bluuebunny/crossref_metadata_2025_split huggingface dataset:
Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial
Authors: Nichols Anthony C. , Lang Pencilla , Prisman Eitan , Berthelet Eric , Tran Eric , Hamilton Sarah , Wu Jonn , Fung Kevin , de Almeida John R. , Bayley Andrew , Goldstein David P. , Eskander Antoine , Husain Zain , Bahig Houda , Christopoulous Apostolos , Hier Michael , Sultanem Khalil , Richardson Keith , Mlynarek Alex , Krishnan Suren , Le Hien , Yoo John , MacNeil S. Danielle , Mendez Adrian , Winquist Eric , Read Nancy , Venkatesan Varagur , Kuruvilla Sara , Warner Andrew , Mitchell Sylvia , Corsten Martin , Rajaraman Murali , Johnson-Obaseki Stephanie , Eapen Libni , Odell Michael , Chandarana Shamir , Banerjee Robyn , Dort Joseph , Matthews T. Wayne , Hart Robert , Kerr Paul , Dowthwaite Samuel , Gupta Michael , Zhang Han , Wright Jim , Parker Christina , Wehrli Bret , Kwan Keith , Theurer Julie , Palma David A. 
Published: February 2020

Abstract
Background
Patients with human papillomavirus-positive (HPV+) oropharyngeal squamous cell carcinoma (OPC) have substantially better treatment response and overall survival (OS) than patients with HPV-negative disease. Treatment options for HPV+ OPC can involve either a primary radiotherapy (RT) approach (± concomitant chemotherapy) or a primary surgical approach (± adjuvant radiation) with transoral surgery (TOS). These two treatment paradigms have different spectrums of toxicity. The goals of this study are to assess the OS of two de-escalation approaches (primary radiotherapy and primary TOS) compared to historical control, and to compare survival, toxicity and quality of life (QOL) profiles between the two approaches.

Methods
This is a multicenter phase II study randomizing one hundred and forty patients with T1–2 N0–2 HPV+ OPC in a 1:1 ratio between de-escalated primary radiotherapy (60 Gy) ± concomitant chemotherapy and TOS ± de-escalated adjuvant radiotherapy (50–60 Gy based on risk factors). Patients will be stratified based on smoking status (< 10 vs. ≥ 10 pack-years). The primary endpoint is OS of each arm compared to historical control; we hypothesize that a 2-year OS of 85% or greater will be achieved. Secondary endpoints include progression free survival, QOL and toxicity.

Discussion
This study will provide an assessment of two de-escalation approaches to the treatment of HPV+ OPC on oncologic outcomes, QOL and toxicity. Results will inform the design of future definitive phase III trials.

Trial Registration
Clinicaltrials.gov identifier: NCT03210103. Date of registration: July 6, 2017, Current version: 1.3 on March 15, 2019.
Laboratory evaluation of the optical properties of two extended-depth-of-focus intraocular lenses
Authors: Chae Sue Hey , Son Hyeck Soo , Khoramnia Ramin , Lee Kyung Heon , Choi Chul Young 
Published: February 2020

Abstract
Background
To experimentally compare the optical performance of two different Extended-Depth-of-Focus (EDOF) intraocular lenses (IOLs) using a standardized optical bench set-up.

Methods
In this experimental study, following IOLs were assessed: the TECNIS® Symfony ZXR00 (Johnson&Johnson, Santa Ana, USA) and the AT LARA 829MP (Carl Zeiss Meditec, Jena, Germany) IOLs. The through-focus modulation transfer function (MTF) values were measured at a spatial frequency of 50 lp/mm and at aperture sizes of 2, 3, and 4.5 mm. Each IOL was measured while centered using ISO 11979-2 Model 1 (aberration-free) and Model 2 (+ 0.28 μm spherical aberration) corneas. United States Air Force (USAF) target images were also recorded for a qualitative evaluation.

Results
At 2 mm pupil with ISO1 cornea, the primary and secondary foci of both IOLs appeared to merge, providing an elongated depth of focus. At 3 and 4.5 mm pupil sizes, the through-focus MTF curves of both IOLs showed a bifocal-like V-pattern. While the Symfony IOL showed an overall superior MTF values when measured with the ISO2 cornea, the opposite propensity could be observed with the AT LARA IOL. This optical behavior could be qualitatively confirmed by the USAF target images.

Conclusions
Although the two EDOF IOLs share similarities in their optical properties, the main difference lies in their optical design and performance with respect to spherical aberration. Such characteristics should be taken into account during IOL and patient selection.
Associations between motor proficiency and academic performance in mathematics and reading in year 1 school children: a cross-sectional study
Authors: Macdonald Kirstin , Milne Nikki , Orr Robin , Pope Rodney 
Published: February 2020

Abstract
Background
A key priority for learning during the early years of school is for children to develop skills in numeracy and literacy. Consequently, less time may be allocated in the curriculum to foster other important developmental areas, including the ongoing motor skill development of school children, which has been positively linked to academic performance. In order to promote holistic approaches to teaching and learning in the early years of school, it is necessary to further delineate the nature of associations between motor skills and foundation academic skills. The aim of this study was to examine associations between fine and gross motor proficiency and academic performance in mathematics and reading in Year 1 children.

Methods
A cross-sectional study was conducted with Year 1 children from two primary schools in New South Wales, Australia (N = 55; 25 boys, 30 girls; mean age 6.77 ± 0.40 years). The Bruininks-Oseretsky Test of Motor Proficiency (2nd Edition) and the Wechsler Individual Achievement Test II (Australian Edition) were used to assess motor proficiency and academic performance in mathematics and reading, respectively. Associations between the components of motor proficiency and academic outcomes were examined using Pearson’s and Spearman’s correlation analyses. Hierarchical multiple linear regression analyses were conducted to determine how much variance in mathematics and reading composite scores could be explained by motor proficiency after controlling for age.

Results
A significant moderate positive association was found between total motor composite and mathematics composite scores (r = .466, p < .001). Fine manual control composite scores were significantly associated with both mathematics (rs = .572, p < .001) and reading (rs = .476, p = .001) composite scores. After controlling for age, fine motor integration was the only component of motor proficiency that explained significant variance in mathematics and reading composite scores.

Conclusions
The results of the study revealed that Year 1 children’s overall motor proficiency was significantly related to their mathematical ability. Children’s fine motor integration skills were also predictive of mathematics and reading ability. These study findings may interest both early childhood educators and paediatric health professionals.
Predictors of outcome in early onset schizophrenia: a 10-year follow-up study
Authors: Xu Lingzi , Guo Yanqing , Cao Qingjiu , Li Xue , Mei Ting , Ma Zenghui , Tang Xinzhou , Ji Zhaozheng , Yang Liu , Liu Jing 
Published: February 2020

Abstract
Background
Younger age at onset is generally thought to be a predictor of poor outcome in Early Onset Schizophrenia (EOS), but there is a paucity of epidemiological data supporting this belief. This study aims to describe long-term outcomes and predictors of patient functioning in EOS, with a focus on the effect of age at onset.

Methods
We consecutively enrolled 118 EOS patients who were hospitalized in 2006. Mean age at baseline was 13.3 ± 2.3 years. Sixty-five subjects were successfully interviewed. Mean length of follow up was 10.4 ± 0.3 years. Baseline data were collected from inpatient medical records, while follow up was conducted primarily through telephone interviews of patient relatives. WHODAS 2.0 was used to measure global functioning at follow up. Outcomes included education, employment, marriage status, physical health, subsequent diagnoses and treatment, and patient functioning. Univariate and multivariate regression models were used to assess predictors of outcome, while propensity scores were used to adjust for confounding in analyzing the effect of age at onset on functional outcome.

Results
Of the 65 subjects where follow-up data were available, 3 were deceased at follow up. Five (8%) discontinued treatment. Diagnostic stability was 76%. Nearly a quarter (24%) were using clozapine at follow up. In male and female patients, 61 and 55% respectively were overweight, while 29 and 32% respectively were obese. Sixteen (26%) were economically self-sufficient, while 34 (55%) were unemployed. Thirteen (21%) patients had ever been married. The median WHODAS score was 15 (IQR 2 to 35), roughly corresponding to the 78th percentile on population norms. Extroverted personality (p = 0.01), suspicious personality (p = 0.02), and high level of education (p = 0.001) predicted better functioning. Age of onset was not associated with function in either the univariate model (p = 0.24), full model (p = 0.17) or the final risk factor model (p = 0.11), nor after using propensity scores to further adjust for confounders.

Conclusion
The long-term functional outcome of EOS is more optimistic than generally believed. Age at disease onset does not predict long-term functional outcome in EOS populations.
Loneliness and social isolation interventions for older adults: a scoping review of reviews
Authors: Fakoya Olujoke A. , McCorry Noleen K. , Donnelly Michael 
Published: February 2020

Abstract
Background
Loneliness and social isolation are growing public health concerns in our ageing society. Whilst these experiences occur across the life span, 50% of individuals aged over 60 are at risk of social isolation and one-third will experience some degree of loneliness later in life. The aim of this scoping review was to describe the range of interventions to reduce loneliness and social isolation among older adults that have been evaluated; in terms of intervention conceptualisation, categorisation, and components.

Methods
Three electronic databases (CINAHL, Embase and Medline) were systematically searched for relevant published reviews of interventions for loneliness and social isolation. Inclusion criteria were: review of any type, published in English, a target population of older people and reported data on the categorisation of loneliness and/or social isolation interventions. Data extracted included: categories of interventions and the reasoning underpinning this categorisation. The methodology framework proposed by Arskey and O’Malley and further developed by Levac, et al. was used to guide the scoping review process.

Results
A total of 33 reviews met the inclusion criteria, evaluating a range of interventions targeted at older people residing in the community or institutionalised settings. Authors of reviews included in this paper often used the same terms to categorise different intervention components and many did not provide a clear definition of these terms. There were inconsistent meanings attributed to intervention characteristics. Overall, interventions were commonly categorised on the basis of: 1) group or one-to-one delivery mode, 2) the goal of the intervention, and 3) the intervention type. Several authors replicated the categorisation system used in previous reviews.

Conclusion
Many interventions have been developed to combat loneliness and social isolation among older people. The individuality of the experience of loneliness and isolation may cause difficulty in the delivery of standardised interventions. There is no one-size-fits-all approach to addressing loneliness or social isolation, and hence the need to tailor interventions to suit the needs of individuals, specific groups or the degree of loneliness experienced. Therefore, future research should be aimed at discerning what intervention works for whom, in what particular context and how.
Biomechanical analysis of single-level interbody fusion with different internal fixation rod materials: a finite element analysis
Authors: Hsieh Yueh-Ying , Tsuang Fon-Yih , Kuo Yi-Jie , Chen Chia-Hsien , Chiang Chang-Jung , Lin Chun-Li 
Published: February 2020

Abstract
Background
Lumbar spinal fusion with rigid spinal fixators as one of the high risk factors related to adjacent-segment failure. The purpose of this study is to investigate how the material properties of spinal fixation rods influence the biomechanical behavior at the instrumented and adjacent levels through the use of the finite element method.

Methods
Five finite element models were constructed in our study to simulate the human spine pre- and post-surgery. For the four post-surgical models, the spines were implanted with rods made of three different materials: (i) titanium rod, (ii) PEEK rod with interbody PEEK cage, (iii) Biodegradable rod with interbody PEEK cage, and (iv) PEEK cage without pedicle screw fixation (no rods).

Results
Fusion of the lumbar spine using PEEK or biodegradable rods allowed a similar ROM at both the fusion and adjacent levels under all conditions. The models with PEEK and biodegradable rods also showed a similar increase in contact forces at adjacent facet joints, but both were less than the model with a titanium rod.

Conclusions
Flexible rods or cages with non-instrumented fusion can mitigate the increased contact forces on adjacent facet joints typically found following spinal fixation, and could also reduce the level of stress shielding at the bone graft.
Profiling of inflammatory mediators in the synovial fluid related to pain in knee osteoarthritis
Authors: Li Li , Li Zhenxing , Li Yuyan , Hu Xi , Zhang Yu , Fan Pei 
Published: February 2020

Abstract
Background
Inflammatory mediators in the synovial fluid (SF) play critical roles in the initiation and development of pain in knee osteoarthritis (KOA). However, data for inflammatory marker expression are conflicting, and the role of SF inflammatory mediators in neuropathic pain is not clear. Therefore, the aim of this study was to identify SF inflammatory mediators associated with nociceptive and neuropathic pain in KOA.

Methods
Levels of IL-1β, IL-6, TNF-α, macrophage colony-stimulating factor, MMP-3, MMP-13, metalloproteinase with thrombospondin motifs 5, calcitonin gene-related peptide, neuropeptide Y, substance P and bradykinin were measured using enzyme-linked immunosorbent assays in 86 patients. Nociceptive pain was assessed using the numeric rating scale (NRS), visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Neuropathic pain was determined using the PainDETECT questionnaire. Moreover, knee function was evaluated by the WOMAC score and range of motion (ROM) assessments. Radiological grade was defined using the Kellgren-Lawrence (K-L) grading scale.

Results
Pain scores measured using different methods correlated highly with each other. A worse K-L grade and knee function were associated with worse pain. Expression of IL-1β and IL-6 was increased in the early stage compared with the late stage. The NRS score correlated positively with age, K-L grade, and the WOMAC score and negatively with ROM and TNF-α expression. The VAS correlated positively with age, K-L grade, and the WOMAC score but negatively with ROM and levels of IL-1β, IL-6 and TNF-α. The WOMAC pain score did not correlate with any of the inflammatory mediators measured; it correlated only with ROM. The PainDETECT score correlated only with the WOMAC score. Expression of other inflammatory mediators did not correlate with any of the pain scores.

Conclusions
IL-1β, IL-6 and TNF-α play critical roles in pain in the early stage of KOA and correlate with pain. The catabolic enzymes and neuropeptides measured do not correlate with nociceptive and neuropathic pain. New biomarkers related to pain in the late stage need to be further investigated.
Design and baseline data in the BAriatic surgery SUbstitution and Nutrition study (BASUN): a 10-year prospective cohort study
Authors: Höskuldsdóttir Gudrún , Mossberg Karin , Wallenius Ville , Al Nimer Angelos , Björkvall Wiveka , Lundberg Sören , Behre Carl-Johan , Werling Malin , Eliasson Björn , Fändriks Lars 
Published: February 2020

Abstract
Background
There is still a lack of knowledge on long-term effects of surgical and non-surgical weight-lowering treatments. BASUN is a prospective study with 10 years of follow-up that will observe the effects and consequences of surgical and medical treatment of obesity. The aims are to cover areas where data on long-term outcomes are lacking, e.g., nutritional deficiencies, substance abuse, psychiatric health, as well as patient-reported outcomes.

Methods
BASUN is a cohort study that recruited study persons with obesity (BMI ≥ 35 kg/m2) referred to the Regional Obesity Centre of Region Västra Götaland. The interventions were Roux-en-Y gastric bypass (RYGB) or Sleeve gastrectomy (SG), or 12 months of structured, multi-professional medical treatment (MT), including very low energy diet, followed by diet and pharmaceutical treatment. The study is not randomized, but based on patients preferences and multidisciplinary assessments. The study persons are examined at baseline, 2, 5, and 10 years with blood tests, measurements and questionnaires. The recruitment period lasted from May 2015 to November 2017.

Results
One thousand one hundred twenty-seven patients were included (74% female). Three hundred eighty-two patients were accepted for medical treatment, 589 for surgical treatment (388 RYGB and 201 SG) and 156 patients left the study without treatment, leaving a final study population of 971 patients. There were slight differences between the treatment groups with regards to age and BMI. Pharmaceutical treatments, level of education, smoking and marital status were not significantly different between the groups.

Conclusion
This study will follow 971 obese subjects in clinical practice treated with the best surgical or medical methods currently available. It has the potential to evaluate outcomes usually not reported in short-term studies, and to assist in identifying factors that are of importance for the choices of treatment. The main limitations are non-randomization and differences in baseline characteristics. The large number of participants and the length of the prospective follow-up are major strengths of the study. BASUN is designed to identify both early and late benefits and adverse events of treatment of obesity.

Trial registration
This trial was prospectively registered on March 03, 2015; NCT03152617.
Understanding the association between self-reported poor oral health and exposure to adverse childhood experiences: a retrospective study
Authors: Ford Kat , Brocklehurst Paul , Hughes Karen , Sharp Catherine A. , Bellis Mark A. 
Published: February 2020

Abstract
Background
Adverse childhood experiences, including physical, sexual or emotional abuse, can have detrimental impacts on child and adult health. However, little research has explored the impact that such early life experiences have on oral health. This study examines whether experiencing adverse childhood experiences before the age of 18 years is associated with self-reported poor dental health in later life.

Methods
Using stratified random probability sampling, a household survey (N = 5307; age range 18–69 years) was conducted in the South of England (Hertfordshire, Luton and Northamptonshire). Data were collected at participants’ homes using face-to-face interviews. Measures included exposure to nine adverse childhood experiences, and two dental outcomes: tooth loss (> 8 teeth lost due to dental caries or damage) and missing or filled teeth (direct or indirect restorations; > 12 missing or filled teeth).

Results
Strong associations were found between exposure to childhood adversity and poor dental health. The prevalence of tooth loss was significantly higher (8.3%) in those with 4+ adverse childhood experiences compared to those who had experienced none (5.0%; p < 0.05). A similar relationship was found for levels of missing or filled teeth (13.4%, 4+ adverse childhood experiences; 8.1%, none; p < 0.001). Exposure to 4+ adverse childhood experiences was associated with a higher level of tooth loss and restorations at any age, compared to individuals who had not experienced adversity. Demographically adjusted means for tooth loss increased with adverse childhood experience count in all age groups, rising from 1.0% (18–29 years) and 13.0% (60–69 years) in those with none, to 3.0% and 26.0%, respectively in those reporting 4+.

Conclusions
Exposure to childhood adversity could be an important predictive factor for poor dental health. As oral health is an important part of a child’s overall health status, approaches that seek to improve dental health across the life-course should start with safe and nurturing childhoods free from abuse and neglect. Given the growing role that dental professionals have in identifying violence and abuse, it seems appropriate to raise awareness in the field of dentistry of the potential for individuals to have suffered adverse childhood experiences, and the mechanisms linking childhood adversity to poor dental health.
Impact of non-surgical periodontal therapy on serum Resistin and periodontal pathogen in periodontitis patients with obesity
Authors: Md Tahir Khairunnisa , Ab Malek Ainul Haliza , Vaithilingam Rathna Devi , Saub Roslan , Safii Syarida Hasnur , Rahman Mohammad Tariqur , Abdul Razak Fathilah , Alabsi Aied M , Baharuddin Nor Adinar 
Published: February 2020

Abstract
Background
Non-surgical periodontal therapy (NSPT) known as gold standard treatment in managing periodontitis. The aim of this study was to investigate the response of NSPT in periodontitis subjects who were obese. Clinical parameters of periodontitis, changes in serum resistin and periodontal pathogens in subgingival plaque were compared before and after NSPT in periodontitis subjects who were obese and with normal weight.

Methods
A total of 48 periodontitis subjects (obese, n = 18; normal weight, n = 30) were recruited (hereafter will be referred as participants) to participate into a prospective, before and after clinical trial. Obesity status is defined by body mass index (BMI) criteria (obese: ≥30 kg/ m2; normal weight < 25 kg/m2). Visible Plaque Index (VPI), Gingival Bleeding Index (GBI), Probing Pocket Depth (PPD) and Clinical Attachment Loss (CAL) were recorded; and serum and plaque were collected at baseline and following 12 weeks post-NSPT. Serum resistin level was analyzed using enzyme-linked immune-sorbant assay (ELISA), while detection of periodontal pathogens in dental plaque were carried out using real time PCR (qPCR).

Results
Following NSPT, means VPI and GBI showed significant improvement between obese and normal weight groups (p <  0.05), but no difference in means PPD and CAL was observed between groups. Obesity remained as a predictor for VPI and GBI after adjusting for smoking habit. No significant difference was observed in serum resistin level and mean counts for P. gingivalis, T. forsythia, and P. intermedia between obese and normal weight groups following NSPT.

Conclusions
Regardless of obesity status, NSPT has a significant impact on VPI and GBI in periodontitis subjects. However, the impact of NSPT towards serum resistin and periodontal pathogens was non-significant in those with periodontitis.

Trial registration
This study followed the Consolidation Standards of Reporting Trials Statement and retrospectively registered on 26/11/2015 at clinicaltrials.gov (No. NCT02618486).