bluuebunny/crossref_metadata_2025_split huggingface dataset:
Experimental and Numerical Evaluation of Small-Scale Cryosurgery Using Ultrafine Cryoprobe
Authors: Okajima Junnosuke , Komiya Atsuki , Maruyama Shigenao 
Published: July 2018

Cryosurgery is one of the surgical treatments using a frozen phenomenon in biological tissue. In order to reduce the invasiveness of cryosurgery, the miniaturization of cryoprobe, which is a cooling device for cryosurgery, has been required. The authors have developed a ultrafine cryoprobe for realizing low-invasive cryosurgery by the local freezing. The objective of this study is to evaluate the small-scale cryosurgery using the ultrafine cryoprobe experimentally and numerically.
The ultrafine cryoprobe has a double-tube structure and consists of two stainless microtube. The outer diameter of ultrafine cryoprobe was 550 μm. The inner tube, which has 70 μm in inner diameter, depressurizes the high-pressure liquidized refrigerant. Depressurized refrigerant changes its state to two-phase and passes through the gap between outer and inner tube. The alternative Freon of HFC-23 was used as a refrigerant, which has the boiling point of −82°C at 0.1 MPa.
The cooling performance of this ultrafine cryoprobe was tested by the freezing experiment of the gelated water kept at 37°C. The gelated water at 37°C is a substitute of the biological tissue. As a result of the cooling in 1 minute, the surface temperature of the ultrafine cryoprobe was reached at −35°C and the radius of frozen region was 2 mm.
In order to evaluate the temperature distribution in the frozen region, the numerical simulation was conducted. The two-dimensional axisymmetric bioheat transfer equation with phase change was solved. By using the result from the numerical simulation, the temperature distribution in the frozen region and expected necrosis area is discussed.
Pile-Soil Interaction Under Cyclic Loadings for Offshore Wind Monopiles
Authors: Shin Yunsup , Saue Morten , Langford Thomas , Petter Hans , Cho Kyunghwan , Park Jongheon 
Published: July 2018

Offshore wind structures are subjected to cyclic loadings from wind, wave and current which must be accounted for when designing foundations. The effects of cyclic loadings can govern the dimension of the foundations. However, less standard and calculation procedure for designing foundations under cyclic loadings is generally accepted in practical design.
A parametric study at the generic clay profiles were carried out by using the conventional beam column approach and the finite element analysis. In addition, a monopile foundation at the layered soil profiles in Korean West Sea were designed taking into cyclic loading effect account.
Both design results show that the bending moments and shear forces along the pile by using beam column approach are larger than the results from the FE analysis. The FE analysis gives less pile displacement and rotation than the beam column approach. The reason for these differences can be partially explained by the soil reactions in the upper soil profiles. For the clay layers the lateral soil resistance is generally higher in the FE analyses compared to the cyclic p-y curves. However the lateral resistance in the silt sand layers is greater by using the standard cyclic p-y curves with a drained friction angle than using the constitutive models applying cyclic properties.
Based on the results, a practical approach of monopile design for the specific offshore location can be recommended by calibrating and simplifying cyclic p-y curves from the results of FE analyses taking into account the cyclic stress-stain response of the soil.
Design of Direct On-Seabed Sliding Foundations
Authors: Deeks Andrew , Zhou Hongjie , Krisdani Henry , Bransby Fraser , Watson Phil 
Published: July 2018

This paper describes a new framework for the geotechnical design of pipeline-related foundations (e.g. foundations for PLETs and Tees) designed to slide directly over the seabed during pipeline operation. This approach can present considerable savings in terms of fabrication and construction costs because of reduced foundation sizes.
Over the design life, a pipeline is likely to endure many thermal/ pressure load cycles due to product and flow rate variations during operation. These cycles result in the foundation sliding back and forth across the seabed within a footprint. These loads and corresponding motions impose cyclic shear stresses on the soil that can (i) degrade foundation bearing capacity and (ii) cause additional foundation settlement.
Often the key design consideration is whether or not the cumulative settlements will eventually compromise the integrity of the pipeline system to which the PLET and its associated foundation are attached. In addition to consolidation and creep, two key mechanisms are shown to control cyclic foundation settlement: (i) bearing mechanism induced burial and (ii) cyclic shear stress driven soil volume reduction. Their relative significance depends on the soil conditions (soil state) and input pipeline movements.
The paper presents key aspects required for the design of direct on-seabed sliding foundations, including the soil parameters and associated testing required. Validation of the design approach is illustrated by comparison to laboratory model tests performed on carbonate soils.
The impact of soil properties on potential foundation performance is illustrated with a design example and the importance of conducting site specific soil testing and settlement analyses is emphasised.
It is also illustrated that close integration of the pipeline, structural and geotechnical analysis is necessary to reliably quantify system performance of these novel foundations.
Volume–outcome relationship in transcatheter aortic valve implantations in Germany 2008–2014: a secondary data analysis of electronic health records
Authors: Kaier Klaus , Oettinger Vera , Reinecke Holger , Schmoor Claudia , Frankenstein Lutz , Vach Werner , Hehn Philip , von zur Mühlen Constantin , Bode Christoph , Zehender Manfred , Reinöhl Jochen 
Published: July 2018

ObjectivesWe examine the volume–outcome relationship in isolated transcatheter aortic valve implantations (TAVI). Our interest was whether the volume–outcome relationship for TAVI exists on the centre level, whether it occurs equally for different outcomes and how it develops over time.DesignSecondary data analysis of electronic health records. The comprehensive German Federal Bureau of Statistics Diagnosis Related Groups database was queried for data on all isolated TAVI procedures performed in Germany between 2008 and 2014. Logistic and linear regression analyses were carried out. Risk adjustment was applied using a predefined set of patient characteristics to account for differences in the risk factor composition of the patient populations between centres and over time. Centres performing TAVI were stratified into groups performing <50, 50–99 and ≥100 procedures per year.SettingGermany 2008–2014.ParticipantsAll patients undergoing isolated TAVI in the observation period.InterventionsNone.Primary and secondary outcome measuresIn-hospital mortality, bleeding, stroke, probability of ventilation >48 hours, length of hospital stay and reimbursement.ResultsBetween 2008 and 2014, a total of 43 996 TAVI procedures were performed in 113 different centres in Germany with a total of 2532 cases of in-hospital mortality. Risk-adjusted in-hospital mortality decreases over the years and is lower the higher the annual procedure volume at the centre is. The magnitude of the latter effect declines over the observation period. Our results indicate a ceiling effect in the volume–outcome relationship: the volume–outcome relationship is eminent in circumstances of relatively unfavourable outcomes. Alongside improving outcomes, however, the volume–outcome relationship decreases. Also, a volume–outcome relationship seems to be absent in circumstances of constantly low event rates.ConclusionsThe hypothesised volume–outcome relationship for TAVI exists but diminishes and may disappear over time. This should be taken into account when considering mandatory minimum thresholds.
Probiotics, prebiotics and synbiotics for chronic kidney disease: protocol for a systematic review and meta-analysis
Authors: Pei Ming , Wei Lijuan , Hu Shouci , Yang Bo , Si Jinhua , Yang Hongtao , Zhai Jingbo 
Published: July 2018

IntroductionThere is a growing interest in probiotic, prebiotic and synbiotic supplements for patients with chronic kidney disease (CKD). However, a systematic review and evaluation is lacking. The purpose of the present study is to assess the efficacy and safety of probiotics, prebiotics and synbiotics for non-dialysis or non-renal transplant patients with CKD.Methods and analysisAn extensive literature search will be undertaken to identify potentially eligible studies from electronic databases including PubMed (1946 to present), EMBASE (1974 to present), Web of Science (1900 to present) and the Cochrane Central Register of Controlled Trials (CENTRAL, all years). No language restriction will be applied to the search. Both parallel and crossover randomised controlled trials will be included. The risk of bias of each included study will be assessed using the Cochrane Risk of Bias Tool. The primary outcome measures are uraemic toxins. Secondary outcomes include kidney function, adverse cardiovascular events, all-cause mortality, cause-specific death, progression to end-stage kidney disease, quality of life, gastrointestinal function and adverse events. Data will be synthesised using appropriate statistical methods. The quality of evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationNo ethical approval is required as no primary data will be collected. We will publish findings from this systematic review in a peer-reviewed scientific journal, and the data set will be made freely available.PROSPERO registration numberCRD42017079177.
Cross-sectional study of the association between healthcare professionals’ empathy and burnout and the number of annual primary care visits per patient under their care in Spain
Authors: Yuguero Oriol , Melnick Edward R , Marsal Josep R. , Esquerda Montserrat , Soler-Gonzalez Jorge 
Published: July 2018

ObjectiveThe aim of this study was to evaluate the association between physician and nurse self-reported empathy and burnout and the number of annual primary care visits per patient under their care.MethodsDesign: A cross-sectional survey study was conducted from January 2013 to July 2014. Site: The 22 primary care centres of the Lleida Health Region in Spain. Main outcome measures: The Jefferson Scale of Physician Empathy and the Maslach Burnout Inventory were used to measure empathy and burnout, respectively. The number of visits and the number of diagnoses coded per visit were obtained through the Region’s electronic health record.ResultsTwo hundred and sixty-seven healthcare professionals (physicians and nurses, 52.6% participation of the total in the region) with 301 657 patients under their care. Healthcare professionals’ degree of burnout and empathy was associated with the number of annual visits per patient under their care. Burned out nurses and physicians received fewer visits (4.5vs3.7 in nurses and 18.1vs18.9 in physicians), whereas more empathic physicians received more visits per patient (19.4vs17.2, p<0.05) and documented more diagnoses per visit (10.2vs9.7, p=0.001). Less burned out and less empathic nurses documented more diagnoses per visit (10.2vs10.0 and 8.2vs9.9, p<0.05).ConclusionsThe number of annual primary care visits per patient that healthcare professionals receive is closely associated with healthcare professionals’ empathy and burnout. These results should serve to promote empathic skills and establish organisational changes that promote efficiency in the practice and, in turn, reduce the degree of burnout of healthcare professionals.
Effectiveness of drug interventions to prevent sudden cardiac death in patients with heart failure and reduced ejection fraction: an overview of systematic reviews
Authors: Al-Gobari Muaamar , Al-Aqeel Sinaa , Gueyffier François , Burnand Bernard 
Published: July 2018

ObjectivesTo summarise and synthesise the current evidence regarding the effectiveness of drug interventions to prevent sudden cardiac death (SCD) and all-cause mortality in patients with heart failure with reduced ejection fraction (HFrEF).DesignOverview of systematic reviews.Data sourcesMEDLINE, Embase, ISI Web of Science and Cochrane Library from inception to May 2017; manual search of references of included studies for potentially relevant reviews.Eligibility criteria for study selectionWe reviewed the effectiveness of drug interventions for SCD and all-cause mortality prevention in patients with HFrEF. We included overviews, systematic reviews and meta-analyses of randomised controlled trials of beta-blockers, angiotensin-converting enzyme inhibitors (ACE-i), angiotensin receptor blockers (ARBs), antialdosterones or mineralocorticoid-receptor antagonists, amiodarone, other antiarrhythmic drugs, combined ARB/neprilysin inhibitors, statins and fish oil supplementation.Review methodsTwo independent reviewers extracted data and assessed the methodological quality of the reviews and the quality of evidence for the primary studies for each drug intervention, using Assessing the Methodological Quality of Systematic Reviews (AMSTAR) and Grading of Recommendations, Assessment, Development and Evaluation(GRADE), respectively.ResultsWe identified 41 reviews. Beta-blockers, antialdosterones and combined ARB/neprilysin inhibitors appeared effective to prevent SCD and all-cause mortality. ACE-i significantly reduced all-cause mortality but not SCD events. ARBs and statins were ineffective where antiarrhythmic drugs and omega-3 fatty acids had unclear evidence of effectiveness for prevention of SCD and all-cause mortality.ConclusionsThis comprehensive overview of systematic reviews confirms that beta-blockers, antialdosterone agents and combined ARB/neprilysin inhibitors are effective on SCD prevention but not ACE-i or ARBs. In patients with high risk of SCD, an alternative therapeutic strategy should be explored in future research.Systematic review registrationPROSPERO 2017: CRD42017067442.
Does early intervention improve outcomes in the physiotherapy management of lumbar radicular syndrome? Results of the POLAR pilot randomised controlled trial
Authors: Reddington Michael , Walters Stephen J , Cohen Judith , Baxter Susan K , Cole Ashley 
Published: July 2018

ObjectiveTo investigate the feasibility of undertaking a definitive randomised controlled trial (RCT).SettingThis was a pilot, pragmatic superiority RCT with a qualitative element, recruiting from 14 general practitioner (GP) practices in England.ParticipantsPatients over 18 years of age presenting to their GP with unilateral lumbar radicular syndrome (LRS), defined as radicular pain and/or neurological symptoms originating from lumbar nerve roots, were eligible to participate in the study, those who did not have a clear understanding of the English language or had comorbidities preventing rehabilitation were ineligible.InterventionsParticipants were randomised into early intervention physiotherapy or usual care with the former receiving their treatment within 2 weeks after randomisation and the latter 6 weeks postrandomisation. Both groups received a patient-centred, goal-orientated physiotherapy programme specific to their needs. Participants received up to six treatment sessions over an 8-week period.Outcome measuresProcess outcomes to determine the feasibility of the study and an exploratory analysis of patient-reported outcomes, including self-rated disability, pain and general health, these were collected at baseline, 6, 12 and 26 weeks postrandomisation.Results80 participants were recruited in 10 GP practices over 34 weeks and randomised to (early intervention physiotherapy n=42, usual care n=38). Follow-up rates at 26 weeks were 32 (84%) in the usual care and 36 (86%) in the early intervention physiotherapy group. The mean area under the curve (larger values indicating more disability) for the Oswestry Disability Index over the 26 weeks was 16.6 (SD 11.4) in the usual care group and 16.0 (SD 14.0) in the intervention group. A difference of −0.6 (95% CI −0.68 to 5.6) in favour of the intervention group.ConclusionsThe results of the study suggest a full RCT is feasible and will provide evidence as to the optimal timing of physiotherapy for patients with LRS.Trial registration numberNCT02618278,ISRCTN25018352.
Using home sensing technology to assess outcome and recovery after hip and knee replacement in the UK: the HEmiSPHERE study protocol
Authors: Grant Sabrina , Blom A W , Whitehouse Michael R , Craddock Ian , Judge Andrew , Tonkin Emma L , Gooberman-Hill Rachael 
Published: July 2018

IntroductionOver 160 000 people with severe hip or knee pain caused by osteoarthritis undergo total hip (THR) or knee replacement (TKR) surgery each year in the UK within the National Health Service (NHS), and this number is expected to increase. Innovative approaches to evaluating surgical outcomes will be needed to respond to the increasing burden of joint replacement surgery. The Sensor Platform for Healthcare in a Residential Environment, Interdisciplinary Research Collaboration (SPHERE-IRC) have developed a system of sensors that can monitor the health-related behaviours of people living at home. The system includes sensors for the home environment (measuring temperature, humidity, room occupancy, water and electricity usage), a wristband body-worn activity monitor and silhouette (body outline) sensors. The aim of HEmiSPHERE (Hip and knEe study of a Sensor Platform of HEalthcare in a Residential Environment) is to (1) determine the accuracy and feasibility of the sensory data as it compares with conventional assessment of health outcomes after surgery using patient self-reported questionnaires, and (2) to explore how the SPHERE system is useful for everyday clinical decision-making.Methods and analysisA feasibility study recruiting and installing the SPHERE system in the homes of up to 30 NHS adult patients as they undergo a THR or TKR. Through a mixed-methods design, the SPHERE system will monitor and record continuous measurements of daily behaviour. Main outcomes will assess the relationships between environmental, behavioural and movement data and the parameters of interest from the standard clinical assessments measuring patient outcomes over time. Patient interviews and focus groups with consultant orthopaedic surgeons will provide in-depth understanding of the acceptability, feasibility and accuracy of the data.Ethics and disseminationWe aim to disseminate the findings through regional talks and seminars, international conferences and peer-reviewed journals and social media.
Study protocol for a single-centre, prospective, non-blinded, randomised, 12-month, parallel-group superiority study to compare the efficacy of pharmacist intervention versus usual care for elderly patients hospitalised in orthopaedic wards
Authors: Komagamine Junpei , Sugawara Kenichi , Kaminaga Miho , Tatsumi Shinpei 
Published: July 2018

IntroductionGiven that polypharmacy and potentially inappropriate prescribing are common in elderly orthopaedic patients, pharmacist interventions to improve medication practices among this population are important. However, past studies have reported mixed results regarding the effectiveness of pharmacist-led interventions in inpatient elderly care. Furthermore, few randomised controlled trials have evaluated patient-relevant outcomes as a primary endpoint. Therefore, we will evaluate whether a pharmacist-led intervention could reduce readmission of hospitalised elderly orthopaedic patients with polypharmacy or potentially inappropriate prescribing.Methods and analysisThis is an ongoing single-centre, prospective, non-blinded, randomised controlled trial designed to evaluate the superiority of a pharmacist-led intervention for hospitalised elderly patients compared with usual care. The trial will include newly admitted orthopaedic patients 70 years of age and older with polypharmacy or at least one potentially inappropriate prescription, as identified by the screening tool of older people’s prescriptions (STOPP) criteria. Usual care includes medication reconciliation, patient education and monitoring, as well as providing information about discharge medications. Pharmacist interventions, in addition to usual care, include advising the patient’s physician to stop unnecessary or inappropriate medications and start necessary medications. The primary outcome is the 1-year readmission rate. Secondary outcomes are the proportion of patients who undergo emergency department visits and the occurrences of all-cause death, a new fracture, myocardial infarction and ischaemic stroke. The study started in November 2017, and up to approximately 220 patients will be enrolled.Ethics and disseminationThe protocol was approved by the Medical Ethics Committee of the National Hospital Organization Tochigi Medical Center (No. 29–22). The trial was registered at the University Hospital Medical Information Network (UMIN) clinical registry. The results of this trial will be submitted for publication in a peer-reviewed journal.Trial registration numberUMIN000029404.
Randomised, open-label, multicentre trial comparing haemodialysis plus haemoperfusion versus haemodialysis alone in adult patients with end-stage renal disease (HD/HP vs HD): study protocol
Authors: Lu Wei , Jiang Geng-Ru 
Published: July 2018

IntroductionHaemodialysis (HD) is the cornerstone treatment for patients with end-stage renal disease (ESRD). However, highly protein bound or large molecular weight uremic toxins such as phenolic and indolic compounds and homocysteine, which are associated with adverse outcomes such as cardiovascular disease of patients with ESRD, are difficult to remove via HD but can be effectively eliminates by haemoperfusion (HP). The proposed trial (referred to as HD/HP vs HD below) is a randomised, open-label, multicentre trial comparing HD plus HP versus HD alone in adult patients with ESRD. The primary endpoint measure is all-cause mortality.Methods and analysisWe plan to enrol 1364 maintenance HD patients from 11 medical centres in Shanghai. Participants will be randomised to receive HD plus HP or HD alone at a 1:1 ratio after 1-month run-in period. In both arms, patients will receive low-flux HD at a frequency of two times a week and haemodiafiltration at a frequency of once a week. In the intervention group, subjects also received HP once every 2 weeks. Follow-up is scheduled at 3, 6, 12, 18 and 24 months after randomisation, and will consist the following: routine physical examinations, standard lab panels (blood routine, liver/residual kidney functions, tests of the coagulation system, etc), dialysis adequacy (standard Kt/V), chest X-ray, ECG, echocardiography, heart function rating. Adverse events will be assessed according to the international conference on harmonisation guidelines. The primary outcome is 24-month all-cause mortality. Secondary outcomes will include cardiovascular-related mortality, the occurrence of major cardiovascular events and the quality of life.Ethics and disseminationThe study protocol has been approved by the Ethical Committees of all 11 participating centres. Clinical Research Unit of Xin Hua Hospital will oversee the study. The results will be presented at national and international academic meetings, and submitted to peer-reviewed journals for publications.Trial registration numberNCT03227770; Pre-results.