bluuebunny/crossref_metadata_2025_split huggingface dataset:
Emotion regulation training in the treatment of obesity in young adolescents: protocol for a randomized controlled trial
Authors: Debeuf Taaike , Verbeken Sandra , Boelens Elisa , Volkaert Brenda , Van Malderen Eva , Michels Nathalie , Braet Caroline 
Published: February 2020

AbstractBackgroundThe prevalence rates of childhood obesity are increasing. The current multidisciplinary treatments for (childhood) obesity are effective but only moderately and in the short term. A possible explanation for the onset and maintenance of childhood obesity is that it reflects a maladaptive mechanism for regulating high levels of stress and emotions. Therefore, the current RCT study aims to test the effectiveness of adding an emotion regulation training to care as usual (multidisciplinary obesity treatment) in young inpatients (10–14) involved in an obesity treatment program compared to care as usual alone.The research model for this RCT study states that when high levels of stress are regulated in a maladaptive way, this can contribute to the development of obesity.MethodsThe current study will recruit 140 youngsters (10–14 years) who are involved in an inpatient multidisciplinary obesity treatment (MOT) program. After giving consent to participate in the study, youngsters will be randomly assigned, during consecutive waves, to one of two conditions: care as usual (receiving MOT) or intervention (receiving MOT in addition to emotion regulation training). The training itself consists of 12 weekly sessions, followed by a booster session after 3 and 5 months. The participants will be tested pretraining, post-training, and at 6 months’ follow-up. We hypothesize that, compared to the control condition, youngsters in the intervention condition will (1) use more adaptive emotion regulation strategies and (2) report less emotional eating, both primary outcome measures. Moreover, on the level of secondary outcome measures, we hypothesize that youngsters in the intervention condition, compared with the control condition, will (3) report better sleep quality, (4) undergo improved weight loss and weight loss maintenance, and (5) experience better long-term (6-months) psychological well-being.DiscussionThis study will add to both the scientific and clinical literature on the role of emotion regulation in the development and maintenance of different psychopathologies, as emotion regulation is a transdiagnostic factor.Trial registrationThe RCT study protocol is registered at ISRCTN Registry, with study ID “ISRCTN 83822934.” Registered on 13 December 2017.
Comparison of two techniques used in routine care for the treatment of inflammatory macular oedema, subconjunctival triamcinolone injection and intravitreal dexamethasone implant: medical and economic importance of this randomized controlled trial
Authors: Couret Chloé , Poinas Alexandra , Volteau Christelle , Riche Valery-Pierre , Le Lez Marie-Laure , Errera Marie-Hélène , Creuzot-Garcher Catherine , Baillif Stéphanie , Kodjikian Laurent , Ivan Catherine , Le Jumeau de Kergaradec Laurence Mathilde , Chiffoleau Anne , Jobert Alexandra , Jaulin Julie , Biron Laetitia , Hervouet Elisabeth , Weber Michel 
Published: February 2020

Abstract
Background
Whether they are injected peri- or intraocularly, corticosteroids are still essential tools in the therapeutic arsenal for treating inflammatory macular oedema. A few years ago, however, only triamcinolone acetonide was available to ophthalmologists. While this compound was initially developed for rheumatological or dermatological use, it has been increasingly deployed in ophthalmology, despite still being off-label. In 2011, the system for delivery of dexamethasone from a biodegradable, injectable implant into the vitreous cavity obtained approval for use in inflammatory macular oedema. While the efficacy and safety of triamcinolone in macular oedema, including inflammatory oedema, have already been studied, there are currently no publications on subconjunctival triamcinolone injections, which are simple, effective and well tolerated. To date, the dexamethasone 700 μg implant has been authorized for the treatment of noninfectious intermediate and posterior uveitis, but there have been no studies to evaluate the efficacy and safety of the different peri- and intraocular strategies, including the treatment of inflammatory macular oedema.

Methods
This protocol is therefore designed to compare the efficacy and safety of peri- and intraocular corticosteroid injections in the treatment of inflammatory macular oedema. In this ongoing study, 142 patients will be included, and the oedematous eye will be randomised to treatment with either subconjunctival triamcinolone injection or an intravitreal implant containing 700 μg dexamethasone. Follow-up is planned for 6 months with monthly visits. Each visit will include visual acuity measurement, a slit lamp examination, fundoscopy, intraocular pressure measurement, laser flare measurement (if available) and spectral domain optical coherence tomography.

Discussion
The results of this trial will have a real impact on public health if it is shown that a Kenacort retard® (i.e. triamcinolone) injection costing just €2.84 and performed in the physician’s office (with no additional overhead costs) is at least as effective as the dexamethasone 700 μg implant (Ozurdex®; costing approximately €960 with the injection performed in a dedicated room), with no increased side effects.

Trial registration
ClinicalTrials.gov, NCT02556424. Registered on 22 September 2015.
Machine learning analysis plans for randomised controlled trials: detecting treatment effect heterogeneity with strict control of type I error
Authors: Watson James A. , Holmes Chris C. 
Published: February 2020

Abstract
Background
Retrospective exploratory analyses of randomised controlled trials (RCTs) seeking to identify treatment effect heterogeneity (TEH) are prone to bias and false positives. Yet the desire to learn all we can from exhaustive data measurements on trial participants motivates the inclusion of such analyses within RCTs. Moreover, widespread advances in machine learning (ML) methods hold potential to utilise such data to identify subjects exhibiting heterogeneous treatment response.

Methods
We present a novel analysis strategy for detecting TEH in randomised data using ML methods, whilst ensuring proper control of the false positive discovery rate. Our approach uses random data partitioning with statistical or ML-based prediction on held-out data. This method can test for both crossover TEH (switch in optimal treatment) and non-crossover TEH (systematic variation in benefit across patients). The former is done via a two-sample hypothesis test measuring overall predictive performance. The latter is done via ‘stacking’ the ML predictors alongside a classical statistical model to formally test the added benefit of the ML algorithm. An adaptation of recent statistical theory allows for the construction of a valid aggregate p value. This testing strategy is independent of the choice of ML method.

Results
We demonstrate our approach with a re-analysis of the SEAQUAMAT trial, which compared quinine to artesunate for the treatment of severe malaria in Asian adults. We find no evidence for any subgroup who would benefit from a change in treatment from the current standard of care, artesunate, but strong evidence for significant TEH within the artesunate treatment group. In particular, we find that artesunate provides a differential benefit to patients with high numbers of circulating ring stage parasites.

Conclusions
ML analysis plans using computational notebooks (documents linked to a programming language that capture the model parameter settings, data processing choices, and evaluation criteria) along with version control can improve the robustness and transparency of RCT exploratory analyses. A data-partitioning algorithm allows researchers to apply the latest ML techniques safe in the knowledge that any declared associations are statistically significant at a user-defined level.
Sinako, a study on HIV competent households in South Africa: a cluster-randomised controlled trial protocol
Authors: Masquillier Caroline , Knight Lucia , Campbell Linda , Sematlane Neo , Delport Anton , Dube Tanyaradzwa , Wouters Edwin 
Published: February 2020

Abstract
Background
With 7.7 million South Africans currently infected with human immunodeficiency virus (HIV) and 4.8 million currently receiving antiretroviral treatment (ART), the epidemic represents a considerable burden for the country’s resource-limited health system. In response to the health and human resource shortages, task shifting to community health workers (CHWs) and empowering people living with HIV (PLWH) are integral parts of a sustainable ART strategy. Despite the success of the ART programme, South Africa still faces both prevention and treatment challenges. To tackle these challenges, future endeavours need to focus on the role played by the households of PLWH in mediating between the community and PLWH themselves. Building health-enabling “HIV competent” households with the capacity to actively stimulate lifestyles that foster health, offers a potential strategy to tackle South Africa’s HIV-related challenges. The aim of the “Sinako: Households and HIV” study is to investigate to what extent and how an intervention can increase HIV competence in PLWH and their households, and subsequently optimise the impact of CHW support on individual ART outcomes.

Methods
The “Sinako” study is a cluster-randomised controlled trial with two arms. In the control arm, CHWs offer a standard package of support to PLWH during home visits, focused on the individual. The intervention arm includes both a focus on the individual and the household to enable the patient to self-manage their treatment within an HIV competent household.
A longitudinal mixed methods design is adopted to analyse the data. For the quantitative data analysis, methods including latent cross-lagged modelling, multilevel modelling and logistic regression will be used. To assess the acceptability and feasibility of the intervention and to construct a comprehensive picture of the mechanisms underlying the impact on the household and the PLWH, qualitative data (in-depth interviews and focus group discussions) will be collected and analysed.

Discussion
Stimulating HIV competence in households could be a feasible and sustainable strategy to optimise the outcomes of CHW interventions and thus be important for HIV treatment interventions in resource-limited settings.

Trial registration
Pan African Clinical Trial Registry, PACTR201906476052236. Registered on 24 June 2019.
A randomised, double-blind, active placebo-controlled, parallel groups, dose-response study of scopolamine hydrobromide (4–6 μg/kg) in patients with major depressive disorder
Authors: Chen Joseph C. C. , Sumner Rachael L. , Krishnamurthy Naga Venkat , Hoeh Nicholas , Ayeni Hafis Adetokunbo , Singh Vikrant , Sundram Frederick , Campbell Douglas , Muthukumaraswamy Suresh 
Published: February 2020

Abstract
Background
Depressive disorders are a leading cause of disability, but current behavioural and pharmacological therapies have a slow onset of response, typically taking several weeks before achieving efficacy. Prior studies using triplicate intravenous scopolamine infusions have been shown to reduce depressive symptomologies within days compared to saline placebo infusions. However, several parameters of scopolamine’s potential antidepressant effect remain unknown, such as its dose–response profile and its washout period. There is also the question as to whether the previously reported antidepressant responses were confounded by unblinding effects due to the lack of an active placebo control. Glycopyrronium bromide was selected as placebo for this trial given it has similar antimuscarinic properties to scopolamine hydrobromide but an inability to cross the blood–brain barrier, thereby hypothetically mimicking only the peripheral effects of scopolamine.

Methods/Design
A parallel group trial of single intravenous scopolamine infusions at three doses (4, 5, and 6 μg/kg) along with one glycopyrronium bromide 4 μg/kg group will be administered to 40 participants with major depressive disorder in a 1:1:1:2 ratio, respectively. The primary outcome measure will be the Montgomery–Åsberg Depression Rating Scale (MADRS) administered at baseline, 4 hours, 1 day, 3 days, 1 week, 2 weeks, 4 weeks, and 6 weeks post-infusion to determine antidepressant efficacy. As a secondary measure, the Quick Inventory of Depressive Symptomatology will be administered alongside the MADRS to further track potential antidepressant responses. Other secondary measures include electroencephalography, blood samples, and Bowdle visual acuity scales recorded at baseline, 5, 10, 15, 20, 30, 60, 120, and 240 min post-infusion to determine the pharmacokinetic-pharmacodynamic profile of scopolamine in depressed participants.

Discussion
This trial contributes to the literature surrounding the efficacy of scopolamine as an antidepressant. Determining the dose–response profile and washout period of scopolamine’s antidepressant effect will also provide important information for designing and conducting crossover trials. The use of an active placebo is important to reduce potentially confounding expectancy effects.

Trial registration
The trial was registered in the Australian New Zealand Clinical Trials Registry (registration number ACTRN12619000569101). Registered on 11 April 2019.
Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis: protocol of a randomized, placebo-controlled, double-blind clinical trial (COMPLETE-PsA)
Authors: Mulder Michelle L. M. , Vriezekolk Johanna E. , den Broeder Nathan , Mahler Elien A. M. , Helliwell Philip S. , van den Hoogen Frank H. J. , den Broeder Alfons A. , Wenink Mark H. 
Published: February 2020

AbstractBackgroundBoth methotrexate (MTX) and leflunomide (LEF) are registered and regularly prescribed as first-line treatments for the use in patients with psoriatic arthritis (PsA) and they are occasionally used in combination. However, evidence about their individual, and especially combined efficacy, in PsA is lacking. The aim of this study is to compare the effectiveness and safety of MTX and LEF combination therapy to MTX monotherapy in patients with PsA.MethodsCOMPLETE-PsA is a randomized, placebo-controlled, double-blind clinical trial. Disease-modifying antirheumatic drug (DMARD)-untreated patients (n = 78) with clinical diagnosis of active (i.e. ≥2 swollen joints) PsA will be randomized 1:1 (stratified for high disease activity, Psoriatic Arthritis Disease Activity Score [PASDAS] ≥ 5.4) to the combination or monotherapy. The intervention group receives MTX 25 mg (oral or subcutaneous) once weekly plus LEF 20 mg daily, and the control group receives the same but with placebo instead of LEF daily. Primary endpoint is between-group difference in PASDAS at 16 weeks, adjusted for baseline PASDAS. Key secondary parameters include between-group comparisons in change in Disease Activity in Psoriatic Arthritis (DAPSA) score, skin score, enthesitis score, dactylitis score, and swollen/tender joint count, as well as the proportion of patients fulfilling minimal disease activity (MDA), American College of Rheumatology (ACR) 20/50/70 response criteria at week 16. Furthermore, safety, function and quality of life (Health Assessment Questionnaire [HAQ], Psoriatic Arthritic Impact of Disease [PSAID], Short Form 12 [SF-12]) will be assessed.DiscussionThis is, to our knowledge, the first randomized, placebo-controlled, double-blind clinical trial assessing the effectiveness of MTX and LEF combination therapy in patients with PsA. The study will provide important information for treatment strategies and treatment recommendations.Trial registrationDutch Trial Register NTR7632 (3 December 2018). CMO NL66544.091.18 (19 November 2018).
Wolbachia strain wAlbB blocks replication of flaviviruses and alphaviruses in mosquito cell culture
Authors: Ekwudu O’mezie , Devine Gregor J. , Aaskov John G. , Frentiu Francesca D. 
Published: February 2020

Abstract
Background
Wolbachia pipientis are bacterial endosymbionts of arthropods currently being implemented as biocontrol agents to reduce the global burden of arboviral diseases. Some strains of Wolbachia, when introduced into Aedes aegypti mosquitoes, reduce or block the replication of RNA viruses pathogenic to humans. The wAlbB strain of Wolbachia was originally isolated from Aedes albopictus, and when transinfected into Ae. aegypti, persists in mosquitoes under high temperature conditions longer than other strains. The utility of wAlbB to block a broad spectrum of RNA viruses has received limited attention. Here we test the ability of wAlbB to reduce or block the replication of a range of Flavivirus and Alphavirus species in cell culture.

Methods
The C6/36 mosquito cell line was stably infected with the wAlbB strain using the shell-vial technique. The replication of dengue, West Nile and three strains of Zika (genus Flavivirus), and Ross River, Barmah Forest and Sindbis (genus Alphavirus) viruses was compared in wAlbB-infected cells with Wolbachia-free controls. Infectious virus titres were determined using either immunofocus or plaque assays. A general linear model was used to test for significant differences in replication between flaviviruses and alphaviruses.

Results
Titres of all viruses were significantly reduced in cell cultures infected with wAlbB versus Wolbachia-free controls. The magnitude of reduction in virus yields varied among virus species and, within species, also among the strains utilized.

Conclusion
Our results suggest that wAlbB infection of arthropods could be used to reduce transmission of a wide range of pathogenic RNA viruses.
Anthropometric, physiological characteristics and rugby-specific game skills of schoolboy players of different age categories and playing standards
Authors: Chiwaridzo Matthew , Ferguson Gillian D. , Smits-Engelsman Bouwien C. M. 
Published: February 2020

Abstract
Background
Rugby is increasingly gaining popularity among school-aged male junior players in countries hardly known for dominating international rugby, such as Zimbabwe. Given rugby combativeness, participating adolescents should possess qualities or skills commensurate with the physical demands of the sport for effective participation. This study investigated the independent and interactive effects of age category and playing standard on anthropometric, physiological characteristics and rugby-specific game skills among Zimbabwean athletes.

Methods
Two hundred and eight elite, sub-elite and non-rugby players competing at Under 16 and Under 19 age categories were assessed using the School Clinical Rugby Measure (SCRuM) test battery. Participants underwent height, sitting height, mass, skinfolds, speed, agility, upper-and-lower muscular strength and power, prolonged high-intensity intermittent running ability, tackling, passing and catching assessments in a cross-sectional experimental design.

Results
Age categories had significant main effect on all SCRuM test items except sum of seven skinfolds (p = 0.45, η2p = 0.003). Playing standard had significant main effects for all variables except height (p = 0.40, η2p = 0.01) and sum of seven skinfolds (p = 0.11, η2p = 0.02). Specifically, upper-and-lower muscular strength and power, prolonged high-intensity intermittent running ability, tackling, passing and catching improved with increasing playing standards. However, two-way analysis of variance only demonstrated significant interactions between the effects of age category and playing standards for vertical jump height (VJ) test, 2-kg medicine ball chest throw (2-kg MBCT) test, Yo-Yo intermittent recovery test level 1 (Yo-Yo IRT L1), and tackling and catching tests. Yo-Yo IRT L1, VJ, tackling and catching tests demonstrated greater discriminative ability among Under 16 s, whereas the 2-kg MBCT test showed better ability in Under 19 s.

Conclusion
All SCRuM variables except skinfolds improved with age, highlighting relative sensitivity in differentiating older from younger athletes. However, the discriminative ability by playing standards for VJ, 2-kg MBCT, Yo-Yo IRT L1, tackling and catching ability tests was age-dependent. These findings informs on general attribute development in junior rugby players with age and on specific players attributes in need of monitoring for attainment of elite status at U16 or U19 level.
Deep learning workflow in radiology: a primer
Authors: Montagnon Emmanuel , Cerny Milena , Cadrin-Chênevert Alexandre , Hamilton Vincent , Derennes Thomas , Ilinca André , Vandenbroucke-Menu Franck , Turcotte Simon , Kadoury Samuel , Tang An 
Published: February 2020

AbstractInterest for deep learning in radiology has increased tremendously in the past decade due to the high achievable performance for various computer vision tasks such as detection, segmentation, classification, monitoring, and prediction. This article provides step-by-step practical guidance for conducting a project that involves deep learning in radiology, from defining specifications, to deployment and scaling. Specifically, the objectives of this article are to provide an overview of clinical use cases of deep learning, describe the composition of multi-disciplinary team, and summarize current approaches to patient, data, model, and hardware selection. Key ideas will be illustrated by examples from a prototypical project on imaging of colorectal liver metastasis. This article illustrates the workflow for liver lesion detection, segmentation, classification, monitoring, and prediction of tumor recurrence and patient survival. Challenges are discussed, including ethical considerations, cohorting, data collection, anonymization, and availability of expert annotations. The practical guidance may be adapted to any project that requires automated medical image analysis.
Edge caching strategy design and reward contract optimization for uAV-enabled mobile edge networks
Authors: Lu Weidang , Yin Bin , Huang Guoxiang , Li Bo 
Published: February 2020

AbstractEdge caching is a promising technology to alleviate the burden on backhaul and improve the quality of experience (QoE) of users in unmanned aerial vehicle (UAV)-enabled mobile edge networks, which has played an important role in wireless communication systems. However, owing to the selfish nature and limited battery life of the user equipments (UEs), only a limited part of the caching resources will be shared by the UEs. To drive the UEs to share more caching resources to improve the social welfare of the UAV-enabled mobile edge network, in this paper, we jointly design an edge caching strategy and reward contract optimization scheme. Aiming to maximize the utility of the UAV, a joint edge caching and contract optimization problem is formulated. Firstly, a novel edge caching strategy is proposed based on the content popularity. Then, an optimal reward contract is designed by reducing the restrictions. Finally, the system performance of the designed caching strategy and reward contract is evaluated compared with two benchmark caching schemes with no incentives. Simulation results show that the proposed scheme performs better than the other two schemes in terms of the utilities of the UAV and UEs, which proves the efficiency of our proposed scheme.