bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effectiveness and safety of massage in the treatment of restless legs syndrome
Authors: Hu Shasha , He Xingwei , Zhang Yajing , Hu Songfeng , He Fan , Zhao Fenfen , Zhang Qin , Liu Tingping , Wang Changkang 
Published: November 2020

Abstract

Background:
Restless legs syndrome (RLS), known as a kind of neurological disease, is prevalent but easy to be ignored. Studies have demonstrated that massage therapy can effectively reduce the symptoms of patients with RLS and improve their quality of life. However, the efficacy of massage therapy for RLS is still controversial. Therefore, this protocol aims to evaluate the reliability of massage therapy in treating RLS in a thorough way.

Methods:
We will search relevant randomized controlled trials from Chinese Biomedical Literature Database, Chongqing VIP, CNKI, Wanfang, Web of Science, Cochrane Library, PubMed, and EMBASE, when publication status and language are not considered and the time limit ends with September 6, 2020. Two experienced researchers will use RevMan V.5.3 software to perform the selection of literature, data collection, data analysis and synthesis separately. Besides, the quality of trials involved in this study will be measured with the Cochrane bias risk assessment tool.

Results:
This protocol will be applied to carry out a systematic evaluation of the massage therapy purposed to treat RLS for its effectiveness and safety.

Conclusion:
The review will provide a credible evidence suggesting whether massage therapy is a reliable intervention for RLS.

INPLASY registration number:
INPLASY202090038
Rivaroxaban-associated intracranial hemorrhage in Saudi atrial fibrillation patients
Authors: Alkhotani Amal , Alrishi Nouf , Alharthi Meshari , Alzahrani Waleed 
Published: November 2020

Abstract
Atrial fibrillation is the most common cardiac arrhythmia. Anticoagulation therapy effectively reduces systemic embolization in patients with non-valvular atrial fibrillation, but intracranial hemorrhage (ICH) is a major possible complication. This study assessed the real-time rate of rivaroxaban-associated ICH in Saudi patients.
We retrospectively reviewed patients with ICH during rivaroxaban therapy, assessing clinical features and outcomes.
Four cases out of 690 patients were identified in total, indicating an incidence of ICH during rivaroxaban therapy of 0.58%. Hematoma expansion developed in 1 case. Three out of four patients were discharged after ICH, and 1 patient died.
The incidence of rivaroxaban-related ICH was similar to that previously reported, and the risk of hematoma expansion was low. Further studies are required to validate our results.
Behavioral problems of Mandarin-speaking late-talking toddlers and preschool aged children
Authors: Lu Hsin-Hui , Tsao Feng-Ming , Tsai Jeng-Dau 
Published: November 2020

Abstract
This study aimed to examine whether Mandarin-speaking late-talking (LT) toddlers have a higher incidence of behavioral problems than typical language developing (TLD) children in toddlerhood and at preschool age from a community sample in Taiwan.
This prospective case–control study comprised 32 LT and 32 TLD toddlers. Participants’ parents provided reports about their children at 2 and 4 years using the Child Behaviors Checklist, a component of the Achenbach System of Empirically Based Assessment.
The results indicated that compared to the TLD group, a higher percentage of the LT group was at risk of behavioral problems at both two and four years. Similarly, the chance of internalizing problems was higher in the LT group than the TLD group at both ages.
The findings indicated that LT toddlers are at risk for behavioral problems not only in toddlerhood, but also at preschool age. Thus, it is crucial to identify LT toddlers with behavioral problems and enroll them in early developmental evaluation programs in their communities and also include them in early intervention programs if necessary. In addition, the underlying mechanism of the association between language delay and behavioral problems in children needs to be longitudinally explored from a young age.
Efficacy and safety of traditional Chinese medicine for erosive oral lichen planus
Authors: You Yanyan , Huang Xiaojin , Chen Yunhui , You Yu 
Published: November 2020

Abstract

Background:
Oral lichen planus (OLP) is a common disease among oral mucous membrane diseases. Erosive oral lichen planus (EOLP) is a type of OLP, it has a potential tendency of cancerization. There have been some randomized controlled trials (RCTs) using Traditional Chinese Medicine (TCM) to treat EOLP. No systematic review on the RCTs of TCM for EOLP has been reported, so we would propose a study protocol that aims to evaluate the evidence the efficacy and safety of TCM for treating patients with EOLP.

Methods:
The following databases from the inception to June 30, 2020 electronically, including PubMed, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure, VIP, Wanfang database, China Biomedical Literature Database will be searched. RCTs that meet the pre-specified eligibility criteria will be included. RevMan software (V5.3) will be performed data synthesis following data extraction and publication risk assessment. Subgroup and sensitivity analysis will be performed according to the condition of included RCTs. The primary outcomes include visual analogy scale, laboratory immune indicators, and scores of oral lesions and signs. Additional outcomes are clinical effective rate, adverse event rate, and recurrence rate. The Grading of Recommendations Assessment, Development and Evaluation system will be used to assess the strength of the evidence.

Results:
This study will provide a well-reported synthesis of RCTs on the efficacy and safety of TCM in the treatment of EOLP.

Conclusion:
This systematic review protocol will be helpful for providing evidence of whether TCM is an effective and safe therapeutic approach for patients with EOLP.

Ethics and dissemination:
Ethical approval is not necessary as this protocol is only for systematic review and it does not involve privacy data or conduct an animal experiment. This protocol will be disseminated by a peer-review journal or conference presentation.

Systematic review registration:
PROSPERO CRD42020172366.
The efficacy of enteral nutrition combined with accelerated rehabilitation in non-small cell lung cancer surgery
Authors: Ji Xiaona , Ding Haiyan 
Published: November 2020

Abstract

Objective:
To investigate the effect of enteral nutrition combined with accelerated rehabilitation in treating the non-small cell lung cancer (NSCLC).

Methods:
It is a randomized controlled experiment to be carried out from June 2021 to December 2021. It was permitted through the Ethics Committee of Cancer Hospital Affiliated to Shandong First Medical University (00923876). 100 patients are included in the study. The inclusion criteria contain: (1) patients with NSCLCs receiving surgery as the primary treatment; (2) over 18 years of age. The exclusion criteria are as follows: (1) age ≥65 years; (2) severe metabolic and systemic diseases, such as diabetes, hypertension, or severe liver and kidney dysfunction; (3) the body mass index <18.5 kg/m2; (4) patients who have received preoperational radiotherapy or chemotherapy. Patients in the control group are provided routine nutrition, including preoperative nutritional risk screening and assessment and preoperative nutrition education and dietary guidance, while patients in the nutrition group are provided additional enteral nutrition preparations combined with accelerated rehabilitation as in the control group. The primary outcomes include the perioperative change of serum albumin, serum prealbumin, hemoglobin, and total lymphocyte counts. The second outcomes include length of hospitalization, quality of life, and risk of postoperative complications.

Results:

Table 1 shows the comparison of indicators after surgery between the 2 groups.

Conclusion:
Enteral nutrition combined with accelerated rehabilitation appears to be beneficial in decreasing the complications and improving postoperative recovery after NSCLC surgery.
Clinical effect of catgut implantation at acupoints for the treatment of simple obesity
Authors: Chen Xia , Huang Wei , Wei Dan , Ding De-Guang , Jiao Yang , Pan Hong-Ling , Jin Yi-Ting , Zheng Yi-Wei , Zhang Yan-Ji , Zhang Ying-Rong , Liu Yi-Ran , Zhou Zhong-Yu 
Published: November 2020

Abstract

Background:
Catgut implantation at acupoints (CIA) is a subtype of acupuncture that has been widely used to treat simple obesity, but evidence for its effectiveness remains scarce. The aim of this study is to evaluate the efficacy and safety of treating simple obesity with CIA.

Objective:
This clinical trial aims to evaluate the effectiveness and safety of CIA used for treatment of simple obesity.

Methods:
This is a multicentre, randomized, parallel, sham-controlled clinical trial. A total of 216 patients with simple obesity will be recruited. They will be randomly assigned in a 1:1 ratio to either the CIA group or the sham control group. All treatments will be given once every 2 weeks. The primary outcome measure is the rate of waistline reduction. Secondary outcome measures are the rates of reduction of body measurements, including weight, body mass index (BMI), hipline, waist-hip-ratio (WHR) and body fat percentage (BFP), the changes in scores on scales, including the Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite), Short Form 36 (SF-36), the Hospital Anxiety and Depression Scale (HAD) and the Self-Esteem Scale (SES), Outcomes will be evaluated at baseline and at weeks 4, 8, 12, 16, 28, and 40, respectively. All adverse events that occur during this study will be recorded. If any participant withdraws from the trial, an intention-to-treat analysis (ITT) will be performed.

Conclusion:
This is a randomized, sham-controlled trial of CIA treatment for simple obesity. The results of this trial will provide more evidence on whether CIA is efficacious and safe for treating obesity.

Trial registration:
ClinicalTrials.gov Identifier: NCT02936973. Registered on October 18, 2016.
Traditional Chinese medicine for irritable bowel syndrome
Authors: Yao Cheng-Jiao , Li Yi-Lin , Pu Meng-Jun , Luo Li-Hong , Feng Pei-Min 
Published: November 2020

Abstract

Background:
Irritable bowel syndrom (IBS) is a common functional gastrointestinal disorder which is characterized as recurrent abdominal pain, abdominal discomfort, and abnormal bowel habits such as diarrhea, constipation, both or alternate appear. Although IBS is not fatal, it seriously affects the patients’ daily life and work. Western drug, such as antidiarrheals, gastrointestinal antispasmodic, often cannot get satisfying curative effects. However, the therapeutic effect of Traditional Chinese medicine (TCM) on IBS is very satisfactory which was shown in a large number of randomized controlled trials. Although TCM has been widely used in clinical practice, its relative effectiveness and safety have not been confirmed. Therefore, this study will use meta-analysis to verify the efficacy and safety of different types of TCM in the treatment of IBS.

Methods:
We search the China National Knowledge Infrastructure, Wanfang Database, Chinese Science and Technology Periodical Database, Chinese Biomedical Literature Database, Pubmed, Embase, Web of Science, and the Cochrane library for all randomized controlled trial of TCM for the treatment of IBS from their inception to Oct 15, 2020. Two authors will independently select studies, extract data based on predesigned inclusion and exclusion criteria. Methodological quality assessment and risk of bias will be assessed using Cochrane bias risk tool. All data analysis will be conducted using Revman5.3, WinBUGS 1.4.3, and Stata14.2 software.

Results:
This study will compare the different outcome indicators of various studies directly and indirectly, and provide a high-quality synthesis of effectiveness and safety of different TCM methods for patients with IBS. The main outcome indicators include effectiveness, remission rate (no drug symptoms), relapse rate, clinical absolute score, and relative score. Secondary outcome indicators included related adverse reactions and serum serotonin concentration.

Conclusion:
The conclusion of this systematic review will provide a high-quality evidence based on the efficacy and safety of different TCM treatment methods for IBS.

Registration number:
This study protocol has been funded through a protocol registry. The registry number is INPLASY2020100052
TWIST1 expression and clinical significance in type I endometrial cancer and premalignant lesions
Authors: Shen Junhua , Chen Qin , Li Na , Bai Xiaoxia , Wang Fenfen , Li Baohua 
Published: November 2020

Abstract
The aim of this study was to assess the correlation of TWIST1 expression with clinical parameters and the prognosis of type I endometrial cancer (EC).
This retrospective study enrolled 345 patients. Immunohistochemical staining was performed on 55 normal endometrium (NE) samples, 27 atypical hyperplasia (AH) samples, and 263 type I EC samples. The association between TWIST1 staining and clinical characteristics and survival was evaluated by univariate and multivariate analyses.
We found significantly higher TWIST1 expression in patients with AHs and type I ECs than NEs, but there was no significant difference between TWIST1 expression in AHs and type I ECs. Aberrant TWIST1 expression was significantly associated with clinical parameters, indicating poor prognosis and shorter patient survival. Pearsons Chi-Squared test showed that high TWIST1 expression was significantly associated with a shorter disease-free survival and overall survival. More importantly, multivariate analysis showed that high TWIST1 expression, in addition to myometrial invasion, lymph vascular space invasion, and lymph node metastasis, was an independent predictor of worse DFS in patients with type I ECs.
Our findings suggest that TWIST1 might be useful in diagnosing ECs and predicting prognosis in patients with AHs and type I ECs.
Depression and survival of breast cancer patients
Authors: Zhu Guanghui , Li Juan , Li Jie , Wang Xinmiao , Dai Minghao , Chen Jiayang 
Published: November 2020

Abstract

Background:
Breast cancer is the most common malignancy in women worldwide. Compared with other malignant tumors, breast cancer patients have a higher incidence of depression and other psychiatric symptoms. The purpose of this meta-analysis was to determine the association between long-term survival and depression in patients with breast cancer.

Methods:
This review will include cohort studies only. Multiple databases will be searched by 2 independent reviewers, including PubMed, EMBASE, the Cochrane Library, and PsycINFO. The language of studies should be English and Chinese, published from inception to the September 2020. Two independent reviewers will carry out literature screening, research selection and data extraction. Revman5.3 software will be used to generate funnel map, assess heterogeneity, make the subgroup analysis and complete sensitivity analysis.

Results:
This review will summarize the available evidence to determine the association between depression and survival in breast cancer patients.

Conclusion:
The results of this study will provide reference for the development of comprehensive treatment for breast cancer, and will promote further research.

PROSPERO registration number:
CRD42020202200
A clinical study on the efficacy of Yiqi Huayu Jiedu decoction for reducing the risk of postoperative recurrence and metastasis of gastric cancer
Authors: Wu Cun-En , Xue Wei-Wei , Zhuang Yu-Wen , Ding Da-Wei , Zhou Jin-Yong , Liu Shen-Lin , Wang Rui-Ping , Shu Peng 
Published: November 2020

Abstract

Background:
Gastric cancer (GC) is one of the top 10 malignant tumors worldwide and poses a great threat to human life and health, the prevention and treatment of which has become the focus and difficulty of medical research. With its unique advantages, traditional Chinese medicine (TCM) is widely used in the prevention and treatment of postoperative recurrence and metastasis of GC as well as the improvement of patients’ quality of life. The aim of this study is to elucidate the curative effect and the underlying mechanism of Yiqi Huayu Jiedu (YQHYJD) decoction.

Methods/design:
This is a prospective, multicenter, randomized controlled trial continuing 3 years. Two hundred ninety-eight eligible patients will be randomly divided into 2 groups, the chemotherapy combined with placebo and the chemotherapy combined with YQHYJD group at a ratio of 1:1. All patients will receive the treatment for 6 months and follow up for 3 years. The primary outcomes are disease-free survival, and 1-year, 2-year, 3-year progression-free survival rate, while the secondary outcomes are tumor makers, TCM syndrome score, quality of life score, overall chemotherapy completion rate, intestinal flora diversity test, immune function (T, B lymphocyte subsets and NK cells) test. The Security index includes blood, urine and stool routine, electrocardiogram, liver function (ALT), and renal function (BUN, Scr). All of these outcomes will be analyzed at the end of the trial.

Discussion:
This research will provide the valuable evidence for the efficacy and safety of Yiqi Huayu Jiedu decoction in postoperative GC. Furthermore, it will be helpful to form a higher level of evidence-based medical basis for TCM in the treatment of GC recurrence and metastasis.

Trial registration:
ChiCTR2000039038
Management of complex liver cystic hydatidosis: challenging benign diseases for the hepatic surgeon
Authors: Fancellu Alessandro , Perra Teresa , Vergari Dario , Vargiu Isabel , Feo Claudio F. , Cossu Maria L. , Deiana Giulia , Porcu Alberto 
Published: November 2020

Abstract
Hydatid cysts of the liver are benign lesions which require a wide range of surgical strategies for their treatment. We hypothesized that cysts larger than 15 cm, or compressing main vascular structures, or located in both hemilivers should be considered, as well as complicated cysts, in the category of complex hydatid cysts.
In a retrospective study including 55 patients, we evaluated the characteristics of complex hydatid cysts, and compared surgical outcomes between patients operated on for complex cysts (Complex Group) and those operated on for non-complex cysts (non-Complex Group).
In the Complex Group, 19% of patients had cysto-biliary communication with recurrent cholangitis, 9.5% had cysts eroding the diaphragm or chest wall, or communicating with the bronchial tree, 31% had cysts with contact with main vascular structures, 11.9% had multiple bilobar cysts, 14.3% had giant cysts with organ displacement, and 14.3% had a combination of the above-mentioned types. Type of surgical treatment was different between the two groups (P < .001). Additional procedures were statistically more frequent in the Complex Group (P = .02). Postoperative morbidity was higher in the Complex Group, although not in a significant manner (P = .07). Median hospital stay was longer in the Complex Group (12 vs 7 days, P < .001). No 30-day mortality occurred. Four patients (7.3%), all belonging to the Complex Group, required reoperation for postoperative complications.
Surgery for complex hydatid cysts of the liver is potentially burdened by serious complications. This kind of benign liver disease requires skill-demanding procedures and should be treated in centers with expertise in both hepato-biliary surgery and hydatid disease management.
Detection and diagnostic value of serum NSE and S100B protein levels in patients with seizures associated with mild gastroenteritis
Authors: Chen Hui , Chen Yong , Zhong Jian Min 
Published: November 2020

Abstract
Benign convulsions with mild gastroenteritis (CwG) and febrile seizures (FS) associated with mild gastroenteritis are 2 different diseases in the spectrum of seizures associated with mild gastroenteritis. However, specific and useful indicators for the identification of the 2 diseases are lacking. A retrospective analysis was performed to compare the serum neuronal-specific enolase (NSE) and S100B protein levels between patients with these 2 diseases to evaluate the value of NSE and S100B for differential diagnosis between these 2 diseases.
The clinical data and NSE and S100B protein levels of 81 children with seizure-associated mild gastroenteritis were collected. According to the axillary temperature at the time of convulsions, all patients were classified into an afebrile seizure (AFS) group, hereafter called the CwG group (n = 46), and a febrile seizure group (FS group, n = 35).
The serum NSE level was higher in the CwG group than in the FS group (14.046 (11.095, 19.266) pg/ml and 9.034 (7.158, 12.165) pg/ml, respectively, P < .001); however, the serum S100B protein levels in the CwG and the FS group were not significantly different (P > .05). Receiver operating characteristic (ROC) curve analysis showed that the area under the curve (AUC) for NSE was 0.806, P = .000, which was statistically significant. The Youden index was largest (0.605) for a serum NSE cut-off value of 10.460 pg/ml, which yielded a sensitivity and specificity of 89% and 71%, respectively, for prediction of a CwG diagnosis.
NSE may contribute to the differential diagnosis of CwG and FS associated with mild gastroenteritis.
Transformative science from the lunar farside: observations of the dark ages and exoplanetary systems at low radio frequencies
Authors: Burns Jack O. 
Published: November 2020

The farside of the Moon is a pristine, quiet platform to conduct low radio frequency observations of the early Universe's Dark Ages, as well as space weather and magnetospheres associated with habitable exoplanets. In this paper, the astrophysics associated with NASA-funded concept studies will be described including a lunar-orbiting spacecraft, DAPPER, that will measure the 21 cm global spectrum at redshifts ≈40–80, and an array of low frequency dipoles on the lunar farside surface, FARSIDE, that would detect exoplanet magnetic fields. DAPPER observations (17–38 MHz), using a single cross-dipole antenna, will determine the amplitude of the 21 cm spectrum to the level required to distinguish the standard ΛCDM cosmological model from those produced by exotic physics such as nongravitational dark matter interactions. FARSIDE has a notional architecture consisting of 128 dipole antennas deployed across a 10 km area by a rover. FARSIDE would image the entire sky each minute in 1400 channels over 0.1–40 MHz. This would enable monitoring of the nearest stellar systems for the radio signatures of coronal mass ejections and energetic particle events, and would also detect the magnetospheres of the nearest candidate habitable exoplanets. In addition, FARSIDE would provide a pathfinder for power spectrum measurements of the Dark Ages.
This article is part of a discussion meeting issue ‘Astronomy from the Moon: the next decades (part 1)’.