bluuebunny/crossref_metadata_2025_split huggingface dataset:
Anticipatory guidance to prevent infant sleep problems within a randomised controlled trial: infant, maternal and partner outcomes at 6 months of age
Authors: Galland Barbara C , Sayers Rachel M , Cameron Sonya L , Gray Andrew R , Heath Anne-Louise M , Lawrence Julie A , Newlands Alana , Taylor Barry J , Taylor Rachael W 
Published: June 2017

ObjectiveTo evaluate the effectiveness of sleep education delivered antenatally and at 3 weeks postpartum to prevent infant sleep problems at 6 months of age.DesignSleep intervention within a randomised controlled trial for the Prevention of Overweight in Infancy (POI) study.Participants802 families were randomly allocated to one of four groups: usual care (control), sleep intervention (sleep), food, activity and breastfeeding intervention (FAB), and combined group receiving both interventions (combination).InterventionsAll groups received standard Well Child care. The sleep intervention groups (sleep and combination) received an antenatal group education session (all mothers and most partners) emphasising infant self-settling and safe sleeping, and a home visit at 3 weeks reinforcing the antenatal sleep education. FAB and combination groups received four contacts providing education and support on breast feeding, food and activity up to 4 months postpartum.Outcome measuresHere we report secondary sleep outcomes from the POI study: the prevalence of parent-reported infant sleep problems and night waking, and differences in sleep duration. Additional outcomes reported include differences in infant self-settling, safe sleep practices, and maternal and partner reports of their own sleep, fatigue and depression symptoms.ResultsLinear or mixed linear regression models found no significant intervention effects on sleep outcomes, with 19.1% of mothers and 16.6% of partners reporting their infant’s sleep a problem at 6 months. Actigraphy estimated the number of night wakings to be significantly reduced (8%) and the duration of daytime sleep increased (6 min) in those groups receiving the sleep intervention compared with those who did not. However, these small differences were not clinically significant and not observed in 24 hours infant sleep diary data. No other differences were observed.ConclusionA strategy delivering infant sleep education antenatally and at 3 weeks postpartum was not effective in preventing the development of parent-reported infant sleep problems.
Sex differences in auditory verbal hallucinations in early, middle and late adolescence: results from a survey of 17 451 Japanese students aged 12–18 years
Authors: Morokuma Yoko , Endo Kaori , Nishida Atushi , Yamasaki Syudo , Ando Shuntaro , Morimoto Yuko , Nakanishi Miharu , Okazaki Yuji , Furukawa Toshi A , Morinobu Shigeru , Shimodera Shinji 
Published: June 2017

ObjectivesWomen have higher rates of auditory verbal hallucinations (AVH) than men; however, less is known about sex differences in the prevalence of AVH in early, middle and late adolescence. We sought to elucidate the differences in the prevalence of AVH and to examine the degree to which these differences could be explained by differences in levels of depressive symptoms.DesignWe used a cross-sectional design and a self-reported questionnaire.SettingParticipants were recruited from public junior and senior high schools in Tsu, Mie Prefecture and Kochi Prefecture, Japan.ParticipantsIn total, 19 436 students were contacted and 18 250 participated. Responses from 17 451 students with no missing data were analysed (aged 12–18 years, Mage=15.2 years (SD=1.7), 50.6% girls).MeasuresAVH were assessed through one of four items adopted from the schizophrenia section of the Japanese version of the Diagnostic Interview Schedule for Children. Depressive symptoms were assessed using the 12-item General Health Questionnaire.ResultsThe prevalence of AVH was 7.0% among early adolescents (aged 12–13 years), 6.2% among middle adolescents (aged 14–15 years) and 4.8% among late adolescents (aged 16–18 years). Being female was significantly associated with a higher prevalence of AVH through adolescence (OR=1.71, 95% CI 1.31 to 2.23 in early adolescence; OR=1.42, 95% CI 1.14 to 1.76 in middle adolescence; OR=1.52, 95% CI 1.23 to 1.87 in late adolescence); however, these differences became non-significant after adjusting for depressive symptoms (OR=1.21, 95% CI 0.92 to 1.60; OR=1.00, 95% CI 0.80 to 1.25; OR=1.16, 95% CI 0.93 to 1.44, respectively).ConclusionsSex differences in auditory hallucinations are seen in both adult and youth populations. The higher rates of auditory verbal hallucinations seen in girls may be secondary to the differences in the rate of depressive symptoms.
AnAnkle Trial study protocol: a randomised trial comparing pain profiles after peripheral nerve block or spinal anaesthesia for ankle fracture surgery
Authors: Sort Rune , Brorson Stig , Gögenur Ismail , Møller Ann Merete 
Published: June 2017

IntroductionAnkle fracture surgery is a common procedure, but the influence of anaesthesia choice on postoperative pain and quality of recovery is poorly understood. Some authors suggest a benefit of peripheral nerve block (PNB) in elective procedures, but the different pain profile following acute fracture surgery and the rebound pain on cessation of the PNB both remain unexplored. We present an ongoing randomised study aiming to compare primary PNB anaesthesia with spinal anaesthesia for ankle fracture surgery regarding postoperative pain profiles and quality of recovery.Methods and analysisAnAnkle Trial is a randomised, dual-centre, open-label, blinded analysis trial of 150 adult patients undergoing primary internal fixation of an ankle fracture. Main exclusion criteria are habitual opioid use, impaired pain sensation, other painful injuries or cognitive impairment. The intervention is ultrasound-guided popliteal sciatic (20 mL) and saphenal nerve (8 mL) PNB with ropivacaine 7.5 mg/mL, and controls receive spinal anaesthesia (2 mL) with hyperbaric bupivacaine 5 mg/mL. Postoperatively all receive paracetamol, ibuprofen and patient-controlled intravenous morphine on demand. Morphine consumption and pain scores are registered in the first 27 hours and reported as an integrated pain score as the primary endpoint. Pain score intervals are 3 hours and we will use the area under curve to get a longitudinal measure of pain. Secondary outcomes include rebound pain on cessation of anaesthesia, opioid side effects (Opioid-Related Symptom Distress Scale), quality of recovery (Danish Quality of Recovery-15 score) and pain scores and medication days 1–7 (diary).Ethics and disseminationThe study has been approved by the Regional Ethics Committees in the Capital Region of Denmark, the Danish Data Protection Agency and the Danish Health and Medical Authority. We will publish the results in international peer-reviewed medical journals.Trial registration numberAnAnkle Trial is registered in the European Clinical Trials Database (EudraCT 2015-001108-76).
The Taking Charge After Stroke (TaCAS) study protocol: a multicentre, investigator-blinded, randomised controlled trial comparing the effect of a single Take Charge session, two Take Charge sessions and control intervention on health-related quality of life 12 months after stroke for non-Māori, non-Pacific adult New Zealanders discharged to community living
Authors: Fu Vivian Wai Yin , Weatherall Mark , McNaughton Harry 
Published: June 2017

IntroductionStroke is one of the leading causes of disability worldwide. Recent data support the possibility that person-centred, self-management interventions can reduce dependence after stroke. However, there is limited information on the generalisability and optimum dose of these interventions.MethodsThe Taking Charge After Stroke (TaCAS) study is a multicentre, investigator-blinded, randomised controlled trial recruiting 400 participants following acute stroke from seven hospitals in New Zealand. All patients discharged to community living who have ongoing symptoms at time of discharge (modified Rankin scale>0) will be eligible. Participants will be randomly assigned to one Take Charge session, two Take Charge sessions 6 weeks apart or control.OutcomesThe primary outcome will be the Physical Component Summary score of the Short-Form 36 at 12 months post stroke. Secondary outcomes will include dependence (modified Rankin scale), performance in activities of daily living (Barthel Index) and carer strain (Caregiver Strain Index), at 6 and 12 months post stroke. All analyses will be conducted on an intention-to-treat basis.Ethics and disseminationThe TaCAS study is funded by a Health Research Council of New Zealand grant. It has been approved by the Central Health and Disability Ethics Committee (15/CEN/115). Results will be published and presented at relevant stroke meetings within New Zealand and internationally, informing the use of a self-management intervention after stroke.Trial registrationAustralia and New Zealand Clinical Trials Registry ACTRN12615001163594. Date registered 02-11-2015. Medical Research Institute of New Zealand Registry TCS01. Universal trial number U1111-1171-4127.
Changes in lung function during exercise are independently mediated by increases in deep body temperature
Authors: Tipton Michael J , Kadinopoulos Pippa , Sa Dan Roiz de , Barwood Martin J 
Published: June 2017

BackgroundThis study examined whether an increase in deep body temperature contributes to increases in ventilatory flow indicative of bronchodilatation.MethodThe study employed a within-participant repeated measures design. Nine participants (mean (SD): age 22 (3) years; height 177.7 (8.3) cm; mass 80.2 (19.1) kg) completed three conditions: exercise (EXERC; 30 min); 40°C water immersion (IMM40; 30 min) to passively raise rectal temperature (Tre) and 35°C immersion (IMM35; 30 min) asa thermoneutral control for IMM40. A forced vital capacity (FVC) manoeuvre was performed at the start of the test and every 10 min thereafter. Forced expiratory volume in 1 s (FEV1), FEV1/FVC, 25%, 50% and 75% maximal expiratory flow during FVC (forced expiratory flow (FEF)25, FEF50, FEF75) were also measured. Data were compared using a repeated measures two-way analysis of variance, with a 0.05 α level.ResultsRectal temperature (Tre) peaked after 30 min in the EXERC (mean (SD) 38.0 (0.3)°C) and IMM40 (38.2 (0.2)°C) conditions and both were higher (p<0.05) than at the corresponding time in the thermoneutral condition (37.2 (0.2)°C). At this time, FEV1was 4.5 (0.6), 4.6 (0.3) and 4.4 (0.6) L, respectively. Tre, FEV1and FEV1/FVC were greater in the IMM40 and EXERC conditions compared with the IMM35 condition. Interaction effects were evident for FEF50 and FEF75 (p<0.05), being higher in IMM40 and EXERC conditions.ConclusionIncreasing deep body temperature, independently, contributes to the increased airflow ascribed to bronchodilatation when exercising.
Time-based measures of treatment effect: reassessment of ticagrelor and clopidogrel from the PLATO trial
Authors: Bellavia Andrea , Wallentin Lars , Orsini Nicola , James Stefan K , Cannon Christopher P , Himmelmann Anders , Sundström Johan , Renlund Henrik , Lytsy Per 
Published: June 2017

ObjectiveTreatment effects to binary endpoints using time-to-event data in randomised controlled trials are typically summarised by reporting HRs derived with Cox proportional hazard models. Alternative and complementary methods include summarising the between-treatment differences on the metric time scale, quantifying the effect as delay of the event (DoE). The aim of this study was to reassess data from the PLATO study expressing the effects as the time by which the main outcomes are delayed or hastened due to treatment.MethodsPLATO was a randomised controlled double-blind multicentre study (n=18,624), conducted between 2006 and 2008, which demonstrated superiority of the antiplatelet treatment ticagrelor over clopidogrel in reducing risk of several cardiovascular events. In the present study, four of the main PLATO outcomes were reassessed by calculating the time by which an event may be delayed due to the treatment.ResultsThe effects of ticagrelor, as compared with clopidogrel, consisted of a substantial delay of the evaluated outcomes, ranging from 83 to 98 days over 400-day follow-up. The Delay of Events Curves showed that the effects progressively increased over time, and the significant findings were concordant with those presented in the original PLATO study.ConclusionsThis study confirmed evidence of a beneficial effect of ticagrelor over clopidogrel, and provided the magnitude of such effects in terms of delayed event time. Investigating time-to-event data with a percentile approach allows presenting treatment effects from randomised controlled studies as absolute measures of the time by which an event may be delayed due to the treatment.Trial registration numberPLATO (www.clinicaltrials.gov;NCT00391872); Results.
Exhumation of a migmatite complex along a transpressive shear zone: inferences from the Variscan Juzbado–Penalva do Castelo Shear Zone (Central Iberian Zone)
Authors: Pereira Inês , Dias Rui , Bento dos Santos Telmo , Mata João 
Published: June 2017

High-grade metamorphic rocks associated with S-type granites are recorded in the Central Iberian Zone, Iberian Variscides. Though most of these occur as inferred metamorphic core complexes affiliated with detachment faults, others, such as the Figueira de Castelo Rodrigo–Lumbrales Anatectic Complex, crop out between low-grade metamorphic rocks separated by steeply-dipping strike-slip shear zones, such as the Juzbado–Penalva do Castelo Shear Zone. Our structural analysis has been able to constrain two major deformation stages during the Variscan D
3
: (a) D
3a
ductile deformation event, with clear sinistral kinematic criteria; and (b) D
3b
thrusting ductile–brittle deformation event. The petrological investigation confirmed the jump in metamorphic grade between the host rocks and the anatectic complex.
P–T
estimates on calc-silicate rocks interlayered with the metapelites of the anatectic complex provided minimum metamorphic peak conditions of
T
= 761 ± 50°C and
P
= 5.0 ± 1.0 kbar. However, petrological modelling results show that
P–T
conditions must have exceeded
T
> 800°C. Both structural and geothermobarometric data support a two-step model for the exhumation of the Anatectic Complex, including a 5 – 8 km vertical exhumation along a 65 – 100 km horizontal displacement due to a simple shear-dominated transpression mechanism during the Variscan D
3
events.

Supplementary material:
The petrology data, mineral chemistry analyses of the calc-silicate units and EPMA analytical conditions, and the
P–T
modelling methodology can be found at
https://doi.org/10.6084/m9.figshare.c.3785648
Early Evaluation of Circulating Tumor DNA as Marker of Therapeutic Efficacy in Metastatic Colorectal Cancer Patients (PLACOL Study)
Authors: Garlan Fanny , Laurent-Puig Pierre , Sefrioui David , Siauve Nathalie , Didelot Audrey , Sarafan-Vasseur Nasrin , Michel Pierre , Perkins Geraldine , Mulot Claire , Blons Hélène , Taieb Julien , Di Fiore Frederic , Taly Valerie , Zaanan Aziz 
Published: June 2017

Abstract
Purpose: Markers of chemotherapy efficacy in metastatic colorectal cancer (mCRC) are essential for optimization of treatment strategies. We evaluated the applicability of early changes in circulating tumor DNA (ctDNA) as a marker of therapeutic efficacy.
Experimental Design: This prospective study enrolled consecutive patients with mCRC receiving a first- or second-line chemotherapy. CtDNA was assessed in plasma collected before the first (C0), second (C1) and/or third (C2) chemotherapy cycle, using picodroplet-digital PCR assays based either on detection of gene mutation (KRAS, BRAF, TP53) or hypermethylation (WIF1, NPY). CT scans were centrally assessed using RECIST v1.1 criteria. Multivariate analyses were adjusted on age, gender, ECOG performance status (PS), metastatic synchronicity, and treatment line.
Results: Eighty-two patients with mCRC treated in first- (82.9%) or second- (17.1%) line chemotherapy were included. Patients with a high (&gt;10 ng/mL) versus low (≤0.1 ng/mL) ctDNA concentration at C0 had a shorter overall survival (OS; 6.8 vs. 33.4 months: adjusted HR, 5.64; 95% CI, 2.5–12.6; P &lt; 0.0001). By analyzing the evolution of the ctDNA concentration between C0 and C2 or C1 (C2or1), we classified the patients in two groups (named “good” or “bad ctDNA responders”). In multivariate analysis, patients belonging to the group called “good ctDNA responder” (n = 58) versus “bad ctDNA responder” (n = 15) had a better objective response rate (P &lt; 0.001), and a longer median progression-free survival (8.5 vs. 2.4 months: HR, 0.19; 95% CI, 0.09–0.40; P &lt; 0.0001) and OS (27.1 vs. 11.2 months: HR, 0.25; 95% CI, 0.11–0.57; P &lt; 0.001).
Conclusions: This study suggests that early change in ctDNA concentration is a marker of therapeutic efficacy in patients with mCRC. Clin Cancer Res; 23(18); 5416–25. ©2017 AACR.
Outcomes of Ventricular Tachycardia Ablation Using Percutaneous Left Ventricular Assist Devices
Authors: Kusa Shigeki , Miller Marc A. , Whang William , Enomoto Yoshinari , Panizo Jorge G. , Iwasawa Jin , Choudry Subbarao , Pinney Sean , Gomes Anthony , Langan Noelle , Koruth Jacob S. , d’Avila Andre , Reddy Vivek Y. , Dukkipati Srinivas R. 
Published: June 2017

Background—
Although percutaneous left ventricular assist devices (pLVADs) facilitate mapping and ablation of hemodynamically unstable ventricular tachycardia (VT), there is limited data whether clinical outcomes are improved. We sought to retrospectively compare the outcomes of patients undergoing scar-related VT ablation with and without pLVAD support.

Methods and Results—

The study population comprised 194 patients (109 pLVAD and 85 non-pLVAD). The pLVAD group more often had dilated cardiomyopathy (33% versus 13%;
P
=0.001), New York Heart Association heart failure class ≥III (51% versus 25%;
P
<0.001), lower left ventricular ejection fractions (26±10% versus 39±16%;
P
<0.001), and electrical storm (49% versus 34%;
P
=0.04). Procedure times (422±112 versus 330±92 minutes;
P
<0.001), postablation VT inducibility (20% versus 7%;
P
=0.02), and length of subsequent hospitalization (median 6 versus 4 days;
P
=0.001) were all higher in the pLVAD group. During median follow-up of 215 days, the primary end point (recurrent VT, heart transplantation, or death) occurred in 36% of the pLVAD versus 26% of the non-pLVAD groups (
P
=0.14). After propensity matching for differences between groups, no differences were seen between groups for both acute procedural outcomes and the primary end point.

Conclusions—
In this large single-center scar-related VT ablation experience, despite the worse clinical status of the patients selected for pLVAD support, clinical outcomes were better than expected and were similar to healthier patients not receiving hemodynamic support. Patients with dilated cardiomyopathy presenting with electrical storm, advanced heart failure, and severe left ventricular dysfunction most frequently received hemodynamic support during VT ablation.
Gut‐Derived Serum Lipopolysaccharide is Associated With Enhanced Risk of Major Adverse Cardiovascular Events in Atrial Fibrillation: Effect of Adherence to Mediterranean Diet
Authors: Pastori Daniele , Carnevale Roberto , Nocella Cristina , Novo Marta , Santulli Maria , Cammisotto Vittoria , Menichelli Danilo , Pignatelli Pasquale , Violi Francesco 
Published: June 2017

Background

Gut microbiota is emerging as a novel risk factor for atherothrombosis, but the predictive role of gut‐derived lipopolysaccharide (
LPS
) is unknown. We analyzed (1) the association between
LPS
and major adverse cardiovascular events (
MACE
) in atrial fibrillation (
AF
) and (2) its relationship with adherence to a Mediterranean diet (Med‐diet).

Methods and Results

This was a prospective single‐center study including 912
AF
patients treated with vitamin K antagonists (3716 patient‐years). The primary end point was a composite of
MACE
. Baseline serum
LPS
, adherence to Med‐diet (n=704), and urinary excretion of 11‐dehydro‐thromboxane B
2
(TxB
2
, n=852) were investigated. Mean age was 73.5 years; 42.9% were women. A total of 187
MACE
(5.0% per year) occurred: 54, 59, and 74 in the first, second, and third tertile of
LPS
, respectively (log‐rank test
P
=0.004). Log‐
LPS
(hazard ratio 1.194,
P
=0.009), age (hazard ratio 1.083,
P
<0.001), and previous cerebrovascular (hazard ratio 1.634,
P
=0.004) and cardiac events (hazard ratio 1.822,
P
<0.001) were predictors of
MACE
. In the whole cohort,
AF
(versus sinus rhythm) (β 0.087,
P
=0.014) and low‐density lipoprotein cholesterol (β 0.069,
P
=0.049) were associated with circulating
LPS
. Furthermore, Med‐diet score (β −0.137,
P
<0.001) was predictive of log‐
LPS
, with fruits (β −0.083,
P
=0.030) and legumes (β −0.120,
P
=0.002) negatively associated with log‐
LPS
levels. Log‐
LPS
and log‐TxB
2
were highly correlated (r=0.598,
P
<0.001). Log‐
LPS
(β 0.574,
P
<0.001) and Med‐diet score (β −0.218,
P
<0.001) were significantly associated with baseline urinary excretion of TxB
2
.

Conclusions

In this cohort of
AF
patients,
LPS
levels were predictive of
MACE
and negatively affected by high adherence to Med‐diet.
LPS
may contribute to
MACE
incidence in
AF
by increasing platelet activation.
The Impact of Social Support on Self-care of Patients With Diabetes: What Is the Effect of Diabetes Type? Systematic Review and Meta-analysis
Authors: Song Youngshin , Nam Soohyun , Park Seyeon , Shin In-soo , Ku Bon Jeong 
Published: June 2017

Purpose This meta-analysis examined relationships between social support and self-care in type 1 (T1DM) and 2 diabetes mellitus (T2DM). Methods We searched for published and unpublished studies using the following databases: PubMed, Embase, PsycINFO, the Cochrane Library, and Medline. MeSH search terms included “diabetes mellitus,” “social support,” “caregiver,” “self-care,” “self-management,” “self-care skills,” and “coping behavior.” Studies reporting correlations between social support and self-care were included. Results Initially, 2 095 studies were extracted. After eliminating duplicate and irrelevant studies, 28 studies involving 5 242 patients with diabetes were included. Of these, 22 studies examined T2DM subjects. Social support was significantly associated with self-care ( k = 28, r = .28, 95% CI: .21-.34, P < .001). Among the diabetes self-care types, the strongest effect was found for glucose monitoring ( k = 6, r = .21, 95% CI: .08-.33). The relationship between social support and self-care was stronger in T2DM ( k = 22, r = .30, 95% CI: .22-.37), relative to T1DM, samples ( k = 5, r = .22, 95% CI: .02-.38). Conclusion It was concluded that the overall effect size for social support on self-care was moderate, and its strength differed by ethnic majority within the sample, type of social support measures, and publication status.
Presenting ADAMTS13 antibody and antigen levels predict prognosis in immune-mediated thrombotic thrombocytopenic purpura
Authors: Alwan Ferras , Vendramin Chiara , Vanhoorelbeke Karen , Langley Katy , McDonald Vickie , Austin Steve , Clark Amanda , Lester William , Gooding Richard , Biss Tina , Dutt Tina , Cooper Nichola , Chapman Oliver , Cranfield Tanya , Douglas Kenny , Watson H. G. , van Veen J. J. , Sibson Keith , Thomas William , Manson Lynn , Hill Quentin A. , Benjamin Sylvia , Ellis Debra , Westwood John-Paul , Thomas Mari , Scully Marie 
Published: June 2017

Key PointsHigh anti-ADAMTS13 antibody and low ADAMTS13 antigen levels adversely affect outcome in immune-mediated TTP with greater mortality seen. A raised troponin at presentation confers a sixfold increase and reduced GCS a nine-fold increase in mortality in acute TTP.