bluuebunny/crossref_metadata_2025_split huggingface dataset:
Long-term survival analysis of masitinib in amyotrophic lateral sclerosis
Authors: Mora Jesus S. , Bradley Walter G. , Chaverri Delia , Hernández-Barral María , Mascias Javier , Gamez Josep , Gargiulo-Monachelli Gisella M. , Moussy Alain , Mansfield Colin D. , Hermine Olivier , Ludolph Albert C. 
Published: July 2021

Background: A randomized, placebo-controlled phase III study (AB10015) previously demonstrated that orally administered masitinib (4.5 mg/kg/day) slowed rate of functional decline, with acceptable safety, in amyotrophic lateral sclerosis (ALS) patients having an ALS Functional Rating Scale-revised (ALSFRS-R) progression rate from disease onset to baseline of <1.1 points/month. Here we assess long-term overall survival (OS) data of all participants from study AB10015 and test whether a signal in OS is evident in an enriched patient population similar to that prospectively defined for confirmatory study AB19001. Methods: Survival status of all patients originally randomized in AB10015 was collected from participating investigational sites. Survival analysis (using the multivariate log-rank test and Cox proportional hazards model, with stratification factors as covariates) was performed on the intention-to-treat population and enriched subgroups, which were defined according to initial randomization, baseline ALSFRS-R progression rate and baseline disease severity. Results: A significant survival benefit of 25 months ( p = 0.037) and 47% reduced risk of death ( p = 0.025) was observed for patients receiving 4.5 mg/kg/day masitinib ( n = 45) versus placebo ( n = 62) in an enriched cohort with ⩾2 on each baseline ALSFRS-R individual component score (i.e. prior to any complete loss or severe impairment of functionality) and post-onset ALSFRS-R progression rate <1.1 (i.e. exclusion of very fast progressors) [median OS of 69 versus 44 months, respectively; hazard ratio, 0.53 [95% CI (0.31–0.92)]]. This corresponds to the population enrolled in confirmatory phase III study, AB19001. Conclusions: Analysis of long-term OS (75 months average follow-up from diagnosis) indicates that oral masitinib (4.5 mg/kg/day) could prolong survival by over 2 years as compared with placebo, provided that treatment starts prior to severe impairment of functionality. This trial was registered at www.ClinicalTrials.gov under identifier NCT02588677 (28 October 2015).
Evaluation of the effectiveness of skin preparation methods for the reduction of Cutibacterium acnes (formerly Propionibacterium acnes) in shoulder surgery: a systematic review
Authors: Sagkrioti Maria , Glass Stephen , Arealis Georgios 
Published: July 2021

Background Cutibacterium acnes ( C. acnes) is the most common pathogen responsible for post-operative shoulder infections. The purpose of this study was to evaluate the effectiveness of skin preparation methods against C. acnes in shoulder surgery. Methods A systematic review was conducted evaluating the effectiveness of skin preparation methods in the reduction of C. acnes in patients undergoing shoulder surgery. Outcomes were assessed based on the effectiveness of the method used; side effects and cost were also analysed. Results Of the 19 included studies, 9 evaluated pre-surgical home treatments: 8 assessed benzoyl peroxide (BPO) and 6 concluded it is effective in reducing C. acnes. Nine studies assessed surgical skin preparation and concluded that Chlorhexidine gluconate (CHG) was not effective; in contrast hydrogen peroxide reduced C. acnes. Finally, one study evaluated an aseptic protocol using CHG and concluded that it was not effective. Conclusions It was demonstrated that BPO as home treatment is effective in reducing C. acnes load on skin ; it rarely causes side effects and is also cost-effective. This study highlights non-effectiveness of CHG. There was some evidence that the addition of hydrogen peroxide could have a positive effect in the reduction of C. acnes skin load; however, more studies are required.
ESC 2019 guidelines on chronic coronary syndromes: could calcium scoring improve detection of coronary artery disease in patients with low risk score. Findings from a retrospective cohort of patients in a district general hospital
Authors: Fyyaz S , Rasoul H , Miles C , Olabintan O , David S , Plein S , Alfakih K 
Published: July 2021

Background The European Society of Cardiology (ESC) published an updated stable chest pain guideline in 2019, recommending the use of an updated pre-test probability (PTP) risk score (RS) to assess the likelihood of coronary artery disease (CAD). We sought to compare the 2019 and 2013 PTPRS in a contemporary cohort of patients. Methods 612 patients who were investigated with computed tomography coronary angiography (CTCA) for stable chest pain were included in a retrospective analysis. Results There were 255 patients with 2019 PTPRS 15–50% with a 9% yield of severe CAD on CTCA, compared with 402 patients and a 4% yield using the 2013 PTPRS (p = 0.01). 355 patients had a 2019 PTPRS of <15%, with 3% found to have severe CAD, compared with 67 patients and none with severe CAD using the 2013 PTPRS (p = 0.14). 336 of patients with 2019 PTPRS of <15% had a calcium score as part of the CTCA. 223 of these had a zero calcium score and only one had severe CAD. In comparison, 113 patients had a positive calcium score, and 10 (9%) had severe CAD (p < 0.001). Discussion The ESC 2019 PTPRS classifies more patients as at lower risk of CAD and hence reduces the risk overestimation associated with the 2013 PTPRS. However, in patients with a 2019 PTPRS of <15%, who would not be investigated, the use of the calcium score detected the majority of patients with significant CAD, who may benefit from secondary prevention and an associated mortality benefit as per the SCOT-Heart trial.
Reconstruction of the Aortic Arch in Neonates and Infants: The Importance of Patch Material
Authors: van Beynum Ingrid M. , Kurul Serife , Krasemann Thomas , Dalinghaus Michiel , de Woestijne Pieter van , Etnel Jonathan R. , Bogers Ad J.J.C. 
Published: July 2021

Objectives: Restenosis after aortic arch reconstruction is a known complication in neonates and infants. Homograft is the most commonly used patch material for aortic arch reconstructions in our center. Since 2014, tissue-engineered bovine pericardium (CardioCel) has been used as an alternative. The aim of our study was to determine whether the choice of material affected the development of restenosis in these patients. Methods: Data of all neonates and infants who underwent aortic arch reconstruction with the use of any patch material between 2005 and 2016 were analyzed. Restenosis was defined by the need for reintervention, either percutaneous or surgical. Results: Forty-one patients underwent aortic arch repair. Excluding the 30-day mortality, 36 patients represented the study population. At primary repair, the aortic arch was reconstructed with homograft (n = 26) or CardioCel (n = 10). Restenosis was documented during the first year of life in 13 patients: Six (23%) patients in the homograft group and seven (70%) patients in the CardioCel group ( P = .01). In the homograft group, the median time from operation to first intervention for restenosis was 22.0 (range: 14-32) weeks, as compared to 14.0 (range: 7-21) weeks in the CardioCel group ( P = .04). Conclusion: We conclude that choice of patch material is likely to be an important determinant for the risk of restenosis needing reintervention following reconstruction of the aortic arch in neonates and infants.
“No Official Help Is Available”—Experience of Parents and Children With Congenital Heart Disease During COVID-19
Authors: Marino L. V. , Wagland R. , Culliford D. J. , Bharucha T. , Sodergren S. C. , Darlington Anne-Sophie E. 
Published: July 2021

Introduction: The purpose was to explore the experience, information and support needs, and decision-making of parents of children with congenital heart disease (CHD), as well as the children/young people themselves, during the COVID-19 crisis. Materials and Methods: A survey study of parents of children with CHD, children and young people, capturing experiences, decision-making, information, and support needs during the COVID-19 crisis was conducted. The survey launched for one month (April 9, 2020) during the first infection wave in the United Kingdom and subsequent restriction of free movement under lockdown rules from March 23, 2020, until May 31, 2020. Results: One hundred eighty-four parents and 36 children/young people completed the survey. Parents were more likely to worry about the virus (86.4%) than children/young people (69.4%), while (89%) parents were more vigilant for symptoms of the virus versus children/young people (69.4%). A thematic analysis of the qualitative comments covered 34 subthemes, forming eight overarching themes: Virus—(1) risk of infection; (2)information, guidance, and advice; (3) change in health care provision; and (4) fears and anxieties, and lockdown and isolation—(5) psychological and social impact, (6) keeping safe under lockdown, (7) provisions and dependence on others, and (8) employment and income. Conclusions: There was widespread concern over the virus especially among parents. Parents and children/young people, however, were frustrated with the lack of specific and pediatric-focused information and guidance, expressing disappointment with the adult-centric information available. Parents also felt alone, especially with their concerns around the implications of cardiac service suspension and the implication for their child’s health. In order to better support children and their families, resources need to be developed to address families’ and children/young people’s concerns for their health during this pandemic.
Gunshot Wounds to the Lumbosacral Spine: Systematic Review and Meta-Analysis
Authors: Platt Andrew , Dafrawy Mostafa H. El , Lee Michael J. , Herman Martin H. , Ramos Edwin 
Published: July 2021

Study Design: Systematic review and meta-analysis. Objectives: Indications for surgical decompression of gunshot wounds to the lumbosacral spine are controversial and based on limited data. Methods: A systematic review of literature was conducted to identify studies that directly compare neurologic outcomes following operative and non-operative management of gunshot wounds to the lumbosacral spine. Studies were evaluated for degree of neurologic improvement, complications, and antibiotic usage. An odds ratio and 95% confidence interval were calculated for dichotomous outcomes which were then pooled by random-effects model meta-analysis. Results: Five studies were included that met inclusion criteria. The total rate of neurologic improvement was 72.3% following surgical intervention and 61.7% following non-operative intervention. A random-effects model meta-analysis was carried out which failed to show a statistically significant difference in the rate of neurologic improvement between surgical and non-operative intervention (OR 1.07; 95% CI 0.45, 2.53; P = 0.88). In civilian only studies, a random-effects model meta-analysis failed to show a statistically significant difference in the rate of neurologic improvement between surgical and non-operative intervention (OR 0.75; 95% CI 0.21, 2.72; P = 0.66). Meta-analysis further failed to show a statistically significant difference in the rate of neurologic improvement between patients with either complete (OR 4.13; 95% CI 0.55, 30.80; P = 0.17) or incomplete (OR 0.38; 95% CI 0.10, 1.52; P = 0.17) neurologic injuries who underwent surgical and non-operative intervention. There were no significant differences in the number of infections and other complications between patients who underwent surgical and non-operative intervention. Conclusions: There were no statistically significant differences in the rate of neurologic improvement between those who underwent surgical or non-operative intervention. Further research is necessary to determine if surgical intervention for gunshot wounds to the lumbosacral spine, including in the case of retained bullet within the spinal canal, is efficacious.
Multimodal nerve injection provides noninferior analgesic efficacy compared with interscalene nerve block after arthroscopic rotator cuff repair
Authors: Ko Sang Hun , Park Se Hun , Jang Seong Min , Lee Kyung Joo , Kim Kwang Ho , Jeon Young Dae 
Published: July 2021

Purpose: This randomized noninferiority trial aimed to evaluate whether combined suprascapular, axillary nerve, and the articular branch of lateral pectoral nerve block (3NB) is noninferior to interscalene nerve block (ISB) for pain control after arthroscopic rotator cuff repair (ASRCR). Materials and Methods: Eighty-five patients undergoing ASRCR were randomized to either 3NB (n = 43) or ISB (n = 42) group. We used 5 and 15 ml of 0.2% ropivacaine for each nerve in the 3NB and ISB groups, respectively. The primary outcome was the visual analog scale (VAS) pain score at 4 h postoperatively measured assessed on an 11-point scale (ranging from 0 = no pain to 10 = worst pain) that was analyzed using noninferiority testing. The secondary outcome was VAS pain scores in the recovery room and at 8, 12, 24, 36, 48, and 72 h postoperatively. Rebound pain, IV-PCA usage during 48 h, dyspnea, muscle weakness, and satisfaction were evaluated. Results: Regarding the primary outcome, the mean difference in VAS pain scores between the 3NB (2.5 ± 1.6) and ISB (2.2 ± 2.3) groups at 4 h postoperatively was 0.3, with a 95% confidence interval (CI) of −0.56 to 1.11. The upper limit of 95% CI is lower than the noninferiority margin of 1.3 ( p < 0.001). At all other time points, except in the recovery room, 3NB showed noninferior to ISB. Rebound pain, IV-PCA usage during the second 24 h, and muscle weakness were lower in the 3NB group (all p < 0.005). The satisfaction was similar in both groups ( p = 0.815). Conclusion: Combined 3NB is noninferior to ISB in terms of pain control after ASRCR; and is associated with low levels of rebound pain, IV-PCA usage, and muscle weakness. Level of evidence: Randomized controlled trial, Level I.
Behavioural and physiological response to frustration in autistic youth: associations with irritability
Authors: Carter Leno Virginia , Forth Georgia , Chandler Susie , White Philippa , Yorke Isabel , Charman Tony , Pickles Andrew , Simonoff Emily 
Published: July 2021

Abstract
Background
Irritability is a common and impairing occurrence in autistic youth, yet the underlying mechanisms are not well-known. In typically developing populations, differences in frustration response have been suggested as important driver of the behavioural symptoms of irritability. Research exploring the role of frustration response as a risk factor for irritability in autistic populations is limited and often uses parent report or observer ratings; objective measures of frustration response appropriate for use in autistic populations are required to advance the field.

Methods
In the current study, fifty-two autistic adolescents aged 13–17 years from a population-based longitudinal study completed an experimental task designed to induce frustration through exposure to periods of unexpected delay. Behavioural (number of button presses) and physiological (heart rate; HR) metrics were collected during delay periods. Irritability was measured using the parent-rated Affective Reactivity Index (ARI). Analyses used mixed-level models to test whether irritability was associated with different slopes of behavioural and physiological response to experimentally induced frustration during the task. Age and baseline HR (for the physiological data only) were included as covariates.

Results
Analyses showed a marginal association between irritability and the slope of behavioural response (incident rate ratio (IRR) =.98, p=.06), and a significant association with the slope of physiological response (b=−.10, p=.04); higher levels of irritability were associated with a dampened behavioural and physiological response, as indicated by flatter slopes of change over the course of the task. The pattern of results largely remained in sensitivity analyses, although the association with physiological response became non-significant when adjusting for IQ, autism symptom severity, and medication use (b=−.10, p=.10).

Conclusions
Results suggest that the current experimental task may be a useful objective measure of frustration response for use with autistic populations, and that a non-adaptive response to frustration may be one biological mechanism underpinning irritability in autistic youth. This may represent an important target for future intervention studies.
From their own perspectives: a qualitative study exploring the perceptions of traditional health practitioners in northern Uganda regarding cancers, their causes and treatments
Authors: Mwaka Amos Deogratius , Achan Jennifer , Adoch Winnie , Wabinga Henry 
Published: July 2021

AbstractBackgroundMany cancer patients in the low- and middle-income countries seek care with traditional health practitioners (THPs) and use traditional and complementary medicines (T&CMs) for treatment of cancers. Little is known about the perceptions and influence of THPs on cancer patients’ help-seeking and treatment decisions. We aimed to explore perceptions of THPs regarding cancers, cancer causes, and preferred treatments for cancers, in order to identify aspects that can inform interventions to improve cancer outcomes in Uganda.MethodsWe conducted this ethnographic study in northern Uganda. In-depth interviews were conducted at the respondents’ homes in quiet, open places, and in the absence of none- respondents. Interviews were audio-recorded and transcribed verbatim within a week of the interviews. Thematic qualitative analysis approaches were used to identify themes and subthemes.ResultsWe included 21 respondents in the study; most were male (16/21), married, with median age of 59 years (range 39 – 80). Most respondents perceived cancer as a new and challenging disease, while one respondent thought of cancer as a result of an imbalance within the body. Most confessed unawareness of the causes of cancers, but believed that cancer could result from the interplay of a number of factors including poor diets, ingestions of chemical agents, and assaults by the spirits of the dead. Some reported that cancers (especially of women’s genital tracts) were sexually transmitted, or caused by accumulation of dirt. Only few healers treated cancers. Most respondents reported that they referred cancer patients to biomedical facilities, sometimes after they have first used their medicines. Most respondents hoped that collaborative research with scientists could help them identify potent T&CMs that cure cancers.ConclusionTraditional health practitioners require training on cancer causes, symptoms and signs, and the necessity for prompt initiation of effective treatments in order to improve cancer outcomes. The predisposition of the majority of respondents to refer cancer patients to biomedical services sets a fertile ground for meaningful cooperation between biomedical and traditional health practices. The national health system in the low- and middle-income countries could formally recognize traditional health practices as a component of the national healthcare system, and encourage the two to practice side by side.
Impact of coronavirus 2019 on mental health and lifestyle adaptations of pregnant women in the United Arab Emirates: a cross-sectional study
Authors: Hashim Mona , Coussa Ayla , Al Dhaheri Ayesha S. , Al Marzouqi Amina , Cheaib Samer , Salame Anastasia , Abu Jamous Dima O. , Naja Farah , Hasan Hayder , Stojanovska Lily , Mohamad Maysm N. , Bataineh Mo’ath F. , Faris MoezAlIslam E. , Al Daour Rameez , Obaid Reyad S. , Saleh Sheima T. , Osaili Tareq M. , Cheikh Ismail Leila 
Published: July 2021

Abstract
Background
In light of the pandemic, pregnant women are particularly vulnerable to increased psychological distress and in need of imperative preventive measures. This study aimed to investigate the impact of the pandemic on mental health, lifestyle adaptations, and their determinants among pregnant women in the United Arab Emirates.

Methods
A survey was conducted electronically between June and August 2020. Pregnant women were recruited from prenatal clinics in the UAE and invited to participate in an online survey developed on Google Forms. The questionnaire included socio-demographic characteristics, the Impact of Event Scale- Revised, the Perceived Support Scale and lifestyle-related factors.

Results
A total of 384 pregnant women completed the questionnaire of whom 20.6% were in their 1st trimester, 46.1% in their 2nd and 33.3% in their 3rd trimester. The mean IES-R score for the respondents was 26.15 ± 13.55, corresponding to a mild stressful impact, which did not differ significantly among trimesters of pregnancy. Pregnant women expressed increased stress from staying home (64%), work (40%), feeling frightened (66%) and apprehensive (59%). Women reported increased support and sharing their feelings with family members (59%), mainly in the 1st and 3rd trimester of pregnancy (P < 0.05). There was a greater attention to mental health (48%), resting time (55.3%), and relaxing time (57.3%); while a decreased amount of time was spent engaging in physical activities (53.6%), which differed significantly between trimesters (P = 0.02).

Conclusions
The COVID-19 pandemic was associated with a mild stressful impact among pregnant women in the UAE, braced by strong family support and self-care mental health behaviors.