bluuebunny/crossref_metadata_2025_split huggingface dataset:
A randomized controlled trial protocol of the cardiovascular safety and efficacy of liraglutide in the treatment of type 2 diabetes
Authors: Liang Ying , Meng Hua , Li Ruiyu , Yang Jianbin , Jia Jingchao , Hou Yongli 
Published: January 2021

Abstract

Background:
Recently, many clinical experiments have evaluated the influences of liraglutide in the treatment of type 2 diabetes. However, the outcomes of these studies are inconsistent, and the number of high-quality prospective trials that conducted to assess the cardiovascular safety is limited. Hence, for this research, it was implemented for the assessment of the cardiovascular effectiveness and safety of liraglutide in type 2 diabetes patients.

Methods:
This research was a 26-week active controlled and randomized trial. Our research protocol follows the guidelines of Good Clinical Practice issued via the Helsinki Declaration and International Conference on Coordination. All the patients will receive the written informed consent in order to involve in our clinical experiment. The participants with type 2 diabetes aged from 18 years to 80 years, patients with 45.0 kg/m2 body-mass index or less, and with glycosylated hemoglobin of 7.5 to 10.0 percent, and received metformin (daily 1500 mg or more) for 3 months or longer were eligible. All the patients were randomized to 1 of 2 interventions (in the ratio of 1:1): liraglutide placebo once daily (blinded) and liraglutide once daily (blinded), respectively, both combined with the glimepiride and metformin (open-labeled). For the efficacy variable, the major endpoint was the baseline glycated hemoglobin change after treating for 26 weeks. The secondary end points involved: the percentage of participants who achieved the goals of postprandial blood glucose, fasting blood glucose, and glycosylated hemoglobin; the changes of mean postprandial blood glucose, fasting blood glucose, and the body weight, pancreatic B-cell function index, and changes in blood pressure and insulin resistance assessed by homeostasis model.

Conclusions:
For this research, the limitations involve the short trial period and the limitation of glimepiride in some countries, thus excluding the maximum doses of glimepiride.

Trial registration:
This study protocol was registered in Research Registry (researchregistry6306).
Adjuvant targeted therapy combined with surgery for advanced and metastatic renal cell carcinoma
Authors: Jin Hongyu , Zhang Man , Jin Kun , Hu Chenggong 
Published: January 2021

Abstract

Background:
The aim of this systematic review and meta-analysis is to evaluate the efficacy and safety of adjuvant targeted therapy by sunitinib combined with surgery in the treatment of advanced or metastatic renal cell carcinoma.

Methods:
PubMed/Medline, Web of Science, Cochrane Library, ClinicalTrials.gov (http://www.ClinicalTrials.gov), China National Knowledge Infrastructure (CNKI) will be searched for clinical research articles related to the efficacy and safety of adjuvant therapy combined with surgery in the treatment of advanced and metastatic RCC. The identification, inclusion and exclusion flow charts will be conducted according to the PRISMA guidelines. The quality assessment will be done by Quadas-2 evaluation tool. Key parameters including OS in 10, 20, 30, and 40 months, PFS in 10, 20, and 30 months, objective response rate (ORR), stable disease (SD) rate, progressive disease (PD) rate, median OS and PFS, types of AEs and their occurrence rates, etc will be extracted. The evaluation of the efficacy and safety will be pooled by CMA.

Results:
This systematic review will provide evidence on the efficacy and safety of adjuvant therapy by sunitinib combined with surgery in treating advanced and metastatic RCC.

Conclusion:
The study aims to generalize data concerning the response rate, OS, PFS and rates of adverse effects of the perioperative use of sunitinib in advanced and metastatic RCC patients. The evidence provided by this systematic review and meta-analysis will help guide the clinical decision making and enlighten the future management of advanced or metastatic RCC.

Registration:
This protocol has been registered on the International Platform of Registered Systematic Review and Meta-analysis Protocols (INPLASY registration number: INPLASY2020110093; INPLASY DOI number: 10.37766/inplasy2020.11.0093 Available at: https://inplasy.com).
The effects and acceptability of different exercise modes on glycemic control in type 2 diabetes mellitus
Authors: Shen Yuanlong , Yu Lina , Hua Zhen , Jia Ningxin , Zhou Yanan , Dong Xiaosheng , Ding Meng 
Published: January 2021

Abstract

Introduction:
Exercise has been believed to have positive effects on blood glucose control in patients with type 2 diabetes mellitus. However, few medical evidences have been found to ascertain which type of exercise has the best effect on blood glucose control in diabetes and which type of exercise is more acceptable. The purpose of this study is to compare the effects and acceptability of different exercise modes on glycemic control in type 2 diabetes patients by using systematic review and network meta-analysis.

Methods and analysis:
Relevant randomized controlled trial studies will be searched from PubMed, EMbase, CochraneCENTRAL, CNKI, VIP, and Chinese medical paper libraries. Primary outcome indicators: glycosylated hemoglobin and dropout rate of the research (number of dropouts/numbers of initially enrolled subjects). Secondary outcome measures: fasting blood glucose, body weight, total cholesterol (TC), low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol, triglycerides (TG), diastolic pressure, systolic pressure (SBP). Two reviewers are arranged to screen Title, Abstract, and then review full text to further extract data. Standard meta-analysis and network meta-analysis of the data are performed afterward. Methodological quality assessment is planned to be conducted using Cochrane risk of bias tool. The outcome will be analyzed statistically according to Bayesian analysis methods. After that, subgroup analysis is conducted on the duration of intervention, whether there is supervision of intervention, frequency of intervention per week, age, gender, and medication use.

Trial registration number:
PROSPERO CRD42020175181

Discussion:
The systematic review and network meta-analysis include evidence of the impact of different exercise modes on blood glucose control in type 2 diabetes mellitus. There are 2 innovative points in this study. One is to conduct a classified study on exercise in as much detail as possible, and the other is to study the acceptability of different exercise modes. The network meta-analysis will reduce the uncertainty of intervention and enable clinicians, sports practitioners, and patients to choose more effective and suitable exercise methods.

Ethics and dissemination:
The findings of the study will be disseminated through publications in peer-reviewed journals and scientific conferences and symposia. Further, no ethical approval is required in this study.
The effectiveness of enteral nutrition for patients with primary liver cancer
Authors: Wang Li , Wang Xiaoyue , Wang Xuejun 
Published: January 2021

Abstract

Objective:
The objective of this study is to explore the influence of the enteral nutrition on primary liver cancer patients after receiving hepatectomy.

Method:
This is a prospective randomized controlled research, which will be conducted between April 2021 and April 2022. Approval is obtained from the Research Ethics Committee of Chun’ an County First People's Hospital (A20201108). Patients who meet the following conditions will be included in this experiment:
Patients with the following characteristics are excluded:
Our investigation includes sixty patients who meet our inclusion criteria. The primary endpoints are length of postoperative hospital stay and liver function index. The secondary results involve the first flatus time and the first defecation time.

Results:
Table 1 indicates the postoperative outcomes between treatment group and control group.

Conclusion:
Enteral nutrition can improve recovery in the primary liver cancer patients after receiving hepatectomy.

Trial registration:
The protocol has been registered in Research Registry (researchregistry6275)
EphA2, vascular endothelial growth factor, and vascular endothelial growth factor correlate with adverse outcomes and poor survival in patients with glioma
Authors: Shen Likui , Sun Ran , Kan Shifeng , Wang Zhimin , Yu Zhengquan 
Published: January 2021

Abstract

Purpose:
To assess expression levels of Ephrin type-A receptor 2 (EphA2), vascular endothelial growth factor (VEGF), and von Willebrand factor (vWF), and assess their potentials as prognostic biomarkers to predict the risk of poor survival in patients with primary lower grade glioma.

Method:
The study included75 patients with histopathologically confirmed primary glioma (World Health Organization Grade IV). All patients underwent combined surgery and postoperative radiotherapy for the management of primary glioma. Immuno-histochemical analysis was performed to evaluate expression levels ofEphA2 and VEGF. Evaluation of tumor microvessel density was also performed at angiogenesis hot spots due to tumor growth. Main outcomes of the study were the prognostic efficiencies of EphA2, VEGF, and vWF in primary low-grade glioma, as well as whether their expression levels were associated with cancer progression.

Results:
Of the patients with glioma, 67% had very strong expression of EphA2. Overall survival was inversely correlated with the expression of EphA2. Regarding VEGF expression, 38 patients (51%) had strong expression, 29 patients (39%) had weak expression, and 8 patients (11%) had no expression. Strong VEGF expression was associated with poor prognosis and poor survival.

Conclusion:
EphA2, VEGF, and vWF could be considered prognostic markers for assessment of primary glioma.
Biceps tenotomy versus tenodesis for lesions of the long head of the biceps tendon
Authors: Zhou Peng , Liu Juncai , Deng Xiangtian , Li Zhong 
Published: January 2021

Abstract

Background:
Biceps tenotomy and biceps tenodesis are 2 most common surgical procedures for long head of the biceps tendon (LHBT) pathology, but debate still exists regarding the choice of treatment. This meta-analysis was conducted to compare clinical results between tenotomy and tenodesis for the treatment of lesions of LHBT. It was hypothesized that there is no difference in outcomes of tenotomy and tenodesis for lesions of LHBT.

Methods:
A comprehensive search of literature published between 1980 and April 2020 was performed using MEDLINE, EMBASE, Web of Science, and the Cochrane Library databases. Randomized controlled trials (RCTs) comparing tenotomy and tenodesis for LHBT lesions were included. The primary outcomes were Constant score and Popeye deformity. The secondary outcomes included the American Shoulder and Elbow Surgeons (ASES) score, visual analog scale (VAS) for pain, muscle strength, cramping pain, and operative time. For primary outcomes, trial sequential analysis (TSA) was conducted to reduce the risk of random errors and the GRADE (grading of recommendations, assessment, development, and evaluations) approach was used to assess the quality of the body of evidence.

Results:
A total of 9 RCTs were included. In pooled analysis, statistical significance was observed in the Constant score (mean difference [MD], 1.59; 95% confidence interval [CI] 0.04–3.14; P = .04), Popeye deformity (risk ratio [RR], 0.33; 95% CI, 0.22–0.49; P < .00001) and operative time (MD, 9.94; 95% CI 8.39–11.50; P < .00001). However, there were no significant differences between the tenodesis and tenotomy in ASES score (P = .71), VAS for pain (P = .79), cumulative elbow flexion strength (P = .85), cumulative elbow supination strength (P = .23), and cramping pain (P = .61) TSA revealed that the results for Constant score was inconclusive.

Conclusion:
For the treatment of LHBT lesions, with the exception of constant score, there was no significant benefit of tenodesis over tenotomy. Although tenotomy is affected by a higher risk of Popeye sign, it is more timesaving.
Spontaneous unscarred uterine rupture in a twin pregnancy complicated by adenomyosis
Authors: Li Xuqing , Li Caihua , Sun Meiguo , Li Hongyan , Cao Yunxia , Wei Zhaolian 
Published: January 2021

Abstract

Introduction:
Uterine rupture during pregnancy is a serious obstetric complication accompanied by a high incidence of maternal morbidity and mortality, and the presence of uterine scars is the main risk factor. In the present case, uterine rupture occurred in an unscarred uterus in a nonlaboring primigravida woman with adenomyosis and twin pregnancy in the third trimester.

Patient concerns:
In this case, the patient suspected to have a history of endometriosis have got twin pregnancies following intracytoplasmic sperm injection, and complained of recurrent lower abdominal pain from 16 weeks to 29 weeks of gestation.

Diagnosis:
After exploratory laparotomy, the patient was diagnosed with uterine rupture and adenomyosis.

Interventions:
The patient was first administered expectant treatment such as antibiotics, tocolytics, and fluid replacement therapy. Symptoms then appeared repeatedly and worsened, followed by eventual peritoneal irritation, and exploratory laparotomy was performed.

Outcomes:
Two live female fetuses were extracted by cesarean section, and the uterine laceration was repaired. The mother recovered without any postoperative complications, and the babies were discharged after receiving one month of prematurity care without any postnatal complications.

Conclusion:
Adenomyosis and the conception of twins may lead to uterine rupture. For pregnant women with a history of adenomyosis with multiple gestations, close monitoring for signs of uterine rupture is necessary. Single-embryo transfer and multifetal pregnancy reduction should be recommended for infertile patients with adenomyosis.
Meta-analysis of FOLFIRINOX-based neoadjuvant therapy for locally advanced pancreatic cancer
Authors: Chen Zhiliang , Lv Yongshuang , Li He , Diao Rui , Zhou Jian , Yu Tianwu 
Published: January 2021

Abstract
Currently, the combination of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) is the standard therapy for metastatic pancreatic cancer. In recent years, FOLFIRINOX-based neoadjuvant therapy for locally advanced pancreatic cancer (LAPC) has been gaining an increasing amount of attention, owing to its ability to reduce disease stage and transform LAPC to borderline resectable or even resectable pancreatic cancer. Accordingly, we aimed to evaluate the efficacy of first-line FOLFIRINOX chemotherapy in patients with LAPC.
We searched PubMed, Embase, and Cochrane Library from the time of establishment till January 1, 2020 and included studies focusing on LAPC patients who received FOLFIRINOX as first-line neoadjuvant treatment. The primary outcomes were: resection rate and radical (R0) resection rate while the secondary outcomes were: objective response rate, overall survival, progression-free survival, and rate of grade 3 to 4 adverse events. The meta package for R 3.6.2 was used for heterogeneity and publication bias testing.
Twenty-one studies, including 653 patients with LAPC, were selected. After treatment with FOLFIRINOX, the resection rate was 26% (95% confidence interval [CI] = 20%–32%, I2 = 61%) and R0 resection rate was 88% (95% CI = 78%–95%, I2 = 62%). The response rate was 34% (95% CI = 25%–43%, I2 = 56%). The median overall survival and progression-free survival durations ranged from 10.0 to 32.7 months and 3.0 to 25.3 months, respectively. The observed grade 3 to 4 adverse events were neutropenia (20.0 per 100 patients, 95% CI = 14%–27%, I2 = 75%), febrile neutropenia (7.0 per 100 patients, 95% CI = 5%–9%, I2 = 42%), thrombocytopenia (6.0 per 100 patients, 95% CI = 5%–8%, I2 = 27%), nausea/vomiting (7.0 per 100 patients, 95% CI = 7%–12%, I2 = 76%), diarrhea (10.0 per 100 patients, 95% CI = 8%–12%, I2 = 38%), and fatigue (9.0 per 100 patients, 95% CI = 7%–11%, I2 = 43%).
FOLFIRINOX-based neoadjuvant chemotherapy has the potential to improve the rates of resection, R0 resection, and median OS in LAPC. Our results require further validation in large, high-quality randomized controlled trials.
Manual passive rehabilitation program for geriatric distal radius fractures
Authors: Zhang Wei , Wang Lei , Zhang Xiong , Zhang Qing , Liang Baoli , Zhang Bing 
Published: January 2021

Abstract
Limitation of wrist range of motion (ROM) is a common complication of distal radius fractures (DRFs) in geriatric patients. The present study aimed to evaluate the effectiveness of rehabilitation in the restoration of wrist ROM after geriatric DRF. Eighty-eight geriatric patients with DRF, 59 women and 29 men aged 71.69 ± 6.232 years participated in the study. The time from wrist immobilization to rehabilitation was 12.89 ± 5.318 weeks. Daily rehabilitation was performed 30 minutes a day for 8 weeks. Active wrist ROM was measured before and at 2, 4, and 8 weeks after rehabilitation. Data were analyzed by the repeated measures multivariate analysis of variance (MANOVA), one-way MANOVA, and analysis of variance (ANOVA). Repeated measures MANOVA suggested a significant time effect for ROM (Wilks Lambda = 0.002, F = 7500.795, P < .001). Compared with before rehabilitation, each wrist ROM was significantly improved at 2, 4, and 8 weeks after rehabilitation. The one-way MANOVA demonstrated that changes in ROM were significantly different between groups (Wilks Lambda = 0.007, F = 559.525, partial eta square = 0.993, P < .001), indicating that patients in the short-term stiffness group (≤3 months) had a significantly greater increase in ROM than patients in the long-term stiffness group (>3 months). The results of this study suggest an 8-week daily rehabilitation program for geriatric patients with limited ROM <3 months after DRF.
Acupuncture combined with moxibustion for insomnia after stroke
Authors: Sun Junjun , Zuo Zheng , Song Ran , Bao Xiongying , Zhu Miansheng 
Published: January 2021

Abstract

Background:
Stroke is the main cause of death and disability in the world and insomnia is a common complication of stroke patients. Insomnia will not only seriously affect the prognosis and quality of life of patients with stroke, but even cause the recurrence of stroke. Many studies have proved that acupuncture and moxibustion can effectively improve insomnia symptoms. This study will systematically evaluate the effectiveness and safety of acupuncture combined with moxibustion in treating insomnia after stroke.

Methods:
The following 8 databases will be searched from the inception to October 31, 2020, including China National Knowledge Infrastructure Database (CNKI), Chinese Scientific Journal Database (VIP database), China Biomedical Literature Database (CBM), Wanfang Data Chinese Database, PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL), Allied and Alternative Medicine Database (AMED), Excerpt Medica Database (Embase). We will also search for ongoing trials from the World Health Organization International Clinical Trial Registration Platform search portal, Chinese Clinical Trial Register, Clinical trials.gov. In addition, the reference lists of studies meeting the inclusion criteria will also be searched for achieving the comprehensive retrieval to the maximum. All randomized controlled trials of acupuncture and moxibustion in treating insomnia after stroke will be included. Two reviewers will conduct literature screening, data extraction, and quality evaluation respectively. The main outcome is the Pittsburgh sleep quality index (PSQI), and the secondary outcomes include clinical efficacy, quality of life, and safety. RevMan V.5.4.1 will be used for meta-analysis. We will express the results as risk ratio (RR) with 95% confidence intervals (CIs) for dichotomous data and mean difference (MD) or standard mean difference (SMD) 95% CIs for continuous data.

Results:
This study will provide a comprehensive review of the available evidence of acupuncture combined with moxibustion in treating insomnia after stroke.

Conclusion:
The conclusion of our study will provide the updated evidence to judge the effectiveness and safety of acupuncture combined with moxibustion for the treatment of insomnia after stroke.

Trial registration number:
PROSPERO CRD42020216720.
Effects of modified ultrafiltration and conventional ultrafiltration combination on perioperative clinical outcomes in pediatric cardiac surgery
Authors: Hu Jiajia , Li Ping , Chen Xuliang , Yan Jianqin , Zhang Junjie , Zhang Chengliang 
Published: January 2021

Abstract

Background:
This meta-analysis was performed to review the effects of the addition of modified ultrafiltration (MUF) and conventional ultrafiltration (CUF) to CUF alone on postoperative hemoglobin, surgical and ultrafiltration data, and postoperative clinical outcomes in pediatric patients undergoing cardiac surgery.

Methods:
A systematic search was performed to identify randomized controlled clinical trials that compared MUF and CUF combination with CUF alone in pediatric cardiac surgery undergoing cardiopulmonary bypass (CPB) in PubMed, Embase, Cochrane Library, and Web of Science without any language or date limitation in February 2020. For each included trial, the primary outcomes including post-CPB and postoperative hematocrit, surgical and ultrafiltration data, postoperative clinical outcomes including volume of chest tube drainage within 48 hours after surgery and perioperative blood requirement, ventilation support duration, and length of stay day in the intensive care unit (ICU) and hospital were collected and analyzed. The analysis was conducted using STATA version 12.0.

Results:
A total of 8 trials encompassing 405 patients were included in this analysis. Analysis indicated that MUF + CUF increased the post-CPB hematocrit (Standard mean difference, SMD = 1.85, 95% confidence interval, 95% CI 0.91–2.79). Meanwhile, ultrafiltration volume was higher in CUF+MUF infants than CUF-alone infants (SMD = 1.46, 95% CI 0.51–2.41, P = .003). The clinical outcomes, including postoperative hemodynamic changes, prime volume, blood requirement, chest tube drainage volume, mechanical ventilation duration, and ICU duration, were unclear because of the unstable sensitivity analyses.

Conclusions:
Beneficial effects of using MUF and CUF for pediatric cardiac surgery, including increase post-CPB hematocrit and ultrafiltration volume when compared with CUF alone. Meanwhile, MUF and CUF did not significantly influence the postoperative hospital stay duration, CPB, and aortic occlusion duration.