bluuebunny/crossref_metadata_2025_split huggingface dataset:
Risk of a seizure recurrence after a breakthrough seizure and the implications for driving: further analysis of the standard versus new antiepileptic drugs (SANAD) randomised controlled trial
Authors: Bonnett L J , Powell G A , Tudur Smith C , Marson AG 
Published: July 2017

ObjectivesA breakthrough seizure is one occurring after at least 12 months seizure freedom while on treatment. The Driver and Vehicle Licensing Agency (DVLA) allows an individual to return to driving once they have been seizure free for 12 months following a breakthrough seizure. This is based on the assumption that the risk of a further seizure in the next 12 months has dropped <20%. This analysis considers whether the prescribed 1 year off driving following a breakthrough seizure is sufficient for this and stratifies risk according to clinical characteristics.Design, setting, participants, interventions and main outcome measuresThe multicentre UK-based Standard versus New Antiepileptic Drugs (SANAD) study was a randomised controlled trial assessing standard and new antiepileptic drugs for patients with newly diagnosed epilepsy. For participants aged at least 16 with a breakthrough seizure, data have been analysed to estimate the annual seizure recurrence risk following a period of 6, 9 and 12 months seizure freedom. Regression modelling was used to investigate how antiepileptic drug treatment and a number of clinical factors influence the risk of seizure recurrence.ResultsAt 12 months following a breakthrough seizure, the overall unadjusted risk of a recurrence over the next 12 months is lower than 20%, risk 17% (95% CI 15% to 19%). However, some patient subgroups have been identified which have an annual recurrence risk significantly greater than 20% after an initial 12-month seizure-free period following a breakthrough seizure.ConclusionsThis reanalysis of SANAD provides estimates of seizure recurrence risks following a breakthrough seizure that will inform policy and guidance about regaining an ordinary driving licence. Further guidance is needed as to how such data should be used.Trial registration numberSANAD is registered with the International Standard Randomised Controlled Trial Number RegisterISRCTN38354748.
Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial
Authors: Battle Ceri , Abbott Zoe , Hutchings Hayley A , O'Neill Claire , Groves Sam , Watkins Alan , Lecky Fiona E , Jones Sally , Gagg James , Body Richard , Evans Philip A 
Published: July 2017

IntroductionA new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). A definitive randomised controlled trial (impact trial) is required to assess the clinical and cost effectiveness of the new model before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design.Methods/analysisThis feasibility trial is designed to test the methods of a multicentre, cluster-randomised (stepped- wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a 5-month period; in the initial period acting as the controls (normal care), and in the second period acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a 6-week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory). Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed.Ethics and disseminationWales Research Ethics Committee 6 granted approval for the trial in September 2016. Patient recruitment will commence in February 2017. Planned dissemination is through publication in a peer-reviewedEmergency Medicine Journal, presentation at appropriate conferences and to stakeholders at professional meetings.Trial registration numberISRCTN95571506; Pre-results.
Optimal cut points of plasma and urine neutrophil gelatinase-associated lipocalin for the prediction of acute kidney injury among critically ill adults: retrospective determination and clinical validation of a prospective multicentre study
Authors: Tecson Kristen M , Erhardtsen Elisabeth , Eriksen Peter M , Gaber A Osama , Germain Michael , Golestaneh Ladan , Lavoria Maria de los Angeles , Moore Linda W , McCullough Peter A 
Published: July 2017

ObjectivesTo determine the optimal threshold of blood and urine neutrophil gelatinase-associated lipocalin (NGAL) to predict moderate to severe acute kidney injury (AKI) and persistent moderate to severe AKI lasting at least 48 consecutive hours, as defined by an adjudication panel.MethodsA multicentre prospective observational study enrolled intensive care unit (ICU) patients and recorded daily ethylenediaminetetraacetic acid (EDTA) plasma, heparin plasma and urine NGAL. We used natural log-transformed NGAL in a logistic regression model to predict stage 2/3 AKI (defined by Kidney Disease International Global Organization). We performed the same analysis using the NGAL value at the start of persistent stage 2/3 AKI.ResultsOf 245 subjects, 33 (13.5%) developed stage 2/3 AKI and 25 (10.2%) developed persistent stage 2/3 AKI. Predicting stage 2/3 AKI revealed the optimal NGAL cutoffs in EDTA plasma (142.0 ng/mL), heparin plasma (148.3 ng/mL) and urine (78.0 ng/mL) and yielded the following decision statistics: sensitivity (SN)=78.8%, specificity (SP)=73.0%, positive predictive value (PPV)=31.3%, negative predictive value (NPV)=95.7%, diagnostic accuracy (DA)=73.8% (EDTA plasma); SN=72.7%, SP=73.8%, PPV=30.4%, NPV=94.5%, DA=73.7% (heparin plasma); SN=69.7%, SP=76.8%, PPV=32.9%, NPV=94%, DA=75.8% (urine). The optimal NGAL cutoffs to predict persistent stage 2/3 AKI were similar: 148.3 ng/mL (EDTA plasma), 169.6 ng/mL (heparin plasma) and 79.0 ng/mL (urine) yielding: SN=84.0%, SP=73.5%, PPV=26.6%, NPV=97.6, DA=74.6% (EDTA plasma), SN=84%, SP=76.1%, PPV=26.8%, NPV=96.5%, DA=76.1% (heparin plasma) and SN=75%, SP=75.8%, PPV=26.1, NPV=96.4%, DA=75.7% (urine).ConclusionBlood and urine NGAL predicted stage 2/3 AKI, as well as persistent 2/3 AKI in the ICU with acceptable decision statistics using a single cut point in each type of specimen.
Sleeping pill use in Brazil: a population-based, cross-sectional study
Authors: Kodaira Katia , Silva Marcus Tolentino 
Published: July 2017

ObjectivesThis study aimed to assess the prevalence of sleeping pill use in Brazil.DesignA population-based cross-sectional study with a three-stage cluster sampling design (census tracts, households and adult residents) was used.SettingThe Brazilian 2013 National Health Survey was used.ParticipantsThe study population consisted of household residents aged ≥18 years. A total of 60 202 individuals were interviewed, including 52.9% women, and 21% reported depressive symptoms.OutcomesThe primary outcome was sleeping pill use, which was self-reported with the question, ‘Over the past two weeks, have you used any sleeping pills?’ The prevalence was calculated and stratified according to sociodemographic characteristics. The associated factors were identified from prevalence ratios (PRs) obtained through a Poisson regression with robust variance and adjusted for sex and age.ResultsThe prevalence of sleeping pill use was 7.6% (95% CI 7.3% to 8.0%), and the average treatment duration was 9.75 (95% CI 9.49 to 10.00) days. Self-medication was found in 11.2% (95% CI 9.6% to 12.9%) of users. The following factors were associated with sleeping pill use: female sex (PR=2.21; 95% CI 1.97 to 2.47), an age of ≥60 years (PR=5.43; 95% CI 4.14 to 7.11) and smoking (PR=1.47; 95% CI 1.28 to 1.68). Sleeping pill use was also positively associated with the severity of depressive symptoms (p<0.001), whereas alcohol intake was inversely associated (PR=0.66; 95% CI 0.56 to 0.77).ConclusionsOne in every 13 Brazilians adults uses sleeping pills. There is a lack of information about the reasons for this use. Actions are required to raise awareness about the risks. The results could assist programmes in targeting rational sleeping pill use and the identification of factors demanding intervention.
CArbon dioxide surgical field flooding and aortic NO-touch off-pump coronary artery bypass grafting to reduce Neurological injuries after surgical coronary revascularisation (CANON): protocol for a randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms
Authors: Szwed Krzysztof , Pawliszak Wojciech , Serafin Zbigniew , Kowalewski Mariusz , Tomczyk Remigiusz , Perlinski Damian , Szwed Magdalena , Tomaszewska Marta , Anisimowicz Lech , Borkowska Alina 
Published: July 2017

IntroductionNeurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offsets survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue is the development of off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved neurological outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques.Methods and analysisIn this randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms, a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment arms and one control arm. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG with partial clamp. The primary endpoint will be the appearance of new lesions on control brain MRI 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis.Ethics and disseminationEthical approval has been granted for this study. Results will be disseminated through peer-reviewed media.Trial registration numberNCT03074604; Pre-results.Date and version identifier10-Mar-2017 Original
Determinants of mortality and prolonged hospital stay among dengue patients attending tertiary care hospital: a cross-sectional retrospective analysis
Authors: Mallhi Tauqeer Hussain , Khan Amer Hayat , Sarriff Azmi , Adnan Azreen Syazril , Khan Yusra Habib 
Published: July 2017

ObjectivesDengue imposes substantial economic, societal and personal burden in terms of hospital stay, morbidity and mortality. Early identification of dengue cases with high propensity of increased hospital stay and death could be of value in isolating patients in need of early interventions. The current study was aimed to determine the significant factors associated with dengue-related prolonged hospitalisation and death.DesignCross-sectional retrospective study.SettingTertiary care teaching hospital.ParticipantsPatients with confirmed dengue diagnosis were stratified into two categories on the basis of prolonged hospitalisation (≤3 days and >3 days) and mortality (fatal cases and non-fatal cases). Clinico-laboratory characteristics between these categories were compared by using appropriate statistical methods.ResultsOf 667 patients enrolled, 328 (49.2%) had prolonged hospitalisation. The mean hospital stay was 4.88±2.74 days. Multivariate analysis showed that dengue haemorrhagic fever (OR 2.3), elevated alkaline phosphatase (ALP) (OR 2.3), prolonged prothrombin time (PT) (OR 1.7), activated partial thromboplastin time (aPTT) (OR 1.9) and multiple-organ dysfunctions (OR 2.1) were independently associated with prolonged hospitalisation. Overall case fatality rate was 1.1%. Factors associated with dengue mortality were age >40 years (p=0.004), secondary infection (p=0.040), comorbidities (p<0.05), acute kidney injury (p<0.001), prolonged PT (p=0.022), multiple-organ dysfunctions (p<0.001), haematocrit >20% (p=0.001), rhabdomyolosis (p<0.001) and respiratory failure (p=0.007). Approximately half of the fatal cases in our study had prolonged hospital stay of greater than three days.ConclusionsThe results underscore the high proportion of dengue patients with prolonged hospital stay. Early identification of factors relating to prolonged hospitalisation and death will have obvious advantages in terms of appropriate decisions about treatment and management in high dependency units.
Efficacy of nanocurcumin supplementation on insulin resistance, lipids, inflammatory factors and nesfatin among obese patients with non-alcoholic fatty liver disease (NAFLD): a trial protocol
Authors: Jazayeri-Tehrani Seyed Ali , Rezayat Seyed Mahdi , Mansouri Siavash , Qorbani Mostafa , Alavian Seyed Moayed , Daneshi-Maskooni Milad , Hosseinzadeh-Attar Mohammad-Javad 
Published: July 2017

ObjectivesDifferent studies have been conducted on the role of curcumin in health since having multiple properties, including antioxidant and anti-inflammatory effects. Due to the lack of studies regarding curcumin effects on obese patients with non-alcoholic fatty liver disease (NAFLD), our protocol was designed to assess nanocurcumin impacts on blood sugar, lipids, inflammatory indices, insulin resistance and liver function, especially by nesfatin.SettingThis trial will be conducted in the Oil Company central hospital of Tehran, Iran with a primary level of care.Participants84 obese patients with NAFLD diagnosed using ultrasonography will be employed according to the eligibility criteria‎.InterventionsThe patients will be randomly divided into two equal groups (nanocurcumin and placebo, two 40 mg capsules per day with meals for 3 months, follow-up monthly). Also, lifestyle changes (low-calorie diet and physical activity) will be advised.Measures of the primary and secondary outcomesA general questionnaire, 24 hours food recall (at the beginning, middle and end) and short-form International Physical Activity Questionnaire will be completed. Blood pressure, anthropometrics, serum sugar indices (fasting blood sugar and insulin, insulin resistance and sensitivity and glycosylated haemoglobin), lipids (triglyceride, total cholesterol and low-density and high-density lipoprotein-cholesterol, inflammatory profiles (interleukin-6, high-sensitivity C-reactive protein, and tumour necrosis factor-alpha), liver function (alanine and aspartate transaminase) and nesfatin will be measured at the beginning and end of the study.ConclusionThis trial would be the first experiment to determine nanocurcumin efficacy on certain blood factors among obese patients with NAFLD. Nevertheless, studying the potential consequences of curcumin in various diseases, especially NAFLD, is required for clinical use.Trial registration numberIRCT2016071915536N3; pre-results.
Subdissociative intranasal ketamine plus standard pain therapy versus standard pain therapy in the treatment of paediatric sickle cell disease vaso-occlusive crises in resource-limited settings: study protocol for a randomised controlled trial
Authors: Young James R , Sawe Hendry Robert , Mfinanga Juma A , Nshom Ernest , Helm Ethan , Moore Charity G , Runyon Michael S , Reynolds Stacy L 
Published: July 2017

IntroductionPediatric sickle cell disease, highly prevalent in sub-Saharan Africa, carries great morbidity and mortality risk. Limited resources and monitoring make management of acute vaso-occlusive crises challenging. This study aims to evaluate the efficacy and safety of subdissociative intranasal ketamine as a cheap, readily available and easily administered adjunct to standard pain therapy. We hypothesise that subdissociative, intranasal ketamine may significantly augment current approaches to pain management in resource-limited settings in a safe and cost-effective manner.Methods and analysisThis is a multicentred, randomised, double-blind, placebo-controlled trial enrolling children 4–16 years of age with sickle cell disease and painful vaso-occlusive pain crises. Study sites include two sub-Saharan teaching and referral hospitals with acute intake areas. All patients receive standard analgesic therapy during evaluation. Patients randomised to the treatment arm receive 1 mg/kg intranasal ketamine at onset of therapy, while placebo arm participants receive volume-matched intranasal normal saline. All participants and clinical staff are blinded to the treatment allocation. Data will be analysed on an intention-to-treat basis. Primary endpoints are changes in self-report pain scales (Faces Pain Scale-Revised) at 30, 60 and 120 minutes and rates of adverse events. Secondary endpoints include hospital length of stay, total analgesia use and quality of life assessment 2–3 weeks postintervention.Ethics and disseminationThe research methods for this study have been approved by the Cameroon Baptist Convention Health Board Institutional Review Board (IRB2015-07), the Tanzanian National Institute for Medical Research (NIMR/HQ/R.8a/Vol. IX/2299), Muhimbili National Hospital IRB (MNH/IRB/I/2015/14) and the Tanzanian Food and Drugs Authority (TFDA0015/CTR/0015/9). Data reports will be provided to the Data and Safety Monitoring Board (DSMB) periodically throughout the study as well as all reports of adverse events. All protocol amendments will also be reviewed by the DSMB. Study results, regardless of direction or amplitude, will be submitted for publication in relevant peer-reviewed journals.Trial registrationClinicalTrials.Gov,NCT02573714. Date of registration: 8 October 2015. Pre-results.
Frequency and preventative interventions for non-suicidal self-injury and suicidal behaviour in primary school-age children: a scoping review protocol
Authors: Bem Danai , Connor Charlotte , Palmer Colin , Channa Sunita , Birchwood Max 
Published: July 2017

IntroductionNon-suicidal self-injury (NSSI) and suicidal behaviour have been witnessed in children as young as 6–7 years of age, but while there are many reviews of preventative interventions for NSSI and suicide in adolescents, few have explored its prevalence in younger children and the potential impact of preventative interventions at this stage of life. NSSI and suicidal behaviour are an increasing concern in schools but school-based programmes can improve knowledge, attitudes and help-seeking behaviours and help prevent escalation of NSSI and later suicide. This scoping review will aim to explore the nature and extent of the evidence on the magnitude of NSSI and suicidal behaviour in primary school children, and to examine whether there are any primary school-based interventions available for the prevention of this phenomenon in 5 to 11-year-olds.Methods and analysisA scoping review will be conducted using established methodology by Arksey and O’Malley and the Joanna Briggs Institute. Multiple bibliographic and indexing databases and grey literature will be searched using a combination of text words and index terms relating to NSSI, suicide, primary schools, frequency and intervention. Two reviewers will independently screen eligible studies for study selection and extract relevant data from included studies. A narrative summary of evidence will be conducted for all included studies with results presented in tables and/or diagrams. Inductive content analysis will be used to understand any narrative findings within the included studies.Ethics and disseminationEthical approval is not required for this scoping review. The results of this review will be disseminated though publication in a peer-reviewed journal and presented at relevant conferences.
Abortion terminology: views of women seeking abortion in Britain
Authors: Cameron Sharon , Lohr Patricia A , Ingham Roger 
Published: July 2017

BackgroundControversy exists as to whether ‘abortion or ‘termination of pregnancy’ should be used by health professionals during interactions with women and in published works.MethodsSelf-administered anonymous questionnaires were distributed to women attending 54 abortion clinics in Scotland, England and Wales during a 4-month period in 2015. Responses were coded and analysed using SPSS. Descriptive statistics were generated and responses compared by demographic characteristics. The main outcome measures were the proportion of respondents reporting that they found the terms ‘abortion’ and ‘termination of pregnancy’ to be distressing, and women’s preferred terminology for referring to induced abortion.ResultsSurveys were completed by 2259 women. The mean age of the respondents was 27(range 13–51) years; 82% identified as white, 51% had children and 36% had previously undergone abortion. Thirty-five percent indicated that they found the word ‘abortion’ distressing compared with 18% who reported that ‘termination of pregnancy’ was distressing (p< 0.001). Forty-five percent of respondents expressed a preference for ‘termination of pregnancy’ and 12% for ‘abortion’. Sixteen percent would choose either term. This pattern of results did not vary statistically by age, reproductive history, country of residence, ethnicity or level of deprivation.ConclusionsMost women seeking abortion did not find the terms ‘abortion’ or termination of pregnancy’ distressing. When given a choice of terms, more women who expressed a preference chose ‘termination of pregnancy’. Healthcare professionals should be sensitive to preferences for terminology when communicating with women seeking abortion.
Thermostability of DNA Complexes with Mitoxantrone at Small Fillings
Authors: Babayan Yuri S. , Hakobyan Sergey N. , Ghazaryan Rusanna S. , Shahinyan Mariam A. 
Published: July 2017

Thermostability of DNA complexes with anti-tumorous compound — mitoxantrone — at 0.011[Formula: see text]M and 0.11 M NaCl ionic strengths of solution by spectrophotometric and microcalorimetric methods has been studied. It was shown that at small fillings when one molecule of mitoxantrone corresponds to 250 or more base pairs of DNA, the thermostability of complexes strongly depends on the solution’s ionic strength; moreover, at an ionic strength of 0.011 M NaCl the melting temperature dependence on mitoxantrone concentration passes through a minimum. In the mentioned region of mitoxantrone concentration the melting enthalpy of the complexes increases linearly with mitoxantrone concentration enhancement. The observed phenomenon, which is not observed for ethidium bromide complexes with DNA, is qualitatively explained by the increasing of coil-shaped state of DNA–mitoxantrone complex due to additional freedom of rotation of mitoxantrone side groups.