bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pragmatic randomised evaluation of stable thoracolumbar fracture treatment outcomes (PRESTO): study protocol for a randomised controlled feasibility trial combined with a qualitative study and survey
Authors: Cook Elizabeth , Booth Alison , Coleman Elizabeth , Scantlebury Arabella , McDaid Catriona , Hewitt Catherine , Corbacho Belen , Rangan Amar , Adamson Joy , Ranganathan Arun , Khan Almas , Ahuja Sashin , Turner Emma , May Peter , Hilton Catherine , Torgerson David J. 
Published: March 2020

Abstract
Background
A thoracolumbar fracture is the most common fracture of the spinal column. Where the fracture is not obviously stable or unstable, the optimal management is uncertain. There are variations between surgeons, treating centres and within the evidence base as to whether surgical or non-surgical approaches should be used. In addition, the boundaries of this zone of uncertainty for stability are unclear.
This study has been designed in response to an NIHR HTA commissioning brief to assess the feasibility of undertaking a large-scale trial to evaluate the effectiveness of surgical and non-surgical treatments for thoracolumbar fractures without neurological deficit.

Methods
Assessment of feasibility will be addressed through three elements: a randomised external feasibility study, a national survey of surgeons and a qualitative study.
The external feasibility study is a pragmatic, parallel-group, randomised controlled trial comparing surgical fixation (intervention) versus non-surgical management (control). Recruitment will take place in three secondary care centres in the UK.
The primary outcome is recruitment rate, defined as the proportion of eligible participants who are randomised. Further outcomes related to recruitment, randomisation, drop-out, cross-over, loss to follow-up, completeness of outcome data, study processes and details of the interventions delivered will be collected.
The survey of surgeons and qualitative study of clinicians, recruiting staff and patients will enhance the feasibility study, enabling a broad overview of current practice in the field in addition to perceived facilitators and barriers to running a full-scale trial.

Discussion
PRESTO is a feasibility study which aims to inform methodology for a definitive trial comparing surgical fixation with non-surgical management for patients with stable thoracolumbar fractures.

Trial registration
The trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN12094890). Date of registration was 22/02/2018 (http://www.isrctn.com/ISRCTN12094890).
Applying intervention mapping approach to a program for early intervention in first-episode mental crisis of a psychotic type
Authors: Machado Daniela Martins , Murta Sheila Giardini , da Costa Ileno Izídio 
Published: March 2020

AbstractThe holotropic mind perspective, an integral part of the framework of transpersonal psychology, has been considered a revolutionary approach to a certain spectrum of experiences in Non-ordinary states of consciousness (NOSC) which conventional approaches tend to treat indiscriminately as pathological processes, because PHM recognizes in these experiences their healing and evolutionary potential. This article describes the needs assessment, implementation, and evaluation of an experiential and educational program on the holotropic mind perspective and its praxis, Holotropic Breathwork® (HB), with students and professionals from the Group for Early Intervention in First-Episode Mental Crisis of a Psychotic Type of the University of Brasilia. The intervention aimed to establish change goals and objectives that would promote the adoption of the holotropic mind perspective’s elements, such as a framework to broaden and strengthen mental health programs that assist people experiencing NOSC. The stages developed, inspired by the Intervention Mapping protocol, included a needs assessment; elaboration of change objective matrices; selection and description of methods based on theory and their applications; conception, planning, and implementation of the intervention; and results evaluation. Participants reported that the intervention allowed the expansion of their theoretical-conceptual and technical frameworks, giving them a less pathologizing understanding of and approach to NOSC and allowing them to perceive and manage such states, not as indiscriminately pathological expressions, but as phenomena inherent to the human condition that can be accepted and cared for without the exclusionary and exhaustive bias of mental disorders. Limitations and practical implications are discussed.
Phase I Escalation and Expansion Study of Bemarituzumab (FPA144) in Patients With Advanced Solid Tumors and FGFR2b-Selected Gastroesophageal Adenocarcinoma
Authors: Catenacci Daniel V.T. , Rasco Drew , Lee Jeeyun , Rha Sun Young , Lee Keun-Wook , Bang Yung Jue , Bendell Johanna , Enzinger Peter , Marina Neyssa , Xiang Hong , Deng Wei , Powers Janine , Wainberg Zev A. 
Published: March 2020

PURPOSE To evaluate the safety, pharmacokinetics, and preliminary activity of bemarituzumab in patients with FGFR2b-overexpressing gastric and gastroesophageal junction adenocarcinoma (GEA). PATIENTS AND METHODS FPA144-001 was a phase I, open-label, multicenter trial consisting of the following 3 parts: part 1a involved dose escalation in patients with recurrent solid tumors at doses ranging from 0.3 to 15 mg/kg; part 1b involved dose escalation in patients with advanced-stage GEA; and part 2 involved dose expansion in patients with advanced-stage GEA that overexpressed FGFR2b at various levels (4 cohorts; high, medium, low, and no FGFR2b overexpression) and 1 cohort of patients with FGFR2b-overexpressing advanced-stage bladder cancer. RESULTS Seventy-nine patients were enrolled; 19 were enrolled in part 1a, 8 in part 1b, and 52 in part 2. No dose-limiting toxicities were reported, and the recommended dose was identified as 15 mg/kg every 2 weeks based on safety, tolerability, pharmacokinetic parameters, and clinical activity. The most frequent treatment-related adverse events (TRAEs) were fatigue (17.7%), nausea (11.4%), and dry eye (10.1%). Grade 3 TRAEs included nausea (2 patients) and anemia, neutropenia, increased AST, increased alkaline phosphatase, vomiting, and an infusion reaction (1 patient each). Three (10.7%) of 28 patients assigned to a cohort receiving a dose of ≥ 10 mg/kg every 2 weeks for ≥ 70 days reported reversible grade 2 corneal TRAEs. No TRAEs of grade ≥ 4 were reported. Five (17.9%; 95% CI, 6.1% to 36.9%) of 28 patients with high FGFR2b-overexpressing GEA had a confirmed partial response. CONCLUSION Overall, bemarituzumab seems to be well tolerated and demonstrated single-agent activity as late-line therapy in patients with advanced-stage GEA. Bemarituzumab is currently being evaluated in combination with chemotherapy in a phase III trial as front-line therapy for patients with high FGFR2b-overexpressing advanced-stage GEA.
Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer
Authors: Makker Vicky , Taylor Matthew H. , Aghajanian Carol , Oaknin Ana , Mier James , Cohn Allen L. , Romeo Margarita , Bratos Raquel , Brose Marcia S. , DiSimone Christopher , Messing Mark , Stepan Daniel E. , Dutcus Corina E. , Wu Jane , Schmidt Emmett V. , Orlowski Robert , Sachdev Pallavi , Shumaker Robert , Casado Herraez Antonio 
Published: March 2020

PURPOSE Patients with advanced endometrial carcinoma have limited treatment options. We report final primary efficacy analysis results for a patient cohort with advanced endometrial carcinoma receiving lenvatinib plus pembrolizumab in an ongoing phase Ib/II study of selected solid tumors. METHODS Patients took lenvatinib 20 mg once daily orally plus pembrolizumab 200 mg intravenously once every 3 weeks, in 3-week cycles. The primary end point was objective response rate (ORR) at 24 weeks (ORRWk24); secondary efficacy end points included duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Tumor assessments were evaluated by investigators per immune-related RECIST. RESULTS At data cutoff, 108 patients with previously treated endometrial carcinoma were enrolled, with a median follow-up of 18.7 months. The ORRWk24 was 38.0% (95% CI, 28.8% to 47.8%). Among subgroups, the ORRWk24 (95% CI) was 63.6% (30.8% to 89.1%) in patients with microsatellite instability (MSI)–high tumors (n = 11) and 36.2% (26.5% to 46.7%) in patients with microsatellite-stable tumors (n = 94). For previously treated patients, regardless of tumor MSI status, the median DOR was 21.2 months (95% CI, 7.6 months to not estimable), median PFS was 7.4 months (95% CI, 5.3 to 8.7 months), and median OS was 16.7 months (15.0 months to not estimable). Grade 3 or 4 treatment-related adverse events occurred in 83/124 (66.9%) patients. CONCLUSION Lenvatinib plus pembrolizumab showed promising antitumor activity in patients with advanced endometrial carcinoma who have experienced disease progression after prior systemic therapy, regardless of tumor MSI status. The combination therapy had a manageable toxicity profile.
Rising Incidence and Incidence-Based Mortality of Thyroid Cancer in California, 2000-2017
Authors: Yan Kimberly L , Li Shanpeng , Tseng Chi-Hong , Kim Jiyoon , Nguyen Dalena T , Dawood Nardeen B , Livhits Masha J , Yeh Michael W , Leung Angela M 
Published: March 2020

Abstract

Context
The increased incidence of thyroid cancer globally over the past several decades is principally attributed to small, indolent papillary thyroid cancers. A possible concomitant increase in thyroid cancer-specific mortality remains debated.

Objective
The changes in thyroid cancer incidence and incidence-based mortality were assessed using a large population-based cohort over an 18-year period.

Design & Patients
A retrospective analysis of all thyroid cancers reported in the California Cancer Registry was performed (2000–2017). Age-adjusted incidence and incidence-based mortality rates were analyzed using a log-linear model to estimate annual percent change.

Results
We identified 69 684 individuals (76% female, median age 50 years) diagnosed with thyroid cancer. The incidence of thyroid cancer increased across all histological subtypes (papillary, follicular, medullary, and anaplastic) and all tumor sizes. The incidence increased from 6.43 to 11.13 per 100 000 person-years (average increase 4% per year; P &lt; 0.001) over the study period. Thyroid cancer-specific mortality rates increased on average by 1.7% per year (P &lt; 0.001). The increased mortality rates were greater in men (2.7% per year, P &lt; 0.001) and patients with larger tumors (2-4 cm) (3.4% per year, P &lt; 0.05).

Conclusions
Data from this statewide registry demonstrate that the incidence of thyroid cancer is increasing, and that this phenomenon is not restricted to small papillary thyroid cancers. Rising incidence in thyroid cancers of all sizes with concurrent increase of incidence-based mortality in men and those with larger tumors suggest a true increase in clinically significant disease.
Association Between Maternal Normal Range HbA1c Values and Adverse Birth Outcomes
Authors: Bi Jianing , Ji Cunwei , Wu Yuntao , Wu Mingyang , Liu Yunyun , Song Lulu , Khatiwada Shikha Upadhyaya , Yang Senbei , Li Bing , Wang Youjie , Wu Li 
Published: March 2020

AbstractContextHigher blood glucose level during gestational periods has been consistently associated with increased risk of adverse birth outcomes. Evidence regarding the association between higher glycated hemoglobin A1c (HbA1c) within the normal range and adverse birth outcomes is limited.ObjectiveWe aimed to examine the association between HbA1c within the normal range and the risk of adverse birth outcomes.Design and SettingThe data were abstracted from the Information System of Guangdong Women and Children Hospital, China, from September 2014 to March 2018.PatientsA total of 5658 pregnant women with normal gestational HbA1c were included in this analysis.Main Outcome MeasuresThe adverse birth outcomes include preterm birth, macrosomia, and large for gestational age (LGA).ResultsAmong 5658 subjects, the rates of preterm birth, macrosomia, and LGA were 4.6% (261/5658), 3.5% (200/5658), and 5.7% (325/5658), respectively. The results of multivariate logistic regression model showed that each 1% increase in maternal HbA1c was positively associated with increased risks of preterm birth (OR 1.58; 95% CI, 1.08-2.31), macrosomia (OR 1.70; 95% CI, 1.10-2.64), and LGA (OR 1.38; 95% CI, 0.98-1.96). The association between gestational HbA1c and preterm birth was more evident among women with prepregnancy body mass index (BMI) ≤ 24 kg/m2.ConclusionsGestational higher HbA1c level within the normal range is an independent risk factor for preterm birth, macrosomia, and LGA. Intervention for reducing HbAc1 may help to prevent adverse birth outcomes.
Intraoperative Cardiac Arrest During Adult Liver Transplantation: Incidence and Risk Factor Analysis From 7 Academic Centers in the United States
Authors: Smith Natalie K , Zerillo Jeron , Kim Sang Jo , Efune Guy E. , Wang Cynthia , Pai Sher-Lu , Chadha Ryan , Kor Todd M. , Wetzel David R. , Hall Michael A. , Burton Kristen K. , Fukazawa Kyota , Hill Bryan , Spad Mia-Ashley , Wax David B. , Lin Hung-Mo , Liu Xiaoyu , Odeh Jaffer , Torsher Laurence , Kindscher James D. , Mandell M. Susan , Sakai Tetsuro , DeMaria Samuel 
Published: March 2020

Background:
Intraoperative cardiac arrest (ICA) has a reported frequency of 1 in 10,000 anesthetics but has a much higher estimated incidence in orthotopic liver transplantation (OLT). Single-center studies of ICA in OLT are limited by small sample size that prohibits multivariable regression analysis of risks.

METHODS:
Utilizing data from 7 academic medical centers, we performed a retrospective, observational study of 5296 adult liver transplant recipients (18–80 years old) between 2000 and 2017 to identify the rate of ICA, associated risk factors, and outcomes.

RESULTS:
ICA occurred in 196 cases (3.7% 95% confidence interval [CI], 3.2–4.2) and mortality occurred in 62 patients (1.2%). The intraoperative mortality rate was 31.6% in patients who experienced ICA. In a multivariable generalized linear mixed model, ICA was associated with body mass index (BMI) <20 (odds ratio [OR]: 2.04, 95% CI, 1.05–3.98; P = .0386), BMI ≥40 (2.16 [1.12–4.19]; P = .022), Model for End-Stage Liver Disease (MELD) score: (MELD 30–39: 1.75 [1.09–2.79], P = .02; MELD ≥40: 2.73 [1.53–4.85], P = .001), postreperfusion syndrome (PRS) (3.83 [2.75–5.34], P < .001), living donors (2.13 [1.16–3.89], P = .014), and reoperation (1.87 [1.13–3.11], P = .015). Overall 30-day and 1-year mortality were 4.18% and 11.0%, respectively. After ICA, 30-day and 1-year mortality were 43.9% and 52%, respectively, compared to 2.6% and 9.3% without ICA.

CONCLUSIONS:
We established a 3.7% incidence of ICA and a 1.2% incidence of intraoperative mortality in liver transplantation and confirmed previously identified risk factors for ICA including BMI, MELD score, PRS, and reoperation and identified new risk factors including living donor and length of surgery in this multicenter retrospective cohort. ICA, while rare, is associated with high intraoperative mortality, and future research must focus on therapy to reduce the incidence of ICA.
Increased Anandamide and Decreased Pain and Depression after Exercise in Fibromyalgia
Authors: STENSSON NICLAS , GERDLE BJÖRN , ERNBERG MALIN , MANNERKORPI KAISA , KOSEK EVA , GHAFOURI BIJAR 
Published: March 2020

ABSTRACT

Purpose
Physical exercise is increasingly being promoted by health care for chronic pain conditions with beneficial outcomes, such as pain and fatigue reduction, and increased quality of life. Nevertheless, knowledge about biochemical consequences of physical exercise in chronic pain is still relatively poor. The endocannabinoid system has been suggested to play a role for acute exercise-induced reward and pain inhibition. The aim of this study is to investigate the chronic outcomes of resistance exercise on levels of endocannabinoids and related lipids in fibromyalgia (FM).

Methods
This study examine the outcomes of a 15-wk person-centered resistance exercise program on plasma levels of the lipid mediators; anandamide, 2-arachidonoylglycerol (2-AG), oleoylethanolamide, palmitoylethanolamide, and stearoylethanolamide (SEA) sampled from 37 women with FM and 33 healthy controls. The associations between clinical scorings of pain, depression, anxiety, fatigue, and muscle strength with levels of these lipid mediators before and after the exercise program are also analyzed.

Results
After the 15-wk exercise program, anandamide levels were significantly increased, and SEA levels significantly decreased in FM. Pain intensity and depression scorings decreased and muscle strength increased, and in a multivariate context, muscle strength was positively associated with 2-AG levels after the resistance exercise program in FM.

Conclusions
The increased anandamide and decreased SEA in women with FM after the 15-wk program might point to a chronic effect of resistance exercise. Pain and depression scorings decreased in the FM group after the program, but no associations between pain, depression, and lipid level changes were assured.
A survey on the occurrence of Brachyspira pilosicoli and Brachyspira hyodysenteriae in growing-finishing pigs
Authors: Dors Arkadiusz , Czyżewska-Dors Ewelina , Woźniakowski Grzegorz 
Published: March 2020

Background: The major pathogenic intestinal spirochetes affecting pigs during the growing- finishing stage of production includeBrachyspira hyodysenteriaeandBrachyspira pilosicoli. The aim of this study was to assess the current occurrence ofB. hyodysenteriaeandB. pilosicoliin Polish pig herds. Moreover, associations between the presence of diarrhea or other intestinal pathogens and occurrence ofB. hyodysenteriaeandB. pilosicoliin pigs were investigated.Methods: Between January 2017 and August 2019, a total of 401 samples of pig feces from 95 different herds were submitted to the National Veterinary Research Institute of Poland. These samples were obtained from pigs older than 7 weeks. All the received fecal samples were examined for the presence ofB. hyodysenteriae,B. pilosicoliandLawsonia intracellularisby real-time PCR.Results:B. pilosicoliwas detected in 4.5% (95% CI, 2.5–7.0%) (18/401) of pig fecal samples. At the herd level 13.7% (95% CI, 7.5–22.3%) (13/95) of herds were positive forB. pilosicoli.B. hyodysenteriaewas detected in 7.0% (95% CI, 4.7–9.9%) (28/401) of pig fecal samples and 18.9% (95% CI, 11.6–28.3%) (18/95) of pig herds were positive. Out of 18B. pilosicolipositive samples, this pathogen was detected alone in 5 samples; simultaneously withL. intracellularisin 9 samples; simultaneously withB. hyodysenteriaein 1 sample and in 3 samples was detected simultaneously with both of these bacteria. The presence ofB. hyodysenteriaein fecal samples was associated with the presence of diarrhea in pigs.Conclusions: This study confirmed thatB. pilosicoliinfections occur in Polish pig herds, but the prevalence is at a low level and the presence ofB. pilosicoliis not associated with the development of diarrhea in pigs.B. hyodysenteriaeis still a common cause of diarrhea among pigs from Polish herds.
Improved reperfusion following alternative surgical approach for experimental stroke in mice
Authors: Trotman-Lucas Melissa , Wong Raymond , Allan Stuart M. , Gibson Claire L. 
Published: March 2020

Background: Following ischemic stroke, recanalisation and restoration of blood flow to the affected area of the brain is critical and directly correlates with patient recovery. In vivo models of ischemic stroke show high variability in outcomes, which may be due to variability in reperfusion. We previously reported that a surgical refinement in the middle cerebral artery occlusion (MCAO) model of stroke, via repair of the common carotid artery (CCA), removes the reliance on the Circle of Willis for reperfusion and reduced infarct variability. Here we further assess this refined surgical approach on reperfusion characteristics following transient MCAO in mice. Methods: Mice underwent 60 min of MCAO, followed by either CCA repair or ligation at reperfusion. All mice underwent laser speckle contrast imaging at baseline, 24 h and 48 h post-MCAO. Results: CCA ligation reduced cerebral perfusion in the ipsilateral hemisphere compared to baseline (102.3 ± 4.57%) at 24 h (85.13 ± 16.09%; P < 0.01) and 48 h (75.04 ± 12.954%; P < 0.001) post-MCAO. Repair of the CCA returned perfusion to baseline (94.152 ± 2.44%) levels and perfusion was significantly improved compared to CCA ligation at both 24 h (102.83 ± 8.41%; P < 0.05) and 48 h (102.13 ± 9.34%; P < 0.001) post-MCAO. Conclusions: Our findings show CCA repair, an alternative surgical approach for MCAO, results in improved ischemic hemisphere perfusion during the acute phase.
The impact of online self-management interventions on midlife adults with type 2 diabetes: a systematic review
Authors: Celik Aycan , Forde Rita , Sturt Jackie 
Published: March 2020

Background: Online self-management education programmes are now recommended for people with type 2 diabetes to improve self-management capacities. There is limited evidence to determine whether such programmes improve the health outcomes for midlife adults with diabetes. Aims: The purpose of this systematic review was to assess the impact of online self-management interventions with digital consulting on glycated haemoglobin (HbA1c), total cholesterol, blood pressure, diabetes distress, self-efficacy, and depression in midlife adults. Methods: A systematic review was undertaken searching Medline, Embase and CINAHL. Studies were appraised using the Cochrane Collaboration's tool. Results: Eight studies were included. Online interventions resulted in the improvement of HbA1c (pooled mean difference on HbA1c: -0.35%, 95% CI (-0.52, -0.18), P<0.001). A narrative synthesis was conducted for all secondary outcomes. No conclusions could be drawn on the impact of these outcomes. Conclusion: Online interventions improve HbA1c. Further research is needed for secondary outcomes.
<p><strong>First occourence of the family Glaresidae in Italy, with description of the new species <em>Glaresis gentile</em> from Sardinia (Coleoptera: Scarabaeoidea: Glaresidae)</strong></p>
Authors: ZIANI STEFANO , ULIANA MARCO , RATTU ROBERTO 
Published: March 2020

Glaresis gentile sp. nov. is described from southwestern Sardinia, Italy, providing the first record of the family Glaresidae from Italy. The new species is compared with the other western European species and with some other taxa described from North Africa. It appears to be closest to the poorly known Iberian G. thiniensis Verdú & Galante, 2001, whose aedeagus morphology is precised. Finally, a key to the European species is provided. Key words: Scarabaeoidea, Glaresidae, Glaresis, new species, taxonomy, Sardinia, Spain, sand dunes
Enhancing extraction efficiency of quantum dot light-emitting diodes introducing a highly wrinkled ZnO electron transport layer
Authors: Zhang Dandan , Xu Jianlong 
Published: March 2020

Light extraction efficiency is crucial for achieving highly efficient and bright quantum dot light-emitting diodes (QLEDs), and current efforts toward introducing light outcoupling nanostructures always require complicated procedures. An extremely simple and efficient method to introduce light outcoupling nanostructures in the ZnO electron transport layer (ETL) is demonstrated by adopting a certain heating rate during the annealing process. The ultimate device exhibits a current efficiency of 9.1 cd/A, giving a 50% efficiency improvement compared to the control device with a flat ZnO ETL. This arises from the increased light extraction efficiency induced by random nanostructures formed on a wrinkled ZnO ETL, which could also be modulated by adjusting the heating rate during the annealing process. This study not only provides a simple and efficient method to introduce light outcoupling nanostructures, but also shows ample room for further performance enhancement of QLEDs with the guideline of light extraction.