bluuebunny/crossref_metadata_2025_split huggingface dataset:
Is PRP Effective in Reducing the Scar Width of Primary Cleft Lip Repair? A Randomized Controlled Clinical Study
Authors: Refahee Shaimaa Mohsen , Aboulhassan Mamdouh A. , Abdel Aziz Omniya , Emara Dawlat , Seif El Dein Hadeel M. , Moussa Basma Gamal , Abu Sneineh Malek 
Published: October 2019

Objective:To evaluate and analyze the effect of platelet-rich plasma (PRP) injection on the scar formed after unilateral complete cleft lip scar repair using a modified Millard technique.Hypothesis:An unavoidable cheiloplasty scar is a result of the wound healing process that not only influences patient self-esteem for life but also affects muscle function.Design:Blind, randomized, controlled clinical trial.Patients:From December 2016 to February 2018, 24 patients with unilateral complete cleft lip undergoing primary cheiloplasties were equally assigned to study and control groups.Intervention:All patients were treated by modified Millard cheiloplasty. In the study group, PRP was injected into the muscle and skin layers immediately after wound closure, while the control group patients were treated with no PRP injection.Outcomes Measures:Scar width was assessed after 6 months through the muscle using ultrasonography and at the skin surface via photographs.Results:Scar width showed a significant improvement in the study group.Conclusions:Injection of autologous PRP provides effective improvement of cutaneous and muscular wound healing and decreases scar tissue formation.
Safety, feasibility, acceptability and effects of a behaviour-change intervention to change physical activity behaviour among people with multiple sclerosis: Results from the iStep-MS randomised controlled trial
Authors: Ryan Jennifer M , Fortune Jennifer , Stennett Andrea , Kilbride Cherry , Lavelle Grace , Hendrie Wendy , DeSouza Lorraine , Abdul Mohammed , Brewin Debbie , David Lee , Anokye Nana , Victor Christina , Norris Meriel 
Published: October 2019

Background: There is limited information regarding the safety, feasibility and acceptability of behaviour-change interventions to increase physical activity (PA) and reduce sedentary behaviour among people with multiple sclerosis (MS). Prior to evaluating efficacy, it is important to identify problems with feasibility and acceptability, which may undermine effectiveness. Objective: To examine the safety, feasibility and acceptability of a behaviour-change intervention to increase PA and reduce sedentary behaviour among people with MS. Methods: Sixty people received a 3-month intervention or usual care. Fatigue, pain and adverse events (AEs) were assessed. Feasibility and acceptability were explored through focus groups with physiotherapists and interviews with participants. Fidelity to intervention content, delivery skills, programme receipt and programme task were assessed. Results: There was no difference in AE rate between groups ( p = 0.965). Fatigue and pain were not higher in the intervention group at 3 or 9 months. Therapists reported the intervention was feasible to deliver and fidelity was acceptable. Twenty-nine participants (97%) attended at least 75% of sessions. Participants found the intervention acceptable but suggested some amendments were required to intervention components. Conclusions: The intervention was safe, feasible and acceptable. Although modifications are required to intervention components, the intervention warrants further evaluation in a future trial.
miR-491 inhibits BGC-823 cell migration via targeting HMGA2
Authors: Liu Zhigang , Lü Yun , Jiang Qiuyu , Yang Yang , Dang Chengxue , Sun Ruifang 
Published: October 2019

Purpose: miR-491 functions as a tumor suppressor in several types of cancer. However, its function and mechanism in gastric cancer proliferation and metastasis have not been well defined. The aim of this study was to explore the role and regulatory mechanism of miR-491 in cell proliferation and migration in gastric cancer. Methods: Quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) was used to detect the expression pattern of miR-491 in gastric cancer tissues. miR-491 overexpression vector, miR-491 inhibitor, and siHMGA2 were used; and MTT, wound healing, and transwell assays were employed to examine proliferation and migration for BGC-823 cells. A dual-luciferase reporter gene was used to measure the target relationship between miR-491 and HMGA2. Results: Most gastric cancer patients exhibit decreased miR-491 expression. miR-491 overexpression inhibited cell proliferation and migration, whereas miR-491 inhibitor treatment produced the opposite effect. Mechanistically, HMGA2 was identified as a direct target of miR-491. Moreover, HMGA2 knockdown inhibited cell proliferation and migration, which was similar to the effect of miR-491 overexpression. HMGA2 was decreased after transfection of the miR-491 vector and increased after transfection of the miR-491 inhibitor. Conclusion: Our results suggest that miR-491 suppressed cell proliferation and cell motility in gastric cancer by targeting HMGA2. Silencing HMGA2 produced a similar effect to miR-491 overexpression on cell proliferation and migration. miR-491/HMGA2 signaling may be a potential therapeutic target for gastric cancer patients with decreased miR-491 expression.
A third trial oversight committee: Functions, benefits and issues
Authors: Lane J Athene , Gamble Carrol , Cragg William J , Tembo Doreen , Sydes Matthew R 
Published: October 2019

Background/aims: Clinical trial oversight is central to the safety of participants and production of robust data. The United Kingdom Medical Research Council originally set out an oversight structure comprising three committees in 1998. The first committee, led by the trial team, is hands-on with trial conduct/operations (‘Trial Management Group’) and essential. The second committee (Data Monitoring Committee), usually completely independent of the trial, reviews accumulating trial evidence and is used by most later phase trials. The Independent Data Monitoring Committee makes recommendations to the third oversight committee. The third committee, (‘Trial Steering Committee’), facilitates in-depth interactions of independent and non-independent trial members and gives broader oversight (blinded to comparative analysis). We investigated the roles and functioning of the third oversight committee with multiple research methods. We reflect upon these findings to standardise the committee’s remit and operation and to potentially increase its usage. Methods: We utilised findings from our recent published suite of research on the third oversight committee to inform guideline revision. In brief, we conducted a survey of 38 United Kingdom–registered Clinical Trials Units, reviewed a cohort of 264 published trials, observed 8 third oversight committee meetings and interviewed 52 trialists. We convened an expert panel to discuss third oversight committees. Subsequently, we interviewed nine patient/lay third committee members and eight committee Chairs. Results: In the survey, most Clinical Trials Units required a third committee for all their trials (27/38, 71%) with independent members (ranging from 1 to 6). In the survey and interviews, the independence of the third committee was valued to make unbiased consideration of Independent Data Monitoring Committee recommendations and to advise on trial progress, protocol changes and recruitment issues in conjunction with the trial leadership. The third committee also advised funders and sponsors about trial continuation and represented patients and the public by including lay members. Of the cohort of 264 published trials, 144 reported a ‘steering’ committee (55%), but the independence of these members was not described so these may have been internal Trial Management Groups. Around two thirds of papers (60%) reported having an Independent Data Monitoring Committee and 26.9% neither a steering nor an Independent Data Monitoring Committee. However, before revising the third committee charter (Terms of Reference), greater standardisation is needed around defining member independence, composition, primacy of decision-making, interactions with other committees and the lifespan. Conclusion: A third oversight committee has benefits for trial oversight and conduct, and a revised charter will facilitate greater standardisation and wider adoption.
Long-term Prognosis and Impact of Osgood-Schlatter Disease 4 Years After Diagnosis: A Retrospective Study
Authors: Guldhammer Clara , Rathleff Michael Skovdal , Jensen Hans Peter , Holden Sinead 
Published: October 2019

Background: Knee pain is common during adolescence, with Osgood-Schlatter disease (OSD) being the most frequent condition. Despite this, research regarding the long-term prognosis of OSD is limited. Purpose: To evaluate the prognosis 2 to 6 years after the diagnosis of OSD. Study Design: Cohort study; Level of evidence, 3. Methods: This retrospective cohort study included patients diagnosed with OSD at a single orthopaedic department between 2010 and 2016. Patients were contacted in 2018 and asked to complete a self-reported questionnaire regarding knee pain, knee function (Knee injury and Osteoarthritis Outcome Score [KOOS] Sports/Recreation subscale), Health-related quality of life (HRQoL) (youth version of EuroQol 5 dimensions 3 levels [EQ-5D-3L-Y]), and physical activity. Results: Out of 84 patients, 43 responded. Of these, 60.5% (n = 26) reported OSD-related knee pain at follow-up (median follow-up, 3.75 years). The median symptom duration was 90 months (interquartile range, 24-150 months) for those still experiencing knee pain, and 42.9% of these reported daily knee pain. Fifty-four percent with knee pain had reduced their sports participation compared with 35.3% of those without knee pain. KOOS Sports/Recreation subscale scores were significantly lower in those with knee pain compared with those without knee pain (53 [95% CI, 42-63] vs 85 [95% CI, 76-94], respectively). Participants with knee pain reported lower HRQoL (0.71 [95% CI, 0.57-0.84]) compared with those without knee pain (0.99 [95% CI, 0.97-1.00]). Conclusion: This study indicates that OSD may not always be self-limiting. The lower self-reported function and HRQoL in those with continued pain may be a consequence of impaired physical activity due to knee pain.
Mid-term results of a new-generation calcar-guided short stem in THA: clinical and radiological 5-year follow-up of 216 cases
Authors: Kutzner Karl Philipp , Donner Stefanie , Loweg Lennard , Rehbein Philipp , Dargel Jens , Drees Philipp , Pfeil Joachim 
Published: October 2019

Abstract
Background
In recent years, a variety of short stems have been introduced. To date, mid- and long-term results of calcar-guided short-stem designs have been rarely available.

Materials and methods
Two hundred and sixteen calcar-guided short stems were included in combination with a cementless cup in a prospective study. Patients were allowed full weight-bearing on the first day postoperatively. Harris hip score (HHS) as well as pain and satisfaction on visual analogue scale (VAS) were assessed during a median follow-up of 61.7 months. Standardised radiographs were analysed at predefined time points regarding radiological alterations such as bone resorption and remodelling, radiolucency, osteolysis and cortical hypertrophy using modified Gruen zones.

Results
At mid-term follow-up, no revision surgery of the stem had to be performed in the whole collective. At 5 years, HHS was 97.8 (SD 4.7), satisfaction on VAS was 9.7 (SD 0.7), rest pain on VAS was 0.1 (SD 0.5), and load pain on VAS was 0.6 (SD 1.2). Compared to the 2-year results, femoral bone resorption increased significantly at the 5-year follow-up (3.9% versus 42.3%). Rate of femoral cortical hypertrophy remained stable, occurring in a total of 9 hips (4.5%). At the 5-year follow-up, 2 stems (1.0%) showed non-progressive radiolucent lines with a maximum width of 2 mm. Signs of osteolysis were not observed. Compared to the 2-year follow-up, no further subsidence was observed.

Conclusions
The rate of stem revision (0%) at the mid-term follow-up was remarkable and indicates the principle of using a calcar-guided short stem as being a safe procedure. However, signs of bone-remodelling, indicating some amount of stress-shielding, must be acknowledged at 5 years depending on stem alignment and type of anchorage.

Level of evidence
IV, Prospective observational study
Trial registration German Clinical Trials Register, DRKS00012634, 07/07/2017 (retrospectively registered)
The use of 5-azacytidine in pregnant patient with Acute Myeloid Leukemia (AML): a case report
Authors: Alrajhi Abdullah M. , Alhazzani Sarah A. , Alajaji Nouf M. , Alnajjar Fouad H. , Alshehry Nawal F. , Tailor Imran K. 
Published: October 2019

AbstractBackgroundThe management of Acute Myeloid Leukemia (AML) during pregnancy remains challenging as both the maternal and fetal outcomes should be considered. Several reports suggested that chemotherapy can be administered safely during the second and third trimester of pregnancy. However, the use of 5-azacytidine presents limitation due to lack of data.Case presentationA 28-years-old woman in the 26th week of gestation diagnosed with FLT3/ITD-mutated AML, complete remission was induced by Daunorubicin and Cytarabine, and subsequently with 5-azacytidine (75 mg/m2 daily for 7 days) with no fetal hematological or toxicity issues. Fetal ultrasound showed no aberrant morphology. Fetal size below the 5th percentile with normal umbilical artery dopplers, normal middle cerebral artery dopplers and ductus venosus doppler.Three weeks post 5-azacytidine, the team determined the most appropriate time for delivery after balancing the risks of prematurity and prevention of disease relapse since patient in hematological remission. The patient underwent elective lower segment caesarian section and had a baby girl delivered at 35 weeks of gestation weighing 1670 g without apparent anomalies.ConclusionTreatment using 5-azacytadine during last trimester of pregnancy resulted in no major fetal and maternal complications. These findings concluded that 5-azacytadine during the third trimester of pregnancy seems to be safe however, potential risks of this agent should be considered.
Demographic and clinical predictors of progression and mortality in connective tissue disease-associated interstitial lung disease: a retrospective cohort study
Authors: Chan Chrystal , Ryerson Christopher J. , Dunne James V. , Wilcox Pearce G. 
Published: October 2019

Abstract

Background
Connective tissue disease-associated interstitial lung disease (CTD-ILD) is associated with reduced quality of life and poor prognosis. Prior studies have not identified a consistent combination of variables that accurately predict prognosis in CTD-ILD. The objective of this study was to identify baseline demographic and clinical characteristics that are associated with progression and mortality in CTD-ILD.

Methods
Patients were retrospectively identified from an adult CTD-ILD clinic. The predictive significance of baseline variables on serial forced vital capacity (FVC), diffusion capacity (DLCO), and six-minute walk distance (6MWD) was assessed using linear mixed effects models, and Cox regression analysis was performed to assess impact on mortality.

Results
359 patients were included in the study. Median follow-up time was 4.0 (IQR 1.5–7.6) years. On both unadjusted and multivariable analysis, male sex and South Asian ethnicity were associated with decline in FVC. Male sex, positive smoking history, and diagnosis of systemic sclerosis (SSc) vs. other CTD were associated with decline in DLCO. Male sex and usual interstitial pneumonia (UIP) pattern predicted decline in 6MWD. There were 85 (23.7%) deaths. Male sex, older age, First Nations ethnicity, and a diagnosis of systemic sclerosis vs. rheumatoid arthritis were predictors of mortality on unadjusted and multivariable analysis.

Conclusion
Male sex, older age, smoking, South Asian or First Nations ethnicity, and UIP pattern predicted decline in lung function and/or mortality in CTD-ILD. Further longitudinal studies may add to current clinical prediction models for prognostication in CTD-ILD.
Assessment of proliferating cell nuclear antigen (PCNA) expression at the invading front of oral squamous cell carcinoma
Authors: Lu Emily Ming-Chieh , Ratnayake Jithendra , Rich Alison Mary 
Published: October 2019

Abstract

Background
Accurate prediction of the behaviour of oral squamous cell carcinoma (OSCC) is necessary to determine prognosis and provide appropriate treatment. Therefore, it is important to investigate potential prognostic markers to determine their predictive ability. Histological assessment of specific features at the invading front of oral squamous cell carcinomas has shown to provide accurate and reproducible prognostic information. Proliferating cell nuclear antigen (PCNA) is a nuclear marker known to reflect cell turnover and may be used as a marker for tumour aggressiveness.

Methods
Twenty cases of OSCC were histologically assessed to evaluate the correlation between proliferating cell nuclear antigen expression and invasive front grading. Each case was first assessed on a haematoxylin and eosin stained slide and an invading front grading (IFG) score was determined. In order to obtain a PCNA score, immunohistological staining was carried out using the peroxidase-labelled streptavidin-biotin technique with the monoclonal antibody PC10.

Results
In all cases, tumour islands had a periphery of intensely stained proliferating cell nuclear antigen-positive epithelial cells. The average IFG score was 8 ± 1.8, and the average PCNA score was 75% ± 11.2. Regression analysis was done using data from the IFG score and PCNA score and taking the latter as the predictor variable. The Pearson correlation coefficient was 0.134, with a p-value of 0.572.

Conclusion
Since the correlation between PCNA score and IFG score was not significant (p > 0.05), we conclude that there is no association between cell proliferation at the invading tumour front and the histological grading of OSCC.
More comprehensively measuring quality of life in life-threatening illness: the McGill Quality of Life Questionnaire – Expanded
Authors: Cohen S. Robin , Russell Lara B. , Leis Anne , Shahidi Javad , Porterfield Pat , Kuhl David R. , Gadermann Anne M. , Sawatzky Richard 
Published: October 2019

AbstractBackgroundDomains other than those commonly measured (physical, psychological, social, and sometimes existential/spiritual) are important to the quality of life of people with life-threatening illness. TheMcGill Quality of Life Questionnaire (MQOL) – Revisedmeasures the four common domains. The aim of this study was to create a psychometrically sound instrument,MQOL – Expanded, to comprehensively measure quality of life by adding to MQOL-Revised the domains of cognition, healthcare, environment, (feeling like a) burden, and possibly, finance.MethodsConfirmatory factor analyses were conducted on three datasets to ascertain whether seven new items belonged with existing MQOL-Revised domains, whether good model fit was obtained with their addition as five separate domains to MQOL-Revised, and whether a second-order factor representing overall quality of life was present. People with life-threatening illnesses (mainly cancer) or aged > 80 were recruited from 15 healthcare sites in seven Canadian provinces. Settings included: palliative home care and inpatient units; acute care units; oncology outpatient clinics.ResultsGood model fit was obtained when adding each of the five domains separately to MQOL-Revised and for the nine correlated domains. Fit was acceptable for a second-order factor model. The financial domain was removed because of low importance. The resulting MQOL-Expanded is a 21-item instrument with eight domains (fit of eight correlated domains: Comparative Fit Index = .96; Root Mean Square Error of Approximation = .033).ConclusionsMQOL-Expanded builds on MQOL-Revised to more comprehensively measure the quality of life of people with life-threatening illness. Our analyses provide validity evidence for the MQOL-Expanded domain and summary scores; the need for further validation research is discussed. Use of MQOL-Expanded will enable a more holistic understanding of the quality of life of people with a life-threatening illness and the impact of treatments and interventions upon it. It will allow for a better understanding of less commonly assessed but important life domains (cognition, healthcare, environment, feeling like a burden) and their relationship to the more commonly assessed domains (physical, psychological, social, existential/spiritual).
Impact of a training program incorporating cardiac magnetic resonance imaging on the accuracy and reproducibility of two-dimensional echocardiographic measurements of left ventricular volumes and ejection fraction
Authors: Nabeshima Yosuke , Namisaki Hidehiro , Teshima Toshihiro , Kurashige Yasuhiko , Kakio Akiko , Fukumitsu Azusa , Otsuji Yutaka , Takeuchi Masaaki 
Published: October 2019

Abstract

Background
Left ventricular (LV) ejection fraction (LVEF) assessed by two-dimensional echocardiography (2DE) is the most widely used parameter for clinical decision-making, but reproducibility and accuracy problems remain. We evaluated the usefulness of a novel training program based on cardiac magnetic resonance (CMR) imaging to obtain more reliable values of 2DE-derived LVEF and LV volumes.

Methods
Fifty-four sonographers from five hospitals independently measured LV volumes and LVEF using the same 2DE images from 15 patients who underwent CMR and 2DE. After receiving a lecture from an expert on how to properly trace the LV endocardium, each sonographer voluntary performed the measurements using the same datasets, and was invited to perform the same analysis for additional patients. The effect of the training intervention was evaluated using the coefficient of variation (CV) and coverage probability (CP).

Results
Before the intervention, the LV volumes were significantly underestimated and the LVEF was significantly overestimated compared to the CMR results; however, these differences were reduced after the intervention. In particular, the CP (0.52 vs. 0.76, p < 0.001) for the LVEF showed significant improvement. However, the degree of improvement differed among institutions, and the CV actually became worse in two hospitals after the intervention. Level of experience and self-practice was associated with the reproducibility after the intervention.

Conclusions
A training program using CMR as a reference improved the accuracy of 2DE-determined LV measurements. Since the degree of improvements differed among hospitals, individualization of training programs and periodical objective evaluation may be required to reduce inter-institutional variability.
Optimizing sequencing protocols for leaderboard metagenomics by combining long and short reads
Authors: Sanders Jon G. , Nurk Sergey , Salido Rodolfo A. , Minich Jeremiah , Xu Zhenjiang Z. , Zhu Qiyun , Martino Cameron , Fedarko Marcus , Arthur Timothy D. , Chen Feng , Boland Brigid S. , Humphrey Greg C. , Brennan Caitriona , Sanders Karenina , Gaffney James , Jepsen Kristen , Khosroheidari Mahdieh , Green Cliff , Liyanage Marlon , Dang Jason W. , Phelan Vanessa V. , Quinn Robert A. , Bankevich Anton , Chang John T. , Rana Tariq M. , Conrad Douglas J. , Sandborn William J. , Smarr Larry , Dorrestein Pieter C. , Pevzner Pavel A. , Knight Rob 
Published: October 2019

Abstract
As metagenomic studies move to increasing numbers of samples, communities like the human gut may benefit more from the assembly of abundant microbes in many samples, rather than the exhaustive assembly of fewer samples. We term this approach leaderboard metagenome sequencing. To explore protocol optimization for leaderboard metagenomics in real samples, we introduce a benchmark of library prep and sequencing using internal references generated by synthetic long-read technology, allowing us to evaluate high-throughput library preparation methods against gold-standard reference genomes derived from the samples themselves. We introduce a low-cost protocol for high-throughput library preparation and sequencing.