significant insights for the doctors handling with DED.

OSF Registration number:
10.17605/OSF.IO/Z28M6.
Ear mold for congenital ear malformation
Authors: Zou Kun , Fan Yanjun , Jiang Lihua , Huang Jincheng , Miao Yunqi , Yang Chunsong , Yang Min , Zhao Li 
Published: July 2020

Abstract

Background:
Congenital auricular deformities (CAD) are prevalent worldwide. The objective of this study is to investigate the effectiveness and safety of ear molding for children with CAD at their early days.

Methods:
One hundred and nighty children (under 3 days) with CAD will be included in the study. Participants will be randomly allocated to treatment or waiting list group (n = 95). The treatment group will receive ear molding within 3 days after birth for 2 weeks. The control group will receive usual care and receive the same ear molding at 6th week if spontaneously recover is not occur. Physician and parent assessment of improvement, parent's anxiety, depression, and quality of life and adverse events will be measured at baseline, 3rd and 6th week of initial treatment. The primary outcome recovery rate will be compared between groups using Chi square test. Secondary continuous outcomes will be compared using analysis of variance.

Discussion:
This study is the first randomized controlled trial to examine the effectiveness, safety and cost-effectiveness of ear molding for CAD comparing with waiting list, to inform clinical decision of CAD treatments and relevant guideline development.
Effectiveness comparisons of catgut implantation at acupoint for obese type 2 diabetes
Authors: Piao Chunli , Zhang Qi , Fu Huiyan , Wang Li , Tang Cheng 
Published: July 2020

Abstract

Background:
With the change of people's life style, many more people are suffering from obese type 2 diabetes mellitus (T2DM). Acupoint catgut embedding is one of the acupuncture treatment principles in traditional Chinese medicine, which is widely used in the treatment of obese T2DM. However, there is no systematic review of the therapeutic effect of acupoint catgut embedding on obesity T2DM. Therefore, this article aims at the meta-analysis of acupoint catgut embedding in the treatment of obese T2DM, to clarify its curative effect.

Methods:
A structured and systemic literature search was conducted in the following databases up to December 1, 2019: PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, EMBASE, CNKI, Wanfang Database. We will use the Review Manager 5.3 software provided by Cochrane collaborative network for statistical analysis. Then we assessed the quality and risk of the included studies and observed the outcome measures.

Results:
This meta-analysis will further determine the beneficial efficacy of acupoint catgut embedding on obesity T2DM.

Conclusion:
The purpose of this meta-analysis is to explore the effect of acupoint catgut embedding intervention on obese T2DM patients, and provide more options for clinicians and patients to treat obese T2DM.

Ethics and dissemination:
This systemic review will evaluate the efficacy and safety of acupoint catgut embedding in the treatment of obesity T2DM. Since all the data included are published, the systematic review does not need ethical approval.

Registration number:
CRD42020160801.
The prognostic value of long noncoding RNA activated by TGF-β in digestive system cancers
Authors: Duan Houyu , Ding Xiang , Luo Hesheng 
Published: July 2020

Abstract

Background:
To systematically evaluate whether the expression level of long non-coding RNA activated by transforming growth factor-β (lncRNA-ATB) is correlated with the prognosis of digestive system cancer (DSC) patients.

Methods:
PubMed, Embase, Cochrane Library, Web of Science, Springerlink, Nature, and Karger databases were searched up to April 20, 2019 by 2 experienced researchers independently. The quality of studies was assessed with the Newcastle-Ottawa scale. The Review Manager 5.2 and STATA 12.0 software were used for this meta-analysis.

Result:
Eleven studies with 1227 DSC patients were included in the meta-analysis. Except for pancreatic cancer, high expression of lncRNA-ATB was associated with lymph node metastasis (risk ratio (RR) = 1.26, 95% confidence interval (CI): 1.12–1.42, P < .001), advanced clinical staging (RR = 1.44, 95%CI: 1.23–1.69, P < .001), reduced overall survival rate (OS) (hazard ratio (HR) = 2.33, 95%CI: 1.22–4.50, P = .01), and recurrence-free survival (RFS) (HR = 2.61, 95%CI: 1.46–4.65, P = .001) compared with low lncRNA-ATB expression in DSCs.

Conclusions:
High expression of lncRNA-ATB was significantly correlated with poor prognosis for most DSCs. The expression level of lncRNA-ATB could be a promising prognostic biomarker for DSC patients.
18F-fluorodeoxyglucose positron emission tomography/computed tomography findings in descending necrotizing mediastinitis and cervical vertebral osteomyelitis in a cancer patient
Authors: Yoo Jin Young , Yoo Min Young , Lee Ki Hyeong , Koong Sung-Soo 
Published: July 2020

Abstract

Rationale:
A deep neck infection (DNI) with descending necrotizing mediastinitis (DNM) has great clinical importance because of its high morbidity and mortality, particularly when associated with predisposing underlying disease. With the expanding clinical use of 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT), it may be necessary to perform FDG PET/CT for immediate diagnosis and treatment of DNM. To the best of our knowledge, this is the first case report of DNI with DNM diagnosed based on FDG PET/CT findings.

Patient concerns:
A 65-year-old man who underwent chemotherapy for stage IV lung cancer complained of sore throat, fever, and mild pain in the right upper arm for 4 days before admission.

Diagnoses:
FDG PET/CT revealed retropharyngeal abscess with acute osteomyelitis of the vertebral bodies of C4 and C5 and DNM. In blood and sputum cultures, Klebsiella pneumoniae was isolated. DNI with DNM was diagnosed based on contrast-enhanced neck and chest CT.

Interventions and outcome:
Because of his underlying condition, antibiotic therapy with ceftriaxone and ciprofloxacin was started. There was initial improvement, but the patient died after 2 weeks from sepsis and multiorgan failure.

Lessons:
The findings of DNI with DNM on FDG PET/CT were as follows: as an acute infection, DNM showed more severe uptake relative to the average maximum standardized uptake value of brown fat or physiologic muscle; showed the prevertebral uptake pattern rather than the paravertebral uptake pattern of brown fat; and showed continuous patterns of hypermetabolic lesions from the retropharyngeal/parapharyngeal space to the thoracic prevertebral space.
What is the appropriate surgical strategy for pulmonary metastasis of colorectal cancer?
Authors: Li Hang , Hu Hong , Li Bin , Sun Xiangjie , Sun Yihua , Chen Haiquan 
Published: July 2020

Abstract
Pulmonary metastasectomy is considered to be a feasible method for selected colorectal cancer (CRC) patients. This study aimed to optimize the individualized surgical strategy of pulmonary metastasectomy, especially in choice of surgery extent and systematic mediastinal lymph nodes dissection.
Data of 267 CRC patients who underwent pulmonary metastasectomy from July 2011 to July 2017 in Shanghai Cancer Center Fudan University were reviewed. Recurrence-free survival (RFS), overall survival (OS) and other clinical characteristics were compared between patients who accepted different surgical strategy.
A total of 93 (34.8%) patients underwent lobectomy, 162 (60.7%) wedge resection, and 12 (4.5%) segmentectomy. Mediastinal lymph nodes dissection or sampling was performed in 106 (39.7%) patients. The median follow-up phase was 32.5 months (range 7.2–104.7 months). Patients were divided into 2 groups according to the surgical extent, lobectomy group and sublobar resection group. The median RFS and OS were 46.4 and 76.5 months for patients underwent, respectively. In the patients whose tumor diameter was ≥ 1.5 cm, RFS (5-year; 44.9% vs 29.8%, log-rank P = .03; hazard ratio, 0.71; 95% CI 0.52–0.89, P = .026) was better in the lobectomy group; however, no difference was found in OS. Meanwhile, in the patients whose tumor size was <1.5 cm, no difference was observed in RFS, as well as in OS. In the patients with metastatic lesion size ≥1.5 cm, a trend towards better RFS was found in patients received lymph nodes dissection, but it did not reach statistical significance.
Lobectomy has more curative significance for CRC patients with single pulmonary metastatic lesion ≥1.5 cm. Systematic mediastinal lymph nodes dissection did not improve clinical outcome for CRC patients occurred pulmonary metastasis.