bluuebunny/crossref_metadata_2025_split huggingface dataset:
Treatment to reduce vascular calcification in hemodialysis patients using vitamin K (Trevasc-HDK)
Authors: Haroon Sabrina-Wong-Peixin , Tai Bee-Choo , Ling Lieng-Hsi , Teo Lynette , Davenport Andrew , Schurgers Leon , Teo Boon-Wee , Khatri Priyanka , Ong Ching-Ching , Low Sanmay , Yeo Xi-Er , Tan Jia-Neng , Subramanian Srinivas , Chua Horng-Ruey , Tan Swee-Yaw , Wong Weng-Kin , Lau Titus-Wai-Leong 
Published: September 2020

Abstract

Introduction:
End stage renal failure patients on hemodialysis have significant vascular calcification This is postulated to be related to sub-clinical vitamin K deficiency, which is prevalent in hemodialysis patients. Vitamin K deficiency result in the failure of the matrix GLA protein (MGP) to undergo carboxylation. MGP is a natural local inhibitor of vascular calcification and the lack of functional carboxylated MGP may contribute to increase vascular calcification. Vitamin K supplement should therefore correct this anomaly and decrease the rate or severity of vascular calcification in this population of patients on long-term maintenance hemodialysis. Our study seeks to evaluate the prevalence and the progression of vascular calcification in a cohort of maintenance hemodialysis patients. It will also evaluate the efficacy of vitamin K supplementation in reducing the progression of vascular calcification in this group of patients.

Methods:
This will be a single-center randomized, prospective and open-label interventional clinical trial of end stage renal failure patients on hemodialysis. We aim to recruit 200 patients. Eligible patients will be randomized to either the standard care arm or active treatment arm. Active treatment arm patients will receive standard care plus supplementation with oral vitamin K2 isoform 360 mcg 3 times weekly for a total duration of 18 months. Primary outcome measured will be absolute difference in coronary artery calcification score at 18-month between control and intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve calcification, percentage of patients with regression of coronary artery calcification of at least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any cause and major adverse cardiovascular over the same period.

Discussion:
Evidence of successful regression or retardation of vascular calcification will support the conduct of larger and longer-term trials aimed at reducing cardiovascular disease mortality and major adverse cardiovascular events in this high-risk population using a safe and inexpensive strategy

Trial registration:
ClinicalTrials.gov NCT02870829. Registered on 17 August 2016 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02870829

National University Hospital's Institutional Review Board (2015/01000)
The efficacy of colchicine in the management of coronavirus disease 2019
Authors: Elshafei Mohamed Nabil , Khalil Ahmed , El-Bardissy Ahmed , Danjuma Mohammed , Ahmed Mohamed Badie , Mohamed Mouhand F.H. 
Published: September 2020

Abstract

Background:
Severe acute respiratory syndrome coronavirus 2 (SARS-COV2) infection is a recently emerged viral infection causing predominantly mild upper respiratory symptoms. However, in some instances, it might result in acute respiratory distress syndrome (ARDS) that poses a significant mortality risk. ARDS is postulated to be mediated by a surge of pro-inflammatory cytokines and chemokines, leading to a dysregulated hyper inflammatory response. Colchicine being an anti-inflammatory agent, might mitigate this dysregulated response. Thus, in the absence of therapeutic options available to manage coronavirus disease 2019 (COVID-19), it is imperative to ascertain the effect of colchicine on improving outcomes in COVID-19 patients.

Method:
We will perform a systematic review including a search of the following databases: PubMed, EMBASE, MEDLINE, Clinicaltrials.gov, Cochrane library, and google scholar since inception. We will include randomized controlled trials exploring the effect of colchicine on the efficacy and safety outcomes of COVID-19 patients. Subsequently, we will perform a meta-analysis utilizing the random-effects to ascertain the effect of colchicine on reducing COVID-19 related mortality (primary endpoint) and other efficacy and safety outcomes.

Results:
Our review results are anticipated in early 2021 (based on the completion of several ongoing randomized controlled trial). Our review results will be published in a peer-reviewed journal.

Conclusion:
This systematic review and meta-analysis, is exploring the effect of colchicine on the efficacy and safety outcomes of COVID-19 patients. If colchicine proved to be effective, it would be a significant milestone in the management of COVID-19, a disease with limited available therapeutic options.

PROSPERO registration number:
CRD42020191086
Long-term safety and efficacy of mirogabalin in Asian patients with postherpetic neuralgia
Authors: Kato Jitsu , Matsui Norimitsu , Kakehi Yoshihiro , Murayama Emiko , Ohwada Shoichi 
Published: September 2020

Abstract

Objective:
Postherpetic neuralgia (PHN) is a condition that results from nerve dysfunction following an episode of acute herpes zoster (shingles). Mirogabalin is a novel, selective oral α2δ ligand that demonstrated safety and efficacy in a multicenter, randomized, double-blind, placebo-controlled 14-week study in Asian patients with PHN. This 52-week, open-label extension study investigated the long-term safety and efficacy of flexible-dosage mirogabalin in Asian patients with PHN.

Methods:
This open-label extension study enrolled patients who completed the placebo-controlled study. Patients started with a dose of 5 mg mirogabalin twice daily (BID), which was followed by a flexible dose of 10 or 15 mg BID. During the study, patients assessed their pain using the Short-Form McGill Pain Questionnaire (SF-MPQ). Adverse events were monitored throughout the study.

Results:
Of 239 enrolled patients, 184 (77.0%) completed the study and 185 patients (77.4%) received the 15 mg BID dose most during the treatment duration. Most treatment-emergent adverse events (TEAEs) were mild or moderate. The most common TEAEs were nasopharyngitis, somnolence, dizziness, weight increased, and edema. All SF-MPQ scales decreased from baseline to week 52.

Conclusions:
This study showed the safety and stable pain management of a long-term flexible dosing regimen of mirogabalin 10 or 15 mg twice daily for 52 weeks in patients with PHN.

Clinical Trial Registered at ClinicalTrials.gov:
NCT02318719.

Summary for Table of Contents:
Mirogabalin—a novel α2δ oral ligand—was shown to be effective and well tolerated for treating postherpetic neuralgia (PHN) in an Asian multicenter, randomized, double-blind, placebo-controlled, 14-week study. This open-label, 52-week study was conducted as an extension of the double-blind study to demonstrate long-term safety and efficacy of mirogabalin.
Sexual dream and family relationships in frequent sexual dreamers and healthy volunteers
Authors: Shao Xu , Wang Chu , Jia Yanli , Wang Wei 
Published: September 2020

Abstract
Early life family relationships affect the sexuality in adulthood, and these influences might be reflected in sexual dreams. The present study was designed to investigate the exact associations between family relationships and sexual dream experience. We therefore invited 62 frequent sexual dreamers (dreamers) and 104 healthy volunteers (controls) to answer the Sexual Dream Experience Questionnaire (SDEQ) and the Family Relationship Questionnaire (FRQ). Compared to controls, dreamers scored higher on all SDEQ factors and sexual dream frequency, higher on FRQ Paternal Abuse, and lower on FRQ General Attachment and Maternal Freedom Release. In controls, Paternal Abuse was associated with Joyfulness, Maternal Dominance with Aversion, and Maternal Abuse with dream frequency (–). In dreamers, Paternal Abuse was associated with Aversion, Bizarreness and dream frequency, and Maternal Freedom Release with Aversion (–). In conclusion, there were pronounced associations between sexual dreams and family relationships in frequent sexual dreamers. Paternal Abuse in particular was associated with sexual dream experience. Adverse family relationships might induce frequent sexual dream occurrence, and family therapy or early intervention of Paternal Abuse might alleviate the negative sexual dream experience.
Home enteral nutrition after esophagectomy for esophageal cancer
Authors: Liu Li , Wang Yu-cui , Liu Qian-wen , Zhong Jiu-di , Li Jin-bo , Wu Xiao-dan , Qin Hui-ying 
Published: September 2020

Abstract

Background:
Not only has the placement rate of enteral feeding tubes during operations for esophageal cancer increased, but also has number of patients who choose to continue enteral feeding at home instead of removing the feeding tube at discharge. The impacts of home enteral nutrition (HEN) after esophagectomy in esophageal cancer patients are analyzed.

Methods:
A systematic review was conducted in accordance with PRISMA and Cochrane guidelines. English and Chinese databases, including PubMed, Embase, Web of Science, The Cochrane Library, Scopus, CBM, CNKI, and Wan Fang were searched from inception to December 7, 2019. Randomized controlled trials evaluating the short-term outcomes of HEN following esophagectomy in cancer patients were included. The risk of bias of the included studies was appraised according to the Cochrane risk of bias tool. The summary of relative risk/weighted mean difference (WMD) estimates and corresponding 95% confidence interval (95% CI) were calculated using fixed- and random-effects models.

Results:
Nine randomized controlled trials involving 757 patients were included in the meta-analysis. Compared with oral diet, HEN was associated with significantly increased body weight (WMD 3 kg, 95% CI 2.36–3.63, P < .001), body mass index (WMD 0.97 kg/m2, 95% CI 0.74–1.21, P < .001), albumin (WMD 3.43 g/L, 95% CI 2.35–4.52, P < .001), hemoglobin (WMD 7.23 g/L, 95% CI 5.87–8.59, P < .001), and total protein (WMD 5.13 g/L, 95% CI 3.7–6.56, P < .001). No significant differences were observed in prealbumin and gastrointestinal adverse reactions. Physical (WMD 8.82, 95% CI 6.69–10.95, P < .001) and role function (WMD 12.23, 95% CI 2.72–21.74, P = .01) were also significantly better in the HEN group. The nausea/vomiting (WMD −5.43, 95% CI −8.29 to −2.57, P = .002) and fatigue symptoms (WMD −11.76, 95% CI −16.21 to −7.32, P < .001) were significantly reduced. Appetite loss (WMD −8.48, 95% CI −14.27 to −4.88, P = .001), diarrhea (WMD −3.9, 95% CI −7.37 to −0.43, P = .03), and sleep disturbance (WMD −7.64, 95% CI −12.79 to −2.5, P = .004) in the HEN group were also significantly less than the control group.

Conclusions:
HEN improved nutrition status, physical and role function, and reduced nausea/vomiting, fatigue, appetite loss, diarrhea, and sleep disturbance compared with an oral diet in esophageal cancer patients postsurgery. HEN did not increase adverse reactions.
The effectiveness and safety of moxibustion for treating benign prostatic hyperplasia
Authors: Chen Hui , Li Qi , Fang Ting , Liao Anting , Xiang Shanshan , Guo Zheng , Chen Mei , Guo Yongqiang , Liu Fushui , Yang Fengyun 
Published: September 2020

Abstract

Background:
Benign prostatic hyperplasia (BPH) is a disease of the urinary system. It is common in middle-aged and elderly men. Moxibustion is widely used to manage BPH and the associated lower urinary tract symptoms, but there is still lack of systematic review of moxibusiton for BPH. So the aim of this review is to comprehensively evaluate the effectiveness and safety of moxibustion in the treatment of BPH.

Methods:
The following 8 electronic databases including PubMed (1966–2020), EMbase (1980–2020), the Cochrane Library, Web of Science (1900–2020), China National Knowledge Infrastructure Database (1979–2020), WanFang Database (1998–2020), Chinese Scientific Journal Database (1989–2020), and Chinese Biomedical Literature Database (1979–2020) will be searched. No language restrictions will be used. Researchers will retrieve databases, identify trials, extract data, and evaluate the quality of eligible randomized controlled trials, independently. The outcomes will include: total effective rate, the American Urologic Association Symptom Score, International Prostate Symptom Score, urinary flow rate (measured in mL/s), changes in prostate size (measured in cc), quality of life, side effects and adverse events. The quality of methodology and evidence will be rated by using the Cochrane risk-of-bias assessment tool and grading of recommendations, assessment, development, and evaluation tool, respectively. Data synthesis will be presented by the manager of the Cochrane Collaboration's RevMan 5.3.0.

Results:
We will show the results of this study in a peer-reviewed journal.

Conclusions:
The findings will provide credible clinical evidence of moxibustion treatment for BPH.

PROSPERO Registration number:
CRD42020190630.
The efficacy and safety of Huangqi Guizhi Wuwu decoction for rheumatoid arthritis
Authors: Wang Lei , Fan Yihua , Xin Ping , Zhao Yuetong , Deng Huaihan , Jia Bo 
Published: September 2020

Abstract

Background:
Rheumatoid arthritis has the characteristics of slow progression, long course, and repeated attacks. At present, western medicine commonly used in clinical practice not only reduces pain and improves symptoms, but also has more adverse reactions, affecting the health, and life of patients. In ancient China, Huangqi Guizhi Wuwu decoction was used by doctors to treat rheumatoid arthritis, with remarkable effect. In recent years, many clinical studies have also shown that Huangqi Guizhi Wuwu decoction has reliable effect in treating rheumatoid arthritis, but there is no evidence of evidence-based medicine. Therefore, this study aims to systematically evaluate the clinical efficacy and safety of Huangqi Guizhi Wuwu decoction in the treatment of rheumatoid arthritis.

Methods:
Using computer to retrieve PubMed, The Cochrance Library, Embase, Web of Science, CNKI, VIP and Wanfang database, in addition manually retrieve Google academic and Baidu academic to collect all randomized controlled trials for Huangqi Guizhi Wuwu decoction in the treatment of rheumatoid arthritis, including relevant academic journal and conference papers, dissertations, from the establishment of the database to July 2020. After 2 evaluators independently screened the literature, extracted the data, and evaluated the risk of bias included in the study, RevMan5.3 software was used to analyze the data.

Results:
This research evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in treating Rheumatoid arthritis from the aspects of clinical efficacy rate, visual analog scale (VAS), swollen joint count (SJC), morning stiffness time, Rrythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), and adverse reaction incidence.

Conclusion:
This study will provide reliable evidence for the clinical application of Huangqi Guizhi Wuwu decoction in the treatment of rheumatoid arthritis.

Ethics and dissemination:
The private information from individuals will not publish. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences.

OSF Registration number:
DOI 10.17605/OSF.IO/RZY3V.
Clinical analysis of reversible splenial lesion syndrome in Chinese adults
Authors: Gao Xiaoyu , Feng Qiaochan , Arif Saeed , Liaqat Jahanzeb , Li Bing , Jiang Kun 
Published: September 2020

Abstract
Reversible splenial lesion syndrome (RESLES) is a clinico-radiological entity that defines a reversible lesion in the splenium of the corpus callosum (SCC) on magnetic resonance imaging (MRI). The clinical and radiological characteristics of RESLES are poorly defined and most RESLES literature is in the form of case reports. We reviewed the clinical and radiological data from 11 RESLES patients in order to more clearly describe the characteristics of this disorder in adults.
Patients included in this study were diagnosed with RESLES from May 2012 to March 2018. We collected clinical, imaging, and laboratory data of 11 adult patients from Neurology Department of the Affliated Yantai Yuhuangding Hospital of Qingdao University. After analyzing various clinico-radiological features and laboratory parameters, including serum sodium, pathogen testing, cerebrospinal fluid (CSF) studies, electroencephalography (EEG), and MRI findings, we made a diagnosis of RESLES based on the criteria proposed previously by Garcia-Monco et al.
Of the 11 patients, 7 (63.63%) were male and 4 (36.36%) were female, ranging in age from 24 to 62 years with an average age of 31.48 ± 11.47 years. Seven cases occurred in the months of winter and spring (December–March). The primary clinical symptoms were headache, seizure, disturbance of consciousness, mental abnormality, and dizziness. All 11 patients had lesions in the SCC and all the lesions disappeared or significantly improved on follow-up imaging that was done within a month of symptom resolution.
We found 5 (45.45%) patients had a CSF opening pressure >180 mmH2O, in addition to elevated protein and(or) leukocytes levels in 3 (27.27%) patients. The serum sodium concentration in 6 (54.55%) patients was low (<137 mmol/L) and EEG showed nonspecific slowing in waves 4 (36.36%) patients.
When we encounter clinical manifestations such as headache accompanied with mental symptoms, disturbance of consciousness or epilepsy, and brain MRI finds lesions of the corpus callosum, we should consider whether it is RESLES. In order to find out the possible cause of the disease, we should carefully inquire about the history of the disease, complete etiology examination, and CSF tests. Of course, it is one of the necessary conditions for the diagnosis that the lesions in the corpus callosum are obviously relieved or disappeared.
Case report: a nonfunctioning juxtaglomerular cell tumor mimicking renal cell carcinoma
Authors: Dong Jie , Xu Weifeng , Ji Zhigang 
Published: September 2020

Abstract

Introduction:
Based on existing literature, the juxtaglomerular cell tumor (JGCT) is a rare renal tumor, typically present with hypertension and hypokalemia. Nonfunctioning JGCT, without hypertension or hypokalemia, is extremely rare.

Patient Concerns:
Herein, we report a case of nonfunctioning JGCT mimicking renal cell carcinoma. The 29-year-old woman with an unremarkable past medical history presented with a left renal tumor without hypertension or hypokalemia.

Diagnosis:
Both CT and 18F-FDG-PET/CT suggested a malignancy, possibly renal cell carcinoma.

Interventions:
The tumor was then removed completely via robotic assistant laparoscopic partial nephrectomy; and pathology result was JGCT. Since the patient had no hypertension or hypokalemia, a nonfunctional JGCT was diagnosed.

Outcomes:
The patient recovered uneventfully, and was in good health in 6-months’ follow-up period.

Conclusion:
Preoperative identification of JGCT is very difficult due to the lack of specific clinical manifestations. This case teaches us that for young patients with renal tumors whose CT enhancement is not obvious at the early phase, JGCT should be considered as a differential diagnosis. Radical nephrectomy should be avoided for JGCT in consideration of its relatively good prognosis.
What is the optimal regimen for intravenous dexamethasone administration in primary total hip arthroplasty?
Authors: Liang Dongliang , Xue Chao , Liu Weibo , Wang Yang 
Published: September 2020

Abstract

Background:
A number of recent studies have investigated the optimal dosage and timing of dexamethasone in total hip arthroplasty (THA) but have inconsistent findings. Therefore, we designed the randomized controlled research to look for the optimal intravenous dexamethasone dose for the treatment of early postoperative pain after the THA.

Methods:
The Declaration of Helsinki principles was followed and the Consolidated Standards of Reporting Trials guidelines for randomized controlled trials was adhered in this study. The First Medical Center in People's Liberation Army General Hospital approved the study (2020-089). After written informed consent was obtained, patients aged between 18 and 80 years with Physical Status I to III of American Society of Anesthesiologists, scheduled for primary unilateral THA, were included in this present work. Randomization is the use of a computer-formed list via a secretary, at a ratio of 1:1:1. The major end points were pain scores at 24 hours, 48 hours, and 72 hours after surgery, with visual analog scale (VAS) utilized at rest, and at 45 degrees passive hip flexion. The secondary outcomes involved the total consumption of morphine, opioid-related side effects, hip range of motion, inflammation markers, and the length of hospital stay.

Results:
We assumed that the patients who received 3 doses of dexamethasone intravenously possessed the best postoperative results compared to those who received 1 or 2 doses of the dexamethasone.
Trial registration: This study protocol was registered in Research Registry (researchregistry5864).
Long sleep duration and risk of increased arterial stiffness in a Chinese population
Authors: Liu Xiaoxue , Song Qiaofeng , Wu Shouling , Wang Xizhu 
Published: September 2020

Abstract
To examine the relationship between self-reported sleep duration and arterial stiffness in a large Chinese population from Kailuan.
From July 2010 to December 2015, a total of 17,018 participants aged 18 to 98 years were enrolled after excluding those with a history of cerebrovascular events and coronary artery disease. Participants were divided into 5 categories according to self-reported night sleep duration: ≤5.0, 6.0, 7 (ref), 8, and ≥9.0 hours. A brachial-ankle pulse wave velocity ≥1400 cm/s was considered to represent arterial stiffness. Multivariate logistic regression models were used to calculate the odds ratio (OR) and confidence interval (CI) for arterial stiffness according to the sleep duration.
Using 7 hours of sleep as the reference group, the multivariable adjusted ORs (95% CI) for arterial stiffness were 1.00 (0.87–1.16), 1.00 (0.90–1.11), 1.0 (ref), 1.03 (0.93–1.14), and 1.48 (1.05–2.08) from the lowest to highest category of sleep duration, respectively. Secondary analysis showed no evidence of interactions between sleep duration and age/sex on the risk of arterial stiffness (P-interaction = .390/.198).
A long night sleep duration was associated with increased arterial stiffness.