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A Randomized Controlled Trial Investigating the Effects of a Special Extract of Bacopa monnieri (CDRI 08) on Hyperactivity and Inattention in Male Children and Adolescents: BACHI Study Protocol (ANZCTRN12612000827831). - Nutrients
Clinical diagnoses of Attention Deficit Hyperactivity Disorder (ADHD) and the use of prescription medications for its treatment have increased in recent years. Current treatments may involve the administration of amphetamine-type substances, a treatment path many parents are apprehensive to take. Therefore, alternative pharmacological treatments are required. Few nutritional or pharmacological alternatives that reduce ADHD associated symptoms (hyperactivity and inattention) have been subjected to rigorous clinical trials. Bacopa monnieri is a perennial creeping herb. CDRI 08 is a special extract of Bacopa monnieri which has been subjected to hundreds of scientific studies and has been shown in human randomized controlled trials (RCTs) to improve memory, attention, and mood. It is hypothesised that chronic administration of CDRI 08 will improve attention, concentration and behaviour in children with high levels of hyperactivity and/or inattention. This paper reports the protocol for the first 16-week, randomized, placebo-controlled, double-blind, parallel groups trial examining the efficacy and safety of CDRI 08 in male children aged 6-14 years with high levels of inattention and hyperactivity. The primary outcome variable will be the level of hyperactivity and inattention measured by the Conners' Parent Rating Scale (CPRS). Secondary outcome variables include cognition, mood, sleep, and EEG.Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000827831.
Upper Airway Collapsibility (Pcrit) and Pharyngeal Dilator Muscle Activity are Sleep-Stage Dependent. - Sleep
An anatomically narrow/highly collapsible upper airway is the main cause of obstructive sleep apnea (OSA). Upper airway muscle activity contributes to airway patency and, like apnea severity, can be sleep stage dependent. Conversely, existing data derived from a small number of participants suggest that upper airway collapsibility, measured by the passive pharyngeal critical closing pressure (Pcrit) technique, is not sleep stage dependent. This study aimed to determine the effect of sleep stage on Pcrit and upper airway muscle activity in a larger cohort than previously tested.Pcrit and/or muscle data were obtained from 72 adults aged 20-64 y with and without OSA.Pcrit was determined via transient reductions in continuous positive airway pressure (CPAP) during N2, slow wave sleep (SWS) and rapid eye movement (REM) sleep. Genioglossus and tensor palatini activity was measured: (1) awake with and without CPAP, (2) during stable sleep on CPAP, and (3) in response to the CPAP reductions used to quantify Pcrit.Pcrit was 4.9 Â± 1.4 cmH2O higher (more collapsible) during REM versus SWS (P = 0.012), 2.3Â±0.6 cmH2O higher during REM versus N2 (P < 0.001), and 1.6 Â± 0.7 cmH2O higher in N2 versus SWS (P = 0.048). Muscle activity decreased from wakefulness to sleep and from SWS to N2 to REM sleep for genioglossus but not for tensor palatini. Pharyngeal muscle activity increased by ~50% by breath 5 following CPAP reductions.Upper airway collapsibility measured via the Pcrit technique and genioglossus muscle activity vary with sleep stage. These findings should be taken into account when performing and interpreting "passive" Pcrit measurements.Copyright Â© 2015 Associated Professional Sleep Societies, LLC. All rights reserved.
Variation in Photos of the Same Face Drives Improvements in Identity Verification. - Perception
People are poor at matching the identity of unfamiliar faces, but very good at identifying familiar faces. Theoretical accounts suggest that representations derived from exposure to variation are instrumental in driving this familiarity based improvement. In support of this, recent work shows that providing multiple photographs of an unfamiliar face improves identity verification accuracy. Here, we test whether the extent of variation is critical to this improvement, by manipulating the degree of within-identity variation that participants are exposed to in a sequential matching test. Participants were more accurate and adopted more liberal response criteria, when matching high-variability pairs to probe images, compared with either low-variability pairs or single images. Importantly, benefits of variation are not explained by independent contributions of single images, suggesting that people extrapolate information across images to produce gains in identification accuracy. These results suggest that photo-ID can be improved by incorporating broader ranges of variation in facial appearance.Â© The Author(s) 2015.
Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial. - BMJ (Clinical research ed.)
How effective is supported computerised cognitive behaviour therapy (cCBT) as an adjunct to usual primary care for adults with depression?This was a pragmatic, multicentre, three arm, parallel randomised controlled trial with simple randomisation. Treatment allocation was not blinded. Participants were adults with symptoms of depression (score â‰¥10 on nine item patient health questionnaire, PHQ-9) who were randomised to receive a commercially produced cCBT programme ("Beating the Blues") or a free to use cCBT programme (MoodGYM) in addition to usual GP care. Participants were supported and encouraged to complete the programme via weekly telephone calls. Control participants were offered usual GP care, with no constraints on the range of treatments that could be accessed. The primary outcome was severity of depression assessed with the PHQ-9 at four months. Secondary outcomes included health related quality of life (measured by SF-36) and psychological wellbeing (measured by CORE-OM) at four, 12, and 24 months and depression at 12 and 24 months.Participants offered commercial or free to use cCBT experienced no additional improvement in depression compared with usual GP care at four months (odds ratio 1.19 (95% confidence interval 0.75 to 1.88) for Beating the Blues v usual GP care; 0.98 (0.62 to 1.56) for MoodGYM v usual GP care). There was no evidence of an overall difference between either programme compared with usual GP care (0.99 (0.57 to 1.70) and 0.68 (0.42 to 1.10), respectively) at any time point. Commercially provided cCBT conferred no additional benefit over free to use cCBT or usual GP care at any follow-up point. Uptake and use of cCBT was low, despite regular telephone support. Nearly a quarter of participants (24%) had dropped out by four months. The study did not have enough power to detect small differences so these cannot be ruled out. Findings cannot be generalised to cCBT offered with a much higher level of guidance and support.Supported cCBT does not substantially improve depression outcomes compared with usual GP care alone. In this study, neither a commercially available nor free to use computerised CBT intervention was superior to usual GP care.Commissioned and funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project No 06/43/05). The authors have no competing interests. Requests for patient level data will be considered by the REEACT trial management groupTrial registration Current Controlled Trials ISRCTN91947481.Â© Gilbody et al 2015.
Systematic Review of guidelines for the assessment and management of High Grade Anal Intraepithelial Neoplasia (AIN II/III). - Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland
There is ambiguity with regard to the optimal management of AIN III. The aim of this review was to assess and compare international/national society guidelines currently available in the literature on the management, treatment and surveillance of AIN III. We also aimed to assess the quality of the studies used to compile the guidelines and to clarify the terminology used in histological assessment.An electronic search of PubMed and Embase was performed using the search terms 'anal intraepithelial neoplasia', 'AIN', 'anal cancer', 'guidelines', 'surveillance' and 'management'. Literature reviews and guidelines or practice guidelines in peer reviewed journals from 1(st) January 2000 to 31(st) December 2014, assessing the treatment, surveillance or management of patients with AIN related to HPV were included. The guidelines identified by the search were assessed for the quality of evidence behind them using the Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence.The database search identified 5159 articles and two further guidelines were sourced from official body guidelines. After inclusion criteria were applied, 28 full text papers were reviewed. Twenty-five of these were excluded, leaving three guidelines for inclusion in the systematic review including those published by the Association of Coloproctology of Great Britain and Ireland (ACPGBI), the American Society of Colon and Rectal Surgeons (ASCRS) and the Italian Society of Colorectal Surgery (SICCR). There were no guidelines identified on the management of AIN III from HIV associations and societies. All three guidelines agree that a high index of clinical suspicion is essential for diagnosing AIN with a disease-specific history, physical examination, digital rectal examination and anal cytology. There is interchange of terminology from High Grade AIN (HGAIN) (which incorporates AIN II/III) and AIN III between the literature leading to confusion in therapy use. Treatment varies from immunomodulation and photodynamic therapy to targeted destruction of areas of HGAIN/AIN II/III using infrared coagulation, electrocautery, cryotherapy or surgical excision but with little consensus between the guidelines. Recommendations on surveillance strategies were similarly discordant, ranging from six-monthly physical examination to annual anoscopy +/- biopsy. Over 50% of the recommendations are based on Level 3 or Level 4 evidence and many were compiled using studies that were greater than 10 years old.Despite concordance regarding diagnosis, there is significant variation amongst the guidelines over recommendations on the treatment and surveillance of patients with HGAIN/AIN II/III. All three sets of guidelines are based on low level, out-dated evidence originating from the 1980s and 1990s. This article is protected by copyright. All rights reserved.This article is protected by copyright. All rights reserved.
Effects of Four-Week Supplementation with a Multi-Vitamin/Mineral Preparation on Mood and Blood Biomarkers in Young Adults: A Randomised, Double-Blind, Placebo-Controlled Trial. - Nutrients
This study explored the effects of four-week multi-vitamin and mineral (MVM) supplementation on mood and neurocognitive function in healthy, young adults. Fifty-eight healthy adults, 18-40 years of age (M = 25.82 years, SD = 4.87) participated in this randomised, double-blind, placebo-controlled trial, in which mood and blood biomarkers were assessed at baseline and after four weeks of supplementation. Compared to placebo, MVM supplementation was associated with significantly lowered homocysteine and increased blood B-vitamin levels (p < 0.01). MVM treatment was also associated with significantly improved mood, as measured by reduced scores on the "depression-dejection" subscale of the Profile of Mood States (p = 0.018). These findings suggest that the four weeks of MVM supplementation may have beneficial effects on mood, underpinned by elevated B-vitamins and lowered homocysteine in healthy young adults.
Biochemistry of the cingulate cortex in autism: An MR spectroscopy study. - Autism research : official journal of the International Society for Autism Research
Neuroimaging studies have uncovered structural and functional alterations in the cingulate cortex in individuals with autism spectrum disorders (ASD). Such abnormalities may underlie neurochemical imbalance. In order to characterize the neurochemical profile, the current study examined the concentration of brain metabolites in dorsal ACC (dACC) and posterior cingulate cortex (PCC) in high-functioning adults with ASD. Twenty high-functioning adults with ASD and 20 age-and-IQ-matched typically developing (TD) peers participated in this Proton magnetic resonance spectroscopy (1H-MRS) study. LCModel was used in analyzing the spectra to measure the levels of N-Acetyl aspartate (NAA), choline (Cho), creatine (Cr), and glutamate/glutamine (Glx) in dACC and PCC. Groups were compared using means for the ratio of each metabolite to their respective Cr levels as well as on absolute internal-water-referenced measures of each metabolite. There was a significant increase in Cho in PCC for ASD adults, with a marginal increase in dACC. A reduction in NAA/Cr in dACC was found in ASD participants, compared to their TD peers. No significant differences in Glx/Cr or Cho/Cr were found in dACC. There were no statistically significant group differences in the absolute concentration of NAA, Cr, Glx, or NAA/Cr, Cho/Cr, and Glx/Cr in the PCC. Differences in the metabolic properties of dACC compared to PCC were also found. Results of this study provide evidence for possible cellular and metabolic differences in the dACC and PCC in adults with ASD. This may suggest neuronal dysfunction in these regions and may contribute to the neuropathology of ASD. Â© 2015 International Society for Autism Research, Wiley Periodicals, Inc.Â© 2015 International Society for Autism Research, Wiley Periodicals, Inc.
Projection of participant recruitment to primary care research: a qualitative study. - Trials
Recruitment to clinical trials remains a challenge, particularly in primary care settings. Initial projections of participant recruitment need to be as accurate as possible in order to avoid the financial, clinical and ethical costs of trial extensions or failures. However, estimation of recruitment rates is challenging and often poorly executed, if attempted at all. We used qualitative methods to explore the experiences and views of researchers on the planning of recruitment in this setting.Participants had registered accrual to a UK-based primary care research study between April 2009 and March 2012. We conducted nine interviews with chief investigators or study managers, using a semi-structured topic guide. Analysis was conducted using the framework approach.Three themes are presented: 1) the factors affecting recruitment rates, 2) the use of planning techniques, and 3) influences on poor estimation. 1) A large number of factors affecting recruitment rates were discussed, including those relating to the study protocol, the clinical setting and the research setting. Use of targeted mail-outs to invite apparently eligible individuals to participate was preferred in order to eliminate some of the uncertainty in the recruitment rate associated with opportunistic clinician referrals. 2) The importance of pilot work was stressed. We identified significant uncertainty as to how best to schedule trial timelines to maximise efficiency. 3) Several potential sources of bias involved in the estimation of recruitment rates were explored and framed as technological, psychological or political factors.We found a large number of factors that interviewees felt impact recruitment rates to primary care research and highlighted the complexity of realistic estimation. Suitable early planning of the recruitment process is essential, and there may be potential to improve the projection of trial timelines by reducing biases involved in the process. Further research is needed to develop formal approaches that would be suitable for use in this setting.
Error Rates in Users of Automatic Face Recognition Software. - PloS one
In recent years, wide deployment of automatic face recognition systems has been accompanied by substantial gains in algorithm performance. However, benchmarking tests designed to evaluate these systems do not account for the errors of human operators, who are often an integral part of face recognition solutions in forensic and security settings. This causes a mismatch between evaluation tests and operational accuracy. We address this by measuring user performance in a face recognition system used to screen passport applications for identity fraud. Experiment 1 measured target detection accuracy in algorithm-generated 'candidate lists' selected from a large database of passport images. Accuracy was notably poorer than in previous studies of unfamiliar face matching: participants made over 50% errors for adult target faces, and over 60% when matching images of children. Experiment 2 then compared performance of student participants to trained passport officers-who use the system in their daily work-and found equivalent performance in these groups. Encouragingly, a group of highly trained and experienced "facial examiners" outperformed these groups by 20 percentage points. We conclude that human performance curtails accuracy of face recognition systems-potentially reducing benchmark estimates by 50% in operational settings. Mere practise does not attenuate these limits, but superior performance of trained examiners suggests that recruitment and selection of human operators, in combination with effective training and mentorship, can improve the operational accuracy of face recognition systems.
Tube Law of the Pharyngeal Airway in Sleeping Patients with Obstructive Sleep Apnea. - Sleep
Obstructive sleep apnea (OSA) is characterized by repetitive pharyngeal collapse during sleep. However, the dynamics of pharyngeal narrowing and re-expansion during flow-limited breathing are not well described. The static pharyngeal tube law (end-expiratory area versus luminal pressure) has demonstrated increasing pharyngeal compliance as luminal pressure decreases, indicating that the airway would be sucked closed with sufficient inspiratory effort. On the contrary, the airway is rarely sucked closed during inspiratory flow limitation, suggesting that the airway is getting stiffer. Therefore, we hypothesized that during inspiratory flow limitation, as opposed to static conditions, the pharynx becomes stiffer as luminal pressure decreases.Physiological study.Sleep laboratory in a tertiary hospital.Eighteen subjects (14 males) with OSA (apnea-hypopnea index = 57 Â± 27events/h), aged 49 Â± 8 y, with a body mass index of 35 Â± 6 kg/m2.Continuous positive (or negative) airway pressure was used to induce flow limitation.Upper airway endoscopy and simultaneous measurements of airflow and epiglottic pressure were performed during natural nonrapid eye movement sleep. Flow-limited breaths were selected for airway cross-sectional area measurements. Relative airway area was quantified as a percentage of end-expiratory area. Inspiratory airway radial compliance was calculated at each quintile of epiglottic pressure versus airway area plot (tube law). A total of 163 flow limited breaths were analyzed (9 Â± 3 breaths per subject). Compliances at the fourth (2.0 Â± 4.7 % area/cmH2O) and fifth (0.0 Â± 1.7 % area/cmH2O) quintiles were significantly lower than the first (12.2 Â± 5.5 % area/cmH2O) pressure quintile (P < 0.05).The pharyngeal tube law is concave (airway gets stiffer as luminal pressure decreases) during respiratory cycles under inspiratory flow limitation.Copyright Â© 2015 Associated Professional Sleep Societies, LLC. All rights reserved.
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