bluuebunny/crossref_metadata_2025_split huggingface dataset:
Peripherally inserted central catheter versus central venous catheter for intravenous access
Authors: Santos Felipe Kenzo Yadoya , Flumignan Ronald Luiz Gomes , Areias Libnah Leal , Sarpe Anna Karina Paiva , Amaral Fabio Cabral Freitas , Ávila Rafael Bernardes de , Vasconcelos Vladimir Tonello de , Guedes Neto Henrique Jorge , Amorim Jorge Eduardo de , Nakano Luis Carlos Uta 
Published: July 2020

Abstract

Background:
Since the first description of the central venous catheter (CVC) in 1952, it has been used for the rapid administration of drugs, chemotherapy, as a route for nutritional support, blood components, monitoring patients, or combinations of these. When CVC is used in the traditional routes (eg, subclavian, jugular, and femoral veins), the complication rates range up to 15% and are mainly due to mechanical dysfunction, infection, and thrombosis. The peripherally inserted central catheter (PICC) is an alternative option for CVC access. However, the clinical evidence for PICC compared to CVC is still under discussion. In this setting, this systematic review (SR) aims to assess the effects of PICC compared to CVC for intravenous access.

Methods:
We will perform a comprehensive search for randomised controlled trials (RCTs), which compare PICC and traditional CVC for intravenous access. The search strategy will consider free text terms and controlled vocabulary (eg, MeSH and Entree) related to “peripherally inserted central venous catheter,” “central venous access,” “central venous catheter,” “catheterisation, peripheral,” “vascular access devices,” “infusions, intravenous,” “administration, intravenous,” and “injections, intravenous.” Searches will be carried out in these databases: MEDLINE (via PubMed), EMBASE (via Elsevier), Cochrane CENTRAL (via Wiley), IBECS, and LILACS (both via Virtual Health Library). We will consider catheter-related deep venous thrombosis and overall successful insertion rates as primary outcomes and haematoma, venous thromboembolism, reintervention derived from catheter dysfunction, catheter-related infections, and quality of life as secondary outcomes. Where results are not appropriate for a meta-analysis using RevMan 5 software (eg, if the data have considerable heterogeneity and are drawn from different comparisons), a descriptive analysis will be performed.

Results:
Our SR will be conducted according to the Cochrane Handbook of Systematic Reviews of Interventions and the findings will be reported in compliance with PRISMA.

Conclusion:
Our study will provide evidence for the effects of PICC versus CVC for venous access.

Ethics and dissemination:
This SR has obtained formal ethical approval and was prospectively registered in Open Science Framework. The findings of this SR will be disseminated through peer-reviewed publications or conference presentations.

Registration:
osf.io/xvhzf.

Ethical approval:
69003717.2.0000.5505.
Randomized, double-blind, placebo-controlled, parallel-group trial of sirolimus for tocilizumab-resistant idiopathic multicentric Castleman disease
Authors: Koga Tomohiro , Hagimori Naoko , Takemori Sachiko , Morimoto Shimpei , Sumiyoshi Remi , Shimizu Toshimasa , Hosogaya Naoki , Fukushima Chizu , Yamamoto Hiroshi , Kawakami Atsushi 
Published: July 2020

Abstract

Background:
Idiopathic multicentric Castleman disease (iMCD) is a rare lymphoproliferative disorder of unknown etiology with systemic symptoms that include fever, night sweats, weight loss, and fatigue. Although tocilizumab (TCZ), which is a recombinant, humanized, anti-human interleukin 6 receptor monoclonal antibody, has been recommended to treat patients with iMCD, 40% of patients with iMCD do not achieve complete remission with TCZ treatment.

Methods/Design:
In this phase II, investigator-initiated, multicenter, double-blind, randomized, parallel-group trial, the efficacy and safety of sirolimus will be compared with placebo in patients with TCZ-resistant iMCD. The study will be conducted in 8 centers in Japan. Participants (n = 20) will be randomly assigned to receive 2 mg of oral sirolimus (n = 10) or placebo (n = 10) once daily for 16 weeks. The primary endpoint is a decrease in CHAP score by ≥1 from baseline at 16 weeks. Secondary endpoints include levels of hemoglobin, albumin, and C-reactive protein; change in CHAP score; SF-36 Health Survey Questionnaire; physician global assessment (100 mm visual analog scale); patient global assessment (100 mm visual analog scale) at 2, 4, 8, 12, and 16 weeks; change in lymphadenopathy at 16 weeks; and pharmacodynamic assessment, including the measurement of whole blood sirolimus level.

Discussion:
This clinical trial will provide evidence of efficacy and safety of sirolimus as a potential new therapeutic agent for patients with TCZ-resistant iMCD.

Trial Registration:
This study was registered with the Japan Registry of Clinical Trials as jRCT2071190029 on October 8, 2019.
Diagnostic value of a spiral breast computed tomography system equipped with photon counting detector technology in patients with implants
Authors: Ruby Lisa , Shim Sojin , Berger Nicole , Marcon Magda , Frauenfelder Thomas , Boss Andreas 
Published: July 2020

Abstract
To evaluate the value of a breast computed tomography (CT) (B-CT) in assessing breast density, pathologies and implant integrity in women with breast implants.
This retrospective study was approved by the local ethics committee. B-CT images of 21 women with implants (silicone/saline; 20 bilateral, 1 unilateral) who underwent opportunistic screening or diagnostic bilateral B-CT were included. Breast density, implant integrity, extensive capsular fibrosis, soft tissue lesions and micro-/macrocalcifications were rated. In 18 of the 21 women, an additional ultrasound and in two patients breast magnetic resonance imaging was available for comparison. The average dose was calculated for each breast using verified Monte Carlo simulations on 3D image data sets.
Breast density was nearly completely fatty (ACR a) in two patients, scattered fibroglandular (ACR b) in five, heterogeneously dense (ACR c) in ten and very dense (ACR d) in four women. In three women showed a unilateral positive Linguine sign indicative of an inner capsule rupture. Extensive capsular fibrosis was found in three women. In three women, soft tissue lesions were depicted, which revealed to be cysts (n = 2) and lymph nodes (n = 1) on subsequent sonography. Diffuse, non-clustered microcalcifications were found in nine women. Eleven women showed cutaneous or intramammary macrocalcifications. Average dose was 6.45 mGy (range 5.81–7.28 mGy).
In women with implants, B-CT presents a promising modality for evaluating breast density, implant integrity, extensive capsular fibrosis, soft tissue lesions and micro-/macrocalcifications without the need of breast compression utilizing a lower dose compared to doses reported for conventional four-view mammography.
The effect of a video-guided educational technology intervention on the academic self-concept of adolescent students with hearing impairment
Authors: Asogwa Uche D. , Ofoegbu Theresa O. , Eseadi Chiedu , Ogbonna Chimaobi Samuel , Eskay Michael , Nji Godfrey C. , Ngwoke Oliver Rotachukwu , Nwosumba Victor Chijioke , Onah Benardine Ifeoma 
Published: July 2020

Abstract

Background/Objective:
Academic self-concept is an important construct within the disciplines of medicine, psychology, and education. Enhancing the academic self-concept of students with special educational needs is very crucial because it is associated with their quality of life. This study aimed to examine the effect of a video-guided educational technology intervention on the academic self-concept of adolescents with hearing impairment who were attending inclusive nonresidential public schools in Southeast Nigeria.

Methods:
This study adopted a randomized controlled trial design. The participants were 60 junior secondary students with hearing impairment. We implemented a video-guided educational technology intervention. It relied on the use of 13-minute video clips with captions/subtitles, which covered academic self-concept-related themes. The Academic Self-Concept Questionnaire, which has been developed by Liu and Wang, was used to collect baseline, posttreatment, and follow-up data. We conducted independent-samples and paired t test and computed Cohen d and Glass Δ to analyze the data.

Results:
The video-guided educational technology intervention significantly improved the academic self-concept of the treatment group participants, when compared with the care-as-usual control group participants, t(58) = 9.07, P < .001. These improvements in academic self-concept were sustained at follow up among the treatment group participants, when compared with the care-as-usual control group participants, t(48.56) = 10.898, P < .001. Within-subjects comparisons showed that the academic self-concept of the treatment group participants had significantly improved across the different time points at which they were assessed.

Conclusion:
The video-guided educational technology intervention was effective in improving the academic self-concept of adolescents with hearing impairment who were attending inclusive nonresidential public schools. Large-scale studies are needed to maximize the impact of video-guided educational technology interventions on students with hearing impairments who attend inclusive non residential public schools in Nigeria.
Chinese Herbs Medicine Huatan Huoxue Prescription for obstructive sleep apnea hypopnea syndrome as complementary therapy
Authors: Zhou Min , Liang Qijun , Pei QiuLan , Xu Fan , Wen Hang 
Published: July 2020

AbstractObjective:The aim of this systematic review and meta-analysis is to assess effectiveness and safety of Chinese Herbs Medicine Huatan Huoxue Prescription (HTHXP) as complementary therapy in treating bronchiectasis.Methods:The following databases will be searched: Embase, Cochrane, PubMed, China National Knowledge Infrastructure, Wan Fang, and VIP database from their inception to April 1, 2020. We performed and completed meta-analysis and methodologic evaluation by Review Manager 5.3.3 and statas 12.0 software. Study selection, data extraction, quality assessment, and assessment of risk bias will be performed by 2 reviewers independently. Odds ratios and correlative 95% confidence intervals will be calculated to present the association between the HTHXP and western medicine treatment using Review Manager version 5.3 when there is sufficient available data.Results:The results will be disseminated through a peer-reviewed journal publication.Conclusion:These systematic review findings will summarize up-to-date evidence for that HTHXP is more effective and safe as adjunctive treatment for patients with bronchiectasis.Ethics and dissemination:Ethics approval and patient consent are not required as this study is a systematic review based on published articles.PROSPERO registration number:INPLASY202050079.
Efficacy of alendronate for the treatment of ankylosing spondylitis
Authors: Tang Hua-yu , Li Yu-zhi , Tang Zhao-chen , Jiang Quan-wei , Zhao Yu 
Published: July 2020

Abstract

Background:
Ankylosing spondylitis (AS) is a very tricky orthopedic disorder. If such condition cannot be managed fairly well, it may significantly affect quality of life and even leads to disability among such population. A variety of studies have reported that alendronate is utilized for the treatment of AS. However, their results are still contrary, and no systematic review has addressed on this topic. Thus, this study will systematically assess the efficacy and safety of alendronate for the treatment of patients with AS.

Methods:
A comprehensive literature search will be performed from the below electronic databases from their commencement to the January 31, 2020 without language and publication status limitations: PubMed, Embase, Cochrane Library, Web of Science, Allied and Complementary Medicine Database, WANGFANG, and China National Knowledge Infrastructure. Only randomized controlled trials focusing on the alendronate for the treatment of patients with AS will be considered for inclusion in this study. Two authors will independently select all identified records, extract essential data from all included studies, and appraise study quality for each eligible trial using Cochrane risk of bias. If any differences occur, another experienced author will be invited to solve them by discussion and a consensus decision will be made. We will implement RevMan 5.3 software to analyze the extracted data.

Results:
This study will summarize high-quality randomized controlled trials to assess the efficacy and safety of alendronate for the treatment of patients with AS through primary outcome of bone densitometry; and secondary outcomes of pain intensity, quality of life, disease activity, functional status, and adverse events.

Conclusion:
This study will provide evidence to help determine whether alendronate is an effective and safe management for patient with AS or not.

Study registration:
INPLASY202040153.
Distribution of traditional Chinese medicine syndromes in type 2 diabetes mellitus with chronic heart failure
Authors: Wang Hui , Zhang Jun , Shi Chun-fang , Jia Jing , Zhang Zhi-min , Sun Jia-jia , Lu Bing-bing 
Published: July 2020

Abstract

Introduction:
The incidence of type 2 diabetes has been increasing year by year in recent years. Type 2 diabetes is an important risk factor in the occurrence and development of heart failure, and it is the second potential risk factor after coronary artery disease. At present, there is no unified etiology, pathogenesis, and syndrome differentiation criteria for type 2 diabetes with chronic heart failure, and it is susceptible to subjective factors. Therefore, standardized, objective, and standardized research is needed to provide reference and guidance for clinical diagnosis and treatment. In this study, the theory of syndrome differentiation is used to initially explore the distribution of traditional Chinese medicine syndromes in patients with type 2 diabetes and chronic heart failure through case data collection, syndrome extraction, and clinical data analysis.

Methods/design:
In this study, we will collect at least 500 cases of type 2 diabetes with chronic heart failure that meet the standard outpatient and hospitalization, and fill out the case information collection form. Then we will collect a number of clinical diagnosis and treatment information, and judge the syndrome based on the sum of the contribution of each syndrome to the relevant syndrome. We will use Microsoft Excel to establish a database, enter the relevant diagnosis and treatment, and syndrome information of the case information collection table, and verify and correct in time to ensure the accuracy of the data.

Discussion:
This study will provide reference and guidance for the clinical diagnosis and treatment of type 2 diabetes with chronic heart failure.

Trial registration:
ClinicalTrials.gov, ChiCTR2000033010, Registered on May 18, 2020.
Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I)
Authors: Kawashiri Shin-ya , Shimizu Toshimasa , Sato Shuntaro , Morimoto Shimpei , Kawazoe Yurika , Sumiyoshi Remi , Hosogaya Naoki , Fukushima Chizu , Yamamoto Hiroshi , Kawakami Atsushi 
Published: July 2020

Abstract

Background:
The introduction of biological disease-modifying anti-rheumatic drugs (bDMARDs) into clinical practice has dramatically improve the clinical outcomes of individuals with rheumatoid arthritis (RA). However, bDMARDs are associated with high costs, which has resulted in restricted treatment access and a burden on medical insurance finances. Although biosimilars offer cost-saving, their effectiveness and safety must be established in Post-Marketing Surveillance (PMS). Infliximab (IFX), a chimeric monoclonal antibody to TNF-alpha, is the first bDMARD; its biosimilar, CT-P13, is the first biosimilar DMARD approved for RA treatment in Japan. We will evaluate whether switching from originator IFX to CT-P13 is not inferior for maintaining non-clinical relapse to continued treatment with originator IFX in RA patients achieving clinical remission.

Methods/design:
This study is an interventional, multicenter, open-label, single-arm against historical control and noninferiority clinical trial with a 24-week follow-up. Eighty RA patients who are treated by originator IFX for ≥24 weeks and are achieving clinical remission will be included. Patients will be switched to CT-P13 with the unchanged dosing regimen. We will evaluate disease activity by measuring clinical disease activity indices and by using musculoskeletal ultrasound (MSUS). The primary endpoint is the ratio of patients who experience a nonclinical relapse during the study period. Important secondary endpoints are the changes from the baseline of the MSUS scores. We will also comprehensively analyze the serum levels of many biomarkers such as cytokines and chemokines.

Discussion:
The study results are expected to show the noninferiority of switching to CT-P13 over the continuation of originator IFX. The strength of this study is its prospective evaluation of therapeutic efficacy using not only clinical disease activity indices but also MSUS to accurately and objectively evaluate disease activity at the joint level among patients drawn from multiple centers with a standardized evaluation by MSUS. We will explore whether parameters at baseline can predict a nonclinical relapse after switching from originator IFX to CT-P13 by integrating multilateral assessments, i.e., clinical disease activity indices, MSUS findings, and serum biomarkers.

Trial registration:
This study was registered in the Japan Registry of Clinical Trials (https://jrct.niph.go.jp) on October 11, 2019 as jRCTs071190030.
An autophagy-related model of 4 key genes for predicting prognosis of patients with laryngeal cancer
Authors: Luo Meng-Si , Huang Guan-Jiang , Liu Hong-Bing 
Published: July 2020

Abstract
Autophagy, a major cause of cancer-related death, is correlated with the pathogenesis of various diseases including cancers. Our study aimed to develop an autophagy-related model for predicting prognosis of patients with laryngeal cancer.
We analyzed the correlation between expression profiles of autophagy-related genes (ARGs) and clinical outcomes in 111 laryngeal cancer patients from The Cancer Genome Atlas (TCGA). Afterward, gene functional enrichment analyses of gene ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) were performed to find the major biological attributes. Univariate Cox regression analyses and multivariate Cox regression analyses were performed to screen ARGs whose expression profiles were significantly associated with laryngeal cancer patients overall survival (OS). Furthermore, to provide the doctors and patients with a quantitative method to perform an individualized survival prediction, we constructed a prognostic nomogram.
Thirty eight differentially expressed ARGs were screened out in laryngeal cancer patients through the TCGA database. Related functional enrichments may act as tumor-suppressive roles in the tumorigenesis of laryngeal cancer. Subsequently, 4 key prognostic ARGs (IKBKB, ST13, TSC2, and MAP2K7) were identified from all ARGs by the Cox regression model, which significantly correlated with OS in laryngeal cancer. Furthermore, the risk score was constructed, which significantly divided laryngeal cancer patients into high- and low-risk groups. Integrated with clinical characteristics, gender, N and the risk score are very likely associated with patients OS. A prognostic nomogram of ARGs was constructed using the Cox regression model.
Our study could provide a valuable prognostic model for predicting the prognosis of laryngeal cancer patients and a new understanding of autophagy in laryngeal cancer.
Efficacy and safety of fire-needle in the treatment of gouty arthritis
Authors: Sun Jiya , Fan Yihua , Yang Zhihua , Jin Rui , Xin Ping , Cai Xuemeng , Li Xinju , Wang Shenjun 
Published: July 2020

Abstract

Background:
Fire needle therapy is an ancient external treatment method of traditional Chinese medicine. This therapy is simple to operate and has fewer side effects. Gouty arthritis (GA) is common disease that is often characterized by high excruciating pain on joint. Evidence from clinical studies show that fire needle exerts therapeutic effects on gout arthritis, but no evidence-based medicine is available. This study aimed to evaluate the efficacy and safety of fire acupuncture in the treatment of gout arthritis.

Methods:
Randomized controlled trials of fire needle in the treatment of GA published until May 2020 will be searched in the English databases (PubMed, EMBASE, Web of Science, the Cochrane Library) and Chinese databases (China National Knowledge Infrastructure, the Chongqing VIP Chinese Science and Technology Periodical Database, Wanfang database, and China Biomedical Literature Database). Additional search will be performed on Google academy and Baidu Academy. Data will be extracted from the studies by 2 reviewers working independently. Subsequently, quality assessment and a meta-analysis will be carried out for the studies using RevMan 5.3.

Results:
The efficacy and safety of fire needle in the treatment of GA will be evaluated based on overall effective rate, visual analog scale, blood uric acid, C-reactive protein, joint swelling and pain score, adverse reaction rate, and other clinical outcomes.

Conclusions:
The proposed systematic review and meta-analysis are expected to provide reliable evidence for the clinical benefits of fire-needle therapy in GA.
Treatment outcomes of multidrug-resistant tuberculosis in Hangzhou, China, 2011 to 2015
Authors: Li Qingchun , Shi Cynthia X. , Lu Min , Wu Limin , Wu Yifei , Wang Meng , Wang Le , Zhao Gang , Xie Li , Qian Han-Zhu 
Published: July 2020

Abstract
Treatment of multidrug-resistant tuberculosis (MDR-TB) is challenging. More research is needed to understand treatment outcomes and associated factors.
A retrospective cohort study was conducted to assess trends and predictors of treatment success among 398 MDR-TB and extensively drug resistant TB patients who started treatment in 2011 to 2015 in Hangzhou, China. Sociodemographic and clinical characteristic data were obtained from the national reporting database. Chi-square test for trend was used to evaluate changes in treatment success rates over the study years, and Cox regression analysis was used to identify predictors for poor treatment outcomes.
The treatment success rate was 76% (301/398) for all participants, 77% (298/387) for MDR-TB cases and 27% (3/11) for extensively drug-resistant tuberculosis -TB cases. Treatment success increased significantly from 66% among patients who started treatment in 2011 to 85% in 2015 (P < .01). Of the 97 (24.4%) patients with unsuccessful treatment outcomes, 10 (2.5%) died, 64 (16.1%) failed treatment, and 23 (5.8%) were lost to follow-up. Patients who started treatment in 2013 to 2015 were less likely to have unsuccessful outcomes than those who started in 2011–2012 (adjusted odds ratio [AOR] 0.4, 95% confidence interval [CI] 0.3–0.6), patients ≥25 years were more likely to have unsuccessful outcomes than younger patients (AOR 1.6, 95% CI 1.3–2.1), and cases with kanamycin resistance was associated with three times the odds of having unsuccessful outcomes than kanamycin-susceptible cases (AOR 3.0, 95% CI 1.5–5.8).
With proper case management of MDR-TB, patients can achieve a high treatment success rate. Hangzhou's program offers clinical evidence that can be used to inform MDR-TB programs elsewhere in China and abroad.