bluuebunny/crossref_metadata_2025_split huggingface dataset:
Study protocol of the multi-centre, randomised controlled trial of the Frankfurt Early Intervention Programme A-FFIP versus early intervention as usual for toddlers and preschool children with Autism Spectrum Disorder (A-FFIP study)
Authors: Kitzerow Janina , Hackbusch Matthes , Jensen Katrin , Kieser Meinhard , Noterdaeme Michele , Fröhlich Ulrike , Taurines Regina , Geißler Julia , Wolff Nicole , Roessner Veit , Bast Nico , Teufel Karoline , Kim Ziyon , Freitag Christine M. 
Published: February 2020

Abstract
Background
Naturalistic developmental behavioural interventions (NDBI) have been shown to improve autism-specific symptoms in young children with Autism Spectrum Disorder (ASD). NDBI approaches, such as the ASD-specific Frankfurt Early Intervention Programme for ASD (A-FFIP), are based on ASD-specific developmental and learning aspects. A-FFIP is a low-intensity intervention which can easily be implemented in the local health care/social welfare system. The aim of the present study is to establish 1-year efficacy of the manualised early intervention programme A-FFIP in toddlers and preschool children with ASD. It is hypothesised that A-FFIP will result in improved ASD-specific symptoms compared to early intervention as usual (EIAU). Child- and family-specific secondary outcomes, as well as moderators and mediators of outcome, will be explored.

Methods/design
A prospective, multi-centre, parallel-group, randomised controlled, phase-III trial comparing A-FFIP versus EIAU. A total of 134 children (A-FFIP: 67, EIAU: 67) aged 24–66 months at baseline assessment meeting the criteria for ASD (DSM-5) will be included. The primary outcome is the absolute change of the total score of the Brief Observation of Social Communication Change (BOSCC-AT) between baseline (T2) and 1-year follow-up (T6). The treatment effect will be tested, adjusted for relevant covariates applying a mixed model for repeated measures. Secondary outcomes are BOSCC social communication and repetitive-behaviour scores, single ASD symptoms, language, cognition, psychopathology, parental well-being and family quality of life. Predictors, moderators and mediating mechanisms will be explored.

Discussion
If efficacy of the manualised A-FFIP early intervention is established, the current study has the potential to change clinical practice strongly towards the implementation of a low-intensity, evidence-based, natural early intervention in ASD. Early intervention in ASD requires specialist training, which subsequently needs to be developed or included into current training curricula.

Trial registration
German Registry for Clinical Trials (Deutscher Register Klinischer Studien, DRKS); ID: 00016330. Retrospectively registered on 4 January 2019. URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00016330.
A randomised controlled trial of hearing and vision support in dementia: Protocol for a process evaluation in the SENSE-Cog trial
Authors:   on behalf of the SENSE-Cog Work Package 3 Investigators, Leroi Iracema , Armitage Christopher J. , Collin Fidéline , Frison Eric , Hann Mark , Hooper Emma , Reeves David , Simkin Zoe , Wolski Lucas 
Published: February 2020

AbstractBackgroundOptimising hearing and vision function may be important in improving a range of outcomes for people living with dementia (PwD) and their companions. The SENSE-Cog cross-national randomised controlled trial (RCT) is evaluating the effectiveness of a sensory intervention (SI) to improve quality of life for PwD with concurrent hearing and/or vision impairment, in five European countries. To ascertain how or why the intervention will, or will not, achieve its outcomes, we have designed a process evaluation to explore potential discrepancies between expected and observed outcomes. This will also help us to understand how context may influence the outcomes. Here we describe the protocol for this process evaluation, which is embedded within the RCT.Methods/designWe will use a mixed methods approach with a theoretical framework derived from the UK Medical Research Council’s’ guidance on process evaluations. It will include the following: (1) evaluating how key aspects of the intervention will bedelivered, which will be important to scale the intervention in real world populations; (2) characterising thecontextualissues, which may shape the delivery and the impact of the intervention in different countries; and (3) investigating possiblecausal mechanismsthrough analyses of potential moderators and mediators. To avoid bias, we will analyse the process data before the analysis of the main effectiveness outcomes.DiscussionThis evaluation will provide insight into how the complex SENSE-Cog SI will be tailored, enacted and received across the different European contexts, all of which have unique health and social care economies. The findings will provide insight into the causal mechanisms effecting change, and will determine whether we should implement the intervention, if effective, on a wider scale for PwD and concurrent sensory impairment.Trial registrationISRCTN,ISRCTN17056211. Registered on 19 February 2018.
CAPAbility: comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability: protocol of a randomised controlled trial
Authors: Clarke Celia , Pomeroy Valerie , Clark Allan , Creelman Graham , Hancock Nicola , Horton Simon , Killett Anne , Mann Charles , Payerne Estelle , Toms Andoni , Roberts Gareth , Smith Toby , Swart Ann Marie , McNamara Iain 
Published: February 2020

AbstractBackgroundOsteoarthritis of the knee is a common condition that is expected to rise in the next two decades leading to an associated increase in total knee replacement (TKR) surgery. Although there is little debate regarding the safety and efficacy of modern TKR, up to 20% of patients report poor functional outcomes following surgery. This study will investigate the functional outcome of two TKRs; the JOURNEY II Bi-Cruciate Stabilised knee arthroplasty, a newer knee prosthesis designed to provide guided motion and improve knee kinematics by more closely approximating a normal knee, and the GENESIS II, a proven existing design.AimTo compare the change in Patient-reported Outcome Measures (PROMs) scores of the JOURNEY II BCS and the GENESIS II from pre-operation to 6 months post operation.MethodsCAPAbility is a pragmatic, blinded, two-arm parallel, randomised controlled trial recruiting patients with primary osteoarthritis due to have unilateral TKR surgery across two UK hospitals. Eligible participants (n = 80) will be randomly allocated to receive either the JOURNEY II or the GENESIS II BCS knee prosthesis. Baseline measures will be taken prior to surgery. Patients will be followed at 1 week, 6 to 8 weeks and 6 months post-operatively. The primary outcome is the Oxford Knee Score (OKS) at 6 months post-operatively. Secondary outcomes include: other PROMs, biomechanical, radiological (computerised tomography, (CT)), clinical efficacy and safety outcomes. An embedded qualitative study will also investigate patients’ perspectives via interview pre and post surgery on variables known to affect the outcome of TKR surgery. A sub-sample (n = 30) will have additional in-depth interviews to explore the themes identified. The surgeons’ perspectives on the operation will be investigated by a group interview after all participants have undergone surgery.DiscussionThis trial will evaluate two generations of TKR using PROMS, kinematic and radiological analyses and qualitative outcomes from the patient perspective.Trial registrationInternational Standard Randomised Controlled Trials Number Registration, ID:ISRCTN32315753. Registered on 12 December 2017.
Validity and reliability of a dish-based semi-quantitative food frequency questionnaire for assessment of energy and nutrient intake among Iranian adults
Authors: Doustmohammadian Azam , Amini Maryam , Esmaillzadeh Ahmad , Omidvar Nasrin , Abtahi Mitra , Dadkhah-Piraghaj Monireh , Nikooyeh Bahareh , Neyestani Tirang R. 
Published: February 2020

AbstractObjectiveThis study aimed to assess the validity and reliability of a dish-based, semi-quantitative food frequency questionnaire (DFFQ) for epidemiological studies in Iran. The DFFQ included 142 items (84 foods and 58 mixed dishes) which was filled in by 230 adults (110 men). All participants completed two separate DFFQs with a 6 months interval as well as six 24-h recalls, each month. Dietary biomarkers and anthropometric measurements were made. The validity was evaluated by comparing the DFFQ against 24-h dietary recalls and dietary biomarkers, including serum retinol and beta-carotene. Reliability was evaluated using intra-class correlation coefficient (ICC) and validity was determined by unadjusted and energy adjusted correlation coefficients (CC), de-attenuated CC, and cross-classification analyses.ResultsICC for reliability ranged between 0.42 and 0.76. De-attenuated CC for the FFQ and the 24-h recalls ranged between 0.13 and 0.54 (Mean = 0.38). The de-attenuated CC between the DFFQ and plasma levels of retinol and beta-carotene were 0.58 (P = 0.0001) and 0.40 (P = 0.0001), respectively. Cross-classification analysis revealed that on average 73% were correctly classified into same or adjacent quartiles and 5% were classified in opposite quartiles.
Acetylation at K108 of the NS1 protein is important for the replication and virulence of influenza virus
Authors: Ma Jingjiao , Wu Rujuan , Xu Guanlong , Cheng Yuqiang , Wang Zhaofei , Wang Heng’an , Yan Yaxian , Li Jinxiang , Sun Jianhe 
Published: February 2020

AbstractNon-structural protein 1 (NS1) of influenza virus is a multifunctional protein that plays an important role in virus replication and virulence. In this study, an acetylation modification was identified at the K108 residue of the NS1 protein of H1N1 influenza virus. To further explore the function of the K108 acetylation modification of the NS1 protein, a deacetylation-mimic mutation (K108R) and a constant acetylation-mimic mutation (K108Q) were introduced into the NS1 protein in the background of A/WSN/1933 H1N1 (WSN), resulting in two mutant viruses (WSN-NS1-108R and WSN-NS1-108Q). In vitro and mouse studies showed that the deacetylation-mimic mutation K108R in the NS1 protein attenuated the replication and virulence of WSN-NS1-108R, while the constant acetylation-mimic mutant virus WSN-NS1-108Q showed similar replication and pathogenicity as the wild-type WSN virus (WSN-wt). The results indicated that acetylation at K108 of the NS1 protein has an important role in the replication and virulence of influenza virus. To further explore the potential mechanism, the type I interferon (IFN-I) antagonistic activity of the three NS1 proteins (NS1-108Q, NS1-108R, and NS1-wt) was compared in cells, which showed that the K108R mutation significantly attenuated the IFN-β antagonistic activity of the NS1 protein compared with NS1-wt and NS1-108Q. Both NS1-wt and NS1-108Q inhibited the IFN-β response activated by RIG-I CARD domain, MAVS, TBK1, and IRF3 more efficiently than the NS1-108R protein in cells. Taken together, the results indicated that acetylation at NS1 K108 is important for the IFN antagonistic activity of the NS1 protein and virulence of the influenza virus.
Chickens can durably clear herpesvirus vaccine infection in feathers while still carrying vaccine-induced antibodies
Authors: Rémy Sylvie , Le Pape Gilles , Gourichon David , Gardin Yannick , Denesvre Caroline 
Published: February 2020

AbstractMarek’s disease (MD) is a major disease of chickens induced by Marek’s disease virus (MDV) associated to lethal lymphomas. Current MD vaccines protect against lymphomas, but fail to prevent infection and shedding. The control of MDV shedding is crucial in order to eradicate this highly contagious virus. Like pathogenic MDV, MD vaccines infect the feather follicles of the skin before being shed into the environment. MD vaccines constitute excellent models to study virus interaction with feathers, the unique excretion source of these viruses. Herein we studied the viral persistence in feathers of a MD vaccine, the recombinant turkey herpesvirus (rHVT-ND). We report that most of the birds showed a persistent HVT infection of feathers over 41 weeks with moderate viral loads. Interestingly, 20% of the birds were identified as low HVT producers, among which six birds cleared the infection. Indeed, after week 14–26, these birds named controllers had undetectable HVT DNA in their feathers through week 41. All vaccinated birds developed antibodies to NDV, which lasted until week 41 in 95% of the birds, including the controllers. No correlation was found between HVT loads in feathers and NDV antibody titers over time. Interestingly, no HVT DNA was detected in the spleens of four controllers. This is the first description of chickens that durably cleared MD vaccine infection of feathers suggesting that control of Mardivirus shedding is achievable by the host.
Isolation and characterization of a new population of nasal surface macrophages and their susceptibility to PRRSV-1 subtype 1 (LV) and subtype 3 (Lena)
Authors: Oh Dayoung , Xie Jiexiong , Vanderheijden Nathalie , Nauwynck Hans J. 
Published: February 2020

AbstractSialoadhesin (Sn) and CD163 have been recognized as two important mediators for porcine reproductive and respiratory syndrome virus (PRRSV) in host macrophages. Recently, it has been demonstrated that the highly virulent Lena strain has a wider macrophage tropism than the low virulent LV strain in the nasal mucosa. Not only CD163+Sn+ macrophages are infected by Lena but also CD163+Sn− macrophages. This suggests that an alternative receptor exists for binding and internalization of PRRSV Lena in the CD163+Sn− macrophages. Further investigation to find the new entry receptor was hampered by the difficulty of isolating these macrophages from the nasal mucosa. In the present study, a new population of CD163+Sn− cells has been identified that is specifically localized in the nasal lamina propria and can be isolated by an intranasal digestion approach. Isolated nasal cells were characterized using specific cell markers and their susceptibility to two different PRRSV-1 strains (LV and Lena) was tested. Upon digestion, 3.2% (flow cytometry)—6.4% (confocal microscopy) of the nasal cells were identified as CD163+ and all (99.7%) of these CD163+ cells were Sn−. These CD163+Sn− cells, designated as “nasal surface macrophages”, showed a 4.9 times higher susceptibility to the Lena strain than to the LV strain. Furthermore, the Lena-inoculated cell cultures showed an upregulation of CD163. These results showed that our new cell isolation system is ideal for the further functional and phenotypical analysis of the new population of nasal surface macrophages and further research on the molecular pathogenesis of PRRSV in the nose.
On some inequalities relative to the Pompeiu–Chebyshev functional
Authors: Ianoşi Daniel , Opriş Adonia-Augustina 
Published: February 2020

AbstractIn this paper we study the utility of the functional Pompeiu–Chebyshev in some inequalities. Some results obtained by Alomari will be generalized regarding inequalities with Pompeiu–Chebyshev type functionals, in which linear and positive functionals intervene. We investigate some new inequalities of Grüss type using Pompeiu’s mean value theorem. Improvement of known inequalities is also given.
Global weak conservative solutions of the μ-Camassa–Holm equation
Authors: Deng Xijun , Chen Aiyong 
Published: February 2020

AbstractIn this paper we consider global weak conservative solutions of a μ-Camassa–Holm equation. By employing a technique of change of variables on the Lagrangian variable, we successfully construct global weak conservative solutions of the μ-Camassa–Holm equation.
Update of the organoprotective properties of xenon and argon: from bench to beside
Authors: Anna Roehl , Rolf Rossaint , Mark Coburn 
Published: February 2020

AbstractThe growth of the elderly population has led to an increase in patients with myocardial infarction and stroke (Wajngarten and Silva, Eur Cardiol 14: 111–115, 2019). Patients receiving treatment for ST-segment-elevation myocardial infarction (STEMI) highly profit from early reperfusion therapy under 3 h from the onset of symptoms. However, mortality from STEMI remains high due to the increase in age and comorbidities (Menees et al., N Engl J Med 369: 901–909, 2013). These factors also account for patients with acute ischaemic stroke. Reperfusion therapy has been established as the gold standard within the first 4 to 5 h after onset of symptoms (Powers et al., Stroke 49: e46-e110, 2018). Nonetheless, not all patients are eligible for reperfusion therapy. The same is true for traumatic brain injury patients. Due to the complexity of acute myocardial and central nervous injury (CNS), finding organ protective substances to improve the function of remote myocardium and the ischaemic penumbra of the brain is urgent. This narrative review focuses on the noble gases argon and xenon and their possible cardiac, renal and neuroprotectant properties in the elderly high-risk (surgical) population. The article will provide an overview of the latest experimental and clinical studies. It is beyond the scope of this review to give a detailed summary of the mechanistic understanding of organ protection by xenon and argon.
The adaptation and evaluation of a CBT-based manual for the inpatient treatment of youth depression: a pilot study
Authors: Frey Michael , Pietsch Kathrin , Weninger Laura , Brockhaus Matthias , Loy Fabian , Claus Nathalie , Wagenbüchler Petra , Kornbichler Selina , Kroboth Jana , Georgii Beatrice , Wermuth Inga , Kititsina Anna , Heiser Katharina , Schulte-Körne Gerd , Platt Belinda 
Published: February 2020

Abstract
Background
Although there is good evidence to support the effectiveness of cognitive behavioral therapy (CBT) for the outpatient treatment of adolescent major depressive disorder (MDD), evidence-based manuals for the inpatient setting are lacking. This pilot study sought to (i) adapt an existing CBT manual (treatment of adolescent depression; TADS) to an inpatient setting (TADS-in), (ii) test its effectiveness at symptom reduction and remission of MDD in a pre-post design, and (iii) assess the strengths and limitations of the manual via a focus-group with clinicians.

Methods
Twenty nine adolescents aged 12–17 years with a primary ICD-10 diagnosis of MDD being treated as inpatients at a psychiatric clinic were included. Embedded in the regular inpatient treatment course (8 weeks), patients received 12 sessions of the TADS-in manual. Quantitative assessment of symptom reduction and remission of MDD was conducted using a non-controlled pre-post design. The quantitative results were supplemented by a focus group with participating psychotherapists.

Results
Of the 29 patients included in the study at the beginning, 19 (65.5%) remained in the study at week 8. Symptoms of depression were statistically significantly lower at the end of treatment than at baseline according to self- (d = 1.38; mean change = 19.88; 95% CI = 12.48–27.28) and other reports (d = 0.64, mean change = 0.35; 95% CI = 0.08–0.62). Clinicians ratings of improvement (CGI-I) suggested that at the end of treatment, 15.8% were very much improved, 68.4% much improved, and 15.8% were minimally improved. According to diagnostic interviews with patients conducted at the end of treatment, 73.3% were in remission. The qualitative analysis showed that on the whole, the TADS-in manual is suitable for the inpatient setting. However, clinicians believed the effectiveness of TADS-in was limited by patient comorbidity and the fact that the inpatients were unable to practice incorporating techniques learnt into everyday life.

Conclusions
This study is the first to adapt the TADS manual to the inpatient setting. The sample of depressed adolescents showed reduced symptomology following treatment, although these findings require replicating in a randomized controlled trial before effects can be attributed to the TADS-in manual specifically. This pilot study informs further development of the manual as well as representing an important first step in the evaluation of the inpatient treatment of adolescent depression.
The study was retrospectively registered (DRKS00017308) and received no external funding.
Toward operationalizing deficient emotional self-regulation in newly referred adults with ADHD: A receiver operator characteristic curve analysis
Authors: Biederman Joseph , DiSalvo Maura , Woodworth K. Yvonne , Fried Ronna , Uchida Mai , Biederman Itai , Spencer Thomas J. , Surman Craig , Faraone Stephen V. 
Published: February 2020

Abstract

Background.
A growing body of research suggests that deficient emotional self-regulation (DESR) is common and morbid among attention-deficit/hyperactivity disorder (ADHD) patients. The main aim of the present study was to assess whether high and low levels of DESR in adult ADHD patients can be operationalized and whether they are clinically useful.

Methods.
A total of 441 newly referred 18- to 55-year-old adults of both sexes with Diagnostic and Statistical Manual of Mental Disorders: Fifth Edition (DSM-5) ADHD completed self-reported rating scales. We operationalized DESR using items from the Barkley Current Behavior Scale. We used receiver operator characteristic (ROC) curves to identify the optimal cut-off on the Barkley Emotional Dysregulation (ED) Scale to categorize patients as having high- versus low-level DESR and compared demographic and clinical characteristics between the groups.

Results.
We averaged the optimal Barkley ED Scale cut-points from the ROC curve analyses across all subscales and categorized ADHD patients as having high- (N = 191) or low-level (N = 250) DESR (total Barkley ED Scale score ≥8 or <8, respectively). Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life compared with those with low-level DESR. There were no major differences in outcomes among medicated and unmedicated patients.

Conclusions.
High levels of DESR are common in adults with ADHD and when present represent a burdensome source of added morbidity and disability worthy of further clinical and scientific attention.