bluuebunny/crossref_metadata_2025_split huggingface dataset:
Liquorice-induced hypokalaemia in patients treated with Yokukansan preparations: identification of the risk factors in a retrospective cohort study
Authors: Shimada Saori , Arai Tetsuaki , Tamaoka Akira , Homma Masato 
Published: June 2017

ObjectiveTo evaluate serum potassium levels and rates of hypokalaemia in patients treated with liquorice-containing Japanese traditional Kampo-medicines Yokukansan (YK) and Yokukansan-ka-chinpihange (YKCH).DesignRetrospective cohort study.SettingPatients receiving YK preparations for dementia and other psychiatric disorders in the University of Tsukuba Hospital in Japan.Participants389 patients (male/female: 174/215, 68.6±16.1 years) were treated with YK preparations for 231 days (range 6–2788 days). Patients whose potassium levels were <3.6 mEq/L before administration of YK preparations, and drug non-compliant patients, were excluded.Main outcome measureThe occurrence rate of hypokalaemia and assessment of the risk factors for YK preparation-induced hypokalaemia.ResultsOf the 389 patients treated with YK preparations, 94 (24.2%) developed hypokalaemia (potassium levels <3.6 mEq/L) 34 days (range 1–1600 days) after administration of the preparations. 36 (38.3%) patients had co-administration with lower potassium-inducing drugs (LPIDs; diuretics, glucocorticoids, mineralocorticoids and glycyrrhizin), which was more frequent in the patients without hypokalaemia (17.3%) (p<0.05). A Cox proportional hazard model identified four risk factors for hypokalaemia: YK administration (not YKCH) (HR 3.093, 95% CI 1.408 to 6.798), co-administration of LPIDs (HR 2.743, 95% CI 1.754 to 4.289), hypoalbuminaemia at baseline (HR 2.145, 95% 1.360 to 3.384), and full dosage administration (7.5 g/day) (HR 1.600, 95% CI 1.005 to 2.549).ConclusionsSerum potassium monitoring should be done at least monthly in patients with the following risk factors: LPID co-administration, YK administration, hypoalbuminaemia, and full dosage administration.
Axillary versus innominate artery cannulation for antegrade cerebral perfusion in aortic surgery: design of the Aortic Surgery Cerebral Protection Evaluation (ACE) CardioLink-3 randomised trial
Authors: Garg Vinay , Peterson Mark D , Chu Michael WA , Ouzounian Maral , MacArthur Roderick GG , Bozinovski John , El-Hamamsy Ismail , Victor Chu F , Garg Ankit , Hall Judith , Thorpe Kevin E , Dhingra Natasha , Teoh Hwee , Marotta Thomas R , Latter David A , Quan Adrian , Mamdani Muhammad , Juni Peter , David Mazer C , Verma Subodh 
Published: June 2017

IntroductionNeurological injury remains the major cause of morbidity and mortality following open aortic arch repair. Systemic hypothermia along with antegrade cerebral perfusion (ACP) is the accepted cerebral protection approach, with axillary artery cannulation being the most common technique used to establish ACP. More recently, innominate artery cannulation has been shown to be a safe and efficacious method for establishing ACP. Inasmuch as there is a lack of high-quality data comparing axillary and innominate artery ACP, we have designed a randomised, multi-centre clinical trial to compare both cerebral perfusion strategies with regards to brain morphological injury using diffusion-weighted MRI (DW-MRI).Methods and analysis110 patients undergoing elective aortic surgery with repair of the proximal arch requiring an open distal anastamosis will be randomised to either the innominate artery or the axillary artery cannulation strategy for establishing unilateral ACP during systemic circulatory arrest with moderate levels of hypothermia. The primary safety endpoint of this trial is the proportion of patients with new radiologically significant ischaemic lesions found on postoperative DW-MRI compared with preoperative DW-MRI. The primary efficacy endpoint of this trial is the difference in total operative time between the innominate artery and the axillary artery cannulation group.Ethics and disseminationThe study protocol and consent forms have been approved by the participating local research ethics boards. Publication of the study results is anticipated in 2018 or 2019. If this study shows that the innominate artery cannulation technique is non-inferior to the axillary artery cannulation technique with regards to brain morphological injury, it will establish the innominate artery cannulation technique as a safe and potentially more efficient method of antegrade cerebral perfusion in aortic surgery.Trial registration numberNCT02554032.
Study protocol: Comparison of the effect of treatment with Nonsteroidal anti-inflammatory drugs added to anti-tumour necrosis factor a therapy versus anti-tumour necrosis factor a therapy alone on progression of Structural damage in the spine over two years in patients with ankyLosing spondylitis (CONSUL) – an open-label randomized controlled multicenter trial
Authors: Proft Fabian , Muche Burkhard , Listing Joachim , Rios-Rodriguez Valeria , Sieper Joachim , Poddubnyy Denis 
Published: June 2017

IntroductionThere is some evidence that non-steroidal anti-inflammatory drugs (NSAIDs), in particular celecoxib, might possess not only a symptomatic efficacy but also disease-modifying properties in ankylosing spondylitis (AS), retarding the progression of structural damage in the spine if taken continuously. In contrast, this remains controversial for tumour necrosis factor alpha (TNF-α) inhibitors, despite their good clinical efficacy. The impact of a combined therapy (a TNF inhibitor plus an NSAID) on radiographic spinal progression in AS is unclear.Methods and analysisThe aim of this study is to evaluate the impact of treatment with an NSAID (celecoxib) when added to a TNF inhibitor (golimumab) compared with TNF inhibitor (golimumab) alone on progression of structural damage in the spine over 2 years in patients with AS. The study consists of a 6-week screening period, a 12-week period (phase I: run-in phase) of treatment with golimumab for all subjects followed by a 96-week controlled treatment period (phase II: core phase) with golimumab plus celecoxib versus golimumab alone, and a safety follow-up period of 4 weeks. At week 108, the primary study endpoint radiographic spinal progression (as assessed by the change in the modified Stoke Ankylosing Spondylitis Spine Score after 2 years) will be evaluated.Ethics and disseminationThe study will be performed according to the principles of good clinical practice and the German drug law. The written approval of the independent ethics committee and of the German federal authority have been obtained. On study completion, results are expected to be published in a peer-reviewed journal.Trial registration numberClinicalTrials.gov register (NCT02758782) and European Union Clinical Trials Register (EudraCT No 2016-000615-33).
Effectiveness of a ‘Workshop on Decluttering and Organising’ programme for teens and middle-aged adults with difficulty decluttering: a study protocol of an open-label, randomised, parallel-group, superiority trial in Japan
Authors: Aso Yasuko , Yamaoka Kazue , Nemoto Asuka , Naganuma Yuki , Saito Masashige 
Published: June 2017

IntroductionHoarding disorder can cause problems with work performance, personal hygiene, health and well-being. The disorder is a growing social problem in Japan. Having difficulty discarding rubbish, decluttering and organising can signal a future hoarding disorder, and early intervention is important. We developed an educational workshop on decluttering and organising for teens and adults with difficulty organising. The objective of this study is to evaluate the effectiveness of a workshop for reducing clutter and improving quality of life among younger people with difficulty decluttering and organising.Methods and analysisAn open-label, parallel-group, randomised controlled trial will be conducted among volunteers aged 12–55 years with mild difficulty decluttering and organising. Those in the intervention group will attend the workshop and receive a visit from a professional cleaning company to declutter their living space. The control group will have only the latter. The primary outcome will be the score on the Japanese version of the Saving Inventory-Revised. Secondary outcomes will be scores on the Clutter Image Rating Scale, the Japanese version of the Rosenberg Self-Esteem Scale and the Roles of Private Space Scale. The results will be examined for differences between the two groups in changes from baseline to 7 months. We will examine crude effects and adjust for gender and age using a general linear model for continuous variables and a logistic regression model for dichotomous variables. Sample size was calculated assuming a significance level of 5% (two tailed), a power of 80% and an effect size of 0.75. In total, 60 subjects (30 in each group) will be required.Ethics and disseminationThe study protocol has been approved by the Medical Ethical Committee of Teikyo University (No. 15-065). The findings will be disseminated widely through peer-reviewed publication and conference presentations.Trial registration numberUMIN000020568. Issue date: 16 January 2016.
Diagnostic value of the antiglycoprotein-2 antibody for Crohn’s disease: a PRISMA-compliant systematic review and meta-analysis
Authors: Deng Chuiwen , Li Wenli , Li Jing , Zhang Shulan , Li Yongzhe 
Published: June 2017

ObjectivesTo perform a meta-analysis to evaluate the diagnostic performance of the antiglycoprotein-2 (GP2) antibody for Crohn's disease (CD).MethodsThree databases (EMBASE, ISI Web of Knowledge and PubMed) were systematically searched. There were 17 eligible studies included in the meta-analysis. A total of 2439 patients with CD and 3184 controls were involved in these studies. STATA V.11.2 and Meta-DiSc V.1.4 were used to perform the meta-analysis.ResultsThe area under the summary receiver operating characteristic curve was 0.68–0.72. The pooled diagnostic sensitivity of the anti-GP2 antibody ranged from 14% to 24%, and the specificity was 96%–98%.ConclusionsThe anti-GP2 antibody is a specific biomarker for CD, and further exploration of its prevalence among different clinical phenotypes of CD will provide a better understanding of its diagnostic performance.
A systematic review of economic evaluations of seasonal influenza vaccination for the elderly population in the European Union
Authors: Shields Gemma E , Elvidge Jamie , Davies Linda M 
Published: June 2017

ObjectivesThe Council of the European Union (EU) has recommended that action should be taken to increase influenza vaccination in the elderly population. The aims were to systematically review and critically appraise economic evaluations for influenza vaccination in the elderly population in the EU.MethodsElectronic searches of the NHS Economic Evaluation, Health Technology Assessment, MEDLINE and Embase databases were run to identify full economic evaluations. Two levels of screening were used, with explicit inclusion criteria applied by two independent reviewers at each stage. Prespecified data extraction and critical appraisal were performed on identified studies. Results were summarised qualitatively.ResultsOf the 326 search results, screening identified eight relevant studies. Results varied widely, with the incremental cost-effectiveness ratio ranging from being both more effective and cheaper than no intervention to costing €4 59 350 per life-year gained. Cost-effectiveness was most sensitive to variations in influenza strain, vaccination type and strategy, population and modelling characteristics.ConclusionsMost studies suggest that vaccination is cost-effective (seven of eight studies identified at least one cost-effective scenario). All but one study used economic models to synthesise data from different sources. The results are uncertain due to the methods used and the relevance and robustness of the data used. Sensitivity analysis to explore these aspects was limited. Integrated, controlled prospective clinical and economic evaluations and surveillance data are needed to improve the evidence base. This would allow more advanced modelling techniques to characterise the epidemiology of influenza more accurately and improve the robustness of cost-effectiveness estimates.
Study protocol of a phase IB/II clinical trial of metformin and chloroquine in patients withIDH1-mutated orIDH2-mutated solid tumours
Authors: Molenaar Remco J , Coelen Robert JS , Khurshed Mohammed , Roos Eva , Caan Matthan WA , van Linde Myra E , Kouwenhoven Mathilde , Bramer Jos AM , Bovée Judith VMG , Mathôt Ron A , Klümpen Heinz-Josef , van Laarhoven Hanneke WM , van Noorden Cornelis JF , Vandertop W Peter , Gelderblom Hans , van Gulik Thomas M , Wilmink Johanna W 
Published: June 2017

IntroductionHigh-grade chondrosarcoma, high-grade glioma and intrahepatic cholangiocarcinoma are aggressive types of cancer with a dismal outcome. This is due to the lack of effective treatment options, emphasising the need for novel therapies. Mutations in the genesIDH1andIDH2(isocitrate dehydrogenase 1 and 2) occur in 60% of chondrosarcoma, 80% of WHO grade II–IV glioma and 20% of intrahepatic cholangiocarcinoma.IDH1/2-mutated cancer cells produce the oncometaboliteD-2-hydroxyglutarate (D-2HG) and are metabolically vulnerable to treatment with the oral antidiabetic metformin and the oral antimalarial drug chloroquine.Methods and analysisWe describe a dose-finding phase Ib/II clinical trial, in which patients withIDH1/2-mutated chondrosarcoma, glioma and intrahepatic cholangiocarcinoma are treated with a combination of metformin and chloroquine. Dose escalation is performed according to a 3+3 dose-escalation scheme. The primary objective is to determine the maximum tolerated dose to establish the recommended dose for a phase II clinical trial. Secondary objectives of the study include (1) determination of pharmacokinetics and toxic effects of the study therapy, for which metformin and chloroquine serum levels will be determined over time; (2) investigation of tumour responses to metformin plus chloroquine inIDH1/2-mutated cancers using CT/MRI scans; and (3) whether tumour responses can be measured by non-invasiveD-2HG measurements (mass spectrometry and magnetic resonance spectroscopy) of tumour tissue, serum, urine, and/or bile or next-generation sequencing of circulating tumour DNA (liquid biopsies). This study may open a novel treatment avenue forIDH1/2-mutated high-grade chondrosarcoma, glioma and intrahepatic cholangiocarcinoma by repurposing the combination of two inexpensive drugs that are already approved for other indications.Ethics and disseminationThis study has been approved by the medical-ethical review committee of the Academic Medical Center, Amsterdam, The Netherlands. The report will be submitted to a peer-reviewed journal.Trial registration numberThis article was registered at ClinicalTrials.gov identifier (NCT02496741): Pre-results.
Colorectal cancer with Synchronous liver-limited Metastases: the protocol of an Inception Cohort study (CoSMIC)
Authors: Siriwardena Ajith K , Chan Anthony K C , Ignatowicz Agnieszka M , Mason James M 
Published: June 2017

IntroductionColorectal cancer is the fourth most common cancer in the UK and an important cause of cancer-related death. In 20% of patients, there is metastasis to the liver or beyond at the time of diagnosis. The management of synchronous disease is complex. Conventional surgery removes the colorectal primary first, followed by chemotherapy, with resection of liver metastases as a final step. Advances in the availability and safety of liver surgery, anaesthesia and critical care have made two alternative options feasible. The first is synchronous resection of the primary and liver metastases. The second is resection of the metastatic disease as the first step, termed the reverse or liver-first approach. Currently, evidence is inadequate to inform the selection of care pathway for patients with colorectal cancer and synchronous liver-limited metastases. Specifically, optimal pathways are not defined and there is a dearth of prospectively recorded cohort-defining factors influencing treatment selection or outcome.Methods and analysisColorectal cancer with Synchronous liver-limited Metastases: an Inception Cohort (CoSMIC) is an inception cohort study of patients with a new diagnosis of colorectal cancer with synchronous liver-limited metastases. The sequence of treatment received, and factors influencing treatment decisions, will be evaluated against European Society of Medical Oncology guidelines. Clinical data will be collected, and quality of life, morbidity, mortality and long-term outcome compared for different treatment sequences adjusted for prognostic factors. Disease-free survival or progression will be measured at 1, 2 and 5 years. A nested qualitative study will ascertain patient experiences and clinician perspectives on delivery of care.Ethics and disseminationThe full study protocol was independently peer reviewed by Professor Kees de Jong (University of Maastricht, Holland). CoSMIC has ethical approval from the National Health Service Research Ethics Committee (14/NW/1397). Results will be disseminated to healthcare professionals and patient groups, and may be used to design a definitive trial addressing areas of equipoise in treatment pathways, as well as optimising current pathways to improve outcomes and experiences.Trial registration numberNCT02456285, pre-results.
Serum fibrinogen and cardiovascular events in Chinese patients with type 2 diabetes and stable coronary artery disease: a prospective observational study
Authors: Yang Sheng-Hua , Du Ying , Zhang Yan , Li Xiao-Lin , Li Sha , Xu Rui-Xia , Zhu Cheng-Gang , Guo Yuan-Lin , Wu Na-Qiong , Qing Ping , Gao Ying , Cui Chuan-Jue , Dong Qian , Sun Jing , Li Jian-Jun 
Published: June 2017

ObjectivesThe aim of this study was to investigate the association of serum fibrinogen with cardiovascular events (CVE) in Chinese patients with type 2 diabetes mellitus (T2DM) and stable coronary artery disease (CAD).DesignAn observational study.SettingFuWai Hospital in Beijing, China.ParticipantsA cohort of 1466 patients with T2DM and angiographic-proven stable CAD was evaluated.Outcome measuresBaseline serum fibrinogen levels were measured and trisected into ‘low’, ‘middle’ and ‘high’. Their association with CVE was explored using Cox proportional hazard models.ResultsWith 20.2 months (average) follow-up, 44 (3%) were lost to follow-up and 96 patients developed CVE. Compared with the patients without CVE, the ones who developed CVE had higher levels of fibrinogen. Univariable regression revealed a significant relation of fibrinogen to CVE (HR (HR) 1.25, 95% CI 1.06 to 1.47, p=0.010) per SD increase of fibrinogen at baseline. After adjusting for multiple established cardiovascular disease (CVD) risk factors, the association persisted (HR 1.30, 95% CI 1.02 to 1.66, p=0.037). Moreover, after adjusting for CVD risk factors, the HRs for middle-serum and high-serum fibrinogen concentration, using ‘low’ group as reference, were 1.23 (95% CI 0.69 to 2.20) and 2.20 (95% CI 1.11 to 3.36, p=0.049).ConclusionsWe first indicated that elevated fibrinogen level was independently associated with increased CVE in Chinese patients with T2DMand stable CAD.
Risk factor modifications and depression incidence: a 4-year longitudinal Canadian cohort of the Montreal Catchment Area Study
Authors: Meng Xiangfei , Brunet Alain , Turecki Gustavo , Liu Aihua , D'Arcy Carl , Caron Jean 
Published: June 2017

ObjectiveFew studies have examined the effect of risk factor modifications on depression incidence. This study was to explore psychosocial risk factors for depression and quantify the effect of risk factor modifications on depression incidence in a large-scale, longitudinal population-based study.MethodsData were from the Montreal Longitudinal Catchment Area study (N=2433). Multivariate modified Poisson regression was used to estimate relative risk (RR). Population attributable fractions were also used to estimate the potential impact of risk factor modifications on depression incidence.ResultsThe cumulative incidence rate of major depressive disorder at the 2-year follow-up was 4.8%, and 6.6% at the 4-year follow-up. Being a younger adult, female, widowed, separated or divorced, Caucasian, poor, occasional drinker, having a family history of mental health problems, having less education and living in areas with higher unemployment rates and higher proportions of visible minorities, more cultural community centres and community organisations, were consistently associated with the increased risk of incident major depressive disorder. Although only 5.1% of the disease incidence was potentially attributable to occasional drinking (vs abstainers) at the 2-year follow-up, the attribution of occasional drinking doubled at the 4-year follow-up. A 10% reduction in the prevalence of occasional drinking in this population could potentially prevent half of incident cases.ConclusionsModifiable risk factors, both individual and societal, could be the targets for public depression prevention programmes. These programmes should also be gender-specific, as different risk factors have been identified for men and women. Public health preventions at individual levels could focus on the better management of occasional drinking, as it explained around 5%~10% of incident major depressive disorders. Neighbourhood characteristics could also be the target for public prevention programmes. However, this could be very challenging. A cost-effectiveness analysis of a variety of prevention efforts is warranted.
Retrospective cohort study of all deaths among infants born between 22 and 27 completed weeks of gestation in Switzerland over a 3-year period
Authors: Berger T M , Steurer M A , Bucher H U , Fauchère J C , Adams M , Pfister R E , Baumann-Hölzle R , Bassler D 
Published: June 2017

ObjectivesThe aim of this research is to assess causes and circumstances of deaths in extremely low gestational age neonates (ELGANs) born in Switzerland over a 3-year period.DesignPopulation-based, retrospective cohort study.SettingAll nine level III perinatal centres (neonatal intensive care units (NICUs) and affiliated obstetrical services) in Switzerland.PatientsELGANs with a gestational age (GA) <28 weeks who died between 1 July 2012 and 30 June 2015.ResultsA total of 594 deaths were recorded with 280 (47%) stillbirths and 314 (53%) deaths after live birth. Of the latter, 185 (59%) occurred in the delivery room and 129 (41%) following admission to an NICU. Most liveborn infants dying in the delivery room had a GA ≤24 weeks and died following primary non-intervention. In contrast, NICU deaths occurred following unrestricted life support regardless of GA. End-of-life decision-making and redirection of care were based on medical futility and anticipated poor quality of life in 69% and 28% of patients, respectively. Most infants were extubated before death (87%).ConclusionsIn Switzerland, most deaths among infants born at less than 24 weeks of gestation occurred in the delivery room. In contrast, most deaths of ELGANs with a GA ≥24 weeks were observed following unrestricted provisional intensive care, end-of-life decision-making and redirection of care in the NICU regardless of the degree of immaturity.