bluuebunny/crossref_metadata_2025_split huggingface dataset:
Timing of dialysis initiation to reduce mortality and cardiovascular events in advanced chronic kidney disease: nationwide cohort study
Authors: Fu Edouard L , Evans Marie , Carrero Juan-Jesus , Putter Hein , Clase Catherine M , Caskey Fergus J , Szymczak Maciej , Torino Claudia , Chesnaye Nicholas C , Jager Kitty J , Wanner Christoph , Dekker Friedo W , van Diepen Merel 
Published: November 2021

AbstractObjectiveTo identify the optimal estimated glomerular filtration rate (eGFR) at which to initiate dialysis in people with advanced chronic kidney disease.DesignNationwide observational cohort study.SettingNational Swedish Renal Registry of patients referred to nephrologists.ParticipantsPatients had a baseline eGFR between 10 and 20 mL/min/1.73 m2and were included between 1 January 2007 and 31 December 2016, with follow-up until 1 June 2017.Main outcome measuresThe strict design criteria of a clinical trial were mimicked by using the cloning, censoring, and weighting method to eliminate immortal time bias, lead time bias, and survivor bias. A dynamic marginal structural model was used to estimate adjusted hazard ratios and absolute risks for five year all cause mortality and major adverse cardiovascular events (composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) for 15 dialysis initiation strategies with eGFR values between 4 and 19 mL/min/1.73 m2in increments of 1 mL/min/1.73 m2. An eGFR between 6 and 7 mL/min/1.73 m2(eGFR6-7) was taken as the reference.ResultsAmong 10 290 incident patients with advanced chronic kidney disease (median age 73 years; 3739 (36%) women; median eGFR 16.8 mL/min/1.73 m2), 3822 started dialysis, 4160 died, and 2446 had a major adverse cardiovascular event. A parabolic relation was observed for mortality, with the lowest risk for eGFR15-16. Compared with dialysis initiation at eGFR6-7, initiation at eGFR15-16was associated with a 5.1% (95% confidence interval 2.5% to 6.9%) lower absolute five year mortality risk and 2.9% (0.2% to 5.5%) lower risk of a major adverse cardiovascular event, corresponding to hazard ratios of 0.89 (95% confidence interval 0.87 to 0.92) and 0.94 (0.91 to 0.98), respectively. This 5.1% absolute risk difference corresponded to a mean postponement of death of 1.6 months over five years of follow-up. However, dialysis would need to be started four years earlier. When emulating the intended strategies of the Initiating Dialysis Early and Late (IDEAL) trial (eGFR10-14veGFR5-7) and the achieved eGFRs in IDEAL (eGFR7-10veGFR5-7), hazard ratios for all cause mortality were 0.96 (0.94 to 0.99) and 0.97 (0.94 to 1.00), respectively, which are congruent with the findings of the randomised IDEAL trial.ConclusionsVery early initiation of dialysis was associated with a modest reduction in mortality and cardiovascular events. For most patients, such a reduction may not outweigh the burden of a substantially longer period spent on dialysis.
Face-to-face interventions to encourage enrolment in cardiac rehabilitation: a scoping review protocol
Authors: Rasmussen Birgit , Håkonsen Sasja Jul , Toft Bente 
Published: November 2021

IntroductionCardiac rehabilitation has become an integral part of secondary treatment of cardiovascular heart disease. Despite evidence demonstrating that cardiac rehabilitation improves prognoses, reduces disease progression and helps patients to find a new foothold in life, many patients do not enrol. Face-to-face interventions can encourage patients to enrol; however, it is unclear which strategies have been developed, how they are structured in a hospital context and whether they target the life-world of the patients. The objective of this scoping review is to map and evaluate the nature and characteristics of studies that have reported on face-to-face interventions to encourage patients to enrol in cardiac rehabilitation.Methods and analysisThis review will be guided by the Joanna Briggs Institute Methodology for Scoping Reviews. A search strategy developed in cooperation with a research secretary will be applied in six databases including studies published from 2000 in English, Danish, Norwegian, Swedish and German with no restriction on publication type or study design. Studies involving adult patients with ischaemic heart disease or heart failure will be included. Studies providing the intervention after enrolment in cardiac rehabilitation will be excluded. Study selection will be performed independently by two reviewers. Data will be extracted by two reviewers using predefined data charting forms. The presentation of data will be a narrative summary of the characteristics and key findings to facilitate the integration of diverse evidence, and as we deem appropriate will be supported by a diagrammatic or tabular presentation.Ethics and disseminationThis scoping review will use data from existing publications and does not require ethical approval. Results will be reported through publication in a scientific journal and presented on relevant conferences and disseminated as part of future workshops with professionals involved in communication with patients about enrolment in cardiac rehabilitation.
Randomised controlled trial comparing rituximab to mycophenolate mofetil in children and young adults with steroid-dependent idiopathic nephrotic syndrome: study protocol
Authors: Lugani Francesca , Angeletti Andrea , Ravani Pietro , Vivarelli Marina , Colucci Manuela , Caridi Gianluca , Verrina Enrico , Emma Francesco , Ghiggeri Gian Marco 
Published: November 2021

IntroductionGlucocorticoids induce remission in 90% of children with idiopathic nephrotic syndrome (INS). Some become steroid-dependent (SD) and require the addition of steroid sparing drugs such as calcineurin-inhibitors (CNI) or cyclophosphamide, to maintain remission. Considering the toxicity of these drugs, alternative interventions are needed for long-term treatment. The anti-CD20 antibody rituximab has shown promising steroid-sparing properties, with conflicting results in complicated forms of SD-INS. Mycophenolate mofetil (MMF) resulted effective in maintaining free-steroid remission, however, studies are limited to few uncontrolled trials with reported different dose of MMF.Methods and analysisThis open-label, two-parallel-arm, superiority controlled randomised clinical trial will enrol children with SD-INS maintained in remission with oral glucocorticoids or CNI. Children and young adults will be randomised to either MMF (1.200 mg/m2) or rituximab (375 mg/m2) infusion. After enrolment, glucocorticoids will be tapered until complete withdrawal. We will enrol 160 children and young adults to detect as significant at the two-sided p value of 0.01 with a power >0.8 a reduction in the risk of 1-year relapse (primary end-point). As secondary endpoints, we will compare the amount of glucocorticoids required to maintain complete remission at 6 and 24 months.Ethics and disseminationThe trial was approved by the local ethics boards (Comitato Etico Regione Liguria CER Liguria https://www.portalericerca-liguria.it/). We will publish the study results at international scientific meetings.Trial registration numbersNCT004585152.
Multicentre cohort study of cochlear implantation outcomes in Thailand
Authors: Piromchai Patorn , Tanamai Napas , Kiatthanabumrung Sivaporn , Kaewsiri Suwicha , Thongyai Kanthong , Atchariyasathian Viraporn , Thanawirattananit Panida , Wacharasindhu Chitsuda , Mukkun Tulakan , Isipradit Permsarp , Yimtae Kwanchanok 
Published: November 2021

ObjectivesTo report the status and outcomes of cochlear implantation in Thailand.DesignCohort study.SettingTertiary care and university hospitals.ParticipantsPatients who underwent cochlear implant surgery in Thailand.InterventionsThis project collected data from all government and university hospitals in Thailand where cochlear implant surgery was performed between 2016 and 2020.Primary and secondary outcome measuresBaseline characteristics, operation data, complications, audiological outcomes and quality of life were reported.ResultsThis study included 458 patients, and nearly half of the patients were children and adolescents (46.94%). The mean age of the patients was 2.96±5.83 years. At 1 year postoperatively, the mean pure tone average of the hearing threshold in the implanted ear significantly improved from unaided preoperative baseline (mean difference (MD) 64.23 dB HL; 95% CI 59.81 to 68.65; p<0.001). The mean speech recognition threshold also improved (MD 55.96 dB HL; 95% CI 49.50 to 62.42, p<0.001). The quality-of-life scores of the EQ-5D-5L, PedsQL and HUI3 questionnaires at 1 year showed improved mobility (range, 0–5; MD 0.65; 95% CI 0.05 to 1.25; p=0.037), hearing (range, 0–6; MD 0.96; 95% CI 0.30 to 1.61; p=0.006) and speech (range, 0–5; MD 0.44; 95% CI 0.04 to 0.84; p=0.031). Common complications included electrode dislodgement (2.18%), vertigo (1.23%) and meningitis (1.93%).ConclusionsExcellent audiological outcomes and improvement in the quality of life in the mobility, hearing and speech domains were observed in patients who underwent cochlear implantation in Thailand.
Epidemiology of uterine rupture among pregnant women in China and development of a risk prediction model: analysis of data from a multicentre, cross-sectional study
Authors: Zhan Wenqiang , Zhu Jing , Hua Xiaolin , Ye Jiangfeng , Chen Qian , Zhang Jun 
Published: November 2021

ObjectivesTo describe the epidemiology of uterine rupture in China from 2015 to 2016 and to build a prediction model for uterine rupture in women with a scarred uterus.SettingA multicentre cross-sectional survey conducted in 96 hospitals across China in 2015–2016.ParticipantsOur survey initially included 77 789 birth records from hospitals with 1000 or more deliveries per year. We excluded 2567 births less than 24 gestational weeks or unknown and 1042 births with unknown status of uterine rupture, leaving 74 180 births for the final analysis.Primary and secondary outcome measuresComplete and incomplete uterine rupture and the risk factors, and a prediction model for uterine rupture in women with scarred uterus (assigned each birth a weight based on the sampling frame).ResultsThe weighted incidence of uterine rupture was 0.18% (95% CI 0.05% to 0.23%) in our study population during 2015 and 2016. The weighted incidence of uterine rupture in women with scarred and intact uterus was 0.79% (95% CI 0.63% to 0.91%) and 0.05% (95% CI 0.02% to 0.13%), respectively. Younger or older maternal age, prepregnancy diabetes, overweight or obesity, complications during pregnancy (hypertensive disorders in pregnancy and gestational diabetes), low education, repeat caesarean section (≥2), multiple abortions (≥2), assisted reproductive technology, placenta previa, induce labour, fetal malpresentation, multiple pregnancy, anaemia, high parity and antepartum stillbirth were associated with an increased risk of uterine rupture. The prediction model including eight variables (OR >1.5) yielded an area under the curve (AUC) of 0.812 (95% CI 0.793 to 0.836) in predicting uterine rupture in women with scarred uterus with sensitivity and specificity of 77.2% and 69.8%, respectively.ConclusionsThe incidence of uterine rupture was 0.18% in this population in 2015–2016. The predictive model based on eight easily available variables had a moderate predictive value in predicting uterine rupture in women with scarred uterus. Strategies based on predictions may be considered to further reduce the burden of uterine rupture in China.
Efficacy and cost-effectiveness of Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis: protocol for a randomised placebo-controlled trial (the SCUlpTOR trial)
Authors: Liu Xiaoqian , Robbins Sarah , Wang Xia , Virk Sonika , Schuck Karen , Deveza Leticia A , Oo Win Min , Carmichael Kirsty , Antony Benny , Eckstein Felix , Wirth Wolfgang , Little Christopher , Linklater James , Harris Anthony , Humphries David , O"Connell R , Heller Gillian , Buttel Thomas , Lohmander Stefan , Ding Changhai , Hunter David J 
Published: November 2021

IntroductionKnee osteoarthritis (KOA) is a highly prevalent disabling joint disease. Intra-articular stem cell therapy is increasingly being used for treating KOA with little high-quality evidence to support its use. The aim of this study is to investigate the efficacy, safety and cost-effectiveness of allogeneic mesenchymal stem cells (Cymerus MSCs) for treating symptomatic tibiofemoral KOA and improving knee structure over 24 months.Methods and analysisThe Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis study is a phase III, multi-centre, parallel, superiority, randomised, double-blind, placebo-controlled trial, which will be conducted in Sydney and Hobart, Australia. 440 participants (220 per arm) aged over 40 years with painful KOA and mild to moderate structural change on X-ray (Kellgren and Lawrence grade 2 or 3) with medial minimum joint space width between 1 and 4 mm in the study knee will be recruited from the community and randomly allocated to receive either intra-articular MSCs or saline at baseline, week 3 and week 52. The coprimary outcomes will be the proportion of participants achieving patient-acceptable symptom state for knee pain at 24 months and quantitative central medial femorotibial compartment cartilage thickness change from baseline to 24 months. Main secondary outcomes include change in knee pain, Patient Global Assessment, physical function, quality of life and other structural changes. Additional data for cost-effectiveness analysis will also be recorded. Adverse events will be monitored throughout the study. The primary analysis will be conducted using modified intention-to-treat.Ethics and disseminationThis protocol has been approved by The University of Sydney (USYD) Human Research Ethics Committee (HREC) #: 2020/119 and The University of Tasmania (UTAS) HREC #: H0021868. All participants will be required to provide informed consent. Dissemination will occur through conferences, social media, and scientific publications.Trial registration numbersAustralian New Zealand Clinical Trials Registry (ACTRN12620000870954); U1111-1234-4897.
Simplified 0+1 and 1+1 pneumococcal vaccine schedules in Ho Chi Minh City, Vietnam: protocol for a randomised controlled trial
Authors: Temple Beth , Tran Hau Phuc , Dai Vo Thi Trang , Bright Kathryn , Uyen Doan Y , Balloch Anne , Licciardi Paul , Nguyen Cattram Duong , Satzke Catherine , Smith-Vaughan Heidi , Nguyen Thuong Vu , Mulholland Kim 
Published: November 2021

IntroductionReduced-dose schedules offer a more efficient and affordable way to use pneumococcal conjugate vaccines (PCVs). Such schedules rely primarily on the maintenance of herd protection. The Vietnam Pneumococcal Trial II (VPT-II) will evaluate reduced-dose schedules of PCV10 and PCV13 utilising an unvaccinated control group. Schedules will be compared in relation to their effect on nasopharyngeal carriage and immunogenicity.Methods and analysisVPT-II is a single-blind open-label randomised controlled trial of 2500 infants in three districts of Ho Chi Minh City, Vietnam. Eligible infants have no clinically significant maternal or perinatal history and are born at or after 36 weeks’ gestation. Participants are recruited at 2 months of age and randomly assigned (4:4:4:4:9) using block randomisation, stratified by district, to one of five groups: four intervention groups that receive PCV10 in a 0+1 (at 12 months) or 1+1 (at 2 and 12 months) schedule or PCV13 in the same 0+1 or 1+1 schedule; and a control group (that receives a single dose of PCV10 at 24 months). Participants are followed up to 24 months of age. The primary outcome is vaccine-type pneumococcal carriage at 24 months of age. Secondary outcomes are carriage at 6, 12 and 18 months of age and the comparative immunogenicity of the different schedules in terms of antibody responses, functional antibody responses and memory B cell responses.Ethics and disseminationEthical approval has been obtained from the Human Research Ethics Committee of the Royal Children’s Hospital Melbourne and the Vietnam Ministry of Health Ethics Committee. The results, interpretation and conclusions will be presented to parents and guardians, at national and international conferences and published in peer-reviewed open access journals.Trial registration numberNCT03098628.
Determining common variants in patients with haemophilia A in South Vietnam and screening female carriers in their family members
Authors: Nguyen Bang Suong Thi , Le Xuan Thao Thi , Huynh Nghia , Nguyen Huy Huu , Truong Nguyen Cong-Minh , Nguyen Bac Hoang 
Published: November 2021

AimsThe aim of this study was to determine common variants inF8, including intron 22 inversion (Inv22), intron 1 inversion (Inv1) and point mutations, the transmission of these variants between patients with haemophilia A (HA) and their family members.MethodsGenetic analysis was conducted in 71 patients who were clinically diagnosed with HA and 152 related female members in South Vietnam by a combination of inversion PCR (I-PCR), multiplex PCR and direct sequencing.ResultsVariants inF8, including Inv22, point mutations (with 37 genotypes) and two novel variants, occupied 60 patients with HA. Among severe patients, the rate of Inv22 was 44%. Missense was the common point mutation of over 50% in patients with moderate HA and mild HA. Inv1 was absent in all patients.F8variants were also found in 119 female carriers (FCs) (78.3%) from families related to patients with HA. There were 56 mothers (93.3%) carryingF8variants and passing the same variants to their sons.ConclusionsThese findings were the first to provide important information about the presence of Inv22 and point mutation in Vietnamese patients with HA, the mothers and their female family members. It demonstrated that genetic diagnosis and counselling for HA carriers were essential factors for future improvements in comprehensive and equitable healthcare polices for patients with HA and FCs in Vietnam.
Postoperative de novo epilepsy after craniotomy: a nationwide register-based cohort study
Authors: Giraldi Laura , Vinsløv Hansen Jørgen , Wohlfahrt Jan , Fugleholm Kåre , Melbye Mads , Munch Tina Nørgaard 
Published: November 2021

Background and objectivesThe risks of postoperative risk of epilepsy after a craniotomy is widely believed to be raised. A study is warranted to quantify the risks for any neurosurgical indication. In this unselected register-based nationwide cohort study with virtually complete follow-up, the short-term and long-term cumulative risks of postoperative de novo epilepsy for all major neurosurgical indications were estimated.MethodsThe study was based on 8948 first-time craniotomy patients in Denmark 1 January 2005 to 31 December 2015 with follow-up until 31 December 2016. The patients were classified according to their underlying neurosurgical pathology. Patients with preoperative epilepsy were excluded. The postcraniotomy risks of de novo epilepsy were estimated using the Aalen-Johansen estimator in a multistate model.ResultsThe overall cumulative 1-year risk of postcraniotomy de novo epilepsy was 13.9% (95% CI 13.2 to 14.6). For patients with intracranial tumour the cumulative 1-year risk was 15.4% (95% CI 14.4 to 16.5), for spontaneous intracranial haemorrhage 11.3% (95% CI 10.1 to 12.6), for traumatic intracranial haemorrhage 11.1% (95% CI 9.6 to 12.9), for cerebral abscess 27.6% (95% CI 22.8 to 33.5) and for congenital malformations 3.8% (95% CI 1.3 to 11.7). The 6-month, 1-year and 5-year risks for all major indications by specific subtypes are provided.ConclusionsThe cumulative risk of de novo epilepsy following craniotomy is high for patients with any indication for craniotomy, as compared with the background population. The results provide comprehensive data to support future recommendations regarding prophylactic antiepileptic treatment and driving restrictions.
Development of a delirium predictive model for adult trauma patients in an emergency and critical care center: a retrospective study
Authors: Matsuoka Ayaka , Miike Toru , Miyazaki Mariko , Goto Taku , Sasaki Akira , Yamazaki Hirotaka , Komaki Moe , Higuchi Masahiro , Mori Kosuke , Shinada Kota , Nakayama Kento , Sakurai Ryota , Asahi Miho , Futami Akiko , Yoshitake Kunimasa , Narumi Shougo , Koba Mayuko , Koami Hiroyuki , Kawaguchi Atsushi , Murakawa Toru Hirachi , Monji Akira , Sakamoto Yuichirou 
Published: November 2021

BackgroundDelirium has been shown to prolong the length of intensive care unit stay, hospitalization, and duration of ventilatory control, in addition to increasing the use of sedatives and increasing the medical costs. Although there have been a number of reports referring to risk factors for the development of delirium, no model has been developed to predict delirium in trauma patients at the time of admission. This study aimed to create a scoring system that predicts delirium in trauma patients.MethodsIn this single-center, retrospective, observational study, trauma patients aged 18 years and older requiring hospitalization more than 48 hours were included and divided into the development and validation cohorts. Univariate analysis was performed in the development cohort to identify factors significantly associated with prediction of delirium. The final scoring system for predicting delirium was developed using multivariate analysis and internal validation was performed.ResultsOf the 308 patients in the development cohort, 91 developed delirium. Clinical Frailty Score, fibrin/fibrinogen degradation products, low body mass index, lactate level, and Glasgow Coma Scale score were independently associated with the development of delirium. We developed a scoring system using these factors and calculated the delirium predictive score, which had an area under the curve of 0.85. In the validation cohort, 46 of 206 patients developed delirium. The area under the curve for the validation cohort was 0.86, and the calibration plot analysis revealed the scoring system was well calibrated in the validation cohort.DiscussionThis scoring system for predicting delirium in trauma patients consists of only five risk factors. Delirium prediction at the time of admission may be useful in clinical practice.Level of evidencePrognostic and epidemiological, level III.
Phase transitions in the logarithmic Maxwell O(3)-sigma model
Authors: Lima F. C. E. , Almeida C. A. S. 
Published: November 2021

AbstractWe investigate the presence of topological structures and multiple phase transitions in the O(3)-sigma model with the gauge field governed by Maxwell’s term and subject to a so-called Gausson’s self-dual potential. To carry out this study, it is numerically shown that this model supports topological solutions in 3-dimensional spacetime. In fact, to obtain the topological solutions, we assume a spherically symmetrical ansatz to find the solutions, as well as some physical behaviors of the vortex, as energy and magnetic field. It is presented a planar view of the magnetic field as an interesting configuration of a ring-like profile. To calculate the differential configurational complexity (DCC) of structures, the spatial energy density of the vortex is used. In fact, theDCCis important because it provides us with information about the possible phase transitions associated with the structures located in the Maxwell–Gausson model in 3D. Finally, we note from theDCCprofile an infinite set of kink-like solutions associated with the parameter that controls the vacuum expectation value.