Eight male collegiate football players ( age = 21.4 1.4 years ; height = 1.87 0.02 m ; mass = 103.6 12.5 kg ) .


Four ATs removed equipment under 4 conditions : removal of helmet only followed by placing the head on the ground ( H ) , removal of the helmet only followed by pack-and-fill ( HP ) , removal of the helmet and shoulder pads followed by placing the head on the ground ( HS ) , and removal of the helmet and shoulder pads followed by pack-and-fill ( HSP ) .


Motion capture was used to track the movement of the head with respect to the sternum during equipment removal .


We measured head movement relative to sternum movement ( translations and rotations ) .


We used 4 4 analyses of variance with repeated measures to compare discrete motion variables ( changes in position and total excursions ) among protocols and ATs .


Protocol HP resulted in a 0.1 0.6 cm rise in head position compared with a 1.4 0.3 cm drop with protocol HS ( P < .001 ) .


Protocol HP produced 4.9 less total angular excursion ( P < .001 ) and 2.1 cm less total vertical excursion ( P < .001 ) than protocol HS .


The pack-and-fill protocol was more effective than shoulder pad removal in minimizing cervical spine movement throughout the equipment-removal process .


This study provides evidence for including the pack-and-fill protocol in future treatment recommendations when helmet removal is necessary for on-field care .


The primary objective of this study was to compare the utility of high-speed video ( HSV ) to videostroboscopy ( VS ) in the assessment of adolescents with normal and abnormal larynges .


A secondary objective was to evaluate the ease of assessment of adolescents with HSV .


Case series with chart review .


Tertiary academic health care center .


This study involved a retrospective review of recordings of 7 adolescents assessed with both HSV and VS. The 14 recordings were randomized and presented to 4 groups of blinded evaluators : 2 fellowship-trained laryngologists , 2 speech language pathologists ( SLP ) with multiyear experience working in a voice clinic , 2 pediatric otolaryngologists , and 2 otolaryngology residents .


Raters were asked to evaluate the videos using a standardized scoring tool .


Raters also completed a questionnaire assessing their opinion of the HSV and VS recordings .


Evaluators required more time to complete their assessment of VS recordings ( 2.95 min 2.41 min ) than HSV recordings ( 2.31 min 1.92 min ) ( P = .004 ) .


There was no difference in ease of evaluation ( P = .878 ) or diagnostic accuracy within evaluator groups by recording modality ( P = .5 ) .


The overall agreement between VS and HSV was moderate ( kappa [ SE ] = 0.446 [ 0.029 ] ) .


The debrief questionnaire revealed that 5 of 8 ( 62.5 % ) preferred VS to HSV .


This is the first comparative study between HSV and VS in patients under 18 years of age .


HSV permitted faster evaluation than VS , but there was no difference in diagnostic accuracy between the 2 modalities .


The evaluators preferred VS to HSV .


In the present study , we examined the effect of a two-herb traditional Chinese medicine ( NF3 ) , comprised of Astragali Radix and Radix Rehmanniae , on the healing of diabetic foot ulcer and the possible molecular mechanisms involved .


This was a prospective randomized double-blind placebo-controlled study .


Sixteen diabetic patients were randomized to receive either placebo or NF3 for 6 months .


Ulcer healing and sensory changes were examined .


Molecular studies included measurement of serum tumor necrosis factor ( TNF ) - and RNA microarray investigation .


The daily rate of reduction in ulcer area was 3.55 % in the NF3 group and 1.52 % in the placebo group ( P = 0.062 ) .


In the index limb , the number of negative tests for sensory neuropathy using monofilament was reduced from 27 % to 7 % in the NF3 group and from 37 % to 35 % in the placebo group ( P < 0.001 ) .


In addition , NF3 significantly decreased serum TNF - levels ( P = 0.034 ) .


Microarray studies revealed concerted changes following NF3 treatment in the expression of genes implicated in fibroblast regeneration , angiogenesis , and anti-inflammation .


In this proof-of-concept study , 6-month treatment with NF3 was associated with improved wound healing and sensation accompanied by concerted changes in gene expression .


N-methyl-D-aspartate receptor antagonists are potential therapies for neuropathic pain , and memantine has a good tolerance profile .


A preclinical study recently reported that presurgery memantine may prevent neuropathic pain development and cognition dysfunction .


Considering the high prevalence of breast cancer and of post-mastectomy neuropathic pain , a clinical trial is carried out to evaluate if memantine may prevent neuropathic pain development and maintain cognitive function and quality of life in cancer patients .


A randomized clinical trial ( NCT01536314 ) includes 40 women with breast cancer undergoing mastectomy at the Oncology Hospital , Clermont-Ferrand , France .


Memantine ( 5 to 20mg/day ; n = 20 ) or placebo ( n = 20 ) is administered for 4 weeks starting 2 weeks before surgery .


Intensity of pain , cognitive function , quality of life and of sleep , anxiety and depression are evaluated with questionnaires .


The primary endpoint is pain intensity on a 0 to 10 ) numerical scale at 3months post-mastectomy .


Data analysis is performed using mixed models and the tests are two-sided , with a type I error set at = 0.05 .


The hypothesis of this translational approach is to confirm in patients the beneficial prophylactic effect of memantine observed in animals .


Such a protective action of memantine against neuropathic pain and cognitive dysfunction would greatly improve the quality of life of cancer patients .


ClinicalTrials.gov : NCT01536314 on 16 February 2012 .


To investigate the feasibility and effectiveness of Sonas , a group intervention involving multisensory stimulation , reminiscence , and light physical activity .


A total of 39 participants with moderate to severe dementia were randomized to receive either 14 sessions of Sonas or treatment as usual .


Measures such as quality of life ( QoL ) , communication , depression , anxiety , and behavioral disturbance were administered at baseline and follow-up .


No statistically significant results were found .


However , participant attendance to sessions was good ( mean = 12.4 sessions of 14 offered ) .


Sonas sessions did not lead to improvements in QoL and behavioral and psychological symptoms of dementia .


Three-dimensional echocardiography ( 3DE ) is a reliable and reproducible tool for assessing left ventricular ( LV ) function but remains sensitive to patient echogenicity .


Contrast-enhanced 3DE ( C3DE ) has the potential to improve quantification in challenging patients .


The aim of this study was to evaluate the impact of temporal resolution , spatial resolution , and image dynamic range on LV function assessed using C3DE compared with cardiac magnetic resonance imaging ( MRI ) in patients with poor echogenicity .


Forty-one patients with poor echogenicity who underwent two-dimensional echocardiography ( 2DE ) , 3DE , C3DE , and MRI were retrospectively investigated .


Before contrast injection , 24 patients had three or more nonvisible segments .


Three cases of 2DE and 12 cases of 3DE were not suitable for quantification .


LV end-diastolic volumes were systematically underestimated by 2DE ( 142 58 mL ) , 3DE ( 146 69 mL ) , and C3DE ( 172 61 mL ) compared with MRI ( 216 85 mL ) ( P < .001 ) .


Similar results were found for LV end-systolic volumes ( 81 65 mL for 2DE , 82 69 mL for 3DE , and 102 80 mL for C3DE vs 129 94 mL for MRI ; P < .001 ) .


C3DE provided the best agreement with MRI ( Lin concordance correlation coefficients of 0.67 , 0.93 , and 0.99 , respectively , for end-diastolic volume , end-systolic volume , and ejection fraction ) as well as the best measurement reproducibility .


Finally , ultrasound settings had no significant effect on LV volumes and ejection fraction measurements .


In these patients with poor ultrasound image quality , C3DE , regardless of instrument settings , outperformed 2DE and 3DE to assess LV volumes and ejection fraction and can thus be proposed as an acceptable alternative when MRI can not be performed in this subgroup .


Pulmonologists frequently encounter indeterminate pulmonary nodules in practice , but it is unclear what clinical factors they rely on to guide the diagnostic evaluation .


To assess the current approach to the management of indeterminate pulmonary nodules and to determine the extent to which the addition of a hypothetical diagnostic blood test will influence clinical decision making .


Selected pulmonologists practicing in the United States were invited to participate in a conjoint exercise based on 20 randomly generated cases of varying age , smoking history , and nodule size .


Some cases included the result of a hypothetical blood test .


Each respondent chose from among three diagnostic options for a patient : noninvasive monitoring ( i.e. , serial CT or positron emission tomography scan ) , a minor procedure ( i.e. , biopsy or bronchoscopy ) , or a major procedure ( i.e. , video-assisted thorascopic surgery or thoracotomy ) .


Multivariate logistic regression was used to assess the impact of the three risk factors and the diagnostic blood test on decision making .


Four hundred nineteen physicians participated ( response rate , 10 % ) .


One hundred fifty-three physician surveys met predetermined criteria and were analyzed ( 4 % of all invitees ) .


A diagnostic procedure was recommended for 23 % of 6-mm nodules , versus 54 , 66 , 77 , and 84 % of nodules 10 , 14 , 18 , and 22 mm , respectively ( P < 0.001 ) .


Older age limited recommendations for invasive testing : 54 % of 80-year-olds versus 61 , 64 , 63 , and 61 % of patients 71 , 62 , 53 , and 44 years of age , respectively ( P < 0.001 ) .


In multivariate analyses , nodule size , smoking history , age , and the blood test each influenced decision making ( P < 0.001 ) .


The pulmonologists who participated in this survey were more likely to proceed with invasive testing , instead of observation or additional imaging , as the size of the nodule increased .


The use of a hypothetical blood test resulted in significant alterations in the decision to pursue invasive testing .


To examine the effects of music listening on sleep quality amongst older community-dwelling adults in Singapore .


In a randomized controlled study , a cohort of older adults ( N = 60 ) age 55 years or above were recruited in one community centre .


Sleep quality , as measured by the Pittsburgh Sleep Quality Index ( PSQI ) , was the primary outcome .


Participants ' demographic variables including age , gender , religion , education level , marital and financial status , any chronic illness , previous experiences of music intervention as well as depression levels were collected .


Participants were asked to listen to soft , instrumental slow sedative music without lyrics , of approximately 60-80 beats per minute , and 40 min in duration , for 6 weeks .


Generalized estimating equations were used to examine the effects of the intervention on the elders ' sleep quality .


Significant reductions in PSQI scores were found in the intervention group ( n = 28 ) from baseline ( meanSD , 10.22.5 ) to week 6 ( 5.92.4 , p < 0.001 ) , while there were no changes in the control group ( n = 32 ) from baseline ( 9.02.4 ) to week 6 ( 9.52.6 ) .


At week 6 , the intervention group showed a better sleep quality than the control ( ( 2 ) = 61.84 , p < 0.001 ) .


Notwithstanding the placebo effect , this study supports music listening as an effective intervention for older adults to improve sleep quality .


Not only does this process improve their sleeping quality at old age , it also individualizes and enhances the quality of care provided by the healthcare provider as the therapeutic relationship between provider and client is being established .


Contemporary gerontology is progressively characterized by collaboration between several approaches with the intent to comprehend the mental aspects of the multifarious process of ageing .


Music listening is one such avenue to enhance sleep quality amongst older adults and make an essential contribution to healthy ageing .


Hypoxia is a major complication in dental patients under intravenous sedation ( IVS ) .


A nasal high-flow ( NHF ) system has been reported to achieve effective oxygenation in patients with sleep apnea syndrome .


This study investigated the ability of the NHF system to prevent hypoxia in dental patients under IVS .


Thirty patients scheduled for dental treatment under IVS were enrolled .


Patients were randomly divided into 3 groups : patients spontaneously breathing oxygen at 5L/minute through a nasal cannula ( NC5 group ) , patients administered oxygen at 30L/minute through the NHF system , and patients administered oxygen at 50L/minute through the NHF system .


Hypnosis was induced by bolus administration of midazolam ( 0.05 mg/kg ) followed by continuous administration of propofol ( target blood concentration , 1.2 to 2g/mL ) .


Noninvasive blood pressure , peripheral capillary oxygen saturation ( SpO2 ) , heart rate , and bispectral index values were recorded every 2.5 minutes before the induction of anesthesia .


Interventions , such as jaw lifting , were recorded during IVS and arterial blood gas analysis was performed at the end of sedation .


Patient and surgeon satisfaction with IVS was evaluated by interview .


Minimum SpO2 was lowest in and surgeons were least satisfied with the NC5 group .


In addition , interventions were required most frequently in the NC5 group ( P < .05 ) .


Compared with the NC5 group , use of the NHF system improved partial pressures of oxygen and carbon dioxide in dental patients under IVS ( P < .05 ) .


These results suggest that use of the NHF system can prevent hypoxia in dental patients under IVS .


Further studies are necessary to determine the appropriate flow rate and indications for NHF in obese patients .


We explored whether readers can understand key messages without having to read the full review , and if there were differences in understanding between various types of summary .


A randomised experiment of review summaries which compared understanding of a key outcome .


Members of university staff ( n = 36 ) .


Universities on the island of Ireland .


The Cochrane Review chosen examines the health impacts of the use of electric fans during heat waves .


Participants were asked their expectation of the effect these would have on mortality .


They were then randomly assigned a summary of the review ( i.e. abstract , plain language summary , podcast or podcast transcription ) and asked to spend a short time reading/listening to the summary .


After this they were again asked about the effects of electric fans on mortality and to indicate if they would want to read the full Review .


Correct identification of a key review outcome .


Just over half ( 53 % ) of the participants identified its key message on mortality after engaging with their summary .


The figures were 33 % for the abstract group , 50 % for both the plain language and transcript groups and 78 % for the podcast group .


The differences between the groups were not statistically significant but suggest that the audio summary might improve knowledge transfer compared to written summaries .


These findings should be explored further using a larger sample size and with other reviews .


To compare the effects of regular intermittent bolus versus continuous infusion for epidural labor analgesia on maternal temperature and serum interleukin-6 ( IL-6 ) level .


This randomized trial was performed in Nanjing Maternity and Child Health Care Hospital , Nanjing , Jiangsu Province , China between October 2012 and February 2014 .


Either regular intermittent bolus ( RIB , n = 66 ) or continuous infusion ( CI , n = 66 ) was used for epidural labor analgesia .


A bolus dose ( 10 ml of 0.08 % ropivacaine + 0.4 ugml-1 sufentanil ) was manually administrated once an hour in the RIB group , whereas the same solution was continuously infused at a constant rate of 10 mlh-1 in the CI group .


Maternal tympanic temperature and serum IL-6 level were measured hourly from baseline to one hour post partum .


The incidences of fever ( > / = 38 degree celsius ) were calculated .


The incidence of maternal fever was similar between the 2 groups .


There was a rising trend in mean temperature over time in both groups , but no statistical difference was detected between the groups at respective time points ; maternal serum IL-6 showed similar changes .


Compared with continuous infusion , regular intermittent bolus presents with the same incidence of maternal fever for epidural labor analgesia .


Interleukin-6 elevation could be involved in mean maternal temperature increase .


Teaching resident physicians to appropriately document patient diagnoses in the medical record is critical to ensure accuracy of publicly reported data and to enable quality improvement initiatives .


We sought to determine if providing real-time feedback to resident or attending physicians would lead to improved medical documentation .


We audited charts to determine if target diagnoses were present and documented .


After a baseline data-gathering period , during the intervention period the first author randomly provided feedback to either residents alone or residents plus their attending physicians .


Capture rates for targeted diagnoses , total diagnoses documented and coded , severity of illness ( SOI ) , risk of mortality ( ROM ) , and case mix index were compared pre - and postintervention .


During the intervention , the proportion of target diagnoses captured increased from 30 % to 54 % ( P < 0.001 ) , as did the median ( interquartile [ IQ ] range ) number of diagnoses captured ( from 11 [ IQ range , 8-13 ] to 12 [ IQ range , 9-16 ] , P < 0.05 ) .


We also achieved significant increases in median ( IQ range ) SOI scores ( from 2 [ IQ range , 2-3 ] to 3 [ IQ range , 2-3 ] , P = 0.04 ) and complication code capture ( 61 % vs 75 % , P = 0.01 ) .


However , there was no significant increase in ROM , case mix index , or hospital billing .


Notifying attending physicians in addition to residents was of no benefit .


An educational program based on real-time feedback to resident physicians regarding documentation improved diagnostic capture and SOI scores , but not case mix index or billing at our public , safety net , teaching hospital .


Even with enhanced education of resident physicians regarding documentation , other interventions are needed to further improve diagnostic capture .


In this substudy of the effect of dietary nitrate on blood pressure , endothelial function , and insulin sensitivity in type 2 diabetes , we report the development of a novel nitrate depleted beetroot juice for use clinical trials and determine if dietary nitrate supplementation improved cognitive function in patients with type 2 diabetes mellitus .


Beetroot juice was treated with the anion exchange resin Purolite A520e .


UV-vis-spectrophotometry , and a blind taste test were performed along with determination of sugar content , measurement of ascorbate and dehydroascorbate , the ionic composition of juice and Proton NMR .


Subsequently , 27 patients , age 67.24.9 years , ( 18 male ) were recruited for a double blind , randomised , placebo-controlled crossover trial .


Participants were randomised to begin in either order beetroot juice ( nitrate content 7.5 mmol per 250 ml ) or placebo ( nitrate depleted beetroot juice nitrate content 0.002 mmol per 250 ml ) .


At the end of each 2 week supplementation period cognitive function was assessed using E-prime , E-Studio software with 5 separate tests being performed .


The tests utilised in the present study have been adapted from the Cambridge Neuropsychological Test Automated Battery ( CANTAB ) .


The differences in the UV-vis spectra were comparable to the natural variation found in differing cultivars .


There were no discernable differences in taste , sugar content , or Proton NMR .


Ascorbate and dehydroascorbate were undetectable in either juice .


After 2 weeks of beetroot juice simple reaction time was significantly quicker in the active arm at 32740 ms versus 341.852.7 ms in the placebo arm , mean difference 13.925.6 ms ( 95 % CI 3.8-24 .0 ms ) , p = 0.009 .


No other measures of cognitive function differed between treatment arms .


We have developed an effective placebo beetroot juice for use in trials of supplementation of dietary nitrate .


Two weeks supplementation of the diet with 7.5 mmol of nitrate per day caused a significant improvement in simple reaction time in individuals with T2DM .


Dental anxiety and anxiety-related avoidance of dental care create significant problems for patients and the dental profession .


Distraction interventions are used in daily medical practice to help patients cope with unpleasant procedures .


There is evidence that exposure to natural scenery is beneficial for patients and that the use of virtual reality ( VR ) distraction is more effective than other distraction interventions , such as watching television .


The main aim of this randomized controlled trial is to determine whether the use of VR during dental treatment can improve the overall dental experience and recollections of treatment for patients , breaking the negative cycle of memories of anxiety leading to further anxiety , and avoidance of future dental appointments .


Additionally , the aim is to test whether VR benefits dental patients with all levels of dental anxiety or whether it could be especially beneficial for patients suffering from higher levels of dental anxiety .


The third aim is to test whether the content of the VR distraction can make a difference for its effectiveness by comparing two types of virtual environments , a natural environment and an urban environment .


The effectiveness of VR distraction will be examined in patients 18years or older who are scheduled to undergo dental treatment for fillings and/or extractions , with a maximum length of 30minutes .


Patients will be randomly allocated into one of three groups .


The first group will be exposed to a VR of a natural environment .


The second group will be exposed to a VR of an urban environment .


A third group consists of patients who receive standard care ( control group ) .


Primary outcomes relate to patients ' memories of the dental treatment one week after treatment : ( a ) remembered pain , ( b ) intrusive thoughts and ( c ) vividness of memories .


Other measures of interest are the dental experience , the treatment experience and the VR experience .


Current Controlled Trials ISRCTN41442806 .


Placement of a totally implantable venous access device in children with cancer often leads to hypertrophic scars after its removal .


This study investigates whether the use of silicone gel sheets has a beneficial effect on scar outcome in children with cancer .


In a three-arm randomized controlled trial , the effects of use of silicone gel sheets for 2 and 6 months were assessed and compared with no intervention in children with cancer after removal of the totally implantable venous access device .


Silicone gel sheets were first administered 14 days after surgery .


The 1-year follow-up included measurements at seven time points .


Next to scar size assessment , the modified Vancouver Scar Scale was used to assess scar outcome .


Thirty-six children participated .


For hypertrophy , no significant differences were found between the two intervention groups and the control group .


However , at 1-year follow-up , the 2-month application group showed significantly smaller scars compared with the group receiving silicone gel sheet treatment for 6 months ( p = 0.04 ) , but not when compared with the control group ( p = 0.22 ) .


Longitudinal multilevel analyses could not confirm these findings and showed no significant intervention effects on both outcomes .


This study provides no strong evidence to support the use of silicone gel sheets after totally implantable venous access device removal in children with cancer .


There seems to be a small benefit for scar width with application for 2 months .


However , for hypertrophy , the scar outcome shows no significant difference between the control group and the 2-month and 6-month treatment groups .


The prevention and treatment of overweight and obese individuals on a population-wide basis is challenging because patients have difficulties with adhering to weight loss programmes .


The present study aimed to evaluate patients ' adherence to the weight reduction programme by identifying factors predictive of both drop-out rate and weight loss success .


One-hundred and twenty-four obese patients participated in a 12-month weight reduction programme , involving group therapy during an intensive 5-day educational intervention , followed by five , 2-h follow-up visits .


The primary outcome measures included drop-out rate and percentage weight loss .


Sociodemographic and clinical characteristics , as well as type of diet , were explored as potential predictive factors .


Type of diet was assigned based on randomisation .


Regression analyses were conducted to identify predictive variables of drop-out and weight loss success .


In total , 33.1 % of all recruited participants were deemed successful because they reduced the initial weight by more than 5 % after the 12-month intervention .


The overall attrition rate was 32.3 % .


In a multiple regression model , initial weight loss and marital status were the strongest predictors of weight loss success after 1-year period ( r ( 2 ) = 0.481 , P < 0.001 ) .


In a separate analysis , subjects more likely to drop-out were those with a lower educational level [ odds ratio ( OR ) = 3.26 , 95 % confidence interval ( CI ) = 1.22-8 .70 , P = 0.018 ] and a higher level of obesity ( OR = 0.974 , 95 % CI = 0.95-0 .99 , P = 0.010 ) .


The present study demonstrates that initial weight loss at 1 month made the strongest unique contribution to the prediction of percentage weight loss after 12 months , whereas being married was a negative predictor .


Those with a lower educational level and a higher level of obesity were more likely to drop-out .


Chronic pain remains a significant challenge for modern health care as its pathologic mechanisms are largely unknown and preclinical animal models suffer from limitations in assessing this complex subjective experience .


However , human brain neuroimaging techniques enable the assessment of functional and neurochemical alterations in patients experiencing chronic pain and how these factors may dynamically change with pharmacologic treatment .


To identify the clinical action of pregabalin , a proven analgesic , the authors performed three complementary brain neuroimaging procedures : ( proton magnetic resonance spectroscopy , functional magnetic resonance imaging , and functional connectivity magnetic resonance imaging ) in 17 chronic pain patients diagnosed with fibromyalgia .


The authors found that pregabalin but not placebo reduces combined glutamate + glutamine levels within the posterior insula ( pregabalin P = 0.016 ; placebo P = 0.71 ) .


Interestingly , reductions in clinical pain were associated with reductions in brain connectivity of this structure to brain regions within the default mode network during pregabalin ( r = 0.82 ; P = 0.001 ) but not placebo ( r = -0.13 ; P = 0.63 ) .


Response of default mode network regions to experimental pain was also reduced with pregabalin ( P = 0.018 ) but not placebo ( P = 0.182 ) .


Perhaps most importantly , baseline values for all three neuroimaging markers predicted subsequent analgesic response to pregabalin but not placebo .


The results of this study suggest that pregabalin works in part by reducing insular glutamatergic activity , leading to a reduction of the increased functional connectivity seen between brain regions in chronic pain states .


The study also supports a role for human brain imaging in the development , assessment , and personalized use of central-acting analgesics .


Agitation is common among patients with Alzheimer disease ; safe , effective treatments are lacking .


To assess the efficacy , safety , and tolerability of dextromethorphan hydrobromide-quinidine sulfate for Alzheimer disease-related agitation .


Phase 2 randomized , multicenter , double-blind , placebo-controlled trial using a sequential parallel comparison design with 2 consecutive 5-week treatment stages conducted August 2012-August 2014 .


Patients with probable Alzheimer disease , clinically significant agitation ( Clinical Global Impressions-Severity agitation score 4 ) , and a Mini-Mental State Examination score of 8 to 28 participated at 42 US study sites .


Stable dosages of antidepressants , antipsychotics , hypnotics , and antidementia medications were allowed .


In stage 1 , 220 patients were randomized in a 3:4 ratio to receive dextromethorphan-quinidine ( n = 93 ) or placebo ( n = 127 ) .


In stage 2 , patients receiving dextromethorphan-quinidine continued ; those receiving placebo were stratified by response and rerandomized in a 1:1 ratio to dextromethorphan-quinidine ( n = 59 ) or placebo ( n = 60 ) .


The primary end point was change from baseline on the Neuropsychiatric Inventory ( NPI ) Agitation/Aggression domain ( scale range , 0 [ absence of symptoms ] to 12 [ symptoms occur daily and with marked severity ] ) .


A total of 194 patients ( 88.2 % ) completed the study .


With the sequential parallel comparison design , 152 patients received dextromethorphan-quinidine and 127 received placebo during the study .


Analysis combining stages 1 ( all patients ) and 2 ( rerandomized placebo nonresponders ) showed significantly reduced NPI Agitation/Aggression scores for dextromethorphan-quinidine vs placebo ( ordinary least squares z statistic , -3.95 ; P < .001 ) .


In stage 1 , mean NPI Agitation/Aggression scores were reduced from 7.1 to 3.8 with dextromethorphan-quinidine and from 7.0 to 5.3 with placebo .


Between-group treatment differences were significant in stage 1 ( least squares mean , -1.5 ; 95 % CI , -2.3 to -0.7 ; P < .001 ) .


In stage 2 , NPI Agitation/Aggression scores were reduced from 5.8 to 3.8 with dextromethorphan-quinidine and from 6.7 to 5.8 with placebo .


Between-group treatment differences were also significant in stage 2 ( least squares mean , -1.6 ; 95 % CI , -2.9 to -0.3 ; P = .02 ) .


Adverse events included falls ( 8.6 % for dextromethorphan-quinidine vs 3.9 % for placebo ) , diarrhea ( 5.9 % vs 3.1 % respectively ) , and urinary tract infection ( 5.3 % vs 3.9 % respectively ) .


Serious adverse events occurred in 7.9 % with dextromethorphan-quinidine vs 4.7 % with placebo .


Dextromethorphan-quinidine was not associated with cognitive impairment , sedation , or clinically significant QTc prolongation .


In this preliminary 10-week phase 2 randomized clinical trial of patients with probable Alzheimer disease , combination dextromethorphan-quinidine demonstrated clinically relevant efficacy for agitation and was generally well tolerated .


clinicaltrials.gov Identifier : NCT01584440 .


End-stage renal disease patients on hemodialysis are on complex drug regimens consisting of multiple medications , many of which are administered in several doses per day .


Consequently , such patients are at high risk for developing drug therapy-related problems ( DTRPs ) .


The aim of this study was to detect DTRPs in children undergoing hemodialysis and to assess and evaluate the impact of interventions by the clinical pharmacist on the clinical outcome of children undergoing hemodialysis .


Fifty hemodialysis outpatients were randomly divided into two groups ( 25 each ) : the control group and the test group .


During the 9-month study period , patients in the control group received the usual medical care , and those in the test group received pharmaceutical care 3 times weekly in addition to the usual medical care .


After 9 months of pharmaceutical care implementation , the test group showed a significant decline in systolic and diastolic blood pressure ( p = 0.0001 ) , serum phosphorus level ( p = 0.006 ) and parathyroid hormone level ( p = 0.001 ) versus their baseline values and versus the control .


The serum Ca * P product level of the test group decreased ( p = 0.001 ) after intervention versus baseline .


Serum calcium level significantly increased in test group ( p = 0.02 ) and decreased in the control group ( p = 0.001 ) versus the respective baseline values .


Satisfaction with the renal treatment significantly improved in the test group ( p = 0.0001 ) versus the control group after 9 months of pharmaceutical care implementation based on Renal Treatment Satisfaction Questionnaire scores .


Pharmacist-initiated pharmaceutical care improved the satisfaction and biochemical findings of patients on hemodialysis .


Motivational Interviewing ( MI ) is a collaborative therapy that focuses on strengthening a person 's internal motivation to change .


Research suggests that MI may be helpful for treating binge eating ; however , findings are limited and little is known about how MI for binge eating compares to active therapy controls .


The present study aimed to build on current research by comparing MI as a prelude to self-help treatment for binge eating with psychoeducation as a prelude to self-help treatment for binge eating .


Participants with full or subthreshold DSM-IV Binge Eating Disorder or nonpurging Bulimia Nervosa were randomly assigned to receive either 60 minutes of MI followed by a self-help manual ( n = 24 ) or 60 minutes of psychoeducation followed by a self-help manual ( n = 21 ) .


Questionnaires were completed pre - and postsession , and at 1 and 4 months postsession .


MI significantly increased readiness to change and confidence in ability to control binge eating , whereas psychoeducation did not .


No group differences were found when changes in eating disorder attitudes and behaviors were examined .


MI offers benefits for increasing motivation and self-efficacy .


However , it may not be a uniquely effective treatment approach for reducing binge eating .


This study sought to evaluate the efficacy and safety of subcutaneous evolocumab compared with oral ezetimibe inhypercholesterolemic patients who are unable to tolerate effective statin doses .


Statin intolerance , which is predominantly due to muscle-related side effects , is reported in up to 10 % to 20 % of patients .


Evolocumab , a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , demonstrated marked reductions in plasma low-density lipoprotein cholesterol ( LDL-C ) in a phase 2 study in statin-intolerant patients .


The GAUSS-2 ( Goal Achievement after Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects ) trial was a 12-week , double-blind study of randomized patients ( 2:2:1:1 ) to evolocumab 140 mg every two weeks ( Q2W ) or evolocumab 420 mg once monthly ( QM ) both with daily oral placebo or subcutaneous placebo Q2W or QM both with daily oral ezetimibe 10 mg .


Co-primary endpoints were percent change from baseline in LDL-C at themean of weeks 10 and12 , and at week 12 .


Three hundred seven patients ( age 62 10 years ; LDL-C 193 59 mg/dl ) were randomized .


Evolocumab reduced LDL-C from baseline by 53 % to 56 % , corresponding to treatment differences versus ezetimibe of 37 % to 39 % ( p < 0.001 ) .


Muscle adverse events occurred in 12 % of evolocumab-treated patients and 23 % of ezetimibe-treated patients .


Treatment-emergent adverse events and laboratory abnormalities were comparable across treatment groups .


Robust efficacy combined with favorable tolerability makes evolocumab a promising therapy for addressing thelargely unmet clinical need in high-risk patients with elevated cholesterol who are statin intolerant .


( Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2 ; NCT01763905 ) .


Chronic low back pain ( CLBP ) is common and results in significant costs to individuals , families and society .


Although some research supports the efficacy of hypnosis for CLBP , we know little about the minimum dose needed to produce meaningful benefits , the roles of home practice and hypnotizability on outcome , or the maintenance of treatment benefits beyond 3 months .


One hundred veterans with CLBP participated in a randomized , four-group design study .


The groups were ( 1 ) an eight-session self-hypnosis training intervention without audio recordings for home practice ; ( 2 ) an eight-session self-hypnosis training intervention with recordings ; ( 3 ) a two-session self-hypnosis training intervention with recordings and brief weekly reminder telephone calls ; and ( 4 ) an eight-session active ( biofeedback ) control intervention .


Participants in all four groups reported significant pre - to post-treatment improvements in pain intensity , pain interference and sleep quality .


The hypnosis groups combined reported significantly more pain intensity reduction than the control group .


There was no significant difference among the three hypnosis conditions .


Over half of the participants who received hypnosis reported clinically meaningful ( 30 % ) reductions in pain intensity , and they maintained these benefits for at least 6 months after treatment .


Neither hypnotizability nor amount of home practice was associated significantly with treatment outcome .


The findings indicate that two sessions of self-hypnosis training with audio recordings for home practice may be as effective as eight sessions of hypnosis treatment .


If replicated in other patient samples , the findings have important implications for the application of hypnosis treatment for chronic pain management .


To assess the effects of active music therapy ( MT ) and individualized listening to music ( LtM ) on behavioral and psychological symptoms of dementia ( BPSDs ) in persons with dementia ( PWDs ) .


Randomized controlled trial .


Nine Italian institutions .


Persons with moderate to severe dementia and BPSDs ( N = 120 ) were randomized to one of three treatments .


All groups received standard care ( SC ) , and two groups attended 20 individualized MT or LtM sessions , twice a week , in addition to SC .


The Neuropsychiatric Inventory ( NPI ) , Cornell Scale for Depression in Dementia ( CSDD ) , and Cornell-Brown Scale for Quality of Life in Dementia ( CBS-QoL ) were administered before treatment , after treatment , and at follow-up to evaluate behavioral and psychological outcomes .


A specific coding scheme ( Music Therapy Check List-Dementia ) was used to evaluate the MT process .


Behavioral assessment did not show significant differences between groups .


All groups showed a reduction over time in NPI global score ( P .001 ) , CSDD ( P = .001 ) , and CBS-QoL ( P = .01 ) .


The NPI global score fell 28 % in the MT group , 12 % in the LtM group , and 21 % in the SC group at the end of treatment .


An exploratory post hoc analysis showed similar within-group improvements for the NPI Delusion , Anxiety , and Disinhibition subscales .


In the MT group , communication and relationships between the music therapists and PWDs showed a positive albeit nonsignificant trend during treatment .


The addition of MT or LtM to standard care did not have a significant effect on BPSDs in PWDs .


Further studies on the effects of the integration of standard care with different types of music interventions on BPSD in PWD are warranted .


Endovenous laser ablation ( EVLA ) is a popular treatment for superficial venous insufficiency .


Debate continues regarding the optimal management of symptomatic varicose tributaries following ablation of the main saphenous trunk .


This randomized trial compared the 5-year outcomes of endovenous laser therapy with ambulatory phlebectomy ( EVLTAP ) with concomitant ambulatory phlebectomy , and EVLA alone with sequential treatment if required following a delay of at least 6weeks .


Patients undergoing EVLA for great saphenous vein insufficiency were randomized to receive EVLTAP or EVLA alone with sequential phlebectomy , if required .


Outcomes included disease-specific quality of life ( QoL ) ( Aberdeen Varicose Vein Questionnaire ; AVVQ ) , requirement for secondary procedures , clinical severity ( Venous Clinical Severity Score ; VCSS ) , residual and recurrent varicose tributaries , and generic QoL .


Patients were followed up for 5years .


Fifty patients were randomized equally into two parallel groups .


The EVLTAP group had lower VCSS scores at 12weeks ( median 0 ( i.q.r. 0-1 ) versus 2 ( 0-2 ) ; P < 0001 ) , and lower AVVQ scores at 6weeks ( median 79 ( i.q.r. 41-107 ) versus 135 ( 109-181 ) ; P < 0001 ) and 12weeks ( 20 ( 04-77 ) versus 96 ( 22-138 ) ; P = 0015 ) .


VCSS and AVVQ scores were equivalent by 1year , but only after 16 of 24 patients in the EVLA group , compared with one of 25 in the EVLTAP group ( P < 0001 ) , had received a secondary intervention .


From 1 to 5 years both groups had equivalent outcomes .


EVLA with either concomitant or sequential management of tributaries is acceptable treatment for symptomatic varicose veins , with both treatments achieving excellent results at 5years .


Concomitant treatment of varicosities is associated with optimal improvement in both clinical disease severity and QoL .


To explore the outcomes of an Xbox Kinect intervention on balance ability , enjoyment and compliance for previously injured young competitive male athletes .


Experimental pre - / post-test design with random assignment .


Sixty-three previously injured young competitive male athletes , aged 161 years .


Participants were divided into three groups : one group received Xbox Kinect ( XbK ) training , one group received Traditional physiotherapy ( TP ) training , and one group did not receive any balance training ( Control ) .


Intervention involved a 24min session , twice weekly for 10 weeks .


Overall stability index ( OSI ) and limits of stability ( LOS ) scores using the Biodex Stability System .


Enjoyment using the Physical Activity Enjoyment Scale .


Self-reported compliance .


Both experimental groups demonstrated an improvement in OSI and LOS mean scores for the right and the left limb after the intervention .


In addition , the results revealed important differences between the experimental groups and the control group on balance test indices .


Group enjoyment rating was greater for XbK compared with TP , while the compliance rating was not .


These findings suggest that the use of XbK intervention is a valuable , feasible and pleasant approach in order to improve balance ability of previously injured young competitive male athletes .


Childbirth fear is associated with increased obstetric interventions and poor emotional and psychological health for women .


The purpose of this study is to test an antenatal psycho-education intervention by midwives in reducing women 's childbirth fear .


Women ( n = 1,410 ) attending three hospitals in South East Queensland , Australia , were recruited into the BELIEF trial .


Participants reporting high fear were randomly allocated to intervention ( n = 170 ) or control ( n = 169 ) groups .


All women received a decision-aid booklet on childbirth choices .


The telephone counseling intervention was offered at 24 and 34 weeks of pregnancy .


The control group received usual care offered by public maternity services .


Primary outcome was reduction in childbirth fear ( WDEQ-A ) from second trimester to 36 weeks ' gestation .


Secondary outcomes were improved childbirth self-efficacy , and reduced decisional conflict and depressive symptoms .


Demographic , obstetric & psychometric measures were administered at recruitment , and 36 weeks of pregnancy .


There were significant differences between groups on postintervention scores for fear of birth ( p < 0.001 ) and childbirth self-efficacy ( p = 0.002 ) .


Decisional conflict and depressive symptoms reduced but were not significant .


Psycho-education by trained midwives was effective in reducing high childbirth fear levels and increasing childbirth confidence in pregnant women .


Improving antenatal emotional well-being may have wider positive social and maternity care implications for optimal childbirth experiences .


Abediterol ( LAS100977 ) is a novel , long-acting 2-agonist , in development for the once-daily treatment of asthma in combination with mometasone .


Here we report the results of a Phase IIa trial of single doses of abediterol added to ongoing maintenance therapy ( inhaled corticosteroids ) in patients with persistent mild-to-moderate asthma .


This was a randomised , double-blind , placebo - and active-comparator-controlled , five-way crossover study .


Male patients ( 18-70 years ) with a clinical diagnosis of persistent asthma received abediterol ( 5 , 10 and 25g ) , salmeterol and placebo , on top of ongoing maintenance therapy .


Lung function was determined using spirometry and whole body plethysmography .


The primary efficacy endpoint was change from baseline in trough forced expiratory volume in 1s ( FEV1 ) after a single dose .


All three abediterol doses induced statistically significant increases in trough FEV1 vs placebo and salmeterol .


Improvements in other lung function parameters were also statistically significantly greater with all abediterol doses vs both placebo ( p < 0.0001 ) and salmeterol ( p < 0.05 ) than the first assessment at 5min post-dose .


These improvements were sustained to 36h post-dose .


The profile of treatment-emergent adverse events judged as related to abediterol was consistent with that seen after adrenergic stimulation and occurred exclusively in patients who received abediterol 10g or 25g .


This first-in-patient study revealed the potent , rapid and long-acting bronchodilatory effect of abediterol in patients with persistent mild-to-moderate asthma together with an overall good safety and tolerability profile .


Further studies are now underway to establish the optimal efficacy-safety-tolerability profile for this compound .


To evaluate the efficacy of 2 mandibular advancement devices in 6-week treatment of patient with severe obstructive sleep apnea hypopnea syndrome ( OSAHS ) who refused to CPAP or CPAP therapy .


A randomized cross-over study was designed and conducted .


Twenty-two male patients with severe OSAHS were included for treatment .


Rod type and controllable type mandibular advancement devices ( MADs ) were used respectively in 6 weeks with 2-week interval , while the whole experimental duration was 14 weeks .


The differences of the indexes of the polysomnography ( PSG ) were analyzed , which were gained before the intervention and 6 weeks after use of 2 types of MADs .


Questionnaires with Epworth sleep and SCL-90 symptoms self evaluation scales were proceeded .


Meanwhile , the parameters such as the stability of the MAD , the adverse reaction and the subjective symptom relief were assessed .


The result was statistically analyzed by SPSS19 .0 software package .


Compared with the apnea hypopnea index ( AHI ) before the intervention ( 48.1613.99 times/hr ) , both the AHI of the rod type ( 19.162.74 times/hr ) and the controllable type ( 18.932.57 times/hr ) were reduced by 50 % .


The remaining parameters showed that both types of MADs had a significant effect on mandibular advancement .


There was significant different decrease in each index of the SCL-90 ( P < 0.01 ) , while significant differences were found in somatization , interpersonal sensitivity and anxiety compared with those before intervention ( P < 0.05 ) .


At the same time , there were significant differences in the indexes of stability and results occlusive comfort between the rod type and the controllable MADs ( P < 0.05 ) .


The objective results and the patients ' physical and mental health are improved obviously by using the 2 types of MADs .


Controllable MADs have more advantages in compliance ; however , further research should be conducted for long-time outcome .


To identify the pyrazinamide MIC above which standard combination therapy fails .


MICs of pyrazinamide were determined for Mycobacterium tuberculosis isolates , cultured from 58 patients in a previous randomized clinical trial in Cape Town , South Africa .


The MICs were determined using BACTEC MGIT 960 for isolates that were collected before standard treatment with isoniazid , rifampicin , pyrazinamide and ethambutol commenced .


Weekly sputum collections were subsequently made for 8 weeks in order to culture M. tuberculosis in Middlebrook broth medium .


Classification and regression tree ( CART ) analysis was utilized to identify the pyrazinamide MIC predictive of sputum culture results at the end of pyrazinamide therapy .


The machine learning-derived susceptibility breakpoints were then confirmed using standard association statistics that took into account confounders of 2 month sputum conversion .


The pyrazinamide MIC range was 12.5 to > 100 mg/L for the isolates prior to therapy .


The epidemiological 95 % cut-off value was > 100 mg/L .


The 2 month sputum conversion rate in liquid cultures was 26 % by stringent criteria and 48 % by less stringent criteria .


CART analysis identified an MIC breakpoint of 50 mg/L , above which patients had poor sputum conversion rates .


The relative risk of poor sputum conversion was 1.5 ( 95 % CI : 1.2-1 .8 ) for an MIC > 50 mg/L compared with an MIC 50 mg/L .


We propose a pyrazinamide susceptibility breakpoint of 50 mg/L for clinical decision making and for development of rapid susceptibility assays .


This breakpoint is identical to that identified using computer-aided simulations of hollow fibre system output .


Psychoeducation programmes for people with schizophrenia are shown to reduce relapses but few studies have indicated significant improvements in patients ' illness awareness and insight , functioning , symptom severity or rates of readmission to hospital .


To examine the effects of a mindfulness-based psychoeducation programme for Chinese people with schizophrenia .


A multisite randomised controlled trial was conducted with 107 out-patients with schizophrenia : 36 and 35 received a 6-month mindfulness-based psychoeducation and a conventional psychoeducation programme , respectively , and 35 received routine care alone .


Patient outcome measures were psychiatric symptom severity , psychosocial functioning , social support , insight into illness/treatment , and frequency and duration of readmissions to hospital ( ClinicalTrials.gov : trial registration NCT01667601 ) .


The mindfulness-based psychoeducation group reported significantly greater improvements in psychiatric symptoms , psychosocial functioning , insight into illness/treatment and duration of readmissions to hospital over 24 months when compared with the other two groups .


Mindfulness-based psychoeducation appears to be a promising approach to treatment for Chinese patients with schizophrenia .


To investigate the optimum period of treatment for post endoscopic submucosal dissection ( ESD ) ulcers .


Patients who underwent ESD for gastric cancer were randomized to two groups and treated with esomeprazole 20 mg per day for 4 wk ( 4W group ) or 2 wk ( 2W group ) .


At 4 wk after ESD , we measured the size of the artificial ulcers by endoscopy and determined the ulcer healing rate , compared with the size of the ESD specimens .


This randomized controlled trial study was approved by our ethics committee and registered in the UMIN Clinical Trial Registry .


A total of 60 consecutive patients were included in the study .


All patients received rebamipide 300 mg per day for 4 wk .


One patient in 2W group who showed bleeding within two weeks and received endoscopic treatment was excluded from further analysis .


The numbers of patients with ulcers in the healing/scar stage in the 2W and 4W groups at 4 wk after ESD were 20/6 and 28/5 , respectively , with no significant difference .


The ulcer healing rate in the 2W and 4W groups were 96.1 % [ 95 % confidence interval ( CI ) : 94.6 % -97.55 ] vs 94.8 % ( 95 % CI : 92.6 % -97.1 % ) , respectively , with no statistical difference ( UMIN000006951 ) .


Two-wk treatment with a proton pump inhibitor is as effective as four-week treatment for healing post ESD ulcers .


The contribution of sweet beverages to weight gain in children is controversial ; the impact of these beverages on caloric adjustment needs clarification .


We studied the influence of energy-density ( ED ) conditioning on the liking for sweet beverages and caloric adjustment after their consumption in children .


We used a within-subject design .


Forty-four 8-11-y-old children were exposed to the following 2 distinctly flavored , sweetened beverages : a high-energy ( HE ) version ( 150 kcal ) and a no-energy ( NE ) version ( 0 kcal ) .


During a 4-wk initial conditioning period , children were exposed either 2 or 7 times to each beverage .


After a 3-wk stability period ( without exposure ) , children were exposed 3 times to both beverages with a reversed association between the ED and flavor ( 4-wk reversed-conditioning period ) .


Flavor liking and food intake during meals after the consumption of each beverage were assessed before and after each period .


After the initial conditioning , the liking for both beverages increased ( P < 0.001 ) .


After the stability period , the liking for the HE flavor was higher than for the NE flavor ( P = 0.024 ) .


After the reversed conditioning , the liking for the flavor initially paired with the HE beverage tended to remain higher than for the NE flavor ( P = 0.089 ) .


Initially , energy intakes during the meal did not differ after the consumption of NE or HE beverages .


After the initial conditioning and up until the end of the reversed conditioning , energy intakes were lower after the HE beverage than after the NE beverage regardless of the beverage flavor ( eg , after reversal ; caloric compensation score : 29 % ) .


The number of exposures did not influence liking or energy intake .


After the association between a flavor and ED and reversal of this association , liking may be first guided by ED and then the flavor firstly associated with ED , whereas the partial caloric compensation may consistently be guided by ED .


This trial was registered at clinicaltrials.gov as NCT02070185 .


To investigate the hemodynamic profile associated with different target temperatures and to assess the prognostic implication of inotropic/vasopressor support and mean arterial pressure after out-of-hospital cardiac arrest .


There is a lack of information how different target temperatures may affect hemodynamics .


Post hoc analysis of a prospective randomized study .


Thirty-six ICUs in 10 countries .


Nine hundred twenty patients ( 97 % ) with available vasopressor data out of 950 patients from the Target Temperature Management trial randomly assigned patients to a targeted temperature management at 33 C or 36 C.


None .


Mean arterial pressure , heart rate , and lactate were registered at prespecified time points .


The population was stratified according to cardiovascular Sequential Organ Failure Assessment = 4 defining the high vasopressor group and cardiovascular Sequential Organ Failure Assessment less than or equal to 3 defining the low vasopressor group .


The targeted temperature management 33 ( TTM33 ) group had a hemodynamic profile with lower heart rate ( -7.0 min ( -1 ) [ 95 % confidence limit , -8.7 , -5.1 ] ; p ( group ) < 0.0001 ) , similar mean arterial pressure ( -1.1 mm Hg [ 95 % confidence limit , -2.3 , 0.2 ] ; p ( group ) = 0.10 ) , and increased lactate ( 0.6 mmol/L [ 95 % confidence limit , 0.3 , 0.8 ] ; p ( group ) < 0.0001 ) compared with the targeted temperature management 36 ( TTM36 ) group .


A cardiovascular Sequential Organ Failure Assessment score = 4 was recorded in 54 % versus 45 % , p = 0.03 in the TTM33 and the TTM36 group , respectively .


The high vasopressor group carried a 53 % mortality rate when compared with a 34 % in the low vasopressor group , p ( log-rank ) less than 0.0001 , with an adjusted hazard ratio of 1.38 ( 95 % CI , 1.11-1 .71 ; p = 0.004 ) .


There was no interaction between vasopressor group and allocated target temperature group ( p = 0.40 ) .


An inverse relationship between mean arterial pressure and mortality was identified ( p = 0.0008 ) .


Targeted temperature management at 33 C was associated with hemodynamic alterations with decreased heart rate , elevated levels of lactate , and need for increased vasopressor support compared with targeted temperature management at 36 C. Low mean arterial pressure and need for high doses of vasopressors were associated with increased mortality independent of allocated targeted temperature management .


Osteopontin ( OPN ) is a malignancy-associated glycoprotein that contributes functionally to tumor aggressiveness .


In metastatic breast cancer , we previously demonstrated that elevated OPN in primary tumor and blood was associated with poor prognosis .


We measured OPN in plasma by ELISA , and in tumors by immunohistochemistry , in 624 ( 94 % ) and 462 ( 69 % ) , respectively , of 667 postmenopausal women with hormone responsive early breast cancer treated by surgery followed by adjuvant treatment with tamoxifen + / - octreotide in a randomized trial ( NCIC CTG MA .14 ; National Cancer Institute of Canada Clinical Trials Group Mammary .14 ) .


Plasma OPN was measured in 2,540 samples ; 688 at baseline and 1,852 collected during follow-up .


Mean baseline plasma OPN was 46ng/ml ( range 22.6 to 290 ) which did not differ from normal levels .


Mean percentage OPN tumor cell positivity was 33.9 ( 95 % CI : 30.2 to 37.9 ) .


There was no correlation between plasma and tumor OPN values .


In multivariate analysis , neither was associated with event-free survival ( EFS ) , relapse-free survival ( RFS ) , overall survival ( OS ) , bone RFS or non-bone RFS .


An exploratory analysis in patients with recurrence showed higher mean OPN plasma levels 60.7 ng/ml ( 23.9 to 543 ) in the recurrence period compared with baseline levels .


The hypothesis that OPN tumor expression would have independent prognostic value in early breast cancer was not supported by multivariate analysis of this study population .


Plasma OPN levels in women with hormone responsive early breast cancer in the MA .14 trial were not elevated and there was no evidence for prognostic value of plasma OPN in this defined group of patients .


However , our finding of elevated mean OPN plasma level around the time of recurrence warrants further study .


NCT00002864 , http://clinicaltrials.gov/show/NCT00002864 .


Children who experience neglect and abuse are likely to have impaired brain development and entrenched learning deficiencies .


Early years interventions such as intensive education and care for these children are known to have the potential to increase their human capital .


The Early Years Education Program ( EYEP ) is a new program offered by the Children 's Protection Society ( CPS ) in Melbourne , Australia .


EYEP is targeted at the needs of children who have been or are at risk of being abused or neglected .


It has the dual focus of seeking to address the consequences of abuse and neglect on children 's brain development and redressing their learning deficiencies .


Our objective is to determine whether EYEP can improve school readiness by conducting a randomised controlled trial ( RCT ) of its impacts .


The RCT is being conducted with 90 participants ( 45 intervention and 45 control ) .


Eligible children must be aged under three years and assessed as having two or more risk factors as defined in the Department of Human Services Best Interest Case Practice Model .


The intervention group participate for three years ( or until school entry ) in EYEP .


The trial does not provide any early years education or care to the control group .


Data are being collected on outcome measures for participants in EYEP and the control group at the baseline , at yearly intervals for three years , and six months after commencing the first year of school .


Outcome measures encompass children 's health and development , academic ability and emotional and behavioural regulation ; and quality of parenting practices .


The study will evaluate the impact of EYEP on these outcomes , and undertake a benefit-cost analysis of the program .


Findings from the study have the potential to influence the quality of care and education for the large population of children in Australia who are at risk of abuse and neglect , as well as for children in mainstream childcare .


The study will provide up-to-date evidence on the impact of an early years intervention relevant to an urban population in Australia ; as well as ( to our knowledge ) being the first RCT of an early years education and care intervention in Australia .


ACTRN 12611000768998 .


Date 22nd July 2011 .


To assess sustained siphon filter usage among a low-income population in Bangladesh and study relevant motivators and barriers .


After a randomised control trial in Bangladesh during 2009 , 191 households received a siphon water filter along with educational messages .


Researchers revisited households after 3 and 6months to assess filter usage and determine relevant motivators and barriers .


Regular users were defined as those who reported using the filter most of the time and were observed to be using the filter at follow-up visits .


Integrated behavioural model for water , sanitation and hygiene ( IBM-WASH ) was used to explain factors associated with regular filter use .


Regular filter usage was 28 % at the 3-month follow-up and 21 % at the 6-month follow-up .


Regular filter users had better quality water at the 6-month , but not at the 3-month visit .


Positive predictors of regular filter usage explained through IBM-WASH at both times were willingness to pay > US$ 1 for filters , and positive attitude towards filter use ( technology dimension at individual level ) ; reporting boiling drinking water at baseline ( psychosocial dimension at habitual level ) ; and Bengali ethnicity ( contextual dimension at individual level ) .


Frequently reported barriers to regular filter use were as follows : considering filter use an additional task , filter breakage and time required for water filtering ( technology dimension at individual level ) .


The technological , psychosocial and contextual dimensions of IBM-WASH contributed to understanding the factors related to sustained use of siphon filter .


Given the low regular usage rate and the hardware-related problems reported , the contribution of siphon filters to improving water quality in low-income urban communities in Bangladesh is likely to be minimal .


The objective of the study was to investigate the effects of a galacto-oligosaccharides ( GOS ) - supplemented formula on the intestinal microbiota in healthy term infants , with a specific consideration for gastrointestinal symptoms as colic , stool frequency and consistency , regurgitation .


This was a randomized , double-blind , controlled , parallel-group clinical trial performed simultaneously by 6 centers in Italy .


Three groups were considered : breastfed , formula-fed , and GOS-supplemented formula-fed infants .


Formula-fed infants were randomized to receive either the control or the study formula and consume the assigned formula exclusively until the introduction of complementary feeding .


The nutritional composition of the 2 formulas were identical , apart from the supplemented GOS ( 0.4 g/100mL ) in the study formula .


Four different types of bacteria were evaluated in order to assess the efficacy of GOS-supplemented formula on infants : Bifidobacterium , Lactobacillus , and Clostridium , Escherichia coli .


A total of 199 breastfed infants and 163 formula-fed infants were recruited .


When considering stool frequency and consistency , GOS-supplemented formula presented normal and soft stools in the majority of episodes ( 89 % ) .


In the supplemented group the incidence of colic was lower with respect to the control group .


A significantly lower count of Clostridium and a higher count of Bifidobacterium were found when comparing study formula and control formula in infants with colic .


In children with colic the ratio between Clostridium count and Bifidobacterium and Lactobacillus count was in favor of the latter two when considering the GOS-supplemented formula group with respect to the control one .


The prebiotic-supplemented formula mimicked the effect of human milk in promoting Bifidobacterium and Lactobacillus growth and in inhibiting Clostridium growth , resulting in a significantly lower presence of colic .


The relapse rate of ulcerative colitis ( UC ) is high .


The efficacy of combined diosmectite and mesalazine treatment for active mild-to-moderate UC was investigated .


A total of 120 patients with UC were enrolled in this randomized , single-blind , placebo-controlled study .


Sixty patients were assigned to the Diosmectite group ( diosmectite and mesalazine ) and 60 were assigned to Placebo group ( placebo and mesalazine ) .


In the induction phase , the primary end point was the clinical remission rate at 8 weeks ; secondary end points were clinical response , endothelial mucosal healing , Mayo score , erythrocyte sedimentation rate , C-reactive protein levels , and defecation frequency .


In the maintenance phase , the primary end point was clinical remission at 52 weeks ; secondary end points were clinical response , endothelial mucosal healing , Mayo score , erythrocyte sedimentation rate , and defecation frequency .


At 8 weeks , the Diosmectite group had a significantly higher clinical remission rate ( 68.3 % vs. 50 % ) and mucosal healing rate ( 66.7 % vs. 48.3 % ) compared with the Placebo group .


There were no significant differences in clinical response rates , Mayo score , erythrocyte sedimentation rate , C-reactive protein , or defecation frequency .


At 52 weeks , the Diosmectite group had a significantly higher clinical remission rate ( 61.7 % vs. 40 % ) and mucosal healing rate ( 60 % vs. 38.3 % ) compared with the Placebo group .


Defecation frequency was lower , but this was not significant .


Combined diosmectite and mesalazine treatment successfully induced and maintained the treatment of active mild-to-moderate UC as indicated by higher rates of clinical remission and mucosal healing .


It is commonly assumed that ablation of any remaining Barrett 's epithelium after endoscopic resection of early Barrett 's neoplasia improves outcome by reducing the rate of metachronous lesions , but this has not yet been evaluated in a randomized trial .


The aim of this study was to compare argon plasma coagulation ( APC ) with surveillance only for the management of residual Barrett 's epithelium following endoscopic resection .


Patients in whom focal early Barrett 's neoplasia ( high grade intraepithelial neoplasia [ HGIN ] or mucosal cancer ) had been curatively resected by endoscopy were randomly assigned to undergo ablation of the residual Barrett 's segment by APC or surveillance only ; pH-metry-adjusted proton pump inhibitor therapy was administered in both groups .


The main outcome parameter was recurrence-free survival .


Follow-up endoscopies with biopsies in cases of further residual Barrett 's epithelium were carried out at 6-monthly intervals in both groups .


A total of 63 patients ( 57 male [ 90.5 % ] ) were included in the study ( ablation group n = 33 ; surveillance group n = 30 ) .


For complete Barrett 's ablation , a mean number of 41.6 APC sessions were required ( range 2-7 ) .


The mean follow-up duration did not differ significantly between ablation ( 28.213.7 months , range 0-44 ) and surveillance patients ( 24.714.8 months , range 0-45 ; P = 0.159 ) .


The number of secondary lesions was 1 in the ablation group ( 3 % ) , and 11 in the surveillance group ( 36.7 % ) , leading to significantly higher recurrence-free survival for the patients undergoing ablation ( P = 0.005 ) .


Thermal ablation of residual Barrett 's epithelium leads to a significant reduction in neoplasia recurrence rate compared with a surveillance strategy during a limited follow-up of 2 years .


A longer follow-up duration may have led to a relatively higher rate of secondary neoplasia in both groups of patients .


Imbalance between work demands and individual resources can lead to musculoskeletal disorders and reduced work ability .


The aim of this study was to evaluate the effect of two contrasting interventions on work ability among slaughterhouse workers with chronic pain and work disability .


Sixty-six slaughterhouse workers with upper-limb chronic pain and work disability were randomly allocated to 10 weeks of either strength training for the shoulder , arm , and hand muscles ( 3 times per week , 10 minutes per session ) or ergonomic training ( usual care control group ) from September to December 2012 .


The outcome measure was the change from baseline to 10-week follow-up in the work ability index ( WAI ) .


A priori hypothesis testing showed a grouptime interaction for WAI ( P < 0.05 ) .


Compared with the ergonomic training group , WAI increased 2.3 [ 95 % confidence interval ( 95 % CI ) 0.9-3 .7 ] in the strength training group corresponding to a moderate effect size ( Cohen 's d 0.52 ) .


Within-group changes indicated that between-group differences were mainly caused by a reduction in WAI in the ergonomic group .


Of the 7 items of WAI , item 2 ( work ability in relation to the demands of the job ) and item 7 ( mental resources ) increased following strength training compared with ergonomic training ( P < 0.05 ) .


Implementation of strength training at the workplace prevents deterioration of work ability among manual workers with chronic pain and disability exposed to forceful and repetitive job tasks .


Thus , strength training performed at the workplace may in fact be regarded as a complex biopsychosocial intervention modality that reaches further than the specific physiological benefits of training per se .


Obstructive sleep apnea ( OSA ) is a chronic progressive disease , and it is well-documented that severe OSA is associated with an increased cardiovascular morbidity and mortality .


Weight reduction has been shown to improve OSA ; however , we need further evidence to determine if it may prevent the progression of OSA in the long term .


The aim of our study was to assess the impact of weight change during a 5-year observational follow-up of an original 1-year randomized controlled trial .


The participants were divided into the two groups according to the weight change at 5-year follow-up using the 5 % weight loss as a cutoff point , which was later referred to as the successful ( n = 20 ) or unsuccessful groups ( n = 27 ) .


The change in apnea-hypopnea index ( AHI ) was the main objective outcome variable .


Fifty-seven patients participated in the 5-year follow-up .


At 5 years from the baseline , the change in AHI between the groups was significant in the successful group ( -3.5 [ 95 % confidence interval { CI } , -6.1 to -0.9 ] ) compared with the unsuccessful group ( 5.0 [ 95 % CI , 2.0-8 .5 ] ) ( P = .002 ) .


Successful weight reduction achieved an 80 % reduction in the incidence of progression of OSA compared to the unsuccessful group ( log-rank test , P = .016 ) .


A moderate but sustained weight reduction can prevent the progression of the disease or even cure mild OSA in obese patients .


Sleep-disordered breathing may impair cerebral oxygenation in patients with OSA syndrome , in particular during altitude travel .


We studied cerebral tissue oxygenation ( CTO ) at low and moderate altitude in patients with OSA and evaluated whether acetazolamide improved CTO .


Eighteen patients with OSA living at < 600 m discontinued CPAP therapy during studies in Zurich ( 490 m ) and during two sojourns of 3 days in the Swiss Alps ( 2 days at 1,860 m and 1 day at 2,590 m ) separated by a 2-week washout period at < 600 m. Patients received acetazolamide ( 2 250 mg/d ) or placebo at altitude in a randomized , double-blind , crossover design .


Nocturnal polysomnography , including CTO monitoring by near-infrared spectroscopy ( NIRS ) , was performed .


At 490 m , medians of CTO , peripheral oxygen saturation as measured by pulse oximetry ( Spo2 ) , and apnea/hypopnea index were 65 % , 93 % , and 57.3 / h , respectively .


At 2,590 m , on placebo , the corresponding values were 59 % , 86 % , and 86.4 / h , respectively ( P < .05 , all corresponding comparisons ) .


Acetazolamide increased CTO and Spo2 at 2,590 m by mean values of 2 % ( 95 % CI , 0 % -4 % ) and 2 % ( 95 % CI , 1 % -3 % ) , respectively , and reduced the apnea/hypopnea index by 23.4 / h ( 95 % CI , 14.0-32 .8 / h ) ( P < .05 , all changes ) .


Cerebral total hemoglobin concentration , a NIRS-derived surrogate reflecting regional cerebral blood volume , increased by a similar degree in response to apneas at 490 m and 2,590 m and during acetazolamide and placebo treatment .


In patients with OSA staying at altitude , nocturnal cerebral and arterial oxygenation were reduced in association with exacerbated sleep apnea .


Acetazolamide partially improved CTO , Spo2 , and sleep apnea without impairing the cerebral blood flow response to apneas .


ClinicalTrials.gov ; No. : NCT00714740 ; URL : www.clinicaltrials.gov .


Controlled hypotension ( CH ) is a well-established technique to decrease blood loss and improve surgical visibility .


Although nitroprusside and remifentanil have been safely and effectively used for this purpose , the hemodynamic changes that occur during CH are unclear .


This study compared the effects of nitroprusside and remifentanil on hemodynamics using a noninvasive cardiac output monitor ( Cheetah NICOM ( ) ; Cheetah Medical Inc. , Maidenhead , Berkshire , UK ) for endoscopic sinus surgery ( ESS ) .


Twenty-eight adult patients scheduled for ESS were randomly assigned to the nitroprusside group ( n = 14 ) or remifentanil group ( n = 14 ) .


After anesthesia induction , hypotension was induced with continuous infusion of nitroprusside or remifentanil at a target mean arterial blood pressure ( MAP ) of 60-70 mmHg .


Cardiac index ( CI ) , stroke volume index ( SVI ) and total peripheral resistance index ( TPRI ) were measured at 10-min intervals .


The heart rate was higher and SVI was lower in the nitroprusside group than in the remifentanil group during CH .


There were no significant differences in MAP , CI or TPRI between the two groups .


Both nitroprusside and remifentanil reduced MAP and TPRI during CH compared with baseline values .


However , there was no significant change in CI .


Both nitroprusside and remifentanil were effective to induce CH and maintain CI during CH .


HIV-infected participants are at a higher risk for cardiovascular disease ( CVD ) .


N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) is a significant predictor of CVD in the general population and is associated with mortality in HIV .


The 96-week Stopping Atherosclerosis and Treating Unhealthy Bone with Rosuvastatin in HIV ( SATURN-HIV ) trial randomized 147 patients on stable antiretroviral therapy with low-density lipoprotein-cholesterol level lower than 130mg/dl and without overt heart failure to 10mg daily rosuvastatin or placebo .


We measured NT-proBNP levels by enzyme-linked immunosorbent assay ( ELISA ) .


Baseline and changes in NT-proBNP were compared between groups .


Spearman correlation was used to explore relationships between baseline NT-proBNP , inflammation , and CVD risk markers .


Multivariable analyses were conducted to assess associations with NT-proBNP levels .


Median age was 46 years , 80 % were men , 69 % were African American , and 46 % were on protease inhibitors .


At baseline , median ( Q1 , Q3 ) NT-proBNP was higher in the rosuvastatin group than placebo [ 41 ( 20 , 66.5 ) versus 25pg/ml ( 11 , 56 ) , P = 0.012 ) ] .


Baseline NT-proBNP correlated with bulb and common carotid artery intima-media thickness , coronary calcium score , interleukin 6 , and cystatin C.


After 96 weeks , median NT-proBNP decreased significantly in the rosuvastatin group versus placebo ( -1.50 versus +4.50 pg/ml , P = 0.041 ) .


Within the rosuvastatin group , changes in NT-proBNP were negatively correlated with changes in insulin resistance and total limb fat .


Rosuvastatin reduces plasma NT-proBNP in HIV-infected participants on antiretroviral therapy .


NT-proBNP correlated with several measures of CVD risk , independent of inflammation markers .


Acute intracranial hemorrhage represents a severe and time critical pathology that requires precise and quick diagnosis , mainly by performing a CT scan .


The purpose of this study was to compare image quality and intracranial hemorrhage conspicuity in brain CT with sinogram-affirmed iterative reconstruction and filtered back-projection reconstruction techniques at standard ( 340 mAs ) and low-dose tube current levels ( 260 mAs ) .


A total of 94 consecutive patients with intracranial hemorrhage received CT scans either with standard or low-dose protocol by random assignment .


Group 1 ( n = 54 ; mean age , 64 20 years ) received CT at 340 mAs , and group 2 ( n = 40 ; mean age , 57 23 years ) received CT at 260 mAs .


Images of both groups were reconstructed with filtered back-projection reconstruction and 5 iterative strengths ( S1-S5 ) and ranked blind by 2 radiologists for image quality and intracranial hemorrhage on a 5-point scale .


Image noise , SNR , dose-length product ( mGycm ) , and mean effective dose ( mSv ) were calculated .


In both groups , image quality and intracranial hemorrhage conspicuity were rated subjectively with an excellent/good image quality .


A higher strength of sinogram-affirmed iterative reconstruction showed an increase in image quality with a difference to filtered back-projection reconstruction ( P < .05 ) .


Subjective rating showed the best score of image quality and intracranial hemorrhage conspicuity achieved through S3/S4 -5 .


Objective analysis of image quality showed in an increase of SNR with a higher strength of sinogram-affirmed iterative reconstruction .


Patients in group 2 ( mean : 744 mGycm/1 .71 mSv ) were exposed to a significantly lower dose than those in group 1 ( mean : 1045 mGycm/2 .40 mSv , P < .01 ) .


S3 provides better image quality and visualization of intracranial hemorrhage in brain CT at 260 mAs .


Dose reduction by almost one-third is possible without significant loss in diagnostic quality .


To compare the anti-inflammatory efficacy of ketorolac of tromethamine 0.4 % and nepafenac 0.1 % eye drops for prophylaxis of cystoid macular oedema ( CME ) after small-incision cataract extraction .


Patients were assigned randomly to three groups .


Group 1 patients received a topical artificial tear substitute ( placebo ) ; group 2 received ketorolac tromethamine 0.4 % ( Acular LS , Allergan ) and group 3 received nepafenac 0.1 % ( Nevanac , Alcon ) .


The incidence and severity of CME were evaluated by retinal foveal thickness on optical coherence tomography ( OCT ) after 1 , 4 and 12weeks .


One hundred and twenty-six eyes of 126 patients were included in this study .


The between-group differences in visual outcomes , central corneal thickness and endothelial cell density were not statistically significant .


In all retinal thickness measurements , an increase was detected starting from the postoperative first week until 12weeks .


There was no statistically significant difference between the three groups in any measurement performed by spectral-domain OCT. .


Used prophylactically after uneventful cataract surgery , non-steroidal anti-inflammatory drugs were not efficacious in preventing macular oedema compared with placebo .


ClinicalTrials : NCT02084576 .


To evaluate the clinical efficacy of electroacupuncture ( EA ) combined with transperineal injection of botulinum toxin-A ( BTX-A ) on neurogenic bladder caused by spinal cord injury .


One day af ter surgery , 35 cases of spinal cord injury accompanied with neurogenic bladder were randomly divided into a BTX-A plus EA group ( 20 cases , group A ) and a BTX-A group ( 15 cases , group B ) .


The two groups were both treated with regular rehabilitation training of bladder function and injection of 200 IU ( 4 ml ) BTX-A through perineum external urethral sphincter ; the group A was additionally treated with EA at Zhongji ( CV 3 ) , Guanyuan ( CV 4 ) , Shenshu ( 3BL 23 ) , Huiyang ( BL 35 ) and Baliao ( Shangliao ( BL 31 ) , Ciliao ( BL 32 ) , Zhongliao ( BL 33 ) , Xialiao ( BL 34 ) ) , once a day , 40 min per treatment .


The treatment was given 6 times per week for 4 weeks .


The urination status in two groups before and after treatment was observed , and urodynamics examination and urethral pressure test were also made .


After 4-week treatment , mean times of urinary incontinence , mean urethral catheter output , pressure of bladder and volume of urinary incontinence were all improved in two groups ( all P < 0.05 ) , which were more significant in the group A ( all P < 0.05 ) .


The residual urine , maximum bladder capacity , maximum urethral closure pressure and maximum urine flow rate were all improved in two groups after treatment ( all P < 0.01 ) ; the improvement of residual urine , maximum bladder capacity , maximum urethral closure pressure in the group A was more significant than that in the group B ( all P < 0.05 ) .


Electroacupuncture com bined with transperineal injection of BTX-A could effectively improve the urination dysfunction in patients with neurogenic bladder after spinal cord injury .


The malaria-specific T-cell response is believed to be important for protective immunity .


Antimalarial chemoprevention may affect this response by altering exposure to malaria antigens .


We performed interferon ( IFN ) ELISpot assays to assess the cellular immune response to blood-stage and pre-erythrocytic antigens longitudinally from 1 to 3 years of age in 196 children enrolled in a randomized trial of antimalarial chemoprevention in Tororo , Uganda , an area of high transmission intensity .


IFN responses to blood-stage antigens , particularly MSP1 , were frequently detected , strongly associated with recent malaria exposure , and lower in those adherent to chemoprevention compared to nonadherent children and those randomized to no chemoprevention .


IFN responses to pre-erythrocytic antigens were infrequent and similar between children randomized to chemoprevention or no chemoprevention .


Responses to blood-stage antigens were not associated with subsequent protection from malaria ( aHR 0.96 , P = .83 ) , but responses to pre-erythrocytic antigens were associated with protection after adjusting for prior malaria exposure ( aHR 0.52 , P = .009 ) .


In this high transmission setting , IFN responses to blood-stage antigens were common and associated with recent exposure to malaria but not protection from subsequent malaria .


Responses to pre-erythrocytic antigens were uncommon , not associated with exposure but were associated with protection from subsequent malaria .


We studied the effects of different neuromuscular electrical stimulation ( NMES ) currents , 2 kHz-frequency alternating currents ( KACs , Russian and Aussie ) and 2 pulsed currents ( PCs ) , on isometric knee extension torque and discomfort level , both in isolation and combined , with maximum voluntary contraction ( MVC ) .


Twenty-one women ( age 21.6 2.5 years ) were studied .


We evaluated torque evoked by NMES or NMES combined with maximum voluntary contraction of the quadriceps muscle of healthy women .


Discomfort level was measured using a visual analog pain scale .


Despite comparable levels of discomfort , evoked torque was lower for Russian current compared with the other modalities ( Russian 50.8 % , Aussie 71.7 % , PC500 76.9 % , and PC200 70.1 % ; P < 0.001 ) .


There was no advantage in combining NMES with MVC compared with isolated NMES .


The Aussie and PC approaches proved superior to Russian current for inducing isometric knee extension torque .


This information is important in guiding decision making with regard to NMES protocols for muscle strengthening .


To assess the superiority of fesoterodine 8 mg vs 4 mg for improvement in urgency urinary incontinence ( UUI ) episodes and other diary variables , diary-dry rate ( proportion of patients with > 0 UUI episodes on baseline diary and 0 UUI episodes on post-baseline diary ) , and improvements in measures of symptom bother , health-related quality of life ( HRQL ) , and other patient-reported outcomes ( PROs ) .


This was a 12-week , randomised , double-blind , placebo-controlled , multinational trial of men and women aged 18 years with overactive bladder ( OAB ) symptoms including UUI ( ClinicalTrials.gov ID NCT01302067 ) .


Patients were randomised ( 2:2:1 ) to receive fesoterodine 8 mg , fesoterodine 4 mg , or placebo once daily ; those randomised to fesoterodine 8 mg started with fesoterodine 4 mg once daily for 1 week , then 8 mg once daily for the remaining 11 weeks .


Patients completed bladder diaries at baseline and weeks 4 and 12 and the Patient Perception of Bladder Condition ( PPBC ) , Urgency Perception Scale ( UPS ) , and Overactive Bladder Questionnaire ( OAB-q ) at baseline and week 12 .


The primary endpoint was change from baseline to week 12 in UUI episodes per 24 h.


At week 12 , patients receiving fesoterodine 8 mg ( 779 patients ) had significantly greater reductions from baseline in UUI episodes , micturitions , and urgency episodes than patients receiving fesoterodine 4 mg ( 790 ) or placebo ( 386 ) ; diary-dry rate was significantly higher in the fesoterodine 8-mg group vs the fesoterodine 4-mg and placebo groups ( all P < 0.05 ) .


At week 12 , patients receiving fesoterodine 8 mg also had significantly greater improvements in scores on the PPBC , UPS , and all OAB-q scales and domains than patients receiving fesoterodine 4 mg or placebo ( all P < 0.01 ) .


Patients receiving fesoterodine 4 mg had significantly greater improvements in UUI episodes , urgency episodes , and micturitions ; significantly higher diary-dry rates ; and significantly greater improvement in PPBC scores and OAB-q scores than patients receiving placebo ( all P < 0.05 ) .


Dry mouth was the most commonly reported adverse event ( AE ) in the fesoterodine groups ( placebo group , 3.4 % ; fesoterodine 4-mg group , 12.9 % ; fesoterodine 8-mg group , 26.1 % ) ; most cases were mild or moderate in all treatment groups .


Rates of serious AEs and discontinuations due to AEs were low in all groups .


In a 12-week , prospectively designed , superiority trial , fesoterodine 8 mg showed statistically significantly superior efficacy vs fesoterodine 4 mg and placebo , as measured by reductions in UUI episodes and other diary variables , diary-dry dry rate , and improvements in measures of symptom bother , HRQL , and other PROs ; clear evidence of dose-dependent efficacy is unique to fesoterodine among antimuscarinics and other oral agents for the treatment of OAB .


Fesoterodine 4 mg was significantly more effective than placebo on all outcomes except for improvements in UPS scores .


These data support the benefit of having two doses of fesoterodine in clinical practice , with the recommended starting dose of 4 mg for all patients and the fesoterodine 8-mg dose available for patients who require a higher dose to achieve optimal symptom relief .


The purpose of this study was to develop and validate a computer-aided diagnosis ( CAD ) tool for automatic classification of pulmonary nodules seen on low-dose computed tomography into solid , part-solid , and non-solid .


Study lesions were randomly selected from 2 sites participating in the Dutch-Belgian NELSON lung cancer screening trial .


On the basis of the annotations made by the screening radiologists , 50 part-solid and 50 non-solid pulmonary nodules with a diameter between 5 and 30 mm were randomly selected from the 2 sites .


For each unique nodule , 1 low-dose chest computed tomographic scan was randomly selected , in which the nodule was visible .


In addition , 50 solid nodules in the same size range were randomly selected .


A completely automatic 3-dimensional segmentation-based classification system was developed , which analyzes the pulmonary nodule , extracting intensity - , texture - , and segmentation-based features to perform a statistical classification .


In addition to the nodule classification by the screening radiologists , an independent rating of all nodules by 3 experienced thoracic radiologists was performed .


Performance of CAD was evaluated by comparing the agreement between CAD and human experts and among human experts using the Cohen statistics .


Pairwise agreement for the differentiation between solid , part-solid , and non-solid nodules between CAD and each of the human experts had a range between 0.54 and 0.72 .


The interobserver agreement among the human experts was in the same range ( range , 0.56-0 .81 ) .


A novel automated classification tool for pulmonary nodules achieved good agreement with the human experts , yielding values in the same range as the interobserver agreement .


Computer-aided diagnosis may aid radiologists in selecting the appropriate workup for pulmonary nodules .


We aimed to evaluate the effects of transcranial direct current stimulation ( tDCS ) on chronic pain in human T-lymphotropic virus type I-infected patients .


This is a sham-controlled randomized clinical trial .


Twenty participants were randomized to receive active or sham anodal tDCS over the primary motor cortex ( M1 ) , with 2 mA , 25 cm electrodes , for 20 minutes on 5 consecutive days .


Pain intensity was measured at baseline and after each day of treatment using a Visual Analog Scale .


Associated factors such as pain components description , pressure pain threshold , and Timed Up and Go task were also assessed .


Mild adverse events were reported by 100 % of patients in the tDCS group and 90 % in the sham group .


Comparison of daily Visual Analog Scale pain scores from both groups demonstrated a significant effect for the factor Time ( P < 0.001 ) , but not for Group ( P = 0.13 ) or TimeGroup interaction ( P = 0.06 ) .


There were 8 ( 80 % ) responders ( reduction of 50 % or more in pain intensity ) in the tDCS group and 3 ( 30 % ) in the sham group ( P = 0.03 ) .


Both groups demonstrated improvements for most associated factors evaluated .


However , there was no difference in between-groups comparison analyses .


The analysis of the main outcomes in this study did not demonstrate a significant advantage of anodal tDCS applied to M1 in patients with human T-lymphotropic virus type I and chronic pain in comparison with sham tDCS , although secondary analysis suggests some superiority of active tDCS over sham .


The large placebo effect observed in this study may explain the small differences between sham versus active tDCS .


Depression remains largely undiagnosed in women residing in rural India and consequently many do not seek help .


Moreover , among those who are diagnosed , many do not complete treatment due to high rates of attrition .


This study was aimed to compare the effectiveness of enhanced care with usual care in improving treatment seeking and adherence to antidepressant medication in women with depression living in rural India .


Six villages from rural Bangalore were randomized to either community health worker supported enhanced care or usual care .


A total of 260 adult depressed women formed the final participants for the analysis .


The outcome measures were number of women who sought and completed treatment , number of clinic visits , duration of treatment with antidepressant , changes in severity of depression ( HDRS ) and changes in quality of life [ WHO-QOL ( Brev ) scale ] .


A significantly greater number of women from the treatment intervention ( TI ) group completed the treatment and were on treatment for a longer duration compared to the treatment as usual ( TAU ) group .


However , there were no significant differences in the severity of depression or quality of life between the TI and the TAU groups or between treatment completers and treatment dropouts at six months .


Enhanced care provided by the trained community health workers to rural women with major depression living in the community resulted in greater number of women seeking help and adhering to treatment with antidepressants .


However , despite enhanced care a significant number of rural women diagnosed with depression either did not seek help or discontinued treatment prematurely .


These findings have significant public health implications , as untreated depression is associated with considerable disability .


Primary graft dysfunction ( PGD ) remains a significant problem after lung transplantation .


Data from animal and clinical studies suggest that remote ischemic conditioning ( RIC ) may reduce ischemia-reperfusion injury in solid organ transplantation .


A pilot randomized controlled trial of 60 patients undergoing bilateral sequential lung transplantation assessed the utility of RIC in attenuating PGD .


Treated recipients underwent 3 cycles of lower limb ischemic conditioning before allograft reperfusion .


The primary outcome measure was a comparison of the partial pressure of arterial oxygen/fraction of inspired oxygen ratio ( P/F ratio ) between treatment groups .


No adverse effects of tourniquet application were observed .


The mean lowest P/F ratio during the first 24 hours after transplantation was 271.3 mm Hg in the treatment arm vs 256.1 mm Hg in the control arm ( p = 0.46 ) .


PGD grade and severity and the rate of acute rejection also showed a tendency to favor the treatment arm .


Sub-group analysis demonstrated a significant benefit of treatment in patients with a primary diagnosis of restrictive lung disease , a group at high risk for the development of PGD .


RIC was not accompanied by systemic release of high-molecular-weight group box 1 .


Levels of cytokines , high-molecular-weight group box 1 , and endogenous secretory receptor for advanced glycation end products peaked within 2 hours after reperfusion and likely reflected donor organ quality rather than an effect of RIC .


RIC did not significantly improve P/F ratios or PGD in this randomized controlled trial .


However , encouraging results in this small study warrant a large multicenter trial of RIC in lung transplantation .


Medical nutritional therapy is important for glycemic control in children and adolescents with type 1 diabetes mellitus ( T1DM ) .


Carbohydrate ( carb ) counting , which is a more flexible nutritional method , has become popular in recent years .


This study aimed to investigate the effects of carb counting on metabolic control , body measurements and serum lipid levels in children and adolescents with T1DM .


T1DM patients aged 7-18 years and receiving flexible insulin therapy were divided into carb counting ( n = 52 ) and control ( n = 32 ) groups and were followed for 2 years in this randomized , controlled study .


Demographic characteristics , body measurements , insulin requirements , hemoglobin A1c ( HbA1c ) and serum lipid levels at baseline and at follow-up were evaluated .


There were no statistically significant differences between the groups in mean HbA1c values in the year preceding the study or in age , gender , duration of diabetes , puberty stage , total daily insulin dose , body mass index ( BMI ) standard deviation score ( SDS ) and serum lipid values .


While there were no differences in BMI SDS , daily insulin requirement , total cholesterol , low-density lipoprotein and triglyceride values between the two groups ( p > 0.05 ) during the follow-up , annual mean HbA1c levels of the 2nd year were significantly lower in the carb counting group ( p = 0.010 ) .


The mean values of high-density lipoprotein were also significantly higher in the first and 2nd years in the carb counting group ( p = 0.02 and p = 0.043 , respectively ) .


Carb counting may provide good metabolic control in children and adolescents with T1DM without causing any increase in weight or in insulin requirements .


To identify the effect of ulinastatin ( UTI ) administration on stress-induced hyperglycemia and acute insulin ( INS ) resistance experienced by patients undergoing partial hepatectomy .


Forty-six patients undergoing partial hepatectomy were assigned randomly to the control group ( group C ) or UTI treatment group ( group U ) .


Six cases underwent partial hepatectomy but were not eligible for inclusion .


The patients in group U had an intravenous infusion of a total amount of 5000 IU/kg UTI before the induction of anesthesia and at the start of surgery .


The patients in group C were given an identical volume of physiological saline in the same manner .


Blood samples for the measurement of interleukin-6 , cortisol , INS , and glucagon were obtained .


Fasting plasma glucose concentration was measured immediately before skin incision ( T1 ) , 20min after the liver lesion was removed ( T2 ) , at the end of surgery ( T3 ) , as well as on the first ( T4 ) and second mornings after partial hepatectomy ( T5 ) .


The insulin sensitivity index ( ISI ) was calculated at these time points .


The fasting plasma glucose concentration in group U was significantly lower than that in group C at all time points except for T1 .


In group U , the insulin sensitivity index was higher , and the levels of interleukin-6 , cortisol , and INS were lower than that in group C ( P < 0.05 ) .


The data suggest that UTI administration improves perioperative hyperglycemia by inhibiting the inflammatory reaction , as well as excessive release of inflammatory factors , and improves INS resistance .


To compare the efficacy of subtenon with peribulbar local anesthesia without hyaluronidase in patients undergoing cataract surgery .


A randomized controlled trial .


Eye `` B '' Unit , Khyber Teaching Hospital , Peshawar , from October 2009 to October 2010 .


Patients undergoing cataract surgery were divided into two groups .


Group A received subtenon anesthesia and group B received peribulbar anesthesia .


Pain score , akinesia and intraocular pressure were compared in the two groups .