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Background: Stuttering, a neurodevelopmental speech fluency disorder, is associated with intermittent disruptions of speech‐motor control. Behavioural treatments for adults who stutter (AWS) concentrate on adopting speech patterns that enhance fluency, such as speaking rhythmically or prolonging speech sounds. However, maintaining these treatment benefits can be challenging. Neuroimaging studies suggest that supplementary motor area (SMA) which play a crucial role in speech initiation, planning and internal timing shows aberrant activation in speech production of AWS and may contribute to stuttering. Preliminary evidence suggests that brain stimulation may impact responsiveness to behavioural treatments. Aims: The present study aims to investigate whether excitatory repetitive transcranial magnetic stimulation (rTMS) of the SMA and rhythmic speech can consistently reduce stuttering severity across various measures. Methods and Procedures: Ten self‐identified Cantonese‐speaking AWS participated in this double‐blinded, sham‐controlled clinical trial study (NCT 05472181). The participants underwent 10 sessions of rhythmic speech training across two phases, combined with either neuronavigated rTMS or sham, with a 2‐week washout period between phases. The stuttering severity was assessed through various outcome measures, including the percentage of syllables stuttered, self‐perceived stuttering severity, and the brief version of Unhelpful Thoughts and Beliefs About Stuttering before and after each treatment phase. Outcomes and Results: Results demonstrated improved speech fluency in various speaking contexts, with no significant difference between rTMS and sham conditions immediately and 1 week post‐treatment. Notably, rTMS specifically led to less stuttering in tongue twister production (d = –0.70). Both treatment conditions effectively reduced self‐perceived stuttering severity and negative thoughts and beliefs about stuttering. Conclusions and Implications: The findings of this study indicate that stimulating the SMA reduced stuttering, only in the production of tongue twisters that may require greater motor control and coordination. Furthermore, it indicates that rhythmic speech might help alleviate negative beliefs and anxiety related to stuttering. This research contributes to our understanding of neuromodulation in stuttering treatment and the role of the SMA in speech motor control and emphasises the need for more research on the potential benefits and limitations of applying rTMS in this condition. WHAT THIS PAPER ADDS: What is already known on the subject: Behavioural treatments for adults who stutter concentrate on adopting speech patterns that enhance fluency, such as speaking rhythmically or prolonging speech sounds. However, maintaining these treatment benefits can be challenging. Neuroimaging studies indicate that aberrant neural activation in speech production regions, like the supplementary motor area (SMA), is involved in stuttering. The SMA plays a crucial role in initiating, planning, and sequencing motor behaviours. Preliminary evidence suggests that brain stimulation (e.g., transcranial direct current stimulation or transcranial magnetic stimulation) may impact responsiveness to behavioural treatments. What this paper adds to existing knowledge: There is limited knowledge regarding the potential effects of stimulating the SMA to enhance speech fluency in people who stutter. Existing research primarily consists of single case studies that lack proper control conditions or involve only a single stimulation session. Due to their limited scope and power, these studies may not provide sufficient evidence. The current study expands upon existing research by investigating whether multiple sessions of repetitive transcranial magnetic stimulation over the SMA, combined with rhythmic speech, improve speech fluency in adults who stutter. Furthermore, it addresses the limitations of brain stimulation methods and proposes directions for future research. What are the potential or actual clinical implications of this work?: This study implies that the stimulation of SMA reduced stuttering only in speaking contexts that may require greater motor control and coordination such as tongue twisters. Additionally, the research suggests that using rhythmic speech could potentially alleviate negative beliefs and anxiety associated with stuttering. [ABSTRACT FROM AUTHOR]

The article presents abstracts on paediatric anesthesia which include "Audit on evaluation of pediatric anesthesia emergence delirium," by N. Kirodian, S. Campbell, and T. Engelhardt, "Assessment of a noninvasive hemoglobin monitor (Masimo SpHb) in infants and small children undergoing craniofacial surgery," by M. Naik and colleagues, and "Emergence delirium in children, a randomized, double-blind trial of total intravenous anesthesia vs sevoflurane," by D. Myers and colleagues.

Background: Although existing studies have shown that both repetitive transcranial magnetic stimulation (rTMS) and music therapy have advantages in the treatment of non‐fluent aphasia, the efficacy of the combination of these two methods remains to be investigated. Aims: To investigate the clinical efficacy of low‐frequency rTMS combined with music therapy on language function and depression in patients with non‐fluent aphasia after stroke. Methods & Procedures: A single‐blind parallel randomised controlled trial was conducted. Sixty patients (mean duration = 93.78 days) with non‐fluent aphasia after stroke were randomly divided into a traditional therapy group (n = 20), a music therapy group (n = 20) and a combined therapy group (n = 20, 1 Hz). The language function and depression were evaluated before and 3 weeks after treatment with the Chinese version of the Western Aphasia Battery scale, Boston Diagnostic Aphasia Examination scale and Stroke Aphasic Depression Questionnaire Hospital Version scale. Outcomes & Results: The combined therapy group was significantly better in all outcomes than the traditional therapy group and was significantly better in depression than the music therapy group. The music therapy group was significantly better in repetition and depression than the traditional therapy group. Language improvement was positively correlated with depression improvement. For adverse events, only two patients in the combined therapy group showed slight dizziness during rTMS treatment and their symptoms improved after rest. Conclusions & Implications: Our preliminary randomised controlled study indicates that low‐frequency rTMS combined with music therapy is feasible and safe in improving language function and depression in non‐fluent aphasia patients after stroke. WHAT THIS PAPER ADDS: What is already known on this subject: Repetitive transcranial magnetic stimulation (rTMS) and music therapy respectively have advantages in the treatment of non‐fluent aphasia after stroke, but whether the combination of the two methods is more effective is still unknown. What this paper adds to the existing knowledge: This is one of the first randomised control trials to investigate whether the clinical efficacy of low‐frequency rTMS combined music therapy for non‐fluent aphasia is better. The findings show that low‐frequency rTMS combined music therapy is superior to traditional therapy in spontaneous speech, auditory comprehension, repetition, naming, aphasia quotient, functional language level and depression, and superior to music therapy in depression, while music therapy is superior to traditional therapy in repetition and depression. What are the potential or actual clinical implications of this work?: Low‐frequency rTMS combined music therapy may be a better method for treatment of non‐fluent aphasia. [ABSTRACT FROM AUTHOR]

Background: Early intervention is recommended for pre‐school children with low language. However, few robustly evaluated language interventions for young children exist. Furthermore, in many interventions the theoretical underpinnings are underspecified and the 'active ingredients' of the interventions not tested. This paper presents a quasi‐experimental study to test the efficacy and examine the active ingredients of Building Early Sentences Therapy (BEST): an intervention based on usage‐based theory designed to support young children to understand and produce two‐, three‐ and four‐clause element sentences. BEST manipulates the input children hear to support them to harness the cognitive mechanisms hypothesized in usage‐based theories to promote the development of abstract linguistic representations. One such input manipulation is the use of signing alongside verbal input signalling both content and morphology of target sentences. Aims: To examine whether (1) BEST is more efficacious than treatment as usual (TAU); and (2) signing of content and morphology is an active ingredient of the intervention. Methods & Procedures: A quasi‐experimental study recruited children aged 3;5–4;5 years from 13 schools. Schools were assigned to receive either BEST with sign, BEST without sign or TAU. The TAU group received their usual classroom provision. Across arms schools were matched with respect to classroom oral language environment and indices of deprivation. Participants were 48 children (28 boys) with expressive and/or receptive language abilities ≤ 16th centile measured using the New Reynell Developmental Language Scales (NRDLS). Outcomes gathered by researchers blind to treatment arm were NRDLS production and comprehension standard scores and measures of production of targeted sentence structures. Outcomes & Results: Primary outcomes indicate that BEST with sign was significantly more efficacious than TAU with respect to NRDLS production standard score, but not comprehension. The advantage for production was maintained at follow‐up. BEST without sign was significantly more efficacious than TAU on measures of targeted vocabulary, sentence structure and morphology. The results from this quasi‐experimental study provide evidence for the efficacy of a usage‐based intervention on expressive language outcomes for preschool children with low language abilities. There is also evidence to support the inclusion of sign as an active ingredient, and so efforts to train interventionists in its use are worthwhile. Conclusions & Implications: Patterns of findings across outcomes suggest signing of content and morphology may support the development of abstract linguistic representations and accelerate language learning. Given these positive results and the scale of this study, a fully powered randomized controlled trial is warranted. WHAT THIS PAPER ADDS: What is already known on the subject: Robust language skills are crucial for positive social, emotional, academic and economic outcomes across the lifespan. There is a paucity of robustly evaluated interventions for preschool children with language difficulties. The development of such interventions is crucial for ameliorating language difficulties and promoting positive educational and psychosocial outcomes. What this study adds to the existing knowledge: This paper evaluates BEST, a novel usage‐based language intervention targeting children with language difficulties in the early years. Findings indicate that a usage‐based intervention is efficacious for treating language difficulties. In particular, BEST benefited expressive language development, bringing benefits to both treated and untreated language structures and improving standard scores. The role of sign as an active ingredient is also supported. Further evaluation is warranted. What are the practical and clinical implications of this work?: Findings suggest that BEST may be effective for targeting children who have been identified as having language difficulties. In particular, expressive language may be improved when the intervention is delivered as it was originally manualized, including a signing system to represent content and grammatical morphology. More broadly, these findings also provide preliminary evidence that the use of a signing system does not hinder oral language development in children with language difficulties and may conversely support their expressive language. Future research exploring the role and underpinning mechanisms of sign in language intervention is warranted. [ABSTRACT FROM AUTHOR]

This paper focuses on plaque control and the management of gingivitis in adults and summarizes the evidence of commercially available dentifrices as gathered from existing systematic reviews. Three internet sources were used to search for appropriate papers (up to and including February 2017). The search strategy was designed to include any systematic review published on dentifrices that also included an evaluation of plaque and gingivitis scores. Characteristics of the individual reviews, such as methodological aspects, quantitative data and conclusions, were extracted. The potential risk of bias was estimated and the acquired evidence was graded. Independent screening of 205 unique reviews resulted in 10 published and eligible systematic reviews. One publication evaluated the mechanical contribution of dentifrice to plaque removal. Eight papers were identified that evaluated the efficacy of a proposed single active ingredients, of which two reviewed more than one potentially active ingredient. One study compared two active ingredients. This meta-review appraised the current state of evidence and found that toothbrushing with a standard fluoride dentifrice does not provide an added effect for the mechanical removal of dental plaque. Evidence suggests that compared with a standard dentifrice, those containing triclosan or stannous fluoride have benefits with respect to gingival health and control of dental plaque. [ABSTRACT FROM AUTHOR]

Zinc deficiency is a global public health problem, affecting ~17% of the world's population, with the greatest burden in low‐ and middle‐income countries. An increasing body of evidence suggests that biofortification may be a cost‐effective and sustainable approach to reducing zinc and other micronutrient deficiencies. Biofortification enhances the nutritional quality of food crops through conventional plant breeding techniques and agronomic practices. This paper presents ongoing research on biofortification in Pakistan, where over 40% of women are zinc deficient. The Biofortified Zinc Flour to Eliminate Deficiency (BiZiFED) project aims to investigate the impact of biofortification as a strategy to alleviate zinc deficiency in Pakistan. The project is supported by the Biotechnology and Biological Sciences Research Council (BBSRC) Global Challenges Research Fund from May 2017 to April 2019. This paper outlines the four objectives and work packages within the BiZiFED project: (1) a double‐blind, randomised controlled trial to examine the effect of consuming flour made from a high zinc variety of biofortified wheat (Zincol‐2016/NR‐421) on dietary zinc intake and status; (2) a cost‐effectiveness study to assess the health and economic impact of agronomic biofortification of wheat; (3) a mixed methods study to explore the cultural acceptability and sustainability of biofortification in Pakistan; (4) capacity building and development of long‐term research partnerships in Pakistan. The findings will contribute to the evidence base for the potential impact of biofortification to alleviate zinc deficiency among the poorest communities. [ABSTRACT FROM AUTHOR]

Objective: To establish the reliability, validity, and sensitivity to change of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) among Chinese subjects with osteoarthritis (OA) of the knee, living in mainland China.Methods: A multicenter, randomized, double-blind, placebo-controlled, parallel-group study was conducted for validation of the electronic personal digital assistant version of the WOMAC Numerical Rating Scale (NRS) 3.1 Index in China. A total of 287 subjects with OA of the knee were randomized to receive either meloxicam (15 mg) or placebo. Psychometric properties of the WOMAC were evaluated by estimating the reliability, validity, and sensitivity to change. Equivalence of the electronic version was also compared with the paper version.Results: Intraclass correlation coefficients for the WOMAC pain, stiffness, and physical function subscales were 0.81, 0.76, and 0.85, respectively, indicating good test-retest reliability. Similarly, internal consistency was strong (Cronbach's alpha for the 3 WOMAC subscales was 0.84, 0.86, and 0.96, respectively). Pearson's correlation coefficients for WOMAC pain and Short Form 36 health survey (SF-36) bodily pain, as well as WOMAC physical function and SF-36 physical functioning domains were >0.4, indicating convergent validity, whereas the coefficients for all 3 WOMAC domains with SF-36 mental health and mental health component scores were <0.4, indicating divergent validity. There was strong discriminant validity between healthy volunteers and OA patients. The effect sizes of change from baseline to week 12 in WOMAC subscale scores were large, demonstrating sensitivity to change. Equivalence between paper and electronic versions was very high.Conclusion: The culturally and linguistically validated Chinese version of the WOMAC NRS 3.1 for mainland China is psychometrically robust in its validity, reliability, and sensitivity to change for patients with OA of the knee. [ABSTRACT FROM AUTHOR]

Aim: To examine the efficacy of Hand-Arm Bimanual Intensive Therapy (HABIT) on daily functioning, unimanual dexterity, and bimanual performance of children with bilateral cerebral palsy (CP) compared with customary care.Method: Forty-one children with bilateral CP, aged 4 to 16 years, classified in levels I to III of the Manual Ability Classification System, were randomly assigned to HABIT (90h) (n=21) or to customary care (4.5h) (n=20). Participants' daily functioning (Pediatric Evaluation of Disability Inventory [PEDI], Canadian Occupational Performance Measure [COPM]), unimanual dexterity (Jebsen-Taylor Test of Hand Function, Box and Blocks Test [BBT]), and bimanual performance (Both Hands Assessment) were assessed pre-, post-, and 6 months after the intervention. Linear mixed-effects models were used for inferential analysis.Results: Children participating in HABIT showed greater improvements in daily functioning (COPMperformance : χ12 =9.50, p<0.01; COPMsatisfaction : χ12 =5.07, p<0.05; PEDIfunctional skills : χ12 =6.81, p<0.01; PEDIcaregiver assistance : χ12 =6.23, p<0.05) and in the dexterity of the dominant hand (BBT: χ12 =3.99, p<0.05) compared with children maintaining customary care. Group or time effects did not explain any variance in bimanual performance or in the dexterity of the non-dominant hand.Interpretation: HABIT may be beneficial for children with bilateral CP, with benefits evidenced for daily functioning outcomes.What This Paper Adds: Hand-Arm Bimanual Intensive Therapy (HABIT) improved daily functioning of children with bilateral cerebral palsy (CP). Bimanual performance, measured by the Both Hands Assessment, did not change after HABIT in children with bilateral CP. Children with asymmetric and symmetric hand use exhibited similar improvements after HABIT. [ABSTRACT FROM AUTHOR]

Aim: This study compared the cost-effectiveness of botulinum neurotoxin A (BoNT-A) injections with two-duct ligation of the submandibular glands as treatment for severe drooling after one treatment cycle.Method: The study was part of a larger, partly single-blinded, randomized clinical trial (trialregister.nl identifier NTR3537). Data were collected between 2012 and 2017. Evaluation was at 32 weeks after one treatment cycle. Fifty-seven patients with cerebral palsy or other neurological, non-progressive disorders and severe drooling classified as having a drooling frequency ≥3 or a drooling severity ≥2, in whom conservative treatment was deemed ineffective, were randomized to treatment by BoNT-A or two-duct ligation. An incremental cost-effectiveness ratio (ICER) was calculated using the success rates as the measure of benefit. Treatment success was defined as a decrease ≥50% from baseline to 32 weeks in the subjective visual analogue scale for the severity of drooling or the objective drooling quotient.Results: Fifty-three patients were analysed (22 females, 31 males; mean age 11y, range 8-22y). Average costs for one treatment cycle, which included one BoNT-A injection, were €1929 (standard error 62) for BoNT-A and €3155 (standard error 99) for two-duct ligation. Treatment success was in favour of two-duct ligation (63% vs 27%; number needed to treat 3). The ICER was €34 per 1% gain in treatment success in favour of two-duct ligation versus BoNT-A.Interpretation: The additional cost of two-duct ligation is to some extent offset by a larger treatment success rate compared with BoNT-A.What This Paper Adds: Botulinum neurotoxin A (BoNT-A) is less expensive per percentage of success than two-duct ligation. The additional cost of two-duct ligation over BoNT-A is offset by greater treatment success. [ABSTRACT FROM AUTHOR]

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objectives: Visual shade selection is the most commonly used method in dentistry and a challenge for every dentist. However, differences to natural tooth color and the differences of each shade guide are well known. The aim of this paper is to investigate the suitability of two different color scales for determining the color of no‐match templates. Materials and methods: Volunteers (N = 76) selected a shade color of a no‐match template with two shade guides (VITA Classical shade guide (VC) and VITA Linearguide 3D‐Master (V3D LG), both Vita Zahnfabrik). The neutral grey background was laterally illuminated with a color differentiation lamp (Dialite, Eickhorst GmbH). For the volunteers' accuracy, the triangle's area was used which are emerge by the color coordinates of a template (LTaTbT) and the color coordinates of the two decisions (L1a1b1 and L2a2b2). Statistical software was used to evaluate the differences in ΔE00 with α =.01. Results: A deviation in the median of ΔE00 of 7.6 (V3D LG, first choice) to 6.6 (VC, second choice) was detected, while U test showed no significant differences in the median for both color scales. But the triangle's area generated by both shade decisions and tooth color with V3D LG was significant smaller (14.2) then VC (19.2) (P ≤.001). Conclusions: When comparing both results no significant difference in the subject's shade selection and the shade guides was detected. The new evaluation strategy using the size of the triangle's areas proves the superiority of the V3D LG due to a better distribution of the tooth color shades within the color space. [ABSTRACT FROM AUTHOR]

Background Immediate implant placement in molar extraction sites has become a treatment option for experienced clinicians. Purpose The aim of this study was to provide a systematic review and meta-analysis of outcomes from recent clinical studies with immediate molar implants. Materials and Methods A systematic review was undertaken of relevant literature published from November 2008 to May 2015. Data collected included implant survival rates after at least 1 year in function, cumulative crestal bone loss, and implant location (maxilla vs mandible) and diameter. Implant diameters were grouped as 'wide' (4-6 mm) or 'ultra-wide' (>6-9 mm). Survival and bone loss with 95% CIs were calculated using a random effects model. Meta-analysis techniques were used to compare survival rates and cumulative mean bone loss between immediate and delayed placement implants. Survival rates also were computed and compared between wide and ultra-wide implants using chi-square testing. The quality of each study was assessed using established criteria. Results The literature search provided 15 papers published between November 2008 and May 2015 that satisfied the inclusion criteria. Data on survival were found for a total of 768 immediate molar implants inserted in 757 patients. Meta-analysis of these data showed an implant survival rate of 98% with no difference between maxilla and mandible. Five studies included delayed molar implants as controls, and no significant differences were detected. A significant difference ( p = .048) was found in relation to implant diameter with implant failures being higher (3.67 vs 1.45%) for ultra-wide (>6-9 mm) versus wide (4-6 mm) implants. The majority of the 15 studies were determined to be either 'average' (prospective case series) or 'fair' (retrospective) in quality. Conclusion While there are still no published reports from double-blind, randomized, controlled (best quality) clinical trials of immediate molar implant placement, high survival rates have been reported. The present data, however, suggests that there may be an optimal diameter for this implant application. Meta-analysis of the limited bone loss data reported estimated the overall mean cumulative bone loss after at least 1 year to be 0.57 mm. [ABSTRACT FROM AUTHOR]

Open wounds are usually closed with suture. However, young patients often do not cooperate and prevent proper suture placement. Young patients are often terrified of mild pain and wholly uncooperative, which is why we introduce this timesaving, less painful, more aesthetic technique of placing and removing stitches. 104 patients with facial lacerations aged 5 to 15 years were treated at a single center from May 2019 to March 2021. Patients were randomly assigned equally to a simple interrupted suture group (the SI group) or a continuous locking with Steri‐Strip group (the CS group). Suture times, times for stitch removal, pain scores at stitch removal and mature scar scores were evaluated. Suture and stitch removal times were significantly shorter, and pain scores at stitch removal and observer scar assessment scale scores were lower in the CS group. Patient scar assessment scale score was non‐significantly lower in the SI group. This study shows that the novel continuous locking with the Steri‐Strip technique is easier and quicker to perform, causes less pain when removing stitches, provides better aesthetic results than the simple interrupted suture technique and suggests the continuous locking with Steri‐Strip technique would be very useful for uncooperative young patients. [ABSTRACT FROM AUTHOR]

Among several semiparametric models, the Cox proportional hazard model is widely used to assess the association between covariates and the time-to-event when the observed time-to-event is interval-censored. Often, covariates are measured with error. To handle this covariate uncertainty in the Cox proportional hazard model with the interval-censored data, flexible approaches have been proposed. To fill a gap and broaden the scope of statistical applications to analyze time-to-event data with different models, in this paper, a general approach is proposed for fitting the semiparametric linear transformation model to interval-censored data when a covariate is measured with error. The semiparametric linear transformation model is a broad class of models that includes the proportional hazard model and the proportional odds model as special cases. The proposed method relies on a set of estimating equations to estimate the regression parameters and the infinite-dimensional parameter. For handling interval censoring and covariate measurement error, a flexible imputation technique is used. Finite sample performance of the proposed method is judged via simulation studies. Finally, the suggested method is applied to analyze a real data set from an AIDS clinical trial. [ABSTRACT FROM AUTHOR]

Black youth account for the largest number of new HIV infections among heterosexual youth. Mental illness and difficulties in emotion regulation contribute to increased reports of HIV/sexually transmitted infection (STI) risk‐related sexual behaviors in this group. Yet limited interventions exist to address this affective component of the sexual decision‐making process. The purpose of this paper was to describe the trial design, research challenges, and baseline characteristics from a study designed to fill this gap. Project GOLD was a pilot randomized controlled trial of a psychoeducational HIV/STI prevention intervention designed to address the role of mental illness and emotion regulation in HIV/STI risk among heterosexually‐active Black youth aged 14 to 17 (N = 108). Challenges encountered in the research process warrant further attention in future research (e.g., disagreement among the regulatory bodies on parental permission requirements). The most common mental health diagnoses were Recurrent Major Depressive Disorder (15.7%) and current substance abuse (7.4%). Participants reported higher levels of emotional suppression, and adaptive methods of emotion management, than culturally inappropriate expressions of anger or sadness. They also reported a mean age of 13.6 at first vaginal sex, used condoms 66% of the time for vaginal sex, and had an average of three sexual partners in the past 6 months. More than one‐quarter (26.9%) had sex with more than one person in the same day. These findings indicate intervention is crucial for this population. The forthcoming trial evaluation will indicate the promise of such interventions in reducing HIV/STI infections in this key population. [ABSTRACT FROM AUTHOR]

Background and purpose Regular rehabilitation is not sufficient for regaining function after a hip fracture, and more targeted interventions for home-dwelling elderly hip-fracture patients are needed. This paper describes the protocol of a study assessing the effectiveness and cost effectiveness of a task specific progressive gait and balance exercise programme for hip-fracture patients, performed 4 months after the fracture. Methods/design A single blind two-arm pragmatic randomised controlled trial was conducted with 142 hip-fracture patients randomized to a 10-week home-based exercise programme or to practice as usual 4 months following the surgery. Inclusion criteria were age >70 years and being home dwelling prior to the fracture. Exclusion criteria are life expectancy <3 months and inability to walk 10 m prior to the fracture. The content and organization of the programme was developed in collaboration between physiotherapy researchers and primary health-care physiotherapists. Participants were followed for 1 year post-surgery, evaluating short-term and long-term effects of the programme. The primary outcome is gait speed, and the secondary outcomes are spatial and temporal gait parameters, free living physical behaviour by activity monitoring, mobility performance, activities of daily living, fear of falling, cognitive function, depression and health-related quality of life. Cost-effectiveness analysis is planned. Discussion This paper describes a task specific exercise programme aimed to improve gait and balance after a hip fracture. Inclusion started in February 2011, and the last 1-year follow-up is performed in March 2014. Broad inclusion criteria and physiotherapy-guided home-based exercises may facilitate the participation from frail patients and thereby increase the generalizability of the findings. Development and completion of the intervention within routine clinical practice will enlighten the implementation of results into clinical practice. Results may add new insight into how physiotherapy can improve gait and thereby activity and functioning in everyday life and have implications on future content and organization of physiotherapy after a hip fracture. Copyright © 2014 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

An introduction is presented in which editor discusses various reports within the issue on topics including the benefits of double-blind reviewing in the scholarly community, the process of double-blind review, and contributors in the writing of a journal.

Previous studies posited the effectiveness of stimulated recall. However, few studies explored how SR is implemented in a relatively static context, for example, online self‐directed learning, or took human factors, for example, cognitive style and gender, into consideration in such a context. To fill this gap, the current study, aims to introduce biofeedback as a stimulus for learners to engage in retrospection regarding their learning behavior. A quasi‐experimental design study was carried out over a 12‐week set of EFL self‐regulated online reading activities. Pretest and posttest on reading performance and their cognitive taxonomy were assessed through a developed scale instrument, whereas physiologicalsignals (e.g., gazing duration, verbal fixation, and brain wave) were captured via eye‐tracking and electroencephalograph (EEG) technology. The results emphasized that (a) students' reading ability and cognitive hierarchy significantly improved through biofeedback stimulation. Moreover, (b) learners in single level‐one cognitive hierarchic groups had significant improvements in both cognitive abilities and reading comprehension, whereas learners in multilevel hierarchic groups had no significant enhancements. Finally, (c) the optical data results and EEG reports showed that males favor procedural feedback and females have a preference for a conclusive assessment. Lay Description: What is already known about this topic: ·The stimulated recall (SR) technique, considered being a valuable tool for learners to capitalize on introspection, has positive effect on learning outcomes and cognitive processes in physical context.The recorded audio and video are generally used as the stimulus in physical learning context.The stimulus source may differ from a research context to another.Learning performance has close relationship with different human factors, such as cognitive taxonomy and gender differences. What this paper adds: Students adopting the biofeedback as stimulus demonstrated significant improvement in the dimensions of cognitive level and reading comprehension.Biofeedback, such as EEG and eye movement, may be applicable stimulus for stimulated recall in online self‐directed learning context.The lower cognitive students have more significant enhancement of taxonomy and reading capacity, when conducting biofeedback‐based stimulated recall.Eye‐track reports showed that males favor procedural feedback and females have a preference for the conclusive assessment. Implications for practice and/or policy: Biofeedback may act as a meta‐cognitive method to help learners realize their personalized learning habits and cognitive modes and encourage them to embark in the often daunting journey of autonomous learning.Biofeedback data could be used as valuable measurements for instructors to adjust their pedagogic design and improve teaching arrangements according to learners' emotional status and human factors.Procedural feedback is adaptive and should be considered utilizing for male students in self‐access learning context, whereas conclusive assessment approach is more applicable for female learners. [ABSTRACT FROM AUTHOR]

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The aim of this paper is to evaluate the efficacy and safety of three different norepinephrine dosing regimens for preventing spinal hypotension in cesarean section. In this randomized double-blinded controlled study, 120 parturients scheduled for elective section delivery under spinal anesthesia were assigned to 1 of 4 groups. In the control group, patients received saline infusion. In three norepinephrine groups, the infusion dosage regimens were 5, 10, and 15 μg/kg/h, respectively. Hypotension was treated with a rescue bolus of 10 μg norepinephrine. The study protocol was continued until the end of surgery. The primary outcome was the proportion of participants that underwent hypotension. The proportion of hypotension participants was significantly reduced in the norepinephrine groups (37.9%, 20%, and 25%, respectively) compared to that in the control group (86.7%). However, the highest dose of norepinephrine (15 μg/kg/h) resulted in more hypertension episodes. In addition, blood pressure was better maintained in the norepinephrine 5 μg/kg/h and 10 μg/kg/h groups than in the control group and 15 μg/kg/h group. No significant differences in other hemodynamic variables, adverse effects, maternal and neonatal blood gases, or Apgar scores were observed among the groups. In summary, for patients who undergo cesarean delivery under spinal anesthesia, infusion of 5–10 μg/kg/h norepinephrine was effective to reduce hypotension incidence without significant adverse effects on maternal and neonatal outcomes. Clinical Trial Registration Number is ChiCTR-INR-16009452. [ABSTRACT FROM AUTHOR]

To cite this article: Int J Dent Hygiene  8, 2010; 258-268 DOI: 10.1111/j.1601-5037.2010.00479.x Van der Sleen MI, Slot DE, Van Trijffel E, Winkel EG, Van der Weijden GA. Effectiveness of mechanical tongue cleaning on breath odour and tongue coating: a systematic review. Background: The objective of this review was to summarize the available evidence regarding the effects of mechanical tongue cleaning compared with no mechanical tongue cleaning on breath odour and tongue coating (TC). Methods: PubMed-MEDLINE, EMBASE and Cochrane-CENTRAL were searched to identify potentially relevant studies. The inclusion criteria included the following: randomized controlled clinical trials (RCTs) or controlled clinical trials (CCTs) conducted in humans in good general health (no systemic disorders) and a patient age of ≥17 years. For the intervention, we considered tongue cleaning [the use of a tongue scraper (TS) or tongue brush (TB)] and for the control, brushing only (B) groups. Clinical parameters such as volatile sulphur compound concentration, organoleptic scores and TC were the outcome variables of interest. Study selection, quality assessment and data extraction were carried out by two independent reviewers. Results: After screening of the titles and abstracts and subsequent full text reading of the potential papers, we identified five publications that met the eligibility criteria and provided seven experiments. The five studies consisted of three RCTs and two CCTs. All experiments show a positive effect of mechanical tongue cleaning in addition to toothbrushing on various parameters of oral malodour. Conclusions: This review demonstrated that mechanical approaches, such as tongue brushing or tongue scraping to clean the dorsum of the tongue, have the potential to successfully reduce breath odour and TC. However, data concerning the effect of mechanical tongue cleaning on chronic oral malodour (halitosis) are insufficient. [ABSTRACT FROM AUTHOR]

Background: There is controversy regarding the best technique for applying Kinesio Taping (KT), and the theory supporting that skin convolutions may explain its efficacy has recently been challenged.Objective: To compare the immediate and short-term effectiveness of KT tightness on mechanosensitivity and spinal mobility in nonspecific low back pain (LBP), and to observe the influence of gender in the outcome measures.Design: Double-blind, randomized, controlled trial.Setting: University-based clinical research center.Participants: A total of 75 individuals with a mean age of 33 years (±7.4 years), 60% female and 40% male, with nonspecific LBP were recruited and randomly assigned to 1 of the following study groups: standard KT tension (n = 26), increased KT tension (n = 25), and no KT tension (n = 24).Interventions: All participants received a two I-strip taping over the paravertebral muscles for 24 hours. Paper-off tension (15%-25% of the available stretch) was used in the standard KT group, which was increased to 40% in the increased KT tension group. The rest of participants received a taping procedure with no KT tension. Measurements were taken at baseline, immediately after the taping, 24 hours after the taping, and after KT removal.Main Outcome Measures: The primary outcome included pressure pain thresholds over the erector spinae and gluteus medius muscles. The secondary outcome was lumbar mobility (assessed with a digital inclinometer, and back-saver sit-and-reach, finger-to-floor, and sit-and-reach tests).Results: In the between-groups analysis of the mean score changes after baseline assessment, no significant differences were found for any of the outcome measures (P > .05) except the left back-saver sit-and-reach test (P = .03). A statistically significant interaction group × gender × time was observed only for mechanosensitivity values (P = .02 for the gluteus and P = .01 for the erector spinae).Conclusion: KT tightness does not seem to influence pain sensitivity and lumbar mobility in chronic LBP in either the immediate or short term.Level Of Evidence: II. [ABSTRACT FROM AUTHOR]

We read the paper by Ljunggren et al[1] with great interest as it addresses the use of mannitol in cardiopulmonary bypass(CPB) prime. In our paper "Cardiopulmonary bypass prime composition: beyond crystalloids versus colloids"[2] we could show significant changes in osmolality when a hyperosmolar prime containing mannitol was used for CPB. More important than confirming that adding osmoles will temporarily change the osmolality was our discussion regarding possible negative outcomes. [Extracted from the article]

Background Current electrocardiographic and echocardiographic measurements in heart failure (HF) do not take into account the complex interplay between electrical activation and local wall motion. The utilization of novel technologies to better characterize cardiac electromechanical behavior may lead to improved response rates with cardiac resynchronization therapy (CRT). Electromechanical wave imaging (EWI) is a noninvasive ultrasound-based technique that uses the transient deformations of the myocardium to track the intrinsic EW that precedes myocardial contraction. In this paper, we investigate the performance and reproducibility of EWI in the assessment of HF patients and CRT. Methods EWI acquisitions were obtained in five healthy controls and 16 HF patients with and without CRT pacing. Responders (n = 8) and nonresponders (n = 8) to CRT were identified retrospectively on the basis of left ventricular (LV) reverse remodeling. Electromechanical activation maps were obtained in all patients and used to compute a quantitative parameter describing the mean LV lateral wall activation time (LWAT). Results Mean LWAT was increased by 52.1 ms in HF patients in native rhythm compared to controls (P < 0.01). For all HF patients, CRT pacing initiated a different electromechanical activation sequence. Responders exhibited a 56.4-ms ± 28.9-ms reduction in LWAT with CRT pacing (P < 0.01), while nonresponders showed no significant change. Conclusion In this initial feasibility study, EWI was capable of characterizing local cardiac electromechanical behavior as it pertains to HF and CRT response. Activation sequences obtained with EWI allow for quantification of LV lateral wall electromechanical activation, thus providing a novel method for CRT assessment. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the editor discusses various reports within the issue on topics including placebos, celiac disease and irritable bowel syndrome.

This study assessed the effect of a commercial carbohydrate menthol drink on cycling time trial (TT) performance in hot and humid conditions compared with a carbohydrate only drink. Ten participants (5 women; V̇O2max: 52.3 ± 8.6 mL kg−1 min−1, Peak Power Output: 286 ± 56 W) completed a 40‐min cycling preload (50% V̇O2max) followed by a 15‐min self‐paced TT in hot (∼35°C) and humid (∼54%) conditions on two occasions (double blind, crossover design). Every 10‐min, 85 mL of carbohydrate (CHO; SIS GO Energy, 60 g h−1) or carbohydrate and menthol (CHO + MEN; SIS Turbo+ 60 g h−1, 0.01% menthol) was swilled (∼10‐s) and ingested. Rectal temperature (Trec) and heart rate (HR) were recorded throughout. Thermal sensation (TS), thermal comfort (TC) and rating of perceived exertion (RPE) were recorded every 5‐min. Taste and aftertaste were rated from very pleasant (+5) to very unpleasant (−5). TT performance (total work; kJ) was similar between CHO (153 kJ [95% CI: 129–177 kJ]) and CHO + MEN (151 kJ [128–178 kJ]). During preload exercise, Trec increased by ∼0.9°C and was similar at the end of the TT (∼38.20°C). Mean preload HR was ∼140 b min−1 in each condition and reached ∼177 b min−1 at the end of the TT. TC was rated as 'much too warm' and TS rated as 'very hot' in both conditions. Both conditions were 'extremely hard' (end point RPE ∼19). All participants preferred the taste and aftertaste of the CHO drink. The commercial carbohydrate menthol drink offered no additional ergogenic benefit compared to a carbohydrate only drink during cycling exercise performed in hot and humid conditions. Highlights: The addition of menthol to a carbohydrate drink had no effect on 15‐min time trial performance.The addition of menthol to a carbohydrate drink had no effect on thermal perceptual measures or physiological measures.Taste and aftertaste perceptions were favourable towards the carbohydrate drink compared to the carbohydrate‐menthol drink. [ABSTRACT FROM AUTHOR]

Experienced Carers Helping Others (ECHO) is an intervention for carers of people with eating disorders. This paper describes the theoretical background and protocol of a pilot multicentre randomised controlled trial that will explore the use of two variants of ECHO for improving outcomes for adolescents with anorexia nervosa (AN) referred for outpatient care. Adolescent patients and their carers (typically parents and close others in a supportive role) will be recruited from 38 eating disorder outpatient services across the UK. Carers will be randomly allocated to receive 'ECHOc' guided self-help (in addition to treatment as usual), 'ECHO' self-help only (in addition to treatment as usual) or treatment as usual only. Primary outcomes are a summary measure of the Short Evaluation of Eating Disorders at 6- and 12-month follow-ups. Secondary outcomes are general psychiatric morbidity of AN patients and carer, carers' coping and behaviour, and change in healthcare use and costs at 6- and 12-month follow-ups. Therapist effects will be examined, and process evaluation of ECHOc will be completed. The findings from this pilot trial will be used in preparation for executing a definitive trial to determine the impact of the preferred variant of ECHO to improve treatment outcomes for AN. Copyright © 2014 John Wiley & Sons, Ltd and Eating Disorders Association. [ABSTRACT FROM AUTHOR]

Constraint-induced movement therapy (CIMT) is a commonly used rehabilitation intervention to improve upper limb function after stroke. CIMT was originally developed for patients with a chronic upper limb paresis. Although there are indications that exercise interventions should start as early as possible after stroke, only a few randomized controlled trials have been published on either CIMT or modified forms of CIMT (mCIMT) during the acute phase after stroke. The implementation of (m)CIMT in published studies is very heterogeneous in terms of content, timing and intensity of therapy. Moreover, mCIMT studies often fail to provide a detailed description of the protocol applied. The purpose of the present paper is therefore to describe the essential elements of the mCIMT protocol as developed for the EXplaining PLastICITy after stroke (EXPLICIT-stroke) study. The EXPLICIT-stroke mCIMT protocol emphasizes restoring body functions, while preventing the development of compensatory movement strategies. More specifically, the intervention aims to improve active wrist -and finger extension, which is assumed to be a key factor for upper limb function. The intervention starts within 2 weeks after stroke onset. The protocol retains two of the three key elements of the original CIMT protocol, that is, repetitive training and the constraining element. Repetitive task training is applied for 1 hour per working day, and the patients wear a mitt for at least 3 hours per day for three consecutive weeks. Copyright © 2012 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Motivation: It is time to reframe fundamentally the research agenda on migration, remittances, payments and development. Many policy‐makers in the developing world, and researchers, tend to view migrant remittances as windfall income, rather than as returns on investment, which is how families with migrants tend see remittances. Migration is thus, among other things, a strategy for financial management in poor households: location is an asset, migration an investment. Purpose: We propose that this shift of perspective on remittances—from windfall to return on investment—leads to more fruitful research questions. Methods: Reviewing the literature, we summarize the research questions that have dominated the literature on migration and remittances and why, owing largely to unhelpful perspectives, they lead us to less informative answers. Findings: We suggest 12 new and alternative research questions that have received relatively little attention in the literature on migration and remittances, to spur new, more productive research. Policy Implications: Migrant remittances are now several times larger than foreign aid. The effects of migration regulation and financial regulation on remittances have directly and significantly affect poverty and human security worldwide. But some of the most basic questions about remittances and their effects remain inadequately answered, in part because of a blinded research agenda. Asking better questions is a step toward better policies, programmes and regulations and, above all, to enable people on low incomes to improve their lives. [ABSTRACT FROM AUTHOR]

The intranasal low intensity GaInP/AlGaInP diode 650nm laser therapy (ILGLT) might improve blood lipid and hemorheologic behavior of patients in view of its previous research, but it should be further supported by a randomized, double-blind, and placebo-controlled clinical study. In this paper, 90 patients with coronary heart disease or cerebral infarction were randomly divided into two groups, 60 in the treatment group and 30 in the control group, and were blindly treated with ILGLT at 8.38 and 0mW/cm² for 30min each time once a day ten days each session for two sessions between which there were three days for rest, respectively. Fasting blood lipid such as total cholesterol and low/high-density lipoprotein cholesterol and hemorheologic behavior such as blood viscosity, plasma viscosity, redox viscosity and red blood cell aggregation were assessed before the first treatment and after the two sessions and were found to be significantly improved by ILGLT. It was concluded that ILGLT may improve blood lipid and hemorheologic behavior of patients with coronary heart disease or cerebral infarction. [ABSTRACT FROM AUTHOR]

Blinding, or 'masking,' is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations and empirical analyses support the blinding of patients, health-care providers, and outcome assessors as to the trial intervention to which patients have been allocated. We encourage extensive pretrial testing of blinding procedures and explicit reporting of who was in the blinded condition and the methods used to ensure blinding. [ABSTRACT FROM AUTHOR]

Please cite this paper as: Modlock J, Nielsen B, Uldbjerg N. Acupuncture for the induction of labour: a double-blind randomised controlled study. BJOG 2010;117:1255–1261. Objective To investigate whether acupuncture is effective for the induction of labour in post-term pregnancies. Design A double-blind multicentre randomised controlled study. Settings Aarhus University Hospital and Herning Regional Hospital, Denmark. Population One hundred and twenty-five healthy women with uneventful pregnancies at gestational week 41+6 were randomised into two groups. Methods The intervention group was given acupuncture twice on the same day at acupuncture point GV20 and bilaterally at points BL67, LI4 and SP6. The control group received sham acupuncture at the same points. Main outcome measures At effect evaluation, which was carried out 24 hours after randomisation, the primary endpoint was labour or delivery. Results The primary endpoint was achieved in seven women (12%) in the acupuncture group and eight women (14%) in the control group ( P = 0.79). Stratification for parity and fetal gender did not alter the results. Conclusion Under the treatment regimen investigated in this study, acupuncture for the induction of labour in post-term women at gestational age 41+6 weeks may not be effective. [ABSTRACT FROM AUTHOR]

Iron deficiency (ID) and ID with anaemia (IDA) are serious global health problems that disproportionately affect women aged 15–49 years. Although food fortification is one of the most effective and sustainable ways to combat nutritional deficiencies, iron remains one of the most difficult micronutrients to fortify, given its tendency to react strongly with food constituents. Therefore, it is important to assess the sensory properties of foods fortified with iron to determine the acceptability and palatability in target populations. We aimed to determine the palatability and acceptability of a novel iron and zinc‐enriched powder fortified in tap water by conducting sensory evaluations in 35 women of reproductive age using a 9‐point hedonic scale, where participants rated the sensory properties of six samples containing different amounts of the active or placebo powder. We found significant differences between samples reconstituted at 1, 2, and 3 g/L for sensory properties, including overall taste. Participants were found to be more willing to drink the mineral‐enriched powder when prepared at the lowest concentration (1 g/L) compared to higher concentrations. Our results provide important insight into the sensory qualities of a novel formulation of an iron and zinc‐enriched powder for at‐home fortification and indicate consumer acceptability in reproductive‐aged women, a key group at risk for ID/IDA. If found to improve iron status, novel treatments like this product will contribute to global efforts to develop safe, acceptable and sustainable interventions for ID and IDA. Key messages: There is a need to develop effective and acceptable treatments for ID/IDA in women of reproductive age, a population most at risk for these conditions.Fortification is one of the most sustainable approaches to combat nutritional deficiencies.Iron is one of the most difficult micronutrients to fortify, as it can result in unacceptable sensory changes that lead to poor long‐term adherence and decreased treatment efficacy.This study provides novel insights into the sensory perceptions of an iron fortification system in reproductive aged women, and can support global efforts towards developing acceptable treatments for ID/IDA in women. [ABSTRACT FROM AUTHOR]

Neuromuscular deficits at the proximal or distal to the knee may contribute to knee valgus and anterior cruciate ligament (ACL) injury. A valgus or abducted position of the knee greater than 12° for females is suggested to be an indicator of the risk of lower extremity injuries. However, there is a lack of examination regarding neuromuscular patterns in both proximal and distal kinetic chains. The purpose of this study was to investigate the effect of 8 weeks of neuromuscular training on knee valgus and co‐activation of the hip and ankle muscles during a countermovement jump in female athletes with a high risk of ACL injury. Twenty‐eight female athletes, with knee valgus greater than 12°, were randomly assigned into two groups: training (n = 14) and control (n = 14). The following measurements were taken before and after the intervention: co‐activation of Gluteus Maximus‐Tensor Fasciae Latae (GMax‐TFL), Gluteus Medius‐Adductor Longus (GMed‐AL), Tibialis Anterior‐Medial Gastrocnemius (TA‐MG), Tibialis Anterior‐Lateral Gastrocnemius (TA‐LG), Medial Gastrocnemius‐Lateral Gastrocnemius (MG‐LG) muscles, and DKV angle during single‐leg countermovement jump task. Following the intervention, the training group demonstrated increased co‐activation of muscles (except TA‐LG) (P < 0.05). The knee valgus angle in the training group decreased by 5.9° (P = 0.001). Our results demonstrated that neuromuscular training alters muscle activity patterns and the neuromuscular group demonstrated a clinically meaningful and statistical reduction in knee valgus. Highlights: Dynamic knee valgus (DKV) is a risk factor for identifying women with a risk of lower extremity injuries.Muscle activity patterns of the hip and ankle, such as DKV, may be modifiable through neuromuscular training.Neuromuscular training with feedback could reduce excessive DKV at a clinically meaningful level. [ABSTRACT FROM AUTHOR]

Background: Transcranial magnetic stimulation (TMS) offers a promising treatment avenue to modulate brain function in alcohol use disorder (AUD). To the best of our knowledge, this pilot study is the first randomized, double‐blind, sham‐controlled trial to deliver intermittent theta burst stimulation to the left dorsolateral prefrontal cortex (DLPFC) among US veterans with AUD. We hypothesized that 20 sessions of real TMS are tolerable and feasible. As a secondary line of inquiry, we hypothesized that, relative to sham TMS, individuals receiving real TMS would experience greater reductions in 6‐month relapse rates, anhedonia, and alcohol cue‐reactivity. Methods: Veterans (n = 17, one woman) were enrolled in a double‐blind, sham‐controlled trial (2–3 sessions/day; 7–10 days; 600 pulses/session; 20 sessions). Pre‐ and posttreatment assessments included responses to self‐report questionnaires and functional magnetic resonance imaging measures of alcohol cue‐reactivity. Alcohol consumption was assessed for 6 months. Linear mixed‐effects models were constructed to predict posttreatment craving, mood, and cue‐reactivity. Results: Individuals who received active iTBS (n = 8) were less likely to relapse within 3 months after treatment than the sham‐treated group (n = 9) (OR = 12.0). Greater reductions in anhedonia were observed following active iTBS (Cohen's d = −0.59), relative to sham (d = −0.25). Alcohol cue‐reactivity was reduced following active iTBS and increased following sham within the left insula (d = −0.19 vs. 0.51), left thalamus (d = −0.28 vs. 0.77), right insula (d = 0.18 vs. 0.52), and right thalamus (d = −0.06 vs. 0.62). Conclusions: Relative to sham, we demonstrate that 20 sessions of real left DLPFC iTBS reduced the likelihood of relapse for at least 3 months. The potential utility of this approach is underscored by observed decreases in anhedonia and alcohol cue‐reactivity—strong predictors of relapse among veterans. These initial data offer a valuable set of effect sizes to inform future clinical trials in this patient population. [ABSTRACT FROM AUTHOR]

Objective: AURORA 2 evaluated the long‐term safety, tolerability, and efficacy of voclosporin compared to placebo in patients with lupus nephritis (LN) receiving an additional two years of treatment following completion of the one‐year AURORA 1 study. Methods: Enrolled patients continued their double‐blinded treatment of voclosporin or placebo randomly assigned in AURORA 1, in combination with mycophenolate mofetil and low‐dose glucocorticoids. The primary objective was safety assessed with adverse events (AEs) and biochemical and hematological assessments. Efficacy was measured by renal response. Results: A total of 216 patients enrolled in AURORA 2. Treatment was well tolerated with 86.1% completing the study and no unexpected safety signals. AEs occurred in 86% and 80% of patients in the voclosporin and control groups, respectively, with an AE profile similar to that seen in AURORA 1, albeit with reduced frequency. Investigator reported AEs of both glomerular filtration rate (GFR) decrease and hypertension occurred more frequently in the voclosporin than the control group (10.3% vs 5.0%, and 8.6% vs 7.0%, respectively). Mean corrected estimated GFR (eGFR) was within the normal range and stable in both treatment groups. eGFR slope over the two‐year period was −0.2 mL/min/1.73 m2 (95% confidence interval [CI] −3.0 to 2.7) in the voclosporin group and −5.4 mL/min/1.73 m2 (95% CI −8.4 to −2.3) in the control group. Improved proteinuria persisted across three years of treatment, leading to more frequent complete renal responses in patients treated with voclosporin (50.9% vs 39.0%; odds ratio 1.74; 95% CI 1.00–3.03). Conclusion: Data demonstrate the safety and efficacy of long‐term voclosporin treatment over three years of follow‐up in patients with LN. [ABSTRACT FROM AUTHOR]

Background: Delgocitinib ointment is usually recommended for use in children at a concentration of 0.25%. However, there are no clear criteria for dosing, except that a 0.5% formulation may also be used, depending on symptom severity. Treatment of atopic dermatitis is based on combinations of topical corticosteroids, tacrolimus ointment, and delgocitinib ointment, but there are no reports on the safety of delgocitinib ointment when used in combination with other drugs. Methods: This is a post‐hoc analysis of data from two delgocitinib ointment trials with pediatric atopic dermatitis patients. The efficacy and safety of the 0.25% and 0.5% formulations were compared. Efficacy and safety were evaluated after up to 4 and 56 weeks of treatment, respectively. The safety of delgocitinib ointment when used in combination with topical corticosteroids and/or tacrolimus ointment was investigated. Results: The dose–response relationship was examined according to baseline disease severity. The proportions of subjects with mild disease who achieved cumulative investigator's global assessment of 0 (clear) or 1 (almost clear) were 46.2% (0.25% ointment), 71.4% (0.5% ointment), and 7.7% (vehicle). For subjects with moderate to severe disease, the corresponding proportions were 19.0%, 20.0%, and 0.0%, respectively. No overall differences were seen in the safety profiles of the 0.25% and 0.5% delgocitinib ointment doses, or in the safety profiles of the two doses relating to disease severity or to concomitant use of topical corticosteroids and/or tacrolimus ointment. Conclusions: These analyses indicate that after up to 4 weeks of treatment, delgocitinib 0.5% ointment may be more effective than the 0.25% dose for mild atopic dermatitis, and that after up to 56 weeks of treatment, delgocitinib is well tolerated in a pediatric trial population when used as prescribed in combination with topical corticosteroids and/or tacrolimus ointment. [ABSTRACT FROM AUTHOR]

Purpose: Since the effect of dietary nitrate (NO3 -) supplementation on rugby performance is unclear, the aim of the present study was to determine the effect of acute NO3 - supplementation, on the modified Yo-Yo intermittent recovery level 1 (IR1) performance test in trained male rugby players. Methods: In a randomised, counterbalanced, double-blind, placebo-controlled crossover design, 12 trained rugby union players performed two experimental trials three hours after supplementation of either 140 mL NO3 - -rich (BRJ; ~12.8 mmol NO3 -) or NO3- -depleted (PLA) BRJ. After blood sampling, players performed the modified Yo-Yo IR1 test. Countermovement jumps (CMJ) were also measured before (pre-CMJ) and after (post-CMJ) the prone Yo-Yo IR1 test. Results: Plasma NO3 - (BRJ: 570 ± 146 µM vs. PLA: 72 ± 23 µM) and nitrite (NO2 -) concentrations (BRJ: 320 ± 123 nM vs. PLA: 103 ± 57 nM) were increased after BRJ compared to PLA supplementation (both P < 0.001). Performance in the modified Yo-Yo IR1 test did not differ between BRJ (542 ± 209 m) and PLA (498 ± 185 m, P = 0.3). The jump height in pre-CMJ and in post-CMJ were similar between trials (both P > 0.05). Conclusions: Acute BRJ supplementation increased plasma NO3 - and NO2 - concentrations but had no benefit on an intermittent running test that reflects the demands of rugby performance, and CMJ performances. The findings do not support acute high-dose NO3 - supplementation as an ergogenic aid to enhance physical performance in trained male rugby players. [ABSTRACT FROM AUTHOR]

Objective: This Phase II, placebo‐controlled, double‐blind study investigated the efficacy, safety, and tolerability of nivasorexant in the treatment of adults with moderate to severe binge‐eating disorder (BED). Methods: Adults meeting the DSM‐5 BED criteria were randomized 1:1 to placebo or nivasorexant (100 mg b.i.d.). The primary endpoint was the change from baseline to Week 12 in the number of binge eating (BE) days per week. Exploratory efficacy endpoints included cessation of BE in the last 4 weeks of treatment; and change from baseline to Week 12 in the number of BE episodes/week, the clinician global impression (CGI) of change, the Yale‐Brown Obsessive‐Compulsive Scale modified for BE, and the Hamilton rating scale for depression (HAMD‐17). Key safety outcomes included treatment‐emergent adverse events (TEAEs) and adverse events of special interest (i.e., somnolence and fatigue). Results: Sixty‐eight participants were randomized to each treatment arm. The change from baseline to Week 12 in the number of BE days/week was the same for placebo (least squares mean [LSM]: −2.93) and nivasorexant (LSM: −2.93), with no difference between the treatment groups (LSM difference =.000 [95% confidence interval (CI): −.69,.69], p =.9992). Furthermore, no differences between treatment groups were observed in the exploratory efficacy endpoints. Nivasorexant was well tolerated; the overall incidence of TEAEs was balanced between treatment groups, and the frequency of somnolence and fatigue in the nivasorexant group were similar to placebo. Discussion: In this proof‐of‐concept study, 100 mg b.i.d. nivasorexant did not improve BE in adults with moderate to severe BED. Public Significance: The results of this Phase II study indicate that nivasorexant was well tolerated in adults with BED, but did not improve binge eating behavior over placebo. Further research is needed to improve our understanding of the role of the orexin‐1 receptor in BED. [ABSTRACT FROM AUTHOR]

Background: The primary prevention of periodontitis is controlling gingivitis daily. The study objective was to compare the efficacy of a pulsating water flosser to a pulsating water flosser infused with air microbubbles on clinical signs of inflammation and plaque. Methods: One hundred and five participants were enrolled in this single‐blind, single‐centre, parallel, 4‐week, IRB/IEC‐approved clinical trial. Participants were randomly assigned to one of three groups: water flosser (WF) plus manual toothbrush, water flosser infused with microbubbles of air (MBWF) plus manual toothbrush, or dental floss (DF) plus manual toothbrush. Bleeding on probing (BOP), Modified Gingival Index (MGI) and Rustogi Modification Navy Plaque Index (RMNPI) scores were recorded at baseline, 2 and 4 weeks. Results: All participants completed the study (n = 105). All groups showed a statistically significant reduction for BOP, MGI and RMNPI at 4 weeks (p < 0.05, except DF marginal RMNPI). The WF group showed a statistically significant greater reduction in whole mouth BOP (0.41) compared to MBWF (0.32) and DF (0.19). This was also true for MGI (0.37, 0.30 and 0.20, respectively) and RMNPI (0.13, 0.11 and 0.06, respectively; p < 0.05 for all comparisons). No adverse events were reported. Conclusion: This study demonstrates that a manual toothbrush and water flosser, with or without microbubbles, is an effective oral care regimen for controlling gingivitis over 4 weeks. [ABSTRACT FROM AUTHOR]

Introduction: It is unknown whether interprofessional identity is able to explain interprofessional behaviours. Extended professional identity theory provides clues by combining two psychological identity approaches. The aim of this study is to investigate whether interprofessional identity is a source for intrinsic motivation towards interprofessional collaboration related to wider group membership. Methods: Participants of this double‐blinded study were 47 dentistry and 41 dental hygiene students (86.3% response) without interprofessional education (IPE) experience. Group productivity was used as indicator of group effort and equal communication as indication for interprofessional direction. The extended professional identity scale (EPIS) was used to measure interprofessional identity eight weeks prior to a mandatory IPE course. Based on EPIS levels, students were assigned to a low or high interprofessional identity group condition. Subsequently, 12 interprofessional teams (four to five members) were randomly composed per condition. Each group received eight problems (regarding roles, responsibilities and collaborative practice) for which they were expected to provide up to 10 solutions. Six trained psychologists rated the validity of solutions after which the percentage of solutions per group was calculated. Additionally, the psychologists rated interprofessional direction by observing team communication (asking questions, topic control, prosocial formulations, and speech frequency) during the second group meeting. Results: No interprofessional identity differences were found with regard to gender and profession. The mean difference between groups with low versus high interprofessional identity was 0.5 (M = 3.4; SD = 0.5 and M = 3.9, SD = 0.4, respectively), t = −5.880, p < 0.001. Groups with high identity generated more solutions compared to low identity groups (91.5% vs. 86.4%), t = −2938, p = 0.004. The correlation between individual interprofessional identity and group effort was significant, r = 0.22, p = 0.036. Groups with high identity showed more interprofessional direction, t = −2.160, p = 0.034. Discussion: Interprofessional identity has a positive effect on congruent interprofessional behaviours after 10 weeks. More research is required to understand interprofessional identity in relation to performance in education and work. Reinders and Krijnen show that interprofessional identity is a source of intrinsic motivation towards interprofessional collaboration, influencing problem solving as well as teamwork. [ABSTRACT FROM AUTHOR]

To evaluate the status of a 7‐month phase 3 study conducted to test the effect of intramuscular injections of VM202 (ENGENSIS), a plasmid DNA encoding human hepatocyte growth factor, into the calf muscles of chronic nonhealing diabetic foot ulcers with concomitant peripheral artery disease. The phase 3 study, originally aimed to recruit 300 subjects, was discontinued because of slow patient recruitment. An unprespecified interim analysis was performed for the 44 subjects enrolled to assess the status and determine the future direction. Statistical analyses were carried out for the Intent‐to‐Treat (ITT) population and separately for subjects with neuroischemic ulcers, using a t‐test and Fisher's exact test. A logistic regression analysis was also conducted. VM202 was safe and potentially should have benefits. In the ITT population (N = 44), there was a positive trend toward closure in the VM202 group from 3 to 6 months but with no statistical significance. Levels of ulcer volume or area were found to be highly skewed between the placebo and VM202 groups. Forty subjects, excluding four outliers in both arms, showed significant wound‐closing effects at month 6 (P =.0457). In 23 patients with neuroischemic ulcers, the percentage of subjects reaching complete ulcer closure was significantly higher in the VM202 group at months 3, 4, and 5 (P =.0391,.0391, and.0361). When two outliers were excluded, a significant difference was evident in months 3, 4, 5, and 6 (P =.03 for all points). A potentially clinically meaningful 0.15 increase in Ankle‐Brachial Index was observed in the VM202 group at day 210 in the ITT population (P =.0776). Intramuscular injections of VM202 plasmid DNA to calf muscle may have promise in the treatment of chronic neuroischemic diabetic foot ulcers (DFUs). Given the safety profile and potential healing effects, continuing a larger DFU study is warranted with modifications of the current protocol and expansion of enrolling sites. [ABSTRACT FROM AUTHOR]

Flight simulators have an essential role in aircrew training. Occasionally, symptoms of motion sickness, defined as simulator sickness, develop during these sessions. Preventive methods for motion sickness have been investigated thoroughly; however, only a few studies have examined preventive treatments for simulator sickness. The aim of this study was to examine the efficacy of scopolamine (an anticholinergic drug) compared with cinnarizine (an antihistaminic drug) for helicopter simulator sickness prevention. A validated simulator sickness questionnaire (SSQ) score was used to determine the severity of simulator sickness symptoms in this study. Preliminary SSQ scores and SSQ scores after each sortie were calculated. Each participant was given scopolamine, cinnarizine, or a placebo in a double‐blind randomized manner before the first sortie of each training day. Forty‐one helicopter pilots participated in the trial. The average age was 30.5 ± 7.1 years. SSQ values significantly improved from an average of 73.30 in the preliminary SSQ questionnaire to an average of 30.92 after 2 hours following the administration of cinnarizine (P =.012, 95%CI 8.071‐76.703). Scopolamine was found to be less effective than both cinnarizine and the placebo in the alleviation of simulator sickness symptoms. This study is the first to compare scopolamine with cinnarizine for simulator sickness prevention. Based on the results of this study, we recommend the use of cinnarizine over scopolamine for simulator sickness prevention. [ABSTRACT FROM AUTHOR]

Objectives: To test the effect of locally delivered doxycycline (DOX) administered 2 weeks prior to minimally invasive periodontal regeneration in terms of presurgical inflammatory status and cytokine expression profile in the gingival crevicular fluid (GCF). Secondary aim was to assess the early wound healing index (EHI) at 2 weeks after surgery. Background: It is hypothesized that healing after periodontal regeneration is dependent on preoperative soft tissue condition, and that local antibiotics may improve the site‐specific inflammatory status at short time. Methods: Sites associated with periodontal intrabony defects requiring regenerative surgery and showing bleeding on probing (BoP) were included. At T0, experimental sites were randomly treated with subgingival instrumentation with or without topic DOX application. After 2 weeks (T1), defects were approached by means of minimally invasive surgical technique. GCF was sampled at both T0 and T1 for inflammatory biomarker analysis. Two weeks after surgery, the EHI was evaluated (T2). Results: Forty‐four patients were included. At T1, the number of BoP+ sites was statistically significantly less in the test group (27.3% vs. 72.7%; p <.01). The total amount of interleukin (IL)‐1β (p <.001), matrix‐metalloproteinases (MMP)‐8 (p <.001), and MMP‐9 (p =.010) in the GCF significantly decreased in the test group at T1, with relevant differences compared to controls. At T2, the EHI had an average value of 1.45 ± 0.86 in the test group while in the control, it was 2.31 ± 1.43 (p =.027). A statistically significantly positive correlation was observed between the amount of IL‐1β and MMP‐9 and EHI scores. Conclusions: Within the limitations of this study, sites treated with DOX showed improved clinical and molecular inflammatory parameters before surgery, as well as soft tissue healing 2 weeks after surgery. [ABSTRACT FROM AUTHOR]

Diabetic foot ulcer (DFU) is a major cause of morbidity, non‐traumatic lower limb amputation in diabetic patients and a high‐cost burden on the healthcare system. New therapeutic products are increasingly tested. Platelet‐rich plasma (PRP) and human platelet lysate (hPL) are reported to be useful. This trial was conducted to test whether the healing effect of hPL in chronic DFU was due to plasma or platelet lysates in a prospective double‐blind design. Autologous PRP was obtained from citrated blood, lysed, and used as drug 1 (active product). The platelet‐poor plasma (PPP) was used as a drug 2 (placebo). Ten patients were enrolled in arm 1 and 9 in arm 2. The drugs were injected perilesionally every 2 weeks for a total of sixinjections. Adverse events were recorded until Week 14. The DFUs were scored per the Texas and Wegner systems. No patient showed any major adverse events. Some reported local pain post‐injection. Wound healing was achieved in the hPL group in 9/10 of patients at a mean of 35.1 days. In the PPP group, no patient had healed by Day 84. The difference was statistically significant at P < 0.00001. We conclude that autologous hPL is safe and highly effective in healing chronic DFU and is superior to autologous PPP. [ABSTRACT FROM AUTHOR]

Aims: To test the effectiveness of a digital intervention to reduce cannabis use (ICan) with adherence‐focused guidance compared with educational cannabis information. Design: This was a single‐blind randomized controlled trial. Follow‐up clinical outcome measurements took place 3 and 6 months after randomization. Setting: The trial was conducted in the Netherlands. The intervention and guidance took place on‐line, with recruitment via Facebook/Instagram advertisement campaigns. Participants: Inclusion criteria were ≥ 18 years, cannabis use on ≥ 3 days/week, the desire to reduce/quit cannabis and using a smartphone. Participants were allocated to either ICan (n = 188) or control (n = 190) (69% male, mean age = 27.5 years). Intervention and comparator: ICan is a mobile (web‐)application based on motivational interviewing and cognitive behavioural therapy and includes three main components: screening, brief intervention (six modules) and referral to treatment. The control condition consisted of non‐interactive educational cannabis information. Measurements Primary outcome was the number of cannabis use days in the 7 days prior to the 6‐month follow‐up measurement. Secondary outcome measures at 3‐ and 6‐month follow‐up were the number of grams of cannabis used and attitudes towards seeking professional help for cannabis use related problems. Findings Intention‐to‐treat analysis showed that 6 months after randomization the mean number of cannabis use days in the past 7 days was reduced in both conditions (time P < 0.001), with no significant group × time interaction effect [ICan = 4.17 days, control = 4.31 days, Cohen's dbetween = 0.06, 95% confidence interval (CI) = −0.15, 0.26, P = 0.93]. Three months after randomization the mean number of grams used in the past 7 days was reduced in both conditions, with a significantly larger reduction in the ICan condition (P = 0.009, Cohen's dbetween = 0.15). At 6‐month follow‐up the significant group × time interaction effect was no longer present (P = 0.30). In both conditions, attitudes towards seeking professional help remained virtually unchanged over time. Conclusions: A digital intervention to reduce cannabis use (ICan) was more effective than non‐interactive educational cannabis information in reducing grams of cannabis used over 3 months, but not more effective at reducing cannabis use days at 6‐month follow‐up. Cannabis use reductions were maintained in both conditions between 3 and 6 months' follow‐up. [ABSTRACT FROM AUTHOR]